Merlintrader’s Daily Briefing
Tuesday, July 14, 2026 — evening wrap. Wall Street shook off the morning’s risk-off tone and finished higher after a cooler-than-expected June inflation report eased Fed rate-hike fears. The S&P 500 rose 0.38% to 7,543.59, the Nasdaq Composite added 0.9% to 26,107.01 and the Dow edged up 9.63 points (+0.02%) to 52,508.27, with semiconductors leading and strong big-bank earnings offsetting a roughly 25% collapse in IBM. Crude stayed firmly bid as the U.S. reimposed its blockade on Iran.
- Close— The S&P 500 rose 0.38% to 7,543.59, the Nasdaq Composite gained 0.9% to 26,107.01 and the Dow added 9.63 points (+0.02%) to 52,508.27.Indices
- Comeback— Indexes reversed a lower open, with the S&P and Nasdaq clawing back Monday’s losses as the soft CPI print reset rate expectations.Reversal
- Semis— Chip stocks led the advance, rebounding from the memory-driven selloff that had dominated the prior session.Chips
- Headline— June CPI rose 3.5% year over year, below the roughly 3.8% consensus and matching the lowest annual pace since 2020.Macro
- Monthly— Prices fell a seasonally adjusted 0.4% on the month, an unexpectedly strong decline led by lower gasoline.Macro
- Read— The soft print cooled Fed rate-hike bets and gave growth and rate-sensitive names room to rally.Rates
Weekly Biotech Catalyst Tracker
Window covered: July 14 → September 30, 2026. Compact homepage board for FDA decisions, advisory committees, regulatory submissions and major clinical readouts. October and later events are excluded from this widget.
$CELCgedatolisibJul 17PDUFA
HR+/HER2- breast cancerCelcuity. NDA PDUFA for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer. Priority Review makes this one of the nearest important small/mid-cap oncology binaries.
$MNKDFUROSCIX ReadyFlowJul 26sNDA
Autoinjector / edemaMannKind. PDUFA for the FUROSCIX ReadyFlow autoinjector sNDA for edema in adults with chronic heart failure or chronic kidney disease.
$OTLKLYTENAVAJul 29Risk
Wet AMD resubmissionOutlook Therapeutics. Class 1 resubmitted BLA PDUFA for LYTENAVA / ONS-5010 in wet AMD. Prior FDA rejection history keeps this high risk.
$CAPRderamiocel panelJul 29AdCom
Panel before Aug PDUFACapricor. FDA advisory committee for deramiocel in Duchenne muscular dystrophy cardiomyopathy. Panel tone and briefing documents are the key pre-PDUFA read-through.
$REPLRP1 panelJul 30AdCom
Melanoma panel reviewReplimune. FDA advisory committee for RP1 plus nivolumab in advanced melanoma after anti-PD-1 therapy. Single-arm evidence risk remains central.
$REPLRP1Aug 2PDUFA
Melanoma BLA resubmissionReplimune. BLA resubmission goal date for RP1. This is a very compressed AdCom-to-PDUFA setup with elevated regulatory risk.
$MRNAmFLUSIVAAug 5PDUFA
mRNA seasonal fluModerna. BLA PDUFA for mRNA seasonal flu vaccine candidate in adults 50+. More platform and lifecycle read-through than pure small-cap binary.
$REGNgaretosmabAugFDA
FOP ultra-rare diseaseRegeneron. BLA target action month for garetosmab in adult fibrodysplasia ossificans progressiva. Month-only calendar item.
$LNTHMK-6240Aug 13NDA
Tau PET imagingLantheus. NDA PDUFA for MK-6240 tau PET imaging in Alzheimer’s disease. Diagnostic/imaging catalyst, not a therapeutic efficacy binary.
$CAPRderamiocelAug 22PDUFA
DMD cardiomyopathyCapricor. BLA PDUFA for deramiocel in Duchenne muscular dystrophy cardiomyopathy. Prior CRL history and July AdCom make this highly binary.
$RAREDTX401Aug 23BLA
GSDIa gene therapyUltragenyx. Priority Review BLA PDUFA for DTX401 in glycogen storage disease type Ia. First of two near-term Ultragenyx gene-therapy decisions.
$BIIBLeqembi IQLIKAug 24sBLA
SC starting doseBiogen / Eisai. sBLA PDUFA for once-weekly subcutaneous Leqembi starting-dose use. Large-cap Alzheimer’s lifecycle catalyst.
$JAZZZiihera comboAug 25sