Savara ($SVRA): What Has the Company Actually Filed Before November 22?

01 Executive answer: a second action date, a clean primary endpoint, and a public record with holes in it

Savara has one asset. MOLBREEVI, inhaled molgramostim, is under review at the FDA for autoimmune pulmonary alveolar proteinosis, a rare lung disease in which the patient’s own antibodies neutralise a growth factor the lung needs to clear surfactant, so surfactant accumulates in the alveoli and gas exchange degrades. There is no approved therapy for it anywhere in the world. The standard of care is whole lung lavage: the patient is anaesthetised and a lung is washed out.

The pivotal trial worked. IMPALA-2 randomised 164 patients across 43 sites in 16 countries and met its primary endpoint — a 6.0 percentage-point placebo-adjusted improvement in haemoglobin-adjusted per cent predicted DLCO at week 24, 95% confidence interval 2.5 to 9.4, p=0.0007, with a larger result at week 48. It is the largest placebo-controlled trial ever conducted in this disease, and the design was endorsed by the FDA, the EMA, the MHRA and Japan’s PMDA before it ran. The results were published in the New England Journal of Medicine in August 2025.

So the question is not whether the drug does something. It is what the agency will do on November 22, 2026, and that question is harder to answer from the public record than it should be, for three reasons.

One: this is the second action date, and the first application was refused

Savara completed a rolling submission on March 26, 2025 and received a refusal-to-file letter in May 2025. A refusal to file is not a rejection on the merits; it is the agency declining to begin a substantive review at all, and here it turned on chemistry, manufacturing and controls. After a Type A meeting Savara reached alignment with the agency on the comparability requirements between drug substance made by its original Argentine supplier and drug substance made by FUJIFILM Diosynth, and resubmitted in December 2025.

The first goal date on that resubmission was August 22, 2026. On April 15, 2026 the company announced that the FDA had deemed its responses to the agency’s information requests a major amendment, adding three months. November 22 is the extended date.

Two: the endpoint ledger is narrower than the summaries

Of the endpoints below the primary in the pre-specified testing hierarchy, exactly two more held. DLCO at week 48 (p=0.0008) and the St George’s Respiratory Questionnaire total score at week 24 (p=0.0072) met the threshold. The same questionnaire at week 48 missed — p=0.1046, with a confidence interval running from −10.76 to +1.01, which crosses zero, and three further secondaries also failed to reach significance: the activity sub-score at week 48 (p=0.1216), exercise capacity at week 24 (p=0.0845) and the alveolar-arterial oxygen difference at week 24 (p=0.1043), the same measure the predecessor trial was built on. Two results that are routinely quoted, the activity sub-score at week 24 and exercise capacity at week 48, are nominal only: the company itself says they did not meet the hierarchy threshold. The chest-CT ground-glass result and the disease-severity responder analyses are post-hoc, and the company says that too.

Three: the public record is unusually thin for a company this close to a decision

This is the finding that distinguishes Savara from almost any comparable file. Over the whole of 2026 the company has filed four Forms 8-K: a corporate slide deck, a loan amendment, an office lease and the annual meeting results. Only the first touches the application, and it does so as a Regulation FD furnishing of a presentation rather than as a disclosure of a regulatory event.

No 8-K for the FDA formally filing the application and granting priority review in February. None for the Day 74 letter in March saying no advisory committee is planned. None for the European validation, none for the British acceptance, and none for the extension of its own action date. None for either set of quarterly results — Savara has never furnished an Item 2.02 earnings 8-K in 2024, 2025 or 2026. All of it went out as press releases and then, in reduced form, into the next periodic report. The company is capable of filing one when it chooses: it filed an Item 8.01 8-K in May 2025 for the refusal-to-file letter.

The consequence for a reader is concrete. The annual report filed on March 13, 2026 contains the string “PDUFA” zero times, on the same day the company issued a press release announcing an August 22 PDUFA date. The action date exists on EDGAR in three documents: the proxy statement of April 24, 2026 and the two 2026 quarterly reports. And the most recent company-originated filing of any kind is dated August 11, 2026 — fifty-one days before this review, fifty-two days before the decision.

What the balance sheet will carry

$173.0 million of cash and investments at June 30, 2026 against operating cash use of $62.8 million in the half — about $10.5 million a month, or roughly sixteen and a half months on current spend, before any launch expenditure. No current debt maturity. No going-concern qualification anywhere in the filings — and no twelve-month sufficiency statement either. What Savara says instead is that it “has sufficient capital to fund many of its planned activities”. Many is not all, and it is not twelve months. The company has never published a runway date.

Against that, there is no at-the-market programme — the Evercore facility was terminated in April 2025 and never replaced — and the only shelf registration lapses around May 2027. If Savara needs equity after a bad outcome, the mechanics are a takedown off an ageing shelf or a new registration, not a quiet drip.

02 Autoimmune PAP, and what MOLBREEVI is

The biology here is unusually tidy, which is part of why the drug is credible.

Granulocyte-macrophage colony-stimulating factor, GM-CSF, is the signal that alveolar macrophages need in order to clear pulmonary surfactant from the air spaces. In autoimmune pulmonary alveolar proteinosis the patient develops autoantibodies that neutralise their own GM-CSF. The macrophages stop clearing surfactant, the alveoli fill with it, and gas exchange falls — which is why the trial’s primary endpoint is the diffusing capacity of the lung for carbon monoxide rather than a symptom score. Autoimmune disease accounts for roughly 90 per cent of all PAP.

MOLBREEVI is molgramostim, recombinant human GM-CSF, delivered as an inhaled biologic: 300 micrograms once daily, nebulised in about five minutes through a proprietary PARI eFlow system. The logic of inhalation is that it puts the growth factor where the autoantibody blockade has to be overcome — locally, in the lung — rather than flooding the circulation.

It is therefore a drug-device combination, which matters for the review: the device is licensed exclusively from PARI Pharma, the two companies hold a joint patent application on the combination, and PARI already has five FDA-approved nebulisers on the same platform.

The population, as the company sizes it

The 16.0 per million figure sits inside a wide published range rather than outside it, and it is what the “more than $2 billion” rests on. What matters is which denominator a reader uses, and how much of the spread is autoimmune PAP against all PAP. Section 16 returns to it.

The name is not final

“MOLBREEVI” has been conditionally accepted by the EMA (February 2024) and the FDA (May 2024). Conditional acceptance becomes final only at approval.

