Independent U.S. Market Research

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.

WEDNESDAY MORNING — AUGUST 26, 2026

A broad Tuesday close, a third day of falling crude, and the July inflation print landing hours before Nvidia reports

All four main U.S. index proxies finished higher on Tuesday, semiconductors and biotechnology carried the tape, and the entire Treasury curve moved down. Wednesday puts two scheduled events on the same day: the July personal consumption expenditures price index at 8:30 a.m. ET, then Nvidia’s fiscal second-quarter results after the close. Every U.S. figure below is an official August 25 close.

TUESDAY’S OFFICIAL CLOSE
  • $SPY 765.91 (+0.32%), $QQQ 710.72 (+0.62%), $DIA 535.24 (+0.30%), $IWM 299.23 (+0.42%). The four proxies closed higher together, with the Nasdaq proxy in front and the spread between best and worst under half a point.INDEXES
  • At index level the S&P 500 added 24.42 points to 7,677.28, the Dow Jones Industrial Average 160.24 points to 53,577.40 and the Nasdaq Composite 171.11 points to 26,151.30, each a gain of roughly a quarter to seven tenths of a point.LEVELS
  • $SMH 555.82 (+1.64%) and $SOXX 514.06 (+1.56%). The semiconductor complex recovered more than the ground it lost at the start of the week and finished as the strongest large group on the board.SEMIS
  • $XBI 169.10 (+3.00%) against $XLV 175.29 (+0.34%). A near nine-to-one ratio between the equal-weighted biotech fund and the broad healthcare fund puts the entire move in small and mid-cap names.BIOTECH
  • Sector spread: $XLK 181.74 (+0.94%), $XLC 113.18 (+0.77%), $XLF 58.31 (+0.15%), $XLI 178.40 (-0.34%), $XLP 86.52 (-1.06%), $XLE 62.06 (-1.66%). Energy and staples were the only groups with a decline worth naming.SECTORS
WHAT LED THE TAPE
  • $AMD 479.18 (+4.91%) and $MRVL 240.38 (+4.84%) were the two strongest large semiconductor names of the session, with $MU 932.97 (+2.48%) and $TSM 417.41 (+1.78%) behind them.CHIPS
  • $NVDA 213.05 (+2.19%) closed at the top of its recent range on the eve of its own report. $AVGO 356.74 (-0.56%) was the one large chip name that did not participate.AHEAD
  • Megacap was split rather than uniform: $META 570.05 (+1.97%) and $MSFT 491.71 (+0.90%) higher, $GOOGL 346.96 (-0.32%), $AMZN 261.06 (-0.39%) and $AAPL 309.90 (-0.14%) marginally lower.MEGACAP
  • $PLTR 172.73 (-1.80%) fell while the chip complex rose, the second session in a row it has moved against the group it is usually traded with.LAGGARD
  • $VXX 18.67 (-1.53%). Volatility exposure came down on a day when two known events were less than twenty-four hours away.VOLATILITY
RATES, DOLLAR AND COMMODITIES
  • The Treasury par yield curve moved down at every point published: the 2-year to 4.17% from 4.24%, the 5-year to 4.35% from 4.41%, the 10-year to 4.64% from 4.70% and the 30-year to 5.17% from 5.23%. $TLT 83.47 (+1.15%) is the long-duration side of the same move.RATES
  • $USO 126.15 (-4.58%) was the largest single move among the broad funds. Brent settled at 88.58 dollars a barrel and West Texas Intermediate at 82.36, both sharply lower, as reported by the wire services covering the settlement.OIL
  • $GLD 428.07 (+0.32%) and $SLV 62.32 (+0.19%). The metals held their level into an inflation release rather than extending, which is the pattern they usually show on the day before a print.METALS
  • The euro traded at 1.1683 dollars at 8:27 a.m. UTC this morning and bitcoin at 78,948 dollars at 8:26 a.m. UTC. $UUP 27.94 (-0.07%) left the dollar proxy effectively unchanged on Tuesday.FX
BIOTECH AND HEALTHCARE
  • $MRNA 158.83 (+14.36%) closed with the largest gain of any large healthcare name, extending the reaction to the Phase 3 readout of intismeran autogene in adjuvant melanoma run with Merck. $MRK 156.45 (+3.84%) and $ARCT 15.44 (+7.67%) moved with it.ONCOLOGY
  • $CAPR 8.29 (+21.91%) and $RGNX 8.91 (+10.61%) both rebounded hard from Monday’s regulatory news. Neither company issued a new release on Tuesday, so both closes are a repricing of documents already public rather than a fresh disclosure.REBOUND
  • $JAZZ 260.23 (+2.26%) after the Ziihera approval in first-line HER2-positive advanced gastroesophageal adenocarcinoma, while the partner $ZYME 27.47 (-4.52%) closed lower after touching 30.50 intraday. The two sides of one approval finished in opposite directions.APPROVAL
  • Also higher: $KURA 13.59 (+9.60%), $BHVN 14.38 (+5.12%), $SMMT 13.36 (+4.95%), $VERA 35.28 (+4.63%), $MCK 905.09 (+3.58%). Lower: $ETON 63.05 (-2.14%), $SLS 14.09 (-1.67%).SPREAD
AFTER THE BELL AND OVERNIGHT
  • $SYRE released topline results from the rheumatoid arthritis sub-study of the SKYWAY Phase 2 trial of SPY072 after Tuesday’s close of 107.36 (+0.67%). Both doses reached statistical significance on one or more of the primary, key secondary and exploratory endpoints, the low dose on the primary DAS28-CRP change at Week 12, and the company said the drug was well tolerated but fell short of its internal thresholds for prioritising monotherapy in this indication.READOUT
