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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.

SUNDAY, SEPTEMBER 6, 2026 — MORNING EDITION

Four sessions, four appointments: today’s OPEC+ meeting, the Apple event on the 9th, Oracle and Adobe alongside the European Central Bank on the 10th and United States inflation on the 11th decide the short week

United States markets stay shut until Tuesday, September 8: Monday the 7th is Labor Day and the last settlement on the tape remains Friday, September 4. The week that follows runs four sessions and its calendar thickens between Wednesday and Friday: the Apple event on September 9, the first with John Ternus as chief executive; on Thursday the 10th the European Central Bank decision in Berlin, the August producer price index and, after the close, results from Oracle and Adobe; on Friday the 11th the August consumer price index, the last reading before the Federal Open Market Committee meets on September 15 and 16. Ahead of all of it sits the OPEC+ meeting called for today, Sunday, September 6, at the end of a week in which crude gained between seven and ten percent. Every equity and exchange-traded fund close below is Marketstack settlement data for September 4, 2026; weekly changes are a Merlintrader calculation from the August 28 settlement.

WHAT IS DECIDED BEFORE TUESDAY’S REOPENING×
  • The OPEC+ meeting is called for today, Sunday, September 6. On August 2 seven members of the group agreed a production adjustment of 188,000 barrels a day effective from September, the last step in unwinding the voluntary cuts of 2023, and named September 6 as the date of the following meeting. This edition goes out before that meeting produces an outcome, which is therefore not reported here.ENERGY
  • With Wall Street closed on Monday as well, any decision announced today lands on prices in a single session, Tuesday, September 8, rather than in two. The same holds for everything released between now and Tuesday morning.MARKETS
  • The starting point is a week in which the indices stood still and the sectors did not: on Marketstack settlement data $SPY closed September 4 at 770.19 dollars, up 0.11 percent from August 28, while $SMH gained 2.56 percent, $ITA lost 3.10 and $USO added 9.45.MARKETS
THE SHORT WEEK, DAY BY DAY×
  • Tuesday, September 8: Wall Street reopens after Labor Day. The first session absorbs the OPEC+ outcome and everything else released across the three closed days.CALENDAR
  • Wednesday, September 9: the Apple «Surprise and shine» event at Apple Park, announced by the company on its developer site. It is the first product event with John Ternus as chief executive, in post since September 1, 2026 in place of Tim Cook, who moved to executive chairman under the Apple release of April 20, 2026. $AAPL closed September 4 at 319.97 dollars, down 2.51 percent on the session and up 0.08 on the week.TECH
  • Thursday, September 10: the European Central Bank decision, with the Governing Council meeting hosted by the Bundesbank in Berlin; the August producer price index from the Bureau of Labor Statistics; and, after the close, quarterly results from Oracle and Adobe.CALENDAR
  • Friday, September 11: the August consumer price index, per the Bureau of Labor Statistics calendar. It is the last macroeconomic reading before the Federal Open Market Committee meeting of September 15 and 16, and the same day carries the Telix PDUFA date.MACRO
RATES: WALLER’S CONDITION AND THE PRINT THAT HAS TO MEET IT×
  • On September 3, the day before the employment report, Federal Reserve governor Christopher Waller said in an interview in Washington that if the data of the following two weeks confirmed signs of disinflation he would be inclined to support holding the federal funds rate at its current level; if instead the August data showed the improvement had been temporary, raising the rate at the September 15 and 16 meeting could be appropriate. The text is published on the Federal Reserve site.RATES
  • The next day the Bureau of Labor Statistics reported 162,000 non-farm payrolls added in August, an unemployment rate of 4.1 percent and average hourly earnings up 0.3 percent on the month and 3.1 percent on the year. Waller had written that he did not expect the employment data to diverge much from the recent trend, and that his decision would rest mainly on August inflation.MACRO
  • The consequence for the week is one of sequence: Waller’s condition is tested on the consumer price index of Friday, September 11, and on the producer price index the day before, not on employment. The committee has been in its blackout period since September 5, so no member will comment on those readings in public before the decision.RATES
ORACLE AND ADOBE: TWO SETS OF RESULTS, ONE EVENING×
  • Oracle reports first-quarter fiscal 2027 results on Thursday, September 10 after the close, with the call at 4 p.m. Texas time, per the company release. $ORCL closed September 4 at 158.78 dollars, up 3.08 percent on the session and up 5.26 on the week.EARNINGS
  • Adobe reports third-quarter fiscal 2026 results the same evening, Thursday, September 10 after the close, with the call from 2 to 3 p.m. Pacific time, per the release of August 31, 2026. On September 3 the board announced that Anil Chakravarthy, currently head of Customer Experience Orchestration and of commercial operations, becomes president and chief executive from December 1, 2026, with Shantanu Narayen as executive chairman.EARNINGS
  • $ADBE closed September 4 at 266.51 dollars, down 6.73 percent in the session that followed the announcement and down 8.58 percent on the week, on Marketstack settlement data. The succession is a documented corporate fact; the reading the market gave it is a price change, and the two are kept separate here.STOCKS
MERLINTRADER WATCHLIST: WHERE TUESDAY RESTARTS×
  • Among the names followed here the widest weekly gain belongs to $ASTS, which closed September 4 at 62.31 dollars, up 7.34 percent from August 28; then $SLS at 13.86, up 4.92, $GERN at 1.57, up 3.97, and $OKLO at 41.27, up 2.82.STOCKS