There is nothing else

The segment note in the quarterly report calls MOLBREEVI the company’s “sole pre-revenue development program”. That is the whole pipeline. The registry shows the historical programmes have been closed out: IMPALA-X, a Phase 3 safety extension, is terminated; ENCORE, in cystic fibrosis with non-tuberculous mycobacteria, is terminated; OPTIMA in NTM lung disease completed; AeroVanc, the Phase 3 inhaled vancomycin programme, completed and discontinued. The annual report’s business section describes no programme other than MOLBREEVI, and there is no clinical hold of any kind disclosed.

One paediatric study remains: IMPACT, an open-label single-arm trial in patients aged six to eighteen, with an estimated enrolment of five patients. The company describes it as a European and British paediatric-investigation-plan commitment rather than an FDA requirement; the registry lists a single site, in Munich. It is irrelevant to November 22. A dating trap sits in it: the annual report and both quarterly reports say the trial was “initiated in the second quarter of 2024”, which is when the contract-research work order was signed, while the registry records an actual study start of October 22, 2025.

03 The regulatory sequence, date by date

Read as a sequence rather than as a headline, the file is fourteen years of designations, one failed Phase 3, one successful Phase 3, one refusal to file and one extension.

What the refusal to file was, in the company’s words

That framing is accurate and it is also the company’s own. What it establishes is that the obstacle on this file has never been the clinical data; it has been the ability to demonstrate that the product can be made consistently at commercial scale by the manufacturers who will actually make it. Section 10 takes that apart.

The designations, complete

• FDA: orphan drug (2012), fast track (2019), breakthrough therapy (2019), priority review (granted February 2026 on the resubmission).
• EMA: orphan drug (2013), carrying ten years of market exclusivity on approval.
• MHRA: Innovation Passport (2022), Promising Innovative Medicine (2022), accelerated review of the application (2026).
• On approval, a biologic carries twelve years of United States exclusivity; the orphan designation carries seven.

Four absences, each checked

• There is no priority review voucher here. The strings “priority review voucher”, “PRV” and “rare pediatric” appear zero times in the annual report, and Savara has never claimed voucher eligibility. Autoimmune PAP is an adult-onset disease and the rare-paediatric pathway does not apply. Any valuation that adds a voucher to this file is adding something that does not exist.
• The “no advisory committee” fact is in a press release, not a filing. It comes from the Day 74 letter and is reported in the March 6, 2026 release. The only references to advisory committees in the annual report are generic descriptions of how a BLA review works. A Day 74 position is a plan, not a commitment, and it can change.
• No Form 483, no establishment inspection report, no pre-approval inspection status of any kind is disclosed anywhere. The annual report and both quarterly reports were searched for “Form 483”, “establishment inspection”, “pre-approval inspection” and “cGMP inspection”. The only hits are boilerplate about how the agency typically inspects facilities, and a GEMA milestone payable on completion of a mock pre-approval inspection. For an application that was refused on manufacturing grounds and resubmitted with a new drug-substance manufacturer, that is the single most important thing not on the record.
• What the information requests asked is nowhere stated. Neither the April announcement nor either quarterly report says what the agency wanted. Given that the refusal was manufacturing-driven and the resubmission changed the manufacturer, manufacturing is the obvious inference — but it is an inference, and this page marks it as one.

On Japan: the annual report notes that the PMDA endorsed the IMPALA-2 design, and that sargramostim — a different GM-CSF — was approved in Japan in April 2024 for autoimmune PAP. No Japanese filing for molgramostim is disclosed. The Japanese approval is worth knowing for a reader who assumes the disease has no approved therapy anywhere: it has none in the United States or Europe, which is what the company says, and it has one in Japan, which is a different molecule.

04 IMPALA-2, endpoint by endpoint

This is the trial the application rests on, and the honest version of it is neither the press-release version nor the sceptic’s version.

The design

Two things in that table are better than they look. A completion rate above 96 per cent in both arms of a 48-week trial in a severe lung disease is unusually high. And every patient who finished the double-blind phase elected to continue into the open-label phase — 160 entered it against 159 completers, the extra being a placebo patient who stopped blinded drug but stayed in the trial. That is not an efficacy result, but it is the kind of behaviour that does not happen when patients feel nothing.

The endpoint ledger

The first eight rows are as posted on the trial registry. The last three come from the company’s January 2026 presentation and are not in the registry’s results section; they are marked.

The company is scrupulous about the labels in its own materials: where a result is nominal it says the p-value “did not meet the p-value threshold required in the pre-specified hierarchical testing procedure”, and where an analysis is post-hoc it says so. The misrepresentation, where it happens, is downstream of the company.

How large is 6.0 points, really

The company offers a benchmark in its own presentation: “the minimal clinically important difference in change in DLCO is 10 per cent in progressive pulmonary fibrosis and 11 per cent in severe COPD,” against which MOLBREEVI showed roughly a 10 per cent increase at week 24 and 12 per cent at week 48.

There is a second, less-quoted fact that does the opposite — it makes the result more concrete. Seventeen patients, roughly ten per cent of the trial, underwent at least one whole lung lavage during the 48 weeks, which was permitted as rescue therapy. The arm split is not disclosed. For a disease whose only existing treatment is that procedure, how often it is avoided is the outcome a patient would care about, and the trial reports it only as “numerically favorable” with no p-value.

The predecessor, which failed

IMPALA, the Phase 2/3, missed its primary endpoint — the alveolar-arterial oxygen gradient at week 24 — and was published in the New England Journal of Medicine in September 2020. The annual report describes “multiple key secondary and exploratory endpoints that either achieved p values < 0.05 or trended in favor of the active drug arms” and does not name a single one of them or give a single value. Breakthrough therapy designation was granted on those data in December 2019, which tells you the agency saw something in them; the filings do not let a reader see it. A small discrepancy for completeness: the annual report says IMPALA enrolled 138 patients, the registry says 139.

05 The safety data, and the fact that they are not in any filing

IMPALA-2’s safety profile is the quietest good news on this file, and a reader cannot get at it from the documents Savara files with the SEC.

Serious adverse events were lower on drug than on placebo, there were no deaths in either arm, and exactly one serious event in the whole trial was assessed as possibly treatment-related: the investigator recorded an “SAE of delusions resulting in psychiatric hospitalization in patient with a past medical history of seizure disorder treated with levetiracetam”. That is a single event in a patient on an anticonvulsant with known neuropsychiatric effects.

The serious-event split by term is the clearest evidence of what the drug is doing. Alveolar proteinosis itself — the disease worsening — was recorded as a serious event in 3 patients on drug against 9 on placebo. On the presentation’s count of events above the 10 per cent threshold it is 4 against 12; on the registry’s combined basis, serious plus non-serious, it is 5 against 13. The direction is the same either way. Hypoxia: 1 against 3. For a trial whose primary endpoint is a lung-function measure, the safety table carrying the disease-progression signal in the same direction is a meaningful corroboration.

