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
Thursday, August 13, 2026, evening edition, written with the U.S. session in its final stretch. Wholesale prices did what consumer prices did on Wednesday: nothing. The July producer price index was flat against a consensus that looked for a rise, and the tape kept the same shape it has held all week, with the semiconductor complex carrying the index while the Dow sits still. The counterweight is a batch of earnings that were good on the numbers and bad on the reaction: Cisco, Cerebras and Coherent all beat and all fell. Applied Materials closes the semiconductor equipment reporting season after the bell. Crude gave ground for a second day as the International Energy Agency cut its demand picture for the year. Index and stock levels below are intraday marks taken at about 2:05 p.m. Eastern and will move before the bell.
- $SPY — The S&P 500 tracker is at $776.87, up 0.57%, a third consecutive session of gains that keeps the index within reach of its record.Equities
- $QQQ — The Nasdaq-100 fund is at $732.23, up 1.18%, twice the move of the broad market and the same gap that has defined every session this week.Equities
- $DIA — The Dow tracker is at $537.11, unchanged to a hundredth of a percent. The blue-chip index has now gone four sessions without a direction.Equities
- $SMH — The semiconductor tracker is at $595.40, up 1.81%, again the strongest sector move of the day and again the reason the two headline indices disagree.Semis
- $IWM — Small caps are at $303.28, up 0.19%. The Russell 2000 fund is participating without leading, which has been the pattern since the start of the month.Small caps
- $XBI — Biotech is the exception: the sector fund is at $157.81, down 0.99%, with $IBB at $199.57, down 0.57%.Biotech
- Producer prices — The July producer price index for final demand was unchanged on a seasonally adjusted basis. The Dow Jones consensus looked for a 0.2% rise. Final demand prices edged down 0.1% in June.Macro
- The composition — Final demand goods fell 0.7% while services rose 0.2% and construction advanced 2.2%. Energy prices dropped 3.1% and foods fell 0.9%, which is where the entire offset came from.Macro
- Twelve months — On an unadjusted basis final demand rose 4.7% for the twelve months ended in July.Macro
- Jobless claims — Initial claims were 209,000 in the week ending August 8, an increase of 9,000 from a previous week revised up to 200,000. The four-week moving average held at 199,000.Macro
- Insured unemployment — Continuing claims fell 22,000 to 1,777,000 for the week ending August 1, with the insured unemployment rate unchanged at 1.2%.Macro
- $CSCO — Cisco is at $112.76, down 8.98%, after a record fiscal fourth quarter. Revenue was $17.3 billion, up 18%, with non-GAAP earnings per share of $1.22. Hyperscaler artificial-intelligence infrastructure orders reached $9.3 billion for the fiscal year and management guides to roughly $7.5 billion of related revenue in fiscal 2027. Adjusted gross margin fell to 66.3% from 68.4% as hardware took a larger share of the mix.Earnings
- $CBRS — Cerebras is at $227.72, down 13.10%, after a second quarter that missed on revenue. UBS lifted its price target to $330 and called the reaction a buying opportunity, while other desks trimmed.AI
- $COHR — Coherent is at $335.18, down 5.75%, despite an artificial-intelligence-driven fourth-quarter beat and raise that prompted Jefferies, Morgan Stanley and Rosenblatt to lift targets as high as $500.Semis
- $TPR — Tapestry is at $129.35, down 15.86%. The company beat fiscal fourth-quarter estimates and announced a $1.7 billion shareholder return plan with $1.35 billion of buybacks and a 16% dividend increase, but the guidance disappointed.Consumer
- Elsewhere in earnings — $STUB is at $7.39, down 13.52%, with second-quarter revenue up 33% on World Cup demand and a raised gross-merchandise outlook but unchanged adjusted profit guidance. $BIRK is at $41.40, up 12.70%, after raising full-year growth guidance to 15%.Earnings
- $AMAT — Applied Materials reports fiscal third-quarter results after the bell, with the call at 4:30 p.m. Eastern. Company guidance put revenue at a midpoint of $8.95 billion and non-GAAP earnings per share at $3.36; consensus sits near $9.0 billion and $3.38. The stock is at $559.62, up 2.09%.Semis
- What it settles — Management has projected more than 30% growth in semiconductor equipment and more than 50% in packaging for 2026. This is the last of the equipment names to report and the one that either confirms or breaks that framing.Semis
- $OMER — Omeros is at $17.01, up 24.07%, the largest move in the sector today. Second-quarter revenue was $28.5 million with earnings per share of $0.15 as the YARTEMLEA launch turned the quarter profitable.Biotech
- $ADCT — ADC Therapeutics is at $1.04, down 15.04%. Second-quarter revenue was $19.2 million, of which $18.6 million was product revenue, and operating expenses fell 29% to $44.7 million. The move came from the regulatory update: after an early-August pre-sBLA meeting, the final minutes record substantial agency concerns over the benefit-risk profile of the Phase 3 LOTIS-5 trial, citing an imbalance in Grade 5 events against what the agency characterised as a marginal treatment benefit. The company says it is reassessing the regulatory path. LOTIS-5 had met its primary endpoint of progression-free survival in June.Biotech
- $ZBIO — Zenas BioPharma is at $28.05, down 10.37%, on a second-quarter loss, and the same release confirmed that the FDA has accepted the obexelimab application in IgG4-related disease with a target action date of May 27, 2027. A European filing is planned for the second half of 2026.PDUFA
- $ABEO — Abeona is at $6.39, down 14.34%. ZEVASKYN revenue rose 31% sequentially to $11.4 million, but management described launch cadence as constrained by operational and manufacturing variability and earnings missed at a loss of $0.35 per share.Biotech
Biotech Catalyst Calendar 2026
Last updated: 22 July 2026Merlintrader 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.
