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Biotech Catalysts, Stock Hubs & U.S. Small/Mid-Cap Research

Merlintrader publishes independent educational research on U.S.-listed biotech and small- and mid-cap stocks, with daily market briefings, FDA and PDUFA tracking, catalyst calendars and dedicated company hubs across biotech, space, defense, AI, cannabis, energy and critical minerals.

THURSDAY MORNING — AUGUST 27, 2026

Nvidia guided to 108 billion dollars for the current quarter, and the American session that preceded it had gone precisely nowhere

The largest single earnings report of the quarter landed after Wednesday’s close and it was bigger than the number the market had been waiting for, on the quarter just finished and on the one now running. The regular session that led into it produced almost no movement at all: the four index proxies finished within two tenths of a percentage point of Tuesday, and the stock itself closed lower on the day before the release. Overnight the reaction has been narrower than the headline suggests, with Asia mixed and American futures higher but not dramatically so. All American figures below are official Wednesday closes unless stated otherwise; overnight and futures marks are timed and labelled where they appear.

NVIDIA, THE NUMBERS
  • $NVDA reported second-quarter fiscal 2027 revenue of 96.221 billion dollars for the quarter ended July 26, up 18 percent from the previous quarter and 106 percent from a year earlier. GAAP and non-GAAP gross margins were both 75.0 percent. GAAP diluted earnings were 2.46 dollars per share and non-GAAP 2.22 dollars.REVENUE
  • The forward number is the one that carried the tape. Third-quarter revenue is guided to 108.0 billion dollars plus or minus 2 percent, with gross margin at 74.0 percent plus or minus 50 basis points. The company states in the release that the outlook assumes no Data Center compute revenue from China at all.OUTLOOK
  • Data Center revenue was 89.0 billion dollars, up 18 percent sequentially and 117 percent year over year, so the segment grew faster than the company as a whole in both comparisons. Edge Computing contributed 7.2 billion dollars, up 13 percent sequentially and 27 percent on the year.SEGMENTS
  • Operating income was 63.734 billion dollars against 28.440 billion a year earlier, a 124 percent increase, on operating expenses of 8.408 billion. Net income was 59.688 billion dollars. Guided third-quarter operating expenses are approximately 9.2 billion dollars on a GAAP basis and 9.0 billion non-GAAP.MARGIN
  • The gap between the two earnings figures is worth reading before quoting either. GAAP other income was 7.773 billion dollars, of which 7.771 billion was gains from equity securities. Strip that out and the 2.46 dollar GAAP figure becomes the 2.22 dollar non-GAAP one, so the higher headline number is investment marks, not chips.ADJUSTMENT
  • The company returned approximately 26.0 billion dollars to shareholders during the quarter through buybacks and dividends and has about 99.0 billion remaining under its repurchase authorization. The next quarterly dividend of 0.25 dollars per share is payable on October 1 to holders of record on September 10.CAPITAL
WHAT THE BALANCE SHEET ADDS
  • Accounts receivable stood at 63.059 billion dollars against 38.466 billion at the January year end, and inventories at 31.575 billion against 21.403 billion. Both grew faster over the six months than the reported revenue line, which is the arithmetic a reader building an AI-demand case should look at next to the growth rate.WORKING CAPITAL
  • Operating cash flow for the quarter was 24.077 billion dollars, against 50.344 billion in the first quarter, and free cash flow 21.341 billion against 48.554 billion. The sequential fall is the working capital build, not a change in profitability.CASH FLOW
