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.

Merlintrader’s Daily Briefing

Friday, August 21, 2026, evening wrap written at 2:00 p.m. in New York, two hours before the closing bell. The week that broke the long end of the Treasury curve is ending with a bid under almost everything except semiconductors: the retail brokers and the bitcoin proxies are up high single to double digits, gold has added better than two per cent, uranium had the best sector session on the board, and the Dow is still heading for its worst week since March. American prices below are Finviz Elite prints taken at 2:00 p.m. New York time and are not closing levels; they will move before the bell.

Where the session stands at 2 p.m.
  • The four proxies — $SPY is 0.40 per cent higher at 765.68, $QQQ 0.37 per cent higher at 713.59, $DIA 0.76 per cent higher at 531.52 and $IWM 0.71 per cent higher at 299.78. The Dow proxy is leading and the Nasdaq proxy is trailing, the mirror image of most of this week.Indices
  • Against what it is bouncing — Thursday was the worst day in three weeks: the S&P 500 fell 0.9 per cent for its fourth loss in the five sessions since its record, the Dow dropped 703 points or 1.3 per cent and the Nasdaq Composite lost 1 per cent. Today’s move recovers part of one session, not the week.Context
  • The long end has not turned — $TLT is 0.46 per cent lower at 81.97, a fifth consecutive session of pressure on long-dated paper. The thirty-year yield set a nineteen-year high earlier in the week and the buyback announcement has not reversed it.Rates
Bessent doubled the buyback and said it could go further
  • What was said — The Treasury Secretary told CNBC on Thursday that the department had doubled the size of its long-dated buyback operations from $2 billion to at least $4 billion per issue, and that the figure could go higher depending on conditions. He declined to name a ceiling.Treasury
  • What it has bought so far — One session of relief on Wednesday, given back on Thursday. The long end is lower again today while equities rise, which is the opposite of the pattern the buyback was meant to produce.Reading
Bitcoin, the Clarity Act and the brokers
  • The move — Bitcoin traded as high as $79,241 today, its best level since June, up roughly 8 per cent over twenty-four hours and about 24 per cent over seven days, before easing back toward $77,900.Crypto
  • The flows behind it — United States spot bitcoin funds took in $606 million on Thursday, the largest daily inflow since May 1 and up from $517 million the day before, taking the week to about $1.6 billion and combined assets above $85 billion against roughly $70 billion in June. BlackRock’s IBIT accounted for $502.99 million of Thursday’s total, more than eighty per cent.ETF flows
  • And the political leg — President Trump met crypto industry executives, including Coinbase and Payward, and pressed the Senate to pass the Clarity Act, the market structure bill that has stalled over a dispute about its ethics provisions. The bill is not law.Policy
  • Where it shows on the tape — $HOOD is 14.16 per cent higher at $108.57, $COIN 8.29 per cent higher at $186.64 and $MSTR 6.69 per cent higher at $119.91. These are the three largest single-name moves on our watchlist today.Movers
Off-price beat the bellwether
  • $ROST — Up 5.82 per cent at $242.31 in the regular session, confirming the after-hours reaction to Thursday evening’s quarter: sales up 13 per cent to $6.265 billion, comparable store sales up 10 per cent, and full-year earnings guided to $8.61 to $8.77 a share. Source: company release.Earnings
  • $WMT — Down a further 0.78 per cent at $103.04 after Thursday’s 9.15 per cent fall, its worst single day in four years, on United States comparable sales excluding fuel of 2.6 per cent against an expected 3.8. Two retailers, the same tariff refund, opposite comparable lines.Consumer
Gold and the miners keep going
  • The metal — Gold futures were quoted 1.44 per cent higher at $4,637.10 an ounce in the early session, with spot readings between roughly $4,577 and $4,634 depending on the source and the hour. The backdrop is the federal debt crossing forty trillion dollars this week.Metals
  • The equity leg — $GLD is 2.17 per cent higher at 424.27, $SLV 2.01 per cent higher at 62.90 and the miners in $GDX 3.02 per cent higher at 102.87. Mining equity is outrunning the metal again, as it has for most of August.Miners
Iran, the blockade and the crude premium
  • Where crude sits — West Texas Intermediate was quoted at $86.75 and Brent at $93.64 in the early session, both marginally lower on the day but on course for a second consecutive weekly gain. $USO is 0.58 per cent higher at 2 p.m.Oil
  • Why the premium is there — Washington has the blockade back in place and has threatened the heaviest financial penalties yet on Iranian exports; the Treasury Secretary said maximum economic pressure makes a large-scale military restart less likely. Tehran called its response to further threats devastating, and finalised a preferential trade agreement with Oman.Geopolitics