Where the drug looks worse

Three classes of event ran against MOLBREEVI, and a reader should hold them against a GM-CSF mechanism rather than dismiss them:

• Infections. COVID-19 18 (22%) against 8 (10%) on the presentation’s count; on the registry’s combined basis bronchitis runs 5 against 2 and pneumonia about 6 against 3, with urinary tract infection 4 against 1. The direction is consistent across several terms. Against that, serious infections were not elevated and the overall serious-event rate was lower on drug.
• Gastrointestinal and vestibular. Diarrhoea 9 (11%) against 2 (2%); nausea 6 against 2; vomiting 6 against 1; dizziness 7 against 2.
• Events of special interest. Chest pain and hypersensitivity, 9 (11%) against 6 (7%) — prospectively defined as of interest, and numerically higher on drug, though only one such event in the whole trial was serious, and that one was on placebo.

None of this is disqualifying. All of it is the kind of detail a label negotiation turns on, and none of it is in a document Savara filed.

Why the location of these numbers matters

The practical point is not that Savara is hiding anything — the data are public, posted and published in the New England Journal of Medicine. It is that the only complete version lives in a slide deck furnished under Regulation FD in January, whose own forward-looking-statements legend still points readers at the 2024 annual report and the September 2025 quarterly report. A furnished exhibit is expressly “not deemed filed”. The trial’s full efficacy table, the full safety table, the disposition flow, the fact that ten per cent of patients needed a rescue lavage, and the entire commercial case including the “more than $2 billion” market figure and the “$400,000 to $500,000” implied price all sit in that one exhibit and in no filed document.

One further wrinkle for anyone pulling this programmatically: the regulatory-timeline dates in that deck are rendered inside the slide images, not in the text. There is no machine-readable action date anywhere in the exhibit.

06 The company that does not file 8-Ks

This section exists because the pattern is unusual enough to be a fact about the investment rather than a technicality, and because every subsequent section depends on understanding where Savara’s information actually appears.

Savara filed four Forms 8-K between January 1 and October 1, 2026. Here they are, in full.

The first of those is a BLA document in substance: its exhibit carries the regulatory timeline, the statement that the application was submitted in December 2025, and the whole trial dataset. But it is furnished under Regulation FD as a presentation, not filed as a disclosure of a regulatory event. Now the list of things that happened in 2026 and were not filed or furnished on a Form 8-K at all:

• February 2026 — the FDA formally files the biologics licence application and grants priority review. This is the single most important regulatory milestone of the company’s year.
• March 6, 2026 — the Day 74 letter; no advisory committee planned.
• March 2026 — the EMA validates the European application.
• April 7, 2026 — the MHRA accepts the British application under accelerated review.
• April 15, 2026 — the FDA extends the review by three months and the action date moves to November 22.
• May 12 and August 11, 2026 — first-quarter and second-quarter results.

There is no Item 2.02 earnings 8-K anywhere in 2024, 2025 or 2026. Savara’s practice is to issue material regulatory and financial news as a press release and then fold a compressed version of it into the next periodic report. The practice is not absolute: the company filed an Item 8.01 8-K on May 27, 2025 announcing the refusal-to-file letter, with the press release as an exhibit. The bad news got an 8-K; the 2026 milestones did not.

This is not unlawful. Item 2.02 is triggered by a public announcement of results, and companies do furnish them; but a Form 8-K is required only for the enumerated events, and “the FDA extended our review” is not one of them unless the company concludes it is material under Item 8.01, which is itself discretionary. Plenty of issuers would have filed. Savara did not, and has not for three years.

What is buried where, for anyone trying to reconstruct the file

• The January slide deck holds the complete IMPALA-2 efficacy and safety tables, the disposition flow, the rescue-lavage count, the commercial sizing and the price assumption. None of it is in a filed document.
• The January loan amendment 8-K describes a facility of “up to an aggregate of $105 million” and does not say that the prior figure was $200 million. To learn that the capacity fell, a reader must go to the accounting note in the annual report, which says it did without giving a figure. The amendment itself was not attached; the 8-K promised it would appear with the annual report, and it did.
• The June annual-meeting 8-K carries, below the routine items, the announcement that the chief financial officer was resigning for health reasons — with his severance terms, a twelve-month equity acceleration, and a $200-an-hour consulting arrangement. There is no exhibit for any of it; it is in the body text.
• The same 8-K records that director Joseph McCracken drew 8,937,566 votes against his election — roughly three times the next-highest director and 5.6 per cent of the votes cast on him. No other filing mentions it.

And the silence since

The most recent company-originated filing of any kind is the quarterly report of August 11, 2026, filed alongside a Form S-8 registering the 18.9 million shares added to the equity plan. Since then Savara has filed no 8-K, no registration statement, no prospectus supplement and no amendment. The only EDGAR event under its number in seven weeks is a Form 4 of September 25 reporting shares withheld for tax.

Fifty-one days of filed silence, fifty-two days before the action date, and the most recent regulatory statement of any kind — the April extension announcement — is 169 days old. The second quarterly report’s regulatory overview repeats the first’s almost exactly, and is shorter: the first carried a subsequent-events block giving the British and European decision expectations, and the second drops it. Nothing has been added to the public record about this review since April 15.

07 Financial position, the burn, and the runway nobody states

Savara’s balance sheet is adequate. It is not comfortable, and the language the company uses about it is more carefully hedged than most readers notice.

One mechanical warning first: the financial statements are presented in thousands, the narrative discussion is in millions, and share counts are in whole shares. “Long-term debt 30,109” means $30.1 million. “Accumulated deficit (685,599)” means $685.6 million. Mixing the units is the easiest error on this file.

The investments are entirely United States government securities, Level 1, with cash equivalents held in Treasury money-market funds. There is no corporate credit, no commercial paper and no asset-backed paper on the sheet. That is a conservative treasury for a company at this stage and it is worth saying so.

The arresting line is general and administrative expense: up 78.2 per cent year on year in the quarter, from $10.7 million to $19.0 million. The company explains it as “$7.5 million of higher personnel costs, driven by increased stock-based compensation expense as well as increased headcount growth as we build out our commercial team ahead of and in support of our planned product launch, in addition to an increase of $0.8 million in certain commercial activities.”

Research and development rose only 5.8 per cent, and the composition is worth noting: personnel costs up $2.0 million on share-based compensation, partially offset by a fall of $0.2 million in chemistry, manufacturing and controls costs and $0.6 million less in regulatory and quality consulting. For a company whose application was refused on manufacturing grounds, manufacturing spend going down is either confidence or a timing artefact, and the filing does not say which.