  • Long-term debt rose to 32.366 billion dollars from 7.469 billion at the year end, with 24.896 billion of debt issuance recorded in the quarter’s financing activities. Non-marketable securities rose to 51.157 billion dollars from 22.251 billion. Total assets were 320.272 billion.FUNDING
  • Under Data Center highlights the company announced strategic partnerships with Apollo, BlackRock, Blackstone, Brookfield, Goldman Sachs and KKR to establish independent compute financing platforms intended to mobilise more than 500 billion dollars of third-party capital over time. The release states these remain subject to definitive agreements.FINANCING
THE WEDNESDAY CLOSE
  • Among the index funds $SPY closed 766.08 (+0.02%), $QQQ 711.37 (+0.09%), $DIA 534.23 (-0.19%) and $IWM 298.93 (-0.10%). The Associated Press put the cash indices at less than 0.1 percent lower for the S and P 500, 0.2 percent lower for the Dow and 0.1 percent lower for the Nasdaq Composite.INDICES
  • Industrials led the sector funds at $XLI 180.34 (+1.09%), ahead of $XLK 182.84 (+0.61%) and $XLE 62.43 (+0.60%). Healthcare was the weakest at $XLV 173.54 (-1.00%), with $XLY 117.16 (-0.67%) and $XLRE 45.09 (-0.60%) behind it.SECTORS
  • $NVDA itself closed 209.66 (-1.59%) on 179.9 million shares before the release, inside a 52-week range of 164.07 to 236.54. $SMH finished 555.77 (-0.01%), so the semiconductor complex as a group did not pre-position in either direction.SEMIS
  • $META 576.14 (+1.07%) after agreeing to pay up to 18 billion dollars and to add child-safety measures to Facebook and Instagram, ending the trial over teen social media addiction and settling claims brought by states, as reported by the Associated Press.SETTLEMENT
  • The largest single-name move of the session was outside technology entirely: $ANF 147.75 (+35.67%). Elsewhere $SEDG 33.08 (+10.71%) and $SMTC 140.80 (+10.41%) led, while quantum and small-cap nuclear names fell with $OKLO 41.60 (-6.03%), $RGTI 15.94 (-5.90%) and $IONQ 40.03 (-4.80%).MOVERS
THE OTHER SOFTWARE REPORTS
  • $CRM 205.62 (-0.03%) into a report that showed revenue of 11.3 billion dollars, up 11 percent, including a 456 million dollar contribution from Informatica. Current remaining performance obligation was 33.5 billion dollars, up 14 percent, and the company raised full-year fiscal 2027 revenue guidance to a range of 46.1 to 46.4 billion dollars.SALESFORCE
  • The Salesforce detail that matters for the AI question is the recurring revenue disclosure: Agentforce and Data 360 annual recurring revenue reached nearly 3.9 billion dollars, up over 210 percent, of which Agentforce alone exceeded 1.5 billion, up over 240 percent. The company notes that Agentforce now includes Slackbot and Headless 360, so the comparison is not like for like.AGENTFORCE
  • Salesforce reported GAAP operating margin of 20.5 percent against non-GAAP 34.1 percent, operating cash flow of 1.3 billion dollars and free cash flow of 1.1 billion. Final settlement of the company’s 25 billion dollar accelerated share repurchase is expected in October, with 103 million shares already delivered.MARGIN
  • $CRWD 189.18 (+2.05%) and $OKTA 134.42 (+2.92%) both closed higher ahead of their own releases. Bloomberg reported CrowdStrike quarterly revenue of 1.47 billion dollars, adjusted earnings of 0.31 dollars per share and a raised full-year revenue range of 5.99 to 6.01 billion dollars.SECURITY
BIOTECH AND HEALTHCARE
  • Today carries a scheduled regulatory decision. $GILD has an FDA target action date of August 27 for a once-daily single-tablet regimen of bictegravir 75 mg and lenacapavir 50 mg in adults with HIV who are virologically suppressed. Priority review was granted and the date announced in the company release of April 27.PDUFA
  • $JAZZ 249.29 (-4.20%) priced an upsized private offering of 1.1 billion dollars of 1.875 percent exchangeable senior notes due 2032, raised from the 1.0 billion announced the previous morning, with a 13-day option for up to 150 million more. Closing is expected on August 31.FINANCING