  • The energy equity did not follow — $XLE is 0.12 per cent lower, $XOP 1.10 per cent higher and $COP unchanged at $134.85. A supply premium in the barrel is not translating into a re-rating of the producers.Energy
Uranium had the best sector session on the board
  • The prints — $URA is 4.30 per cent higher at 45.73, $CCJ 5.68 per cent higher at $101.02, $SMR 4.76 per cent higher at $9.50, $LEU 3.95 per cent higher at $183.10 and $OKLO 1.70 per cent higher at $42.37.Uranium
  • The caveat — No company release dated today explains the move on any of these names. It is a sector bid, and sector bids without a document behind them are the ones that reverse fastest.Reading
Biotechnology bounced, semiconductors did not
  • The sector — $XBI is 1.52 per cent higher at 165.87, $IBB 1.45 per cent higher at 213.88, $XLV 1.37 per cent higher and $ARKG 3.76 per cent higher at 49.43, the strongest of the healthcare proxies.Biotech
  • $MRNA — Up 7.44 per cent at $143.24 after two sessions of give-back that took it from an intraday $155.00 on Thursday to a $133.32 close. The mRNA cancer story is being repriced daily in both directions.Volatility
  • Our names — $ETON is 4.00 per cent higher at $62.31 and $TVTX 2.76 per cent higher at $66.24, both without a company release today.Watchlist
  • Chips went the other way — $SMH is 0.21 per cent lower, $NVDA 0.37 per cent lower at $216.06 with results due next week, and $MRVL 4.99 per cent lower at $238.49 after Thursday’s jump on the Google custom-chip reporting.Semis
Broadcom is borrowing against the build
  • The size — $AVGO is in talks with lenders over a debt package reported at upwards of $70 billion and in some accounts as much as $100 billion, structured around a senior tranche near $45 billion and a junior tranche near $35 billion. Blackstone and Apollo are among the parties in discussion. Reported by CNBC and Bloomberg; no filing has been made.AI credit
  • What it funds — An extension of the $35 billion partnership announced in June with Apollo and Blackstone to expand Anthropic’s computing capacity on Broadcom custom silicon, against a stated target of more than 20 gigawatts of compute for leading laboratories by 2028. $AVGO is 0.78 per cent higher at $366.87.Compute
Space, defence and the speculative tail
  • Space — $ARKX is 1.28 per cent higher, $ASTS 5.13 per cent higher at $68.40, $LUNR 4.91 per cent higher at $18.81 and $RKLB 1.52 per cent higher at $74.06, a partial recovery after a week in which the whole complex fell together.Space
  • Defence stayed flat — $ITA is 0.15 per cent higher at 237.93, barely off Thursday’s level and the weakest of the thematic proxies this week. $BBAI is 4.40 per cent higher at $3.21 and $PDYN 1.07 per cent higher at $6.17.Defence
  • The tail ran — $IONQ is 7.73 per cent higher at $44.74, $QBTS 7.29 per cent higher at $20.17 and $PLTR 3.09 per cent higher at $179.33. High-beta names lead when long-duration risk gets a bid, and they lead on the way down too.High beta
The macro print and the regulatory one
  • Flash PMI — The S&P Global flash United States manufacturing PMI for August came in at 53.2, below the 53.9 expected and down from the 53.8 recorded in July. Still above the fifty line that separates expansion from contraction.Macro
  • Uber — The Dutch data protection authority fined $UBER 825 million euros, about 966 million dollars, for automated suspensions of driver accounts between 2020 and 2022 without adequate human oversight. It is the second-largest penalty issued under the GDPR. Uber has said it strongly disagrees and will appeal.Regulation
Bottom line
  • What the week established — A Treasury that doubled its buybacks could not hold the long end for more than a session, and the market has spent the rest of the week deciding what to own without cheap long-dated money. The answer today is gold, uranium, the crypto brokers and anything with a policy headline behind it. The answer is not semiconductors, not defence and not the retail bellwether.Bottom line
  • What lands next — Nvidia reports next week and is the single largest weight on the AI trade. The Clarity Act sits in the Senate. The Treasury’s next buyback operation is the test of whether four billion dollars an issue is enough.Calendar
What could not be verified
  • Method and limits — All American equity and fund levels are Finviz Elite prints at 2:00 p.m. New York time on August 21 and are not closing prices. Crude, gold and silver figures are quoted prices from the early session, not settlements. Bitcoin levels and fund flows come from market reporting, not from a fund issuer document. The August flash PMI figure is taken from press coverage of the S&P Global release; the release itself was not yet posted on the S&P Global press page when this was written. The Broadcom debt package is press reporting only, with no filing behind it, and the reported size varies by source between roughly 60 and 100 billion dollars.Method
Read the full Daily BriefingRead the Weekly 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 21 → 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.