Weekly Biotech Catalyst Tracker
Window covered: August 8 → 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. October and later events are excluded from this widget.
$NRXPKETAFREEOngoingFDA review
First-cycle review complete; vial certification remainsNRx Pharmaceuticals. The July 29 GDUFA goal date has passed, but the file is no longer accurately described as having “no outcome.” On August 7, NRx reported that FDA completed the first-cycle review of the ANDA for preservative-free intravenous ketamine with no major deficiencies related to the drug product, ingredients, proposed labeling, CMC or other drug-related matters. One major deficiency remains tied to the container-closure system: manufacturer certification concerning the luer-lock vial tip. Following an August 6 clarification meeting, FDA requested signed documentation and, according to the company, intends to review it in the shortest applicable cycle. No new exact action date has been disclosed.
$REGNgaretosmabAugBLA
Priority Review in adult FOPRegeneron. The BLA for garetosmab in adults with fibrodysplasia ossificans progressiva remains under Priority Review. Regeneron continues to guide to an FDA decision in August 2026 without disclosing an exact day.
$LNTHMK-6240Aug 13NDA
Tau PET imaging in Alzheimer’s diseaseLantheus. PDUFA target date for the MK-6240 NDA. The F-18 PET imaging agent is intended to visualize tau pathology in Alzheimer’s disease. This is a diagnostic and imaging catalyst, not a therapeutic-efficacy binary.
$BMYiberdomide comboAug 17NDA
RRMM · iberdomide + daratumumab/dexamethasoneBristol Myers Squibb. Priority Review PDUFA for iberdomide combined with daratumumab and dexamethasone in relapsed or refractory multiple myeloma. The application also has Breakthrough Therapy Designation for this indication.
$CAPRderamiocelAug 22Extreme risk
PDUFA after 9–3 negative AdCom efficacy voteCapricor. The resubmitted BLA for deramiocel in Duchenne muscular dystrophy-associated cardiomyopathy remains formally under review with an August 22 action date. On July 29, the advisory committee voted 9–3 that the available evidence did not provide the required substantial evidence of effectiveness. FDA is not bound by the vote, but the negative panel result, disputes over endpoint interpretation and the prior CRL make this an exceptionally high-risk regulatory event.
$RAREDTX401Aug 23BLA
Gene therapy for GSDIaUltragenyx. Priority Review PDUFA for the DTX401 (pariglasgene brecaparvovec) BLA in glycogen storage disease type Ia. The company reaffirmed the August 23 date in its August 4 update.
$JAZZZiihera comboAug 25sBLA
First-line HER2-positive GEAJazz 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.
$GILDBIC/LENAug 27NDA
Once-daily oral HIV regimenGilead. 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.
$PTGXrusfertideAugNDA
Priority Review in polycythemia veraProtagonist / Takeda. The rusfertide NDA in polycythemia vera is under Priority Review with a publicly disclosed August 2026 PDUFA goal month. Because no independently verifiable exact day has been published, this board correctly shows the month only.
$TLXPixclaraSep 11NDA
PET imaging in gliomaTelix Pharmaceuticals. PDUFA target date for the resubmitted Pixclara (TLX101-Px) NDA. The PET imaging agent is intended to help characterize suspected recurrent or progressive glioma versus treatment-related changes.
$RAREUX111Sep 19BLA
Gene therapy for Sanfilippo syndrome type AUltragenyx. 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.
$MRKWINREVAIRSep 21sBLA
PAH · HYPERION-based label updateMerck. 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.
$IONSzilganersenSep 22NDA
Alexander diseaseIonis. 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.
$GRALGalleriSep 23FDA panel
AdCom on the multi-cancer MCED test PMAGRAIL. 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.
$MIRMzilurgisertibSep 26NDA
FOP · patients aged 12 and olderMirum 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.