The burn, and why the loss overstates it

Operating cash use of $62.8 million in six months is about $10.5 million a month, or $31.4 million a quarter. The reported net loss of $77.5 million runs $14.7 million ahead of that, mostly because $18.5 million of half-year expense was non-cash share-based compensation — 3.3 times the $5.6 million of a year earlier — partly offset by working-capital movements and investment accretion.

On $173.0 million at June 30 and $10.5 million a month, the arithmetic gives roughly sixteen and a half months — into about mid-November 2027 — before any launch expenditure, and before the contingent capital described below. That calculation is this page’s, not the company’s.

The sufficiency language, which is not the usual sufficiency language

There is no going-concern qualification and no substantial-doubt language: the strings do not appear in the annual report or in either quarterly report, and the auditor’s report carries no explanatory paragraph. But the standard comfort sentence is also missing. What the liquidity note says, verbatim, is:

“Many of its planned activities” is not “all”, and it is not “for at least twelve months from the issuance date of these financial statements” — the formulation almost every development-stage company uses. Savara has never published a cash-runway date in any filing. The nearest it came was a chief executive’s remark in November 2025 that recent financings “significantly increase our cash runway”; that phrase does not appear in any 2026 document.

Three items that are easy to miss

• A Danish research tax credit: Denmark remits 22 per cent of qualifying spend through the Danish subsidiary. The 2025 credit of $0.9 million is expected in the fourth quarter of 2026; the half-year 2026 credit of $0.8 million not until the fourth quarter of 2027.
• A royalty derivative liability of $385,000 relating to the RTW agreement, carried inside accrued expenses rather than on its own line. The inputs moved oddly between periods: at December 31 the company assessed “a 20% probability that a change of control would occur prior to the closing date… and a 50% probability that the purchaser would exercise its right to the prepayment”; at June 30 it assessed “a remote probability that a Change of Control would occur” while stating that “the probability of repayment… was unchanged since December 31, 2025”. The two statements sit uneasily together.
• Subsequent events: none. The second-quarter report, filed August 11, states that the company “determined there were no events that required disclosure or recognition”.

08 The debt facility that got smaller, and the lien that got bigger

On January 27, 2026 Savara filed a Form 8-K under Items 1.01 and 2.03 announcing an amendment to its Hercules Capital loan agreement. The company’s own press-release headline read: “Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon FDA Approval”.

Here is what the amendment did.

The covenant relief is genuine and matters. Two covenants are keyed to market capitalisation rather than to operations:

• The cash requirement — maintain unrestricted cash equal to 50 per cent of outstanding principal, rising to 70 per cent if the approval milestone has not been achieved — does not apply in any period when market capitalisation exceeds $600 million.
• The conditional minimum revenue covenant, which bites only above $50 million drawn, does not apply while market capitalisation exceeds $500 million and cash covers half the principal.

At the September 30 close, on either share-count basis, Savara sits well clear of both thresholds. For the $600 million trigger to come into play the shares would have to fall to roughly $2.92 on the 205.5 million shares outstanding, or about $2.36 on the 254.1 million base most vendors publish. That is a long way down — but it is the kind of level a single-asset biotech can reach on a refusal, and it is why the covenant structure belongs in a risk section rather than a footnote.

The terms as they stand

• Maturity April 1, 2030. Floating rate: the greater of the prime rate or 6.0 per cent, plus 1.45 per cent.
• Interest-only through March 2028, then equal monthly principal and interest — but if the approval milestone is achieved, interest-only extends all the way to maturity.
• An end-of-term charge on outstanding principal that escalates with time: 3.95 per cent within 24 months of closing, rising to 6.95 per cent after 48 months. Two terms run the other way: the rate steps down 25 basis points on the revenue milestone, and the cash covenant falls from 50 to 35 per cent on the same milestone.
• Carrying value at June 30: total future minimum payments $32.1 million, less an unamortised end-of-term charge of $1.6 million and $0.4 million of fees, giving $30.1 million, all long-term, with no current portion. First scheduled payment is in 2028.

The $150 million that is not available

Savara has repeated the same phrase in March, May and August 2026: access to “up to an additional ~$150 million in non-dilutive capital” on FDA approval. It is two pieces, and both are conditional.

• $75 million from RTW Investments, under a royalty purchase agreement signed October 29, 2025. It is payable only on FDA approval on or before March 31, 2027. In exchange RTW buys a tiered United States royalty running from 7.0 per cent down to 1.0 per cent, with the top tier stepping up to 9.5 per cent in any year where the prior year’s sales miss a specified level, capped at a $187.5 million maximum payment — 2.5 times the purchase price. Savara “expects the effective royalty rate over the life of the Purchase Agreement will be in the low-single digits”, which is a company projection, not a term. And a portion of the money must be used to repay outstanding debt unless the lenders agree otherwise.
• Up to $75 million from Hercules, in the two post-approval tranches above, with a June 30, 2027 outside date.

The figure stayed at $150 million through three quarters while its composition changed underneath it: before the January amendment the Hercules portion was $80 million on fixed calendar dates; afterwards it is $75 million on clocks that only start when an approval arrives. And the March 31, 2027 long-stop on the RTW money is the hard edge. A decision on November 22 leaves about four months of slack. A complete response letter followed by a six-month Class 2 resubmission would consume all of it, and the filings do not discuss what happens then.

09 Capital structure, and the 48.6 million warrants that decide the market cap

There is a single fact on this file that determines whether you think Savara is worth a billion dollars or a third more than that, and most coverage never states it.

The honest statement is the one with both numbers in it. The third row is built on the June 30 share count plus the 67,878,126 shares reserved for issuance, and it excludes the 4,562,000 performance units, which the filing discloses separately. The four tranches are legacy financing instruments: 32,175,172 from 2021, 7,142,857 from the October 2025 offering, 5,666,667 from 2023 and 3,615,516 from a private placement. None moved between December 31, 2025 and June 30, 2026. There are also 77,793 ordinary warrants at $2.87 expiring between 2027 and 2028 — immaterial.

Share count, and how little it has moved in 2026

The count grew 18.6 per cent through 2025 and 0.4 per cent in the first half of 2026 — the 2026 movement is option exercises and vesting, nothing else. No stock has been sold this year.

How the 2025 money was raised

• October 2025 underwritten offering, closed October 31: 28,452,381 shares including the full exercise of the underwriters’ option, at $4.20, plus pre-funded warrants for 7,142,857 shares at $4.199 each. Gross $149.5 million, net about $140.2 million.
• July 2024 underwritten offering: 26,246,720 shares at $3.81, gross $100.0 million, net $93.8 million.
• During 2024, 6,038,650 shares were sold under the at-the-market programme to a single institutional investor for $24.4 million.