28On board
16FDA / Reg
12Data / Filing
Aug 21Updated
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, NRx reported that FDA 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, while the KETAFREE filing included testing of more than 3,500 vials from seven manufactured lots without observed luer-lock failures. On August 17, NRx confirmed that the requested manufacturer attestation had been submitted to FDA. No new exact action date has been disclosed.

$REGN Pasatru Aug 19 Approved Second FDA-approved treatment for FOP

Regeneron. On August 19, 2026 the FDA approved Pasatru (garetosmab-grts) to reduce the formation of new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva, closing the August decision window the company had guided to without naming a day. Approval was based on the Phase 3 OPTIMA trial, which showed a 90 to 94 per cent reduction in new heterotopic ossification lesions and a decrease in flare-ups at 56 weeks. Pasatru is a fully human monoclonal antibody directed against activin A. The recommended starting dose is 10 mg/kg infused intravenously over 60 minutes once every four weeks, reducible to 3 mg/kg where the higher dose is not tolerated, and it can be administered across a range of care settings including home infusion. FDA describes it as the second approved treatment for FOP.

$CAPR deramiocel Aug 22* Extension expected BLA remains active; new 24-month data amendment planned

Capricor. The resubmitted deramiocel BLA remains under FDA review following the July 29 advisory committee vote of 9–3 against the sufficiency of the efficacy evidence for DMD-associated cardiomyopathy. Capricor subsequently said it plans to submit a BLA amendment incorporating 24-month HOPE-3 open-label-extension data and additional analyses focused on upper-limb function. The company has said FDA is willing to review the new information and that the August 22 deadline will be extended after the amendment is received. Until FDA or Capricor formally announces the revised action date, August 22 remains the last published PDUFA date but should no longer be treated as a fixed final-decision deadline.

$RARE GENGLYCOS Aug 19 Approved Accelerated approval four days ahead of the August 23 PDUFA

Ultragenyx. On August 19, 2026 the FDA granted accelerated approval to GENGLYCOS (pariglasgene brecaparvovec-opnr), previously known as DTX401, in adults and children aged eight years and older with glycogen storage disease type Ia. The decision landed four days before the August 23 PDUFA goal date the company had reaffirmed on August 4. The approved indication is narrower than the disease itself: the FDA label (STN 125858) covers the reduction of daily cornstarch intake as an adjunct to nutritional management, and continued approval may depend on verification of clinical benefit in confirmatory trials. The therapy can only be given to patients with no detectable anti-AAV8 antibodies, and the label carries warnings for hypersensitivity and infusion reactions, adrenal insufficiency and a theoretical risk of tumorigenicity from vector DNA integration. Approval rests on the 48-week randomised, double-blind, placebo-controlled Phase 3 GlucoGene study, which treated 46 participants and showed a statistically significant reduction in daily raw cornstarch requirements; the modified intention-to-treat population comprised 44 participants, 20 on DTX401 and 24 on placebo. It is the first gene therapy approval in the company history and its fifth FDA approval overall, and it carried a Priority Review Voucher.

$JAZZ Ziihera combo Aug 25 sBLA First-line HER2-positive GEA

Jazz Pharmaceuticals. Priority Review PDUFA for the Ziihera (zanidatamab-hrii) sBLA in combination with chemotherapy, with or without tislelizumab, for first-line locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.

$GILD BIC/LEN Aug 27 NDA Once-daily oral HIV regimen

Gilead. Priority Review PDUFA for the bictegravir 75 mg/lenacapavir 50 mg NDA, a once-daily single-tablet regimen for virologically suppressed adults with HIV. This is a strategic lifecycle catalyst for the HIV franchise.