$BFRIAmeluz PDTSep 28sNDA
Expansion into superficial BCCBiofrontera. 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.
$SRRKapitegromabSep 30BLA
SMA · review continues with second fill-finish siteScholar 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.
$ROIVbrepocitinibQ3NDA
Dermatomyositis · Priority ReviewPriovant / 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.
$QUREAMT-130Q3BLA
Accelerated-approval BLA filing in Huntington’s diseaseuniQure. 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.
$SLNdivesiranAugData
SANRECO Phase 2 in polycythemia veraSilence Therapeutics. Phase 2 SANRECO topline data for divesiran in polycythemia vera are expected in August. The readout also provides a particularly relevant class comparison with rusfertide from $PTGX / Takeda.
$TENXTNX-103AugPhase 3
Registrational LEVEL study · PH-HFpEFTenax Therapeutics. Topline results from the registrational Phase 3 LEVEL study of TNX-103, oral levosimendan, in pulmonary hypertension associated with heart failure with preserved ejection fraction are expected in August 2026. The results are also scheduled for a Late-Breaking Clinical Science presentation at ESC on August 29.
$EYPTDURAVYU / LUGANOAugPhase 3
Pivotal wet AMD toplineEyePoint. Phase 3 LUGANO topline data for DURAVYU (vorolanib intravitreal insert) in wet age-related macular degeneration are expected in August 2026. LUGANO is the first of two fully enrolled global pivotal trials comparing six-month DURAVYU dosing with on-label aflibercept; LUCIA is expected to read out in the fourth quarter. Key variables include visual-acuity noninferiority, supplemental anti-VEGF use, anatomy and ocular safety.
$IMMXNXC-201Late SepData
NEXICART-2 · AL amyloidosisImmix 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.
$KPTIselinexor comboAugsNDA
Selinexor + ruxolitinib filing in myelofibrosisKaryopharm. 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.
$KODDAYBREAKSepPhase 3
Wet AMD · Zenkuda and KSI-501Kodiak 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.
$ALMSenvudeucitinibQ3Data
LUMUS Phase 2b in SLEAlumis. 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.
$IVVDVYD2311Q3Data
DECLARATION pivotal studyInvivyd. Topline data from the pivotal Phase 3 DECLARATION study of VYD2311 are expected in the third quarter of 2026. The timing remains company guidance rather than a calendar-specific date.
$AMLXavexitideLate Aug / early SepPhase 3
Pivotal LUCIDITY study in PBHAmylyx. Topline results from the pivotal Phase 3 LUCIDITY study of avexitide in post-bariatric hypoglycemia are now expected in late August or early September 2026. The last participant has completed the final visit in the double-blind treatment period.
$PHVSdeucrictibant XRQ3Phase 3
CHAPTER-3 · HAE prophylaxisPharvaris. 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.
$SYRESPY003SepData
SKYLINE Phase 2 in ulcerative colitisSpyre Therapeutics. SPY003 Part A topline data from the Phase 2 SKYLINE study in ulcerative colitis are expected in September 2026, according to the company’s August 4 update.
$VERATRUTAKNA / ataciceptQ3eGFR
ORIGIN 3 confirmatory follow-upVera 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.
$XENEazetukalnerQ3NDA
Focal-onset seizure filingXenon. 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.
$BBIOinfigratinibQ3NDA
Achondroplasia filingBridgeBio. The company intends to submit the infigratinib NDA in achondroplasia in the third quarter. The immediate catalyst is the submission; FDA acceptance and any PDUFA date would follow.
$CLNNCNM-Au8Q3NDA
Accelerated pathway in ALSClene. The company continues to target a third-quarter NDA submission for CNM-Au8 in amyotrophic lateral sclerosis through an accelerated-approval pathway. Regulatory risk remains high: a planned submission is not the same as FDA filing acceptance or approval.
$MLTXsonelokimabLate SepBLA
Hidradenitis suppurativa filingMoonLake. 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
Board rule
Only future or still materially unresolved catalysts through September are shown. $NRXP remains because first-cycle review of the KETAFREE ANDA ended with a residual container-closure certification request and no new exact action date. $SVRA has been removed because FDA extended the MOLBREEVI PDUFA date to November 22, 2026, outside this board. Resolved events for $REPL, $MRNA, $BIIB and $GSK/zidesamtinib have been removed, as have $MPLT’s completed ZEPHYR readout and the former Q3 $OCGN items now guided to 2027. For $KPTI, the completed endometrial-cancer readout has been replaced by the planned August myelofibrosis sNDA. The September 23 $GRAL/Galleri panel and the August $TENX LEVEL and $EYPT LUGANO readouts are included. Month-only and quarter-only windows reflect disclosed company guidance and are not exact FDA dates.
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.
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