  • The Jazz structure includes a concurrent repurchase of approximately 225.0 million dollars of ordinary shares from purchasers of the notes, priced at 249.29 dollars, which was the last reported sale price on August 26. The financing follows the FDA approval of Ziihera, zanidatamab-hrii, announced on August 25.TERMS
  • Wednesday’s biotech leaders held most of their intraday gains into the close. $BHVN finished 16.95 (+17.87%) on the Kv7 licence to SK Biopharmaceuticals, $CAPR 9.36 (+12.91%) and $SMMT 14.23 (+6.51%), with $VERA 36.82 (+4.37%) alongside.MOVERS
  • The sector funds went the other way despite those names. $XBI closed 168.39 (-0.42%) and $IBB 215.23 (-0.54%), against $XLV at -1.00 percent, so the large-cap pharmaceutical weight, not the small-cap complex, produced the sector decline.BREADTH
OVERNIGHT IN ASIA
  • The reaction split along supply-chain lines rather than by index. South Korea’s Kospi rose 1.5 percent to 6,909.81 with Samsung Electronics 2 percent higher, and Taiwan’s Taiex added 0.5 percent. Japan’s Nikkei 225 slipped 0.2 percent to 66,162.72, with SoftBank Group up 0.1 percent.ASIA
  • Hong Kong’s Hang Seng lost 0.4 percent to 25,548.83 while the Shanghai Composite rose 0.6 percent to 3,935.99. Australia’s S and P/ASX 200 was the weakest of the session, 0.9 percent lower at 9,041.70, and India’s Sensex edged down 0.1 percent.CHINA
  • China reported that growth in industrial profits slowed to 11.2 percent in July from 15.1 percent in June. The rate remains in double digits, so the reading is a deceleration in the pace rather than a contraction.DATA
  • American futures were higher without matching the headline. Read at roughly 08:10 in Rome, S and P 500 futures stood at 7,712.50 (+0.29%), Nasdaq 100 futures 29,451.75 (+0.55%) and Dow futures 53,621.00 (+0.19%), while Russell 2000 futures were 3,007.80 (-0.08%).FUTURES
  • Volatility eased rather than collapsed, with the VIX at 15.21 (-1.55%) on the same reading. The small-cap future going the other way from the three large-cap contracts is the detail to watch when the cash session opens.VOLATILITY
RATES, DOLLAR AND CRUDE
  • Treasury funds fell modestly on Wednesday, with $TLT 83.30 (-0.20%) and $IEF 93.32 (-0.20%), so yields edged higher across the belly and the long end. A settled par yield for August 26 was not available on the Treasury’s own daily curve page at the time of writing and is therefore not quoted here.TREASURIES
  • The dollar firmed, with $UUP 28.02 (+0.29%) against $FXE 107.60 (-0.19%). Early Thursday the dollar was at 159.38 Japanese yen from 159.31, and the euro at 1.1655 dollars from 1.1651, so the overnight move in the majors was very small.CURRENCIES
  • Crude rose in the American session and gave it back overnight. $USO closed 127.35 (+0.95%) and $UNG 10.41 (+1.76%). Early Thursday Brent was 0.5 percent lower at 86.49 dollars a barrel and American benchmark crude 0.5 percent lower at 81.84 dollars.ENERGY
  • Precious metals were the clearest directional move of the Wednesday close, with $GLD 421.32 (-1.58%) and $SLV 61.59 (-1.17%). Gold futures were 0.21 percent higher at 4,663.10 dollars on the early Thursday reading, recovering part of it.METALS
THE DAY AHEAD
  • The weekly Department of Labor report on initial and continuing unemployment claims is due at 8:30 in New York. It is the only recurring federal release of the session and the last labour reading before the monthly employment report cycle resumes.CLAIMS
  • The Nvidia guidance sets an explicit test rather than a mood. A third quarter at 108.0 billion dollars requires a further 12 billion of sequential revenue, and the company has told readers in writing that none of it is assumed to come from Data Center compute sales into China.TEST
  • The memory and networking suppliers are the second-order read on that guidance, and they moved overnight before the American open. $MU closed 938.40 (+0.58%) on Wednesday, $AMD 480.93 (+0.37%) and $AVGO 355.59 (-0.32%).SUPPLIERS
METHOD