$PTGX rusfertide Q3 NDA Priority Review in polycythemia vera

Protagonist / Takeda. The rusfertide NDA in polycythemia vera is under Priority Review and no decision has been announced as of August 21. The joint Takeda and Protagonist announcement of the FDA filing acceptance, dated March 2, 2026, places the PDUFA goal date in the third quarter of 2026 without naming a month or a day, so the board shows the quarter rather than August. Rusfertide also holds Breakthrough Therapy, Orphan Drug and Fast Track designations. The submission rests on the Phase 3 VERIFY study together with the Phase 2 REVIEW 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 PDUFA goal date for the resubmitted Pixclara (TLX101-Px) NDA. The application has already been submitted and accepted for review; the September catalyst is therefore the FDA decision on that NDA, not the NDA filing itself. Pixclara is a PET imaging agent intended to help characterize suspected recurrent or progressive glioma versus treatment-related changes.

$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. The company reaffirmed September 19 in its August 4 update; the application seeks accelerated approval.

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

Merck. PDUFA for an sBLA seeking a U.S. label update for WINREVAIR (sotatercept-csrk) based on the Phase 3 HYPERION study in pulmonary arterial hypertension. Merck reaffirmed the September 21 date with its second-quarter results.

$IONS zilganersen Sep 22 NDA Alexander disease

Ionis. Priority Review PDUFA for the zilganersen NDA in Alexander disease, a rare progressive neurological disorder. It remains one of September’s most closely watched rare-disease regulatory catalysts.

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

GRAIL. FDA’s Molecular and Clinical Genetics Panel will meet on September 23 to discuss and vote on the Galleri premarket approval application. Galleri is a blood-based multi-cancer early detection test proposed for screening adults aged 50 and older. This is not a drug PDUFA; it is a device and diagnostics regulatory catalyst that is nevertheless material to the stock.

$MIRM zilurgisertib Sep 26 NDA FOP · patients aged 12 and older

Mirum Pharmaceuticals / Incyte. Priority Review PDUFA for the zilurgisertib NDA in fibrodysplasia ossificans progressiva in patients aged 12 years and older. Mirum holds exclusive worldwide rights under license from Incyte.

$BFRI Ameluz PDT Sep 28 sNDA Expansion into superficial BCC

Biofrontera. PDUFA for the Ameluz photodynamic-therapy sNDA in superficial basal cell carcinoma. FDA completed its filing review without identifying filing deficiencies and assigned September 28 as the target action date.

$SRRK apitegromab Sep 30 BLA SMA · review continues with second fill-finish site

Scholar Rock. The apitegromab BLA in spinal muscular atrophy remains targeted to September 30. On August 7, the company said that, in coordination with FDA, Catalent Indiana is being removed from the BLA and review is continuing using the second fill-finish facility; the related data package is under review. CMC and manufacturing risk therefore remain central, while the company continues to state that the action date is unchanged.

$ROIV brepocitinib Q3 NDA Dermatomyositis · Priority Review

Priovant / Roivant. The brepocitinib NDA in dermatomyositis is under Priority Review. The company has disclosed a PDUFA target action date in the third quarter of 2026 and, if approved, has pointed to a possible U.S. launch around the end of September. No exact PDUFA day has been made public.

$QURE AMT-130 Q3 BLA Accelerated-approval BLA filing in Huntington’s disease

uniQure. The company is preparing an AMT-130 BLA in Huntington’s disease after alignment with FDA on a pathway that may use comparison with an external control as the primary basis of the application. The submission remains a Q3 2026 catalyst; it is not a PDUFA, and FDA filing acceptance would be the next formal step.

$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. The program is designed as BLA-enabling/registrational, and subsequent follow-up is expected to contribute to the regulatory path.

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

Karyopharm. The former XPORT-EC-042 endometrial-cancer catalyst is resolved: on July 30, the study did not meet its primary progression-free-survival endpoint. The active event is now the sNDA the company plans to submit in August for selinexor combined with ruxolitinib in myelofibrosis, with a request for Priority Review.

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

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. The study evaluates Zenkuda (tarcocimab tedromer) and KSI-501 in parallel against aflibercept.

$ALMS envudeucitinib Q3 Data LUMUS Phase 2b in SLE

Alumis. Phase 2b LUMUS results for envudeucitinib in systemic lupus erythematosus are expected in the third quarter. For an autoimmune readout, the market will assess not only statistical significance but also dose consistency, clinical endpoints and the safety profile.