Both underwritten offerings were priced below the current share price, which is unusual and worth noting. Cumulatively, Savara had raised net cash proceeds of approximately $738.1 million since inception as of December 31, 2025, against an accumulated deficit of $685.6 million at June 30, 2026 — two different dates, but close enough to show that essentially everything raised has been spent.

There is no at-the-market programme, and the shelf is ageing

This is the part of the capital structure most likely to be assumed rather than checked.

• The $100 million Evercore sales agreement was terminated by Savara effective April 2, 2025, with no penalty. No shares were sold under it during 2025, and it has not been replaced. There is no at-the-market capacity of any kind.
• The only shelf is Form S-3 File No. 333-279274, filed May 9, 2024 and effective May 21, 2024, for $400 million. Against it Savara has taken down $100.0 million (July 2024) and $149.5 million (October 2025), so roughly $150.5 million of nominal capacity remains — a figure the company states nowhere; it is arithmetic. A Form S-3 is effective for three years, so this shelf lapses around May 21, 2027 and no replacement has been filed.

If the November decision goes badly and Savara needs equity, the mechanics are a marketed takedown off a shelf with about seven and a half months left on it, or a new registration. There is no quiet drip available.

The equity plan, and the awards that depend on an approval

Two features are unusual and both cut in the shareholder’s favour relative to the sector. There is no evergreen provision, and the proxy says so in terms: “No Evergreen Provision. The 2024 Plan does not contain an automatic provision to replenish the shares of common stock authorized for issuance.” Adding shares requires a shareholder vote, which is why the 18,900,000-share increase went to a proposal at the June 2026 annual meeting (156.7 million for, 2.3 million against) and was registered on a Form S-8 in August. And authorised common stock was raised from 300 million to 600 million effective June 4, 2026, so unlike many peers Savara has no authorised-share ceiling problem at all.

The performance units are the item to watch. 4,562,000 units vest on conditions that include FDA approval of the application, EMA approval, a revenue target, or a combination; the annual report describes 225,000 units requiring approval on or before a date it does not disclose, a detail the June quarterly report drops. Savara deems the conditions probable and is expensing them, which is what drove share-based compensation from $5.6 million to $18.5 million year on year. Unrecognised cost on unvested units stood at $18.6 million over a weighted-average 0.8 years at June 30.

Who owns it, and the footnote that changes the table

One more caution. All six Schedule 13G filings made in 2026 carry an event date of December 31, 2025. None reports a position taken during 2026. There were no Schedule 13D filings and no 13D amendments in 2026 at all. Nantahala’s February filing reports 7,344,783 shares, 3.61 per cent — a drop below the five per cent threshold rather than an exit. Whatever these holders have done with their positions during the review, the beneficial-ownership record does not show it.

10 Manufacturing: the reason the first application was refused, and the thing still not disclosed

Every other section of this page describes something a reader can check. This one describes the opposite: the part of the file that decided the May 2025 refusal, that almost certainly drove the information requests behind the April 2026 extension, and about which the filings say nothing at all.

Who makes what

What the refusal to file actually was

The application Savara submitted in March 2025 was built on material made by GEMA in Argentina — the supplier that made the trial drug. The commercial supplier was to be Fujifilm. A refusal to file on chemistry, manufacturing and controls grounds in that configuration almost always means the same thing: the agency was not satisfied it could establish that the commercial material is the same as the material that generated the clinical data. The annual report confirms the shape of it — after a Type A meeting, Savara reached alignment with the FDA “on the comparability requirements between GEMA-made and Fujifilm-made drug substance” — and the December resubmission went in with Fujifilm as the manufacturer.

One number sits oddly alongside this. The Fujifilm total estimated accumulated fees rose from $46.3 million to $57.1 million in a single quarter — a $10.8 million increase the management discussion does not explain — in the same quarter in which it reports that chemistry, manufacturing and controls costs fell by $0.2 million year on year. Those two facts are not contradictory (one is a cumulative contractual estimate, the other a period expense), but a reader should notice that commercial-scale manufacturing commitments are growing while reported manufacturing spend is flat.

The concentration risk, stated plainly

One commercial drug-substance manufacturer, with the original Argentine supplier retained as a possible second source the company says it “may decide to use” after approval. One drug-product site with no qualified alternative. One device partner holding the exclusive licence to the nebuliser the product is delivered through. And a contractual obligation to keep buying a share of the drug substance from a supplier in Argentina for ten years after approval, at a low-single-digit royalty, regardless of what Fujifilm can do. Each link is single-threaded, and the one that already failed is the one the agency is still reviewing.

11 The royalty stack, and what approval actually pays Savara

MOLBREEVI, if approved, is not a wholly-owned product in economic terms. Three separate royalty claims sit on United States net sales, with a fourth claimant taking interest and security rather than sales, and the filings never aggregate them.

In the early years after launch, the combined royalty burden on United States sales is 3.5 per cent to PARI plus low single digits to GEMA plus the 7.0 to 9.5 per cent top RTW tier. Savara’s own characterisation — that it “expects the effective royalty rate over the life of the Purchase Agreement will be in the low-single digits” — is true over the whole life of the agreement, because the tiers step down steeply and the payment is capped. It is not true of the first years, which are the years that determine whether the company funds itself from product revenue or goes back to the market.

The RTW structure deserves one more sentence, because it is a true sale of a royalty rather than a loan, and the economics are asymmetric by design: Savara receives $75 million and may pay up to $187.5 million, with the rate rising if sales disappoint. That is a rational structure for a buyer taking approval risk. It is also a structure that costs more precisely in the scenario where Savara can least afford it.

12 The litigation that the latest filing does not mention

Read the second-quarter report in isolation and Savara has never been sued. Part II, Item 1 says, in full: “From time to time, we may become involved in various claims and legal proceedings… We are not currently a party to any material pending litigation or other material legal proceeding.” Nothing else.

That is accurate as of the filing date, and it is also the first Savara document in a year not to describe what happened.

The disclosure pattern is worth recording because it repeats the one in section 06. The annual report and the first-quarter report both carry the sentence “we are not currently a party to any material pending litigation” immediately followed by a full description of all three cases and their dismissals. In the second-quarter report the sentence stands alone and the cases have disappeared. Nothing improper has happened — the cases are over — but a reader who starts with the most recent filing will not know that a securities class action over the company’s regulatory statements was ever brought.

No docket numbers appear in any Savara filing; all three cases are identified by caption and court only.

13 Ownership, float, and a short position that has risen every single reporting period

The most informative number on this file is not the price. It is the short interest, and specifically its shape.