  • On the downside $PLTR leads, closing at 174.33 dollars, down 4.49 percent in Friday’s session alone and down 6.42 on the week; $SOUN at 6.74, down 5.20; $BBAI at 2.92, down 4.26; $RYTM at 102.74, down 4.13; $ETON at 58.45, down 2.22.STOCKS
  • Close to unchanged on the week were $RKLB at 64.26 dollars, down 0.20 percent, $PDYN at 5.71, down 0.87, $UMAC at 23.76, down 0.92, and $ALDX at 1.48, down 0.34. These are Marketstack settlement closes for September 4, 2026; for none of these names did Merlintrader find a company release during the week that on its own explains the move, which should be read as market action.STOCKS
  • In semiconductors, beyond memory, Friday’s session saw $AMD close at 477.57 dollars, up 4.69 percent, and $INTC at 95.80, up 4.51 percent on the day and 7.07 on the week; $CRWV closed at 89.36, up 5.68 on the session, and $POET at 7.92 dollars, up 8.05 percent on Friday and 5.60 on the week.SEMIS
BIOTECH: SEPTEMBER’S CONFIRMED DATES×
  • The first confirmed date of the short week is Friday, September 11: the Food and Drug Administration decision on Telix’s Pixclara, a floretyrosine F 18 PET imaging agent for glioma, taken from the Merlintrader register, which ties it to a company filing with the Securities and Exchange Commission. $TLX closed September 4 at 11.94 dollars, up 5.76 percent on the week.BIOTECH
  • After Telix the register carries, in order, Ultragenyx on September 19 for UX111 in Sanfilippo syndrome type A, Merck on the 21st for the Winrevair label update, GRAIL on the 23rd for the Galleri test, Mirum on the 26th for zilurgisertib, Biofrontera on the 28th for Ameluz and Bristol Myers Squibb on the 30th for the Camzyos extension to adolescents. $RARE closed at 15.30 dollars, down 40.26 percent on the week; $MIRM at 100.90, up 3.53; $GRAL at 80.34, up 0.43; $BFRI at 1.61, up 1.26.CATALYSTS
  • Every date in the register carries the link to its own primary source and was re-verified on September 5, 2026. A decision can arrive ahead of the date, as Ionis did on September 3, or be postponed: the date is an agency target, not a promise of outcome. $XBI closed the week at 163.81 dollars, up 0.88 percent.CATALYSTS
EUROPE: THE ECB IN BERLIN AND THE SPREAD BELOW 90×
  • On Thursday, September 10 the Governing Council of the European Central Bank meets away from home, hosted by the Bundesbank in Berlin: the decision at 14:15 and the press conference at 14:45 Central European Time, per the ECB calendar. It arrives fifteen minutes before the United States producer price index and one day before United States August inflation.EUROPE
  • The spread between ten-year Italian and German government bonds closed the week between 82 and 83 basis points, with the ten-year BTP yield between 4.15 and 4.18 percent depending on the reading, and the euro around 1.162 dollars. Milan closed Friday, September 4 down 0.3 percent with the FTSE MIB at 52,100 points. These levels come from Italian market reporting, not from Marketstack settlement files.ITALY
  • On United States exchange-traded funds the euro-area proxy $FEZ closed at 70.65 dollars, down 0.99 percent on the week, $EFA at 108.35, up 0.58, and $EWJ on Japan at 98.28, up 2.51.EUROPE
CRUDE, GOLD, BITCOIN AND THE MORNING IN ONE LINE×
  • Crude closed the week with its widest gain since last July: Brent at 96.28 dollars a barrel on Friday, roughly 7.6 percent higher on the week, and WTI at 91.48, roughly 9.7 percent higher, on market readings carried in press coverage, with renewed military exchanges between the United States and Iran and restrictions in the Strait of Hormuz given as the causes. On Marketstack settlement data $USO closed at 141.96 dollars, up 9.45 percent, $XLE at 64.06, up 2.20, and $URA at 46.06, up 1.08.ENERGY
  • Gold ended the week slightly lower, with $GLD at 406.77 dollars, down 0.52 percent, and $TLT at 82.21, down 0.73. On the crypto side $IBIT closed at 45.23 dollars, down 2.42 percent on Friday and up 3.03 on the week, $MSTR at 142.80, up 12.17 on the week, and $COIN at 184.64, up 3.36.MARKETS
  • The morning in one line: three days without trading, an OPEC+ meeting in the middle, and then four sessions in which the Apple event of the 9th, the Oracle and Adobe results and the ECB of the 10th and United States inflation of the 11th arrive one after another, with Waller’s condition settled on the last of those readings and a committee that does not speak until September 16.BOTTOM LINE
  • Sourcing note. Equity and exchange-traded fund closes are Marketstack settlement data for September 4, 2026; session and weekly changes are a Merlintrader calculation on the September 3 and August 28 settlements respectively. The employment report and the PPI and CPI calendars come from the Bureau of Labor Statistics; the Waller remarks from the Federal Reserve site; the Oracle, Adobe and Apple dates from company releases and the Apple developer site; the ECB meeting from the ECB calendar; the OPEC+ meeting from the OPEC release of August 2, 2026; the biotech dates from the Merlintrader register. FTSE MIB levels, the spread, yields, the exchange rate and crude prices come from market reporting rather than exchange settlements.SOURCES
  • This content is provided for information and education only. It is not investment advice, a public solicitation of savings or a recommendation to buy or sell any security, in line with CONSOB and SEC guidance. Readers should carry out their own verification and consult an authorised adviser.DISCLAIMER
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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: September 2 → September 30, 2026. Compact homepage board for unresolved FDA decisions, regulatory submissions and major clinical readouts. A prior-date item remains visible only when a material result or regulatory action still needs one continuity update. October and later events are excluded from this widget.
Last verified: September 4, 2026.