$IVVD VYD2311 Late Q3 Data DECLARATION pivotal study

Invivyd. Topline data from the pivotal DECLARATION study of VYD2311 are expected approximately toward the end of the third quarter of 2026. The timing remains company guidance rather than a calendar-specific date.

$PHVS deucrictibant XR Q3 Phase 3 CHAPTER-3 · HAE prophylaxis

Pharvaris. Phase 3 CHAPTER-3 topline data for extended-release deucrictibant in hereditary-angioedema prophylaxis remain expected in the third quarter of 2026. This is one of the quarter’s most important registrational HAE readouts.

$SYRE SPY003 Sep Data SKYLINE Phase 2 in ulcerative colitis

Spyre Therapeutics. SPY003 Part A topline data from the Phase 2 SKYLINE study are expected in September 2026. The company has now specified September rather than only the broader third-quarter window; no exact day has been disclosed.

$VERA TRUTAKNA / atacicept Q3 eGFR ORIGIN 3 confirmatory follow-up

Vera Therapeutics. The ORIGIN 3 eGFR analysis is expected in the third quarter following accelerated approval of atacicept. This is not another approval decision; its significance lies in the durability of the renal effect and the read-through for the confirmatory pathway.

$XENE azetukalner Q3 NDA Focal-onset seizure filing

Xenon. The azetukalner NDA submission in focal-onset seizures remains on track for the third quarter. Filing confirmation would begin FDA’s filing-review stage and set up a later PDUFA assignment.

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

BridgeBio. BridgeBio confirmed on August 10, 2026 that it had submitted the NDA for oral infigratinib in achondroplasia to FDA. The former Q3 “submission” catalyst has therefore occurred. The program remains on the board because the regulatory process is materially open: FDA filing acceptance and any subsequent PDUFA assignment are now the next formal milestones. Infigratinib has Breakthrough Therapy, Fast Track and Rare Pediatric Disease designations in the United States.

$MLTX sonelokimab Late Sep BLA Hidradenitis suppurativa filing

MoonLake. The sonelokimab BLA submission in hidradenitis suppurativa is expected around the end of September 2026. FDA filing acceptance would create the next formal regulatory event.

Most attention-worthy watchlist

$NRXP $CAPR $RARE $PTGX $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. Two FDA approvals landed on August 19 and both stay on the board for now: $RARE/GENGLYCOS, cleared four days ahead of its August 23 PDUFA, and $REGN/Pasatru, which closed the August decision window Regeneron had guided to without naming a day. $AMLX/LUCIDITY has rolled off after one update; the August 18 Phase 3 readout was positive on the primary endpoint and on all secondary endpoints, and Amylyx still guides to an NDA by the end of 2026. $EYPT/LUGANO has been removed after EyePoint reported the readout on August 17; the full dataset did not meet the primary BCVA noninferiority endpoint, although an ad hoc analysis excluding nine patients supported noninferiority and several secondary measures were favorable. $TENX/LEVEL has been removed after the August 10 Phase 3 readout failed both the primary 6MWD endpoint and the key KCCQ-TSS secondary endpoint. $SLN/SANRECO has been removed after the August 10 positive Phase 2 results. $BMY/iberdomide has been removed after FDA granted accelerated approval to ZENBEXUS on August 13. $LNTH/TAUKLARIFY, approved on August 14, has also rolled off the board. $CLNN has been removed because Clene moved the planned CNM-Au8 ALS NDA submission to early Q4 2026, outside this widget. $NRXP remains because the requested manufacturer vial attestation has now been submitted to FDA but no new exact action date has been disclosed. $CAPR remains because the BLA review is still open. The August 22 date falls tomorrow and no revised action date has been announced as of August 21; the most recent company statement on the planned 24-month HOPE-3 amendment is the August 13 second-quarter update, in which Capricor said FDA had indicated it was willing to review the amendment and to extend the action date once it is received. $BBIO remains because the infigratinib NDA was submitted on August 10 and filing acceptance is now the next formal regulatory milestone. For $SYRE, company guidance now specifies September 2026 for SPY003. $PTGX moves from August to Q3 because the only primary-source statement on the rusfertide goal date, the March 2 filing-acceptance announcement, says third quarter of 2026 and names neither a month nor a day. $KPTI stays on an August window: as of its August 13 second-quarter update Karyopharm was on track to submit the selinexor plus ruxolitinib sNDA during August with a request for Priority Review, and no announcement confirming the submission has been found. 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.