How large it is depends on the denominator, which is the same problem as section 09:

• 33.4 per cent of a 129.73 million free float — and 42.1 per cent of the 103.06 million float a different widely-used provider reports. The two providers differ by a quarter on the float itself, and this page reports both rather than choosing.
• 21.1 per cent of the 205.46 million shares actually outstanding
• 17.1 per cent of the 254.14 million base most vendors publish

Short interest is reported semi-monthly and published with a lag, so the September 15 settlement date is the right date to quote — the position at the September 30 close is not knowable. The float is small relative to the share count because the strategic and venture holders — Bain, New Enterprise Associates, Venrock, Farallon, Deerfield, TCG Crossover, BlackRock — hold a large block between them, and because the 48.6 million pre-funded warrants are not float.

The September 30 session

A 3.4-times volume day on a 1.57 per cent move is an outlier in participation without a corresponding move in price — worth noting, not worth building on.

The beta deserves a caveat rather than a citation. A single-asset biotech fifty-two days from a binary regulatory decision, with a third of its float sold short, does not carry one-fifth of the market’s risk. A beta of 0.20 says that this stock’s moves are uncorrelated with the index, not that they are small. It is a statistical artefact of idiosyncrasy, and treating it as a risk measure here would be a category error.

The shape is the point. Up 44.5 per cent over twelve months, down 16.2 per cent in the quarter and down 14.4 per cent year to date. The twelve-month gain reflects a low base — the stock closed at $3.57 on September 30, 2025, a month before the October financing priced at $4.20. The de-rating is more recent than the extension: the shares fell to $4.85 by late April, then rallied to $6.38 by July 8 before rolling over. The slide dates from July, not from April.

The analysts

Coverage is small and unanimous, and the two vendor datasets do not agree on who the analysts are — which is itself worth knowing before quoting a consensus.

One dataset lists five brokers with a mean of $11.20 and a range of $9 to $16; another lists eight analysts with an average of $10.94 and a median of $10.25. Both report a consensus with no Hold and no Sell, though only five of the eight are individually visible. All five dated actions fall between August 12 and August 26, immediately after the second-quarter report, and none has been revised since.

Take that for what it is. Every published target is above the $5.16 close, by between 74 and 210 per cent, and published sell-side coverage of a single-asset pre-approval biotech is a probability-weighted view of one outcome. The useful observation is not the size of the gap but the asymmetry of positioning: the entire published analyst community is on one side of November 22, and a third of the float is on the other.

14 Retail attention, and the absence of a sentiment reading

Retail interest in $SVRA is substantial but quieter than the short interest would suggest.

The absence of a published bullish-or-bearish score is reported here rather than substituted for. Where a comparable name heading into a binary date would typically carry a sentiment reading in the seventies with ninety per cent of tagged messages on one side, $SVRA has a watchlist in the low twenty-thousands and no score at all. That is consistent with a stock held more by institutions than by a retail crowd — institutional ownership is 58 per cent — and with a story that is harder to compress into a message board post than a gene-therapy or obesity file.

One asymmetry is worth naming even without a sentiment score. Message volume has fallen roughly a fifth over the past month while short interest rose to its highest reading of the year. Retail attention drifting away as professional positioning concentrates is a specific pattern, and it is the opposite of the one that precedes a retail-driven squeeze. It says nothing about which side is right.

15 Management, incentives, and an insider record of one sale and no purchases

2026 is an unusually quiet year on Savara’s Form 4 record, and the few transactions in it are concentrated in one person.

Five Form 4 filings in all of 2026, by four reporting persons. No Forms 3 and no Forms 5. For contrast, December 2025 alone produced fourteen, the annual grant cycle.

The one sale

On June 22, 2026, David Lowrance, then chief financial and administrative officer, exercised six option tranches at strikes between $1.11 and $4.45, had 185,659 shares withheld for tax at $5.50, and sold 394,528 shares at a weighted-average $5.6813, with the footnote recording a range of $5.54 to $5.78. Gross proceeds about $2.24 million. His ending holding was 536,032 shares — exactly where the March exercises had left him. He had held 286,045 before those, so across the two filings he took his position from 286,045 to 536,032 and converted the June tranche entirely into cash.

Three facts sit around that transaction and they should be stated together, without being welded into an inference:

• The Form 8-K disclosing that Lowrance would resign “due to health reasons” was filed on June 8, 2026, with the board having acted on June 5. The sale was fourteen days later.
• The second-quarter report states, in Item 5(c): “During the quarter ended June 30, 2026, no officer or director of the Company adopted or terminated any contract, instruction, or written plan” intended to satisfy Rule 10b5-1. The first-quarter report says the same for its quarter. The Form 4 checkbox for a plan transaction is not ticked, the footnotes reference no plan, and the Form 144 describes the acquisition as a “Cashless Stock Option Exercise” through Raymond James.
• That is an absence of disclosure, not proof of absence. The Item 5(c) language covers adoption or termination in the quarter; a plan adopted earlier would not appear there. No document in the file says there was a plan, and no document says there was not.

Lowrance’s departure terms are in the June 8-K and are not small: severance under his employment agreement, twelve months’ acceleration of unvested equity, and a consulting arrangement at $200 an hour terminable on thirty days’ notice, filed as an exhibit to the second-quarter report.

The rest of the record

Matthew Pauls, chairman and chief executive, filed no Form 4 in 2026. Nor did any other director or officer beyond the four above. Lutz’s option strike of $5.81 is the closing price on July 15, 2026, which is how the exercise price was set: the incoming chief financial officer’s options are under water against the $5.16 close.

Governance: one result at the annual meeting

The meeting of June 4, 2026 passed everything — six directors elected, the authorised-share increase approved, the plan amendment approved, auditors ratified, say-on-pay approved. One number in the routine Item 5.07 is not routine.

The board’s own holdings are modest. All twelve executive officers and directors together held 10,854,054 shares, 5.30 per cent, as of April 6, 2026 — the chief executive 3,541,002 of them.

16 The commercial case, and the two numbers it rests on

This is where the file is most often read too generously and too harshly at once, and the published literature settles more of it than the filings do.

What the drug is competing against, in practice

The company’s framing is that autoimmune PAP has no approved therapy in the United States or Europe. That is true, and it is not the whole picture.

The standard of care is whole lung lavage: general anaesthesia, single-lung ventilation, warmed saline instilled and drained in staged sessions. It works, and it does not last. A two-centre protocol paper describes the recurrence pattern directly (published online in October 2025, in the bound 2026 volume): about one-third of patients require a repeat lavage within two to three years, and the same authors now treat inhaled GM-CSF as the standard adjunct — Ataya et al., Chest, 2025. A systematic review across 50 reports and 2,855 patients records progressive hypoxaemia, reduced exercise capacity, reduced quality of life, an increased rate of serious infections, frequent misdiagnosis, and medical costs higher than for matched non-PAP controls — McCarthy et al., European Respiratory Review, 2026. One disclosure belongs with that citation: the author list includes an employee of Savara, so it is not an arm’s-length source.