United States equity and exchange-traded fund prices are official closing marks for Wednesday, August 26, 2026 taken from the Finviz Elite feed, with percentage changes measured against the August 25 close. The Nvidia figures for the second quarter of fiscal 2027 and the third-quarter outlook are taken from the company’s earnings release of August 26 and the accompanying condensed consolidated statements filed with the Securities and Exchange Commission. The Salesforce figures are from the company’s second-quarter fiscal 2027 release of August 26. The CrowdStrike figures are as reported by Bloomberg on August 26 and are labelled as such. The Gilead target action date is from the company’s release of April 27 announcing priority review. The Jazz Pharmaceuticals terms are from the pricing release issued in the early hours of August 27. Asian index levels, the Chinese industrial profits figure, the crude benchmarks and the currency marks are from the Associated Press market report timed at 1:10 a.m. Eastern on August 27; the futures and volatility marks are a published third-party reading taken at approximately 08:10 in Rome on the same morning and are labelled as such. This page is educational research, not investment advice and not a recommendation to buy or sell any security; readers should do their own work and consult a licensed adviser.

Read the extended Daily BriefingWeekly Market Pulse

Biotech Catalyst Calendar 2026

Last updated: 22 July 2026

Merlintrader tracks upcoming biotech catalysts for U.S.-listed companies, including PDUFA dates, FDA decisions, clinical-trial readouts, advisory committee meetings and other regulatory milestones. Alongside each date you will find the source, company context and the key risks that can move the stock, plus links to deeper Merlintrader research when it is available. The focus is educational and risk-aware, with particular attention to small and mid-cap biotech names, where catalyst timing, cash runway and dilution risk can drive sharp moves in volatility. Dates can change and FDA decisions can arrive early or late, so always confirm an event against company filings and regulatory sources before acting on it.

Listed / exchange-traded biotech focus

Weekly Biotech Catalyst Tracker

Window covered: August 25 → September 30, 2026. Compact homepage board for unresolved FDA decisions, regulatory submissions and major clinical readouts. A prior-date item remains visible only when the regulatory process is still materially open; catalysts resolved in the past few days are retained briefly for continuity. October and later events are excluded from this widget.

29On board
14FDA / Reg
15Data / Filing
Aug 26Updated
FDA / PDUFA Clinical data Filing watch High risk Large cap
$JAZZ Ziihera combo Aug 25 Approved FDA approval in first-line HER2-positive GEA

Jazz Pharmaceuticals. On August 25, 2026 the FDA approved Ziihera (zanidatamab-hrii) in two first-line regimens for locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: with tislelizumab and fluoropyrimidine- and platinum-based chemotherapy for IHC 3+ and IHC 2+/ISH+ tumours, and with chemotherapy alone for IHC 3+ tumours. The decision landed on the Priority Review goal date. Approval rests on the Phase 3 HERIZON-GEA-01 trial, where median progression-free survival was 12.4 months against 8.1 months and median overall survival 26.4 months against 19.2 months. The label carries a boxed warning for diarrhoea and embryo-fetal toxicity. Zanidatamab was discovered by Zymeworks ($ZYME), which confirmed the approval the same day.

$NRXP KETAFREE Ongoing FDA review First-cycle review complete; manufacturer vial attestation submitted

NRx Pharmaceuticals. The July 29 GDUFA goal date has passed, but the ANDA remains active. On August 7 the company reported that FDA had completed its first-cycle review of the preservative-free intravenous ketamine ANDA with no major deficiencies related to the drug product, ingredients, proposed labeling, CMC or other drug-related review matters. The sole remaining major deficiency involved the container-closure system and a manufacturer attestation concerning the luer-lock vial. The same vial is used in three approved ANDA products that collectively shipped 11.9 million units in the United States over the prior 12 months, and the filing included testing of more than 3,500 vials from seven lots without observed luer-lock failures. On August 17 NRx confirmed that the requested attestation had been submitted. No company release has followed since August 17 and no new exact action date has been disclosed.

$GILD BIC/LEN Aug 27 NDA Once-daily oral HIV regimen · decision due this week

Gilead. Priority Review PDUFA for the bictegravir 75 mg and lenacapavir 50 mg NDA, a once-daily single-tablet regimen for virologically suppressed adults with HIV, supported by the ARTISTRY-1 and ARTISTRY-2 studies. No approval, extension or complete response letter had been announced as of August 25, so the decision remains due within days. It is a lifecycle catalyst for the HIV franchise rather than a first entry into the class.