  • Asia traded higher into Wednesday: the Nikkei 225 up 0.6% at 66,227.55 in morning dealing, the Hang Seng up 0.8% at 25,712.29 and the Kospi up 1.6% at 6,849.92, with the oil move and the pending Nvidia report cited as the two reference points.ASIA
  • Europe closed Tuesday with the Stoxx Europe 600 up 0.3% and opened Wednesday marginally higher. Brent slid for a third consecutive session in European hours, trading in the mid-eighties after Iran said it had restarted talks with Oman on managing the Strait of Hormuz.EUROPE
TODAY’S TWO SCHEDULED EVENTS
  • The July personal consumption expenditures price index is published at 8:30 a.m. ET by the Bureau of Economic Analysis. Consensus compiled ahead of the release looks for headline inflation at 3.6% year over year against 3.7% in June, and the core measure at 3.2% against 3.3%, with core rising about 0.18% on the month.MACRO
  • $NVDA reports fiscal second-quarter results after the close. Company guidance was 91.0 billion dollars plus or minus two per cent; the analyst consensus sits marginally above that midpoint at roughly 91.9 billion with earnings near 2.08 dollars a share, against 46.74 billion and 1.05 dollars in the same quarter a year earlier.EARNINGS
  • Two more reports land in the same after-close window: $CRM 205.69 (-1.61%) and $CRWD 185.38 (-2.78%), both of which closed lower on Tuesday while the broader software and technology tape rose.ALSO TONIGHT
  • July new home sales, released Tuesday by the Census Bureau and HUD, ran at a seasonally adjusted annual rate of 607,000, 10.5% below June’s 678,000 and 6.3% below July 2025. Inventory stood at 488,000 units, a 9.6-month supply, with a median sale price of 393,800 dollars.HOUSING
SINGLE-STOCK MOVERS
  • Nuclear and uranium closed as the strongest thematic group of the session: $OKLO 44.27 (+11.54%), $LEU 193.39 (+9.17%), $SMR 9.81 (+8.40%), $UEC 13.27 (+6.08%), $CCJ 106.96 (+4.59%).NUCLEAR
  • Power generation tied to data-centre demand followed: $VST 139.03 (+2.48%) and $CEG 278.42 (+1.82%).POWER
  • Crypto-linked equities outran the coin: $HOOD 112.09 (+8.17%), $COIN 187.16 (+4.28%), $MSTR 126.83 (+3.42%), against $IBIT 44.72 (+0.18%).CRYPTO
  • Space and defence stayed out of the advance: $RKLB 66.91 (-2.01%), $ASTS 62.01 (-0.55%), $LUNR 16.60 (-0.36%), $LMT 556.52 (-1.35%), $NOC 542.52 (-1.23%). $TGT 163.47 (-3.78%) was the weakest large consumer name.LAGGARDS
  • Merlintrader coverage: $RYTM 113.35 (+1.71%), $INCY 129.72 (+1.36%), $GERN 1.55 (+1.97%), $ALDX 1.55 (+1.97%), $PDYN 5.86 (+1.38%), $SOUN 7.05 (+0.71%), $BBAI 3.09 (+0.65%), $DRTS 14.70 (unchanged), $UMAC 24.35 (-0.90%).WATCHLIST
WHAT COMES NEXT
  • THU AUG 27 — Gilead’s action date for the once-daily bictegravir plus lenacapavir HIV regimen. $GILD closed 148.77 (+1.38%). The Jackson Hole symposium opens the same day and runs through August 29.FDA
  • FRI AUG 28 — Kevin Warsh delivers his first Jackson Hole keynote as Federal Reserve Chair, in the morning session. It follows a week in which the whole Treasury curve has moved lower.FED
  • $CAPR — the deramiocel target action date now sits on November 22, 2026 after the three-month extension disclosed on August 24. A target date can resolve before, on or after the stated day, and only the company release settles it.AHEAD
  • Trade policy remains an open input: Canada has set out retaliatory tariffs covering about 20 billion dollars of U.S. goods, and the measures on both sides feed directly into the goods prices that the inflation series tracks.TRADE
METHOD

U.S. equity and ETF prices are official closing values for Tuesday, August 25, 2026, taken from the Marketstack end-of-day feed and compared with the August 24 close. Index point moves are as reported for the same session. Treasury yields are the published par yield curve rates for August 24 and August 25. The euro and bitcoin quotes carry the time at which they were read. The Spyre results are taken from the company’s own release and its Form 8-K, the new home sales figures from the joint Census Bureau and HUD estimate, and the Nvidia figures from the company’s prior guidance alongside published analyst consensus. 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.

Most attention-worthy watchlist

$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.

Educational content only — not investment advice or a recommendation to buy or sell securities. Verify dates and primary filings before trading around binary events. Full catalyst calendar FDA SEC EDGAR

Biotech Catalyst Lookup

Type a ticker to get an AI-generated snapshot of the next catalyst (PDUFA, clinical data, regulatory events) with a link to the primary source.

Disclaimer. This content is for educational and informational purposes only. It is not investment advice and not a recommendation to buy or sell any security, in line with SEC (USA) guidance. Data is generated by AI from web sources and may contain errors or be out of date — always verify against the linked primary source. Do your own research and consult a licensed advisor. Full disclaimer: merlintrader.com/disclaimer.