That is the counterfactual an FDA reviewer is weighing a 6.0-point DLCO gain against. It is a strong one.

That matters in two directions and both belong on the page. It raises the probability of approval, because the mechanism is already endorsed by the specialist community and the agency is not being asked to accept something novel. And it complicates the pricing assumption, because a physician who already reaches for nebulised sargramostim has to be persuaded to move to a branded product at the company’s implied price.

The effect size, corroborated from outside the trial

IMPALA-2’s 6.0-point placebo-adjusted DLCO improvement does not stand alone. A systematic review and meta-analysis of nebulised GM-CSF in autoimmune PAP found a pooled improvement in per cent predicted DLCO of 5.09 points (95% CI 2.05 to 8.13, p=0.001), alongside a St George’s questionnaire improvement of 8.09 points and a reduction in the alveolar-arterial gradient, with minimal heterogeneity and no serious treatment-related events — Munsif et al., European Respiratory Review, 2023. Savara’s 6.0 points sits just above that pooled estimate. One qualification matters and is rarely made: of the three trials pooled, one is Savara’s own IMPALA — the study that missed its primary endpoint — so the corroboration is partial rather than wholly independent. The other two are sargramostim and a Chinese biosimilar, and the consistency across three different molecules is still the most useful thing in the comparison.

And on the outcome that would actually matter to a patient — avoiding the procedure — a 30-month randomised study of whole lung lavage followed by inhaled sargramostim found that seven of nine control patients (78 per cent) needed a rescue lavage against one of nine on GM-CSF (11 per cent), with time to first rescue lavage longer on treatment — 30 months against 18 for controls (p=0.0078) — Campo et al., European Respiratory Journal, 2024. IMPALA-2 reported its own lavage outcome only as “numerically favorable”, with no p-value and no arm split, even though ten per cent of its patients had one. The external evidence is stronger on this endpoint than Savara’s own trial is.

The two numbers the commercial case rests on

Both inputs are defensible and both are at the generous end. A claims-based prevalence figure can legitimately exceed a registry figure, because claims capture diagnosed patients the registries miss, and the company’s own slide carries a published estimate well above its 16.0. The caution is narrower than “the number is too high”: the “more than $2 billion” headline is the product of a patient number at the upper end of a wide range and a price assumption with no disclosed basis, multiplied together. Halve the prevalence and the market is about $1 billion; halve the price as well and it is around $500 million — against a current equity value of $1.06 to $1.31 billion. None of those numbers is a forecast; they are the arithmetic of the company’s own slide, run with the company’s own annual-report prevalence instead.

What makes the commercial model work at any of those levels is the distribution: an “exclusive pharmacy network” and a “small customer facing footprint”, in the company’s words, reaching a few thousand patients concentrated in specialist centres. That is a genuinely low-cost launch if it works — and it is also the model that makes the general and administrative line, up 78 per cent on commercial build-out ahead of an approval that has not arrived, worth watching.

17 The catalyst map

Dated events first, then the ones with a window rather than a date. Everything here is sourced to a filing or a company release; nothing is a forecast of outcome.

Undated but live

• Any disclosure of inspection status. No Form 483, establishment inspection report or pre-approval inspection outcome appears anywhere in the filings, for an application refused once on manufacturing grounds and resubmitted with a new drug-substance manufacturer.
• Any description of what the April information requests asked. The extension announcement gave none, and neither quarterly report has added one since.
• A Form 8-K about the review. Savara has not filed one in 2026 for any regulatory event, though it filed one in May 2025 for the refusal-to-file letter. Breaking the 2026 pattern would itself be information.
• A refiling of the securities class action. Ho v. Savara was dismissed without prejudice in February 2026 and can be brought again.
• Qualification of a second drug-product source, which the company says it plans to do “following commercialization”.
• The paediatric trial, IMPACT, a five-patient European and British obligation with primary completion estimated in June 2027. Not an FDA requirement and not relevant to November.
• The IMPALA-2 open-label phase, running to an estimated completion of May 30, 2027, in which all 160 double-blind completers are receiving drug. Long-term data from it would be the next substantive clinical disclosure.

18 Red flags

These are the items on this file a reader should weigh deliberately rather than discover late. Each is sourced; none is a prediction.