$PTGX rusfertide Aug NDA Polycythemia vera · company guidance now says August, and no decision has been announced

Protagonist / Takeda. The rusfertide NDA in polycythemia vera is under Priority Review and no FDA decision had been announced as of August 25. The most recent primary-source wording is narrower than the original one: Protagonist’s second-quarter release and Form 10-Q, both dated August 5, 2026, state that the application carries “a Prescription Drug User Fee Act target action date in August 2026”. The earlier joint Takeda and Protagonist announcement of March 2, 2026 had placed the goal date in the third quarter without naming a month. The exact day has never been made public, so the window is closing, or has closed, without an announcement. Rusfertide also holds Breakthrough Therapy, Orphan Drug and Fast Track designations, and the submission rests on the Phase 3 VERIFY study with the Phase 2 REVIVE study and the THRIVE long-term extension.

$TLX Pixclara Sep 11 PDUFA FDA decision on the resubmitted Pixclara NDA

Telix Pharmaceuticals. September 11, 2026 is the FDA goal date for the resubmitted Pixclara (TLX101-Px) NDA, reconfirmed by the company in the half-year announcement filed on Form 6-K on August 20, 2026. The application was resubmitted in March and accepted in April, so the September catalyst is the decision on that NDA, not the filing itself. Pixclara is a PET imaging agent intended to help characterise suspected recurrent or progressive glioma against treatment-related changes. In the same document Telix confirmed that the Zircaix BLA has still to be resubmitted.

$RARE UX111 Sep 19 BLA Gene therapy for Sanfilippo syndrome type A

Ultragenyx. PDUFA for the resubmitted UX111 (rebisufligene etisparvovec) BLA in Sanfilippo syndrome type A, seeking accelerated approval. The date was set with the acceptance of the BLA resubmission and the company reaffirmed it in its August 4 update; no extension has been announced since. The August 19 accelerated approval of GENGLYCOS in glycogen storage disease type Ia is a separate programme and does not change this review.

$MRK WINREVAIR Sep 21 sBLA PAH · HYPERION-based label update

Merck. PDUFA for a supplemental BLA seeking a U.S. label update for WINREVAIR (sotatercept-csrk) based on the Phase 3 HYPERION study in pulmonary arterial hypertension. The September 21 date is stated in the Form 10-Q filed on August 7, 2026, and nothing published since changes it.

$IONS zilganersen Sep 22 NDA Alexander disease · Priority Review

Ionis. Priority Review PDUFA for the zilganersen NDA in Alexander disease, a rare progressive neurological disorder. The date is confirmed in the Form 10-Q filed on July 29, 2026. Ionis is preparing to commercialise the product itself in the United States, while ex-U.S. rights were licensed to Recordati in June 2026. It remains one of September’s most closely watched rare-disease decisions.

$GRAL Galleri Sep 23 FDA panel AdCom on the multi-cancer MCED test PMA

GRAIL. FDA’s Molecular and Clinical Genetics Panel is scheduled to meet on September 23, 2026 to discuss and vote on the Galleri premarket approval application. The meeting notice was published in the Federal Register on August 10, 2026, the session runs from 9:00 to 18:00 Eastern at White Oak in hybrid form, and public comments close on September 8. The FDA advisory committee calendar still carries the meeting with no postponement note. Galleri is a blood-based multi-cancer early detection test proposed for adults aged 50 and older; this is a device and diagnostics catalyst rather than a drug PDUFA, and it is the first FDA advisory committee ever convened on an MCED test.

$MIRM zilurgisertib Sep 26 NDA FOP · NDA rests on secondary endpoints

Mirum Pharmaceuticals / Incyte. Priority Review PDUFA for the zilurgisertib NDA in fibrodysplasia ossificans progressiva in patients aged 12 and older; the application is Incyte’s and Mirum holds exclusive worldwide rights under a licence signed in April 2026, with 25 million dollars due on FDA approval. The date is confirmed in Mirum’s Form 10-Q of August 5, 2026. The same filing states in its risk factors that “while the NDA for zilurgisertib is supported by secondary endpoints, the pivotal study did not reach statistical significance on the primary endpoint”. That pivotal study is the Phase 2 PROGRESS trial, whose results the company presented at ENDO 2026 without addressing the primary endpoint.

$BFRI Ameluz PDT Sep 28 sNDA Expansion into superficial basal cell carcinoma

Biofrontera. PDUFA for the Ameluz photodynamic-therapy sNDA in superficial basal cell carcinoma. The date comes from the filing-acceptance release of February 11, 2026, in which FDA identified no filing deficiencies, and the company reaffirmed a late-September action date in its second-quarter release of August 13, 2026, pointing to a launch in the first quarter of 2027. No filing or release has followed since.

$SRRK apitegromab Sep 30 BLA SMA · Catalent Indiana removed from the BLA on August 21

Scholar Rock. The apitegromab BLA in spinal muscular atrophy remains targeted to September 30. On August 21, 2026 the company said it had successfully removed Catalent Indiana as a commercial fill-finish facility from the BLA under FDA guidance, after Catalent notified customers on August 7 that its April inspection had been classified Official Action Indicated. In the same August 21 update Scholar Rock confirmed the action date as unchanged, said the European marketing authorisation application had been withdrawn following the CHMP written procedure of August 20 and would be resubmitted with the alternative site, and pointed to a Japanese filing by the end of 2026. Manufacturing and CMC risk therefore stays central to this review.

$ROIV brepocitinib Q3 NDA Dermatomyositis · Priority Review, exact day never disclosed

Priovant / Roivant. The brepocitinib NDA in dermatomyositis is under Priority Review. The acceptance release of March 3, 2026 states a target action date in the third quarter of 2026 and no exact day has ever been made public. Roivant’s quarterly update of August 6, 2026 describes the application as still under review and points to a commercial launch by the end of September if approval arrives.

$QURE AMT-130 Q3 BLA Huntington’s disease · filing plus four-year data in September

uniQure. The AMT-130 accelerated-approval BLA in Huntington’s disease was still to be filed as of August 25; the July 29, 2026 quarterly update describes U.S. and U.K. submissions as on track for the third quarter. Official minutes of the Type B meeting received in July confirm alignment on a filing based on existing clinical data with comparison to an external control, while the design of the confirmatory study was still being discussed. Topline four-year data from the Phase I/II study are expected in September 2026, which makes the quarter dense for this programme.

$IMMX NXC-201 Late Sep Data NEXICART-2 · AL amyloidosis

Immix Biopharma. The next NEXICART-2 update for NXC-201 in relapsed or refractory AL amyloidosis is expected in late September 2026, a window stated in the company release of May 21, 2026. Enrolment of 45 patients is complete, as confirmed in the Form 10-Q of August 7, 2026, and one-year follow-up data due by the end of March 2027 are expected to guide the BLA. The programme is designed to be registrational.

$KPTI selinexor combo Aug sNDA Selinexor plus ruxolitinib filing in myelofibrosis

Karyopharm. The company plans to submit the selinexor plus ruxolitinib sNDA in myelofibrosis during August under the accelerated-approval pathway, requesting Priority Review at the same time; FDA has given written feedback that SVR35 appears to qualify as a reasonably likely surrogate endpoint. The plan was reaffirmed in the second-quarter release of August 13, 2026 and no announcement confirming the submission has appeared since, so the filing itself is still the open event. The former endometrial-cancer catalyst is closed: XPORT-EC-042 missed its primary progression-free-survival endpoint on July 30.

$KOD DAYBREAK Sep Phase 3 Wet AMD · Zenkuda and KSI-501 against aflibercept

Kodiak Sciences. One-year primary-endpoint topline results from the Phase 3 DAYBREAK study in wet age-related macular degeneration are expected in September 2026, a guidance restated in the second-quarter release of August 13, 2026. The study evaluates Zenkuda (tarcocimab tedromer) and KSI-501 in parallel arms against aflibercept, and enrolment is complete. Cash stood at 125.9 million dollars at June 30 with runway stated into 2027, which raises the stakes on the readout.

$ALMS envudeucitinib Q3 Data LUMUS Phase 2b in systemic lupus erythematosus

Alumis. Potentially pivotal Phase 2b LUMUS results for envudeucitinib in systemic lupus erythematosus are expected in the third quarter, guidance repeated in the second-quarter release of August 13, 2026. The study is randomised, double-blind and placebo-controlled with BICLA as the primary endpoint. Decisions on Sjogren’s and cutaneous lupus are explicitly tied to this outcome, and for an autoimmune readout the market will weigh dose consistency and safety alongside statistical significance.