27On board
9FDA / Reg
18Data / Filing
Sep 4Updated
FDA / PDUFA Clinical data Filing watch High risk Large cap
$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.

$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 ZANVASTRO / zilganersen Sep 3 Approved FDA approval arrived ahead of the former Sep 22 PDUFA

Ionis. On September 3, 2026, the FDA approved ZANVASTRO (zilganersen) for Alexander disease in pediatric and adult patients, making it the first and only disease-modifying treatment for the ultra-rare neurological disorder. The approval arrived ahead of the previously scheduled September 22 PDUFA date, so that date is no longer an unresolved catalyst. ZANVASTRO is administered intrathecally every 12 weeks and Ionis expects U.S. availability in the coming weeks. FDA also awarded a Rare Pediatric Disease Priority Review Voucher. Ex-U.S. rights remain licensed to Recordati, with European and Japanese regulatory submissions expected in 2027.

$STOK zorevunersen Sep 3 Data reported Four-year Dravet OLE data strengthen durability ahead of Phase 3 EMPEROR

Stoke Therapeutics / Biogen. On September 3 the companies reported four-year open-label-extension data for zorevunersen in Dravet syndrome showing substantial and durable seizure reductions together with continuing improvements in cognition and behaviour. New exploratory analyses also showed reductions in the most severe seizure types associated with SUDEP risk and quality-of-life improvement through 28 months. The programme has more than five years of clinical experience in some patients. The registrational question remains unresolved: data from the global randomized, double-blind, sham-controlled Phase 3 EMPEROR study are expected in Q3 2027 and are intended to complete the planned rolling U.S. NDA.

$CLYM CLYM116 Sep 3 Phase 1 data Long half-life and deep APRIL suppression support Q8W/Q12W IgAN dosing

Climb Bio. Initial Phase 1 data reported September 3 showed an approximately 29-day half-life for CLYM116 and deep, persistent pharmacodynamic activity. A single 320 mg dose produced near-complete APRIL suppression and roughly 60–75% reductions in IgA and Gd-IgA1 through 12 weeks. The company reported no serious adverse events, dose-limiting toxicities or hypogammaglobulinemia in the initial healthy-volunteer dataset. Phase 2 NAVIGATE-2 in IgA nephropathy is ongoing, with initial patient data expected in H1 2027; the September result therefore validates PK/PD and dosing strategy, not patient efficacy.

$APVO mipletamig triplet Sep 3 AML data 93% clinical-benefit rate in a 14-patient TP53-mutated frontline AML analysis

Aptevo Therapeutics. On September 3 the company reported clinical benefit in 13 of 14 evaluable frontline AML patients with TP53 mutations treated with the mipletamig plus venetoclax/azacitidine triplet. The signal is notable in a very difficult-risk population, but the dataset is small, open-label and non-randomized, so cross-trial comparisons should not be treated as head-to-head evidence. A separate September 3 SEC prospectus registered up to 6,444,858 common shares issuable on exercise of pre-funded, common and inducement warrants, versus 1,810,215 common shares outstanding before the offering, keeping financing and dilution risk central to the read-through.