1. This is the second action date, and the first application was refused for filing. A rolling submission completed in March 2025 drew a refusal-to-file letter in May 2025 on chemistry, manufacturing and controls. The resubmission went in that December with a different drug-substance manufacturer. November 22 is a three-month extension of the resubmission’s August 22 goal date.
2. No inspection status is disclosed anywhere. No Form 483, no establishment inspection report, no pre-approval inspection outcome, for an application whose only previous obstacle was manufacturing, with one commercial drug-substance maker and one drug-product site that has no qualified second source.
3. What the FDA asked in its information requests has never been described, by the April announcement or by either quarterly report. The extension is the single most important regulatory event of the year and the public record contains one sentence about it.
4. Savara filed no Form 8-K for any regulatory event of 2026 — not for the filing acceptance and priority review, not for the Day 74 letter, not for the European or British filings, not for the extension, not for either set of results. There has been no Item 2.02 earnings 8-K since at least 2024. It did file one in May 2025 for the refusal-to-file letter, so the practice is selective rather than absolute.
5. Fifty-one days of filed silence. The most recent company-originated filing of any kind is dated August 11, 2026. The only EDGAR event since is a third party’s tax-withholding Form 4 on September 25.
6. The annual report does not contain the action date. The string “PDUFA” appears zero times in the 2025 annual report, filed on the same day as a press release announcing an August 22 action date. The November 22 date reaches EDGAR only in the proxy statement of April 24 and the two quarterly reports.
7. The endpoint ledger is narrower than the summaries. Three endpoints met the pre-specified hierarchy. The week-48 quality-of-life endpoint missed at p=0.1046 with an interval crossing zero, and three more secondaries missed outright, including the alveolar-arterial oxygen difference at p=0.1043, the measure the predecessor trial failed on. Two further results are nominal only and two more are post-hoc, and the company labels them as such.
8. The “no advisory committee” fact is in a press release, not a filing, and a Day 74 position is a plan that can change.
9. Arm-level safety appears in no SEC filing. The complete tables exist only on ClinicalTrials.gov and in a slide deck furnished under Regulation FD, which is expressly not deemed filed.
10. The debt facility was cut from $200 million to $105 million in January, which the accounting note calls “a decrease in the borrowing capacity” while the company’s headline called it additional funding — and in the same amendment the lenders took a first-priority lien on the intellectual property that had previously been unencumbered, reverting to a negative pledge only if Savara walks away from the RTW agreement while holding $50 million or more of cash.
11. The “$150 million of non-dilutive capital” is entirely contingent, and $75 million of it expires if approval has not arrived by March 31, 2027. Part of it must be used to repay debt. It is not available cash.
12. There is no twelve-month sufficiency statement. The company says it has “sufficient capital to fund many of its planned activities” and has never published a cash-runway date. There is no going-concern qualification either.
13. There is no at-the-market programme — the Evercore facility was terminated in April 2025 and never replaced — and the only shelf lapses around May 2027 with no replacement filed.
14. $18.5 million of half-year expense is share-based compensation, 3.3 times the prior year, driven by performance units whose conditions the company has deemed probable and which include FDA approval among them. Forfeiture triggers a cumulative reversal that would flatter a future quarter’s loss while nothing improves.
15. A securities class action over the company’s regulatory statements was dismissed without prejudice, not on the merits, and is not described in the most recent filing at all. The class period ran from the original submission to the announcement of the refusal.
16. Short interest rose for ten consecutive reporting periods into the date, from 27.6 million shares at the April 30 settlement to 43.3 million at September 15 — 33.4 per cent of the float on one provider’s figure, 42.1 per cent on another’s — with days to cover almost tripling since June.
17. Every published analyst rating is a Buy, with no Hold and no Sell, and no target has been revised since late August. Unanimity on one side of a binary is a positioning fact, not a validation.
18. The market capitalisation is $1.06 billion or $1.31 billion depending on whether 48.6 million pre-funded warrants are counted, and the company itself counts them in basic earnings per share.
19. Single asset. The segment note calls MOLBREEVI the company’s “sole pre-revenue development program”. Every historical programme is terminated or completed and discontinued.
20. The commercial sizing rests on a claims-based prevalence figure of 16.0 per million, against 6 to 7 per million for all PAP in the company’s own annual report and a published range on its own slide running from 6.2 to 26.6, multiplied by a stated price of $400,000 to $500,000 whose basis is not given. All of it sits in a presentation furnished under Regulation FD, not in a filed document.
21. A royalty stack the filings never aggregate: 3.5 per cent to PARI, low single digits to GEMA and a top RTW tier of 7.0 per cent, rising to 9.5 per cent in any year after sales miss a specified level, plus a ten-year obligation to keep buying drug substance from the original Argentine supplier.
22. A director drew 8,937,566 votes against his election at the June annual meeting, roughly three times the next-highest, with no company comment and no mention in any other filing.

19 What to watch, in order

1. Any filing at all before November 22. Savara has been silent on EDGAR for fifty-one days and has filed no 8-K for any regulatory event this year. One appearing before the date — on any subject — would break the 2026 pattern, and the subject would tell you a great deal.
2. The November 22 outcome, and its exact form. Three outcomes are materially different and are routinely collapsed into two: approval; a complete response letter; or an approval with post-marketing commitments, a narrower label or a restricted distribution requirement. For a drug-device combination with a single unqualified drug-product site, the third is not remote.
3. The British decision, expected in the fourth quarter. It could land before or after the American one. A first approval anywhere would be a genuine de-risking event, and a British refusal ahead of November 22 would be the reverse.
4. Whether any inspection news ever surfaces. The absence of disclosed inspection status is the largest single hole in the public record here. The third-quarter report is the next opportunity to fill it.
5. The performance-unit probability assessment in the third-quarter report. Savara has deemed the performance conditions “probable” for accounting purposes and is expensing 4,562,000 units accordingly. If that assessment changes before the date, it changes in a filing, and it would be management’s own revised view of its odds.
6. Any equity raise. With no at-the-market programme and a shelf lapsing in May 2027, a raise would have to be a marketed takedown — visible, dated and priced. Its absence before the decision is itself a signal about management’s confidence; its arrival after one would say the opposite.
7. Any insider purchase. Nine months, five filings, zero code-P transactions, and the chief executive has not filed a Form 4 all year. The first open-market purchase would be the cheapest signal available on this file.
8. The next short-interest report. Ten consecutive increases into the date. Whether the seventh continues the run, or the position starts to come off ahead of the decision, is the clearest read on how the professional side is positioning.

20 Bottom line

Savara arrives at November 22, 2026 with a drug that works, in a disease that has nothing, and a public record that does not let a reader assess the one thing that will decide the outcome.

The positive case is strong and does not need charity. IMPALA-2 is the largest placebo-controlled trial ever conducted in autoimmune pulmonary alveolar proteinosis; it met its primary endpoint with a 6.0 percentage-point placebo-adjusted improvement in DLCO at week 24, p=0.0007, and the two endpoints immediately below it; it was published in the New England Journal of Medicine; and its effect size sits just above the 5.09-point pooled improvement found in a meta-analysis of nebulised GM-CSF trials — though one of the three pooled trials is Savara’s own earlier study, so the corroboration is partial rather than wholly external. Serious adverse events were lower on drug than on placebo, there were no deaths, and every single patient who completed the double-blind phase chose to continue. The mechanism is already first-line in the international guidelines. The FDA has granted priority review and says it does not plan an advisory committee. The balance sheet carries $173.0 million with no current debt maturity.

The negative case is not about the drug. It is about everything around it. The first application was refused for filing on manufacturing grounds, and whether the manufacturing problem has been resolved is the one question that matters — and the filings contain no inspection status of any kind, no description of what the FDA asked in the information requests that produced the three-month extension, and no Form 8-K about any of it. The company has not filed anything in fifty-one days. Its annual report does not contain the action date. Its debt facility was cut by $95 million in January while the lenders took a lien on its patents. Its $150 million of post-approval capital is contingent and partly expires in March 2027. Its commercial sizing rests on a prevalence figure double the one in its own annual report. A third of its float is sold short and the position has risen every reporting period since April.

What the two cases share is that the public record does not separate them. The clinical question looks answered. The manufacturing question — the only one that has ever stopped this application — is unanswerable from the outside, because Savara has chosen a disclosure practice in which regulatory news goes out as a press release and arrives on EDGAR, in compressed form, a quarter later. Every published analyst is positioned for approval; a third of the float is positioned against it; and both are working from the same documents, which do not contain the answer.

That is the honest shape of it: a credible drug in an indication with real unmet need, a company whose last substantive disclosure is seven weeks old, a decision fifty-two days out, and a market split down the middle on information neither side has.

This page is informational and educational. It is not investment advice, not a recommendation to buy or sell any security, and not a solicitation. Nothing here is personalised to any reader’s circumstances. Figures are as filed or as of the stated date and may change. Readers should do their own research and consult a licensed financial adviser before any decision.