$IVVD VYD2311 Late Q3 Data DECLARATION pivotal study · enrolment complete

Invivyd. Topline data from the pivotal DECLARATION study of VYD2311 are planned later in the third quarter of 2026, per the second-quarter release of August 13, 2026, which also describes the study as approaching its planned analysis after being upsized to roughly 2,400 participants. Topline from LIBERTY is guided to the same window. Cash of 160.1 million dollars is stated as sufficient through the DECLARATION readout, and the company has flagged the July notice terminating the PEMGARDA emergency use authorisation with twelve months’ notice.

$PHVS deucrictibant XR Q3 Phase 3 CHAPTER-3 · hereditary angioedema prophylaxis

Pharvaris. Phase 3 CHAPTER-3 topline data for extended-release deucrictibant in hereditary-angioedema prophylaxis are expected in the third quarter of 2026, confirmed in the Form 6-K release of August 12, 2026, which puts randomisation at 85 participants assigned two to one to 40 mg daily or placebo over 24 weeks. It is one of the quarter’s most important registrational HAE readouts. Separately, the immediate-release NDA carries a PDUFA date of April 23, 2027.

$SYRE SPY003 Sep Data SKYLINE Part A in ulcerative colitis

Spyre Therapeutics. SPY003 Part A topline data from the Phase 2 SKYLINE study are expected in September 2026, as stated in the second-quarter release of August 4, 2026; enrolment of Part A is complete and SPY003 is the last of the three readouts, after SPY001 and SPY002 in April and June. The RA sub-study of SKYWAY is guided to the same month. With 1.145 billion dollars in cash and runway into the second half of 2029, financing risk is not the issue here.

$VERA TRUTAKNA / atacicept Q3 eGFR ORIGIN 3 final efficacy analysis

Vera Therapeutics. The ORIGIN 3 final efficacy analysis is expected in the third quarter, as restated in the second-quarter release of August 10, 2026. It follows the accelerated approval of TRUTAKNA (atacicept-vymj) on July 7, 2026, which rested on proteinuria, while ORIGIN 3 continues blinded and placebo-controlled with eGFR as the confirmatory endpoint. The timing was pulled forward from 2027 after alignment with FDA announced on June 2, 2026, and a supplemental BLA is guided to the fourth quarter. This is not another approval decision: what matters is the durability of the renal effect and the read-through for the confirmatory pathway.

$XENE azetukalner Q3 NDA Focal-onset seizure filing after the pre-NDA meeting

Xenon. The azetukalner NDA submission in focal-onset seizures is on track for the third quarter following the pre-NDA meeting with FDA, as stated in the second-quarter release of August 6, 2026. The application had not been filed as of August 25. Filing confirmation would open FDA’s filing-review stage and set up a later PDUFA assignment.

$BBIO infigratinib Aug 10 NDA submitted Achondroplasia · FDA filing acceptance is the next step

BridgeBio. BridgeBio confirmed on August 10, 2026 that it had submitted the NDA for oral infigratinib in achondroplasia, and its own pipeline table lists the next milestone as FDA setting a PDUFA date. Neither filing acceptance nor a PDUFA date had been announced as of August 25, so the programme stays on the board with the regulatory process materially open. Infigratinib holds Breakthrough Therapy, Fast Track and Rare Pediatric Disease designations, U.S. launch is guided to mid-2027 and a European application is planned for the fourth quarter.

$MLTX sonelokimab Late Sep BLA Hidradenitis suppurativa filing after positive IZAR-1

MoonLake. The sonelokimab BLA in hidradenitis suppurativa is expected around the end of September 2026, with the company guiding to a PDUFA date allocation and a decision on Priority Review by the end of November. The milestone table sits in the August 10, 2026 release that also carried positive topline results from the Phase 3 IZAR-1 trial. The filing had not been announced as of August 25.

$BNTX pumitamig · WCLC Sep 12-15 Data WCLC 2026 · PRESERVE-003 overall survival update

BioNTech. On August 20, 2026 the company disclosed its programme for the World Conference on Lung Cancer in Seoul, held from September 12 to 15, 2026. It includes a late-breaking oral presentation with the first data on the combination of pumitamig and elfetabart drozuntecan, and an overall survival update from the Phase 3 PRESERVE-003 study of gotistobart in squamous non-small cell lung cancer. Conference presentations are not regulatory events, but for this programme they are the readout of the quarter.