$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 remains listed on FDA’s advisory-committee calendar for 9:00–18:00 ET in hybrid form. The public docket remains open through September 16; comments received by September 8 will be provided to the Committee before the meeting. Galleri is a blood-based multi-cancer early detection test proposed for adults aged 50 and older. This is a device/diagnostics catalyst rather than a drug PDUFA and is the first FDA advisory committee 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.

$QURE AMT-130 Sep 2 BLA submitted AMT-130 BLA filed; Priority Review requested; four-year data still due in Q3

uniQure. On September 2, 2026, uniQure submitted a U.S. BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington’s disease and simultaneously submitted a Marketing Authorisation Application to the U.K. MHRA. The company requested Priority Review; FDA now has the standard 60-day filing-review period before acceptance and any formal review clock are known. The applications are supported by the three-year Phase I/II analysis versus a propensity-score-matched Enroll-HD external control. uniQure still plans to present a four-year analysis from the ongoing Phase I/II programme before the end of Q3 2026, so the programme remains on the board for both filing acceptance and new clinical follow-up.

$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 + ruxolitinib Aug 31 sNDA filed Accelerated-approval filing submitted; Priority Review requested

Karyopharm. On August 31, 2026, the company submitted an sNDA seeking accelerated approval of XPOVIO (selinexor) plus ruxolitinib in myelofibrosis and requested Priority Review. The application is based on the Phase 3 SENTRY programme, including the spleen-volume response data and longer-term overall-survival follow-up intended to verify clinical benefit. FDA filing acceptance and the formal review timetable are now the next regulatory events; no PDUFA date has yet been assigned.

$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.

$IVVD VYD2311 / DECLARATION + LIBERTY End Q3 Data / filing path Topline remains due around quarter-end; the regulatory route is not yet selected

Invivyd. DECLARATION and LIBERTY are approaching completion, with topline data still expected around the end of the third quarter. The company is evaluating two possible regulatory paths after discussions with FDA: full unblinding followed by a traditional BLA, or partial unblinding followed by an accelerated-approval BLA based on antiviral activity and safety. Invivyd has not yet selected a route, and there is no public FDA confirmation that either path has been accepted. The company said further updates are expected within weeks.

$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 gotistobart / pumitamig Sep 14–15 WCLC data PRESERVE-003 OS update and first pumitamig/ADC combination data

BioNTech. Two distinct WCLC 2026 readouts are on the board. On September 14, a mini-oral presentation (MO07.04) will report updated overall survival from stage 1 of the Phase 3 PRESERVE-003 trial of gotistobart versus docetaxel in advanced squamous NSCLC after PD-(L)1 progression. On September 15, a late-breaking oral presentation (OA14.01) will provide the first lung-cancer data for pumitamig combined with the B7H3-targeted ADC elfetabart drozuntecan. These are separate assets and studies, not one combined Phase 3 event.

$SMMT ivonescimab / HARMONi Sep 15 WCLC data Detailed updated overall-survival follow-up before the November PDUFA

Summit Therapeutics. Additional detail from the June 2026 overall-survival update in the global Phase 3 HARMONi trial will be presented at WCLC on September 15, 2026, at 13:02–13:12 KST in session OA14, abstract OA14.05. Summit previously reported an overall-survival hazard ratio of 0.76 in both the intention-to-treat population and western subgroup at the June cut-off, without publishing the full statistical package. The presentation lands two months before the November 14 PDUFA goal date for ivonescimab plus chemotherapy in EGFR-mutated NSCLC after third-generation TKI progression.

$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

$NRXP$TLX$RARE$GRAL$MIRM$SRRK$PHVS$QURE$IMMX$KPTI$VERA$SMMT$RGNX

Board rule

Only future or still materially unresolved catalysts through September are shown; a newly resolved event can remain for one continuity update. $IONS/ZANVASTRO is corrected from a September 22 PDUFA to FDA approval on September 3, with U.S. launch expected in the coming weeks. $QURE/AMT-130 is corrected from a planned Q3 filing to a BLA submitted on September 2, with Priority Review requested and four-year data still due before quarter-end. $STOK, $CLYM and $APVO join for one continuity cycle after material September 3 clinical updates. $GRAL now carries the correct FDA public-comment timetable: the docket closes September 16, while comments received by September 8 are forwarded to the advisory committee. $PTGX/MIMRYLO, $ROIV/LISRAYA, $ALMS/LUMUS and $NVS/remibrutinib roll off after their prior continuity update. $KPTI remains because filing acceptance and the formal review timetable are still open. Month-only and quarter-only windows remain company guidance, not exact FDA or readout 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.