$SMMT ivonescimab · WCLC Sep 15 Data WCLC 2026 · updated HARMONi overall survival, two months before the PDUFA

Summit Therapeutics. On August 25, 2026 Summit said the updated overall-survival follow-up from the global Phase III HARMONi study will be presented at the IASLC World Conference on Lung Cancer on September 15, 2026, in session OA14, abstract OA14.04. The same day the company announced publication of the HARMONi primary analysis in The Lancet Oncology: median progression-free survival 6.8 against 4.4 months, hazard ratio 0.52 (95% CI 0.41–0.66; p<0.0001), with the primary overall-survival analysis showing a positive trend that did not reach statistical significance. The FDA has told the company a statistically significant overall-survival benefit is necessary in this setting, which is what makes a survival update three weeks before the November 14 target action date the readout to watch. Partner Akeso separately reported a statistically significant overall-survival benefit in first-line advanced biliary tract cancer (HARMONi-GI1), a single-region China study run and analysed by Akeso.

$RGNX RGX-202 · Duchenne Q3 BLA Duchenne BLA submission still guided to this quarter, after the RGX-121 hold

REGENXBIO. On August 24, 2026 the FDA placed a clinical hold on the Phase I/II/III trial of RGX-121 in mucopolysaccharidosis type II, following asymptomatic spine MRI findings in five participants of the CAMPSIITE study, and the company said it does not expect to resubmit the RGX-121 Biologics License Application in the near term. In the same release it stated that the Duchenne and retinal programmes use a different capsid and different routes of administration, and that their near-term catalysts are on track: the planned submission of the Duchenne BLA this quarter, and wet AMD topline pivotal data in the fourth quarter. Investigators deemed the spine findings non-serious and radiologists believe they are likely benign; no brain nodules or masses were identified. The stock fell sharply on the hold, which makes the Duchenne filing the near-term item that either confirms or undermines the company’s separation of the two programmes.

$GOSS seralutinib Sep NDA PAH filing tied to a 125 million dollar financing tranche

Gossamer Bio. On August 21, 2026 the company said it expects to submit the seralutinib NDA in pulmonary arterial hypertension in September 2026. The filing carries a direct financial consequence: the 250 million dollar private placement announced alongside it is structured so that a second tranche of roughly 125 million dollars unlocks on FDA acceptance of the application within 2026. Submission and acceptance are therefore two distinct events to track.

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$NRXP $PTGX $GILD $RARE $IONS $GRAL $MIRM $SRRK $PHVS $QURE $IMMX

Board rule

Only future or still materially unresolved catalysts through September are shown; catalysts resolved in the past few days are retained briefly for continuity. $JAZZ/Ziihera stays for one update: the FDA approved it on August 25 in first-line HER2-positive gastroesophageal adenocarcinoma, on its goal date. $CAPR has been removed from the grid. On August 24 the FDA extended the deramiocel PDUFA target action date from August 22 to November 22, 2026, after Capricor filed a BLA amendment with 24-month HOPE-3 open-label-extension data supporting a refined indication focused on upper limb function; CBER classified the submission as a major amendment. The new date falls outside the window this widget covers. $REGN/Pasatru and $RARE/GENGLYCOS have rolled off after one update: both were approved on August 19, the second for FOP and the first gene therapy in Ultragenyx history respectively. $PTGX has been corrected from Q3 back to August. The company’s own second-quarter release and Form 10-Q of August 5 both state a target action date in August 2026, which supersedes the March 2 wording of a third-quarter goal date; the exact day has never been published and no decision has been announced. $SRRK has been corrected as well: the removal of Catalent Indiana from the BLA was announced on August 21, not on August 7, which is the date Catalent notified customers of the Official Action Indicated classification. $BNTX and $GOSS join the board: BioNTech disclosed its WCLC programme on August 20 with a PRESERVE-003 overall survival update, and Gossamer Bio guided on August 21 to a September seralutinib filing. $NRXP remains because the manufacturer vial attestation has been submitted but no new exact action date has been disclosed and no company release has followed since August 17. $KPTI stays on an August window because no announcement confirming the selinexor plus ruxolitinib submission has been found, and $BBIO stays because filing acceptance for infigratinib is still the next formal step. Month-only and quarter-only windows reflect disclosed guidance and are not exact FDA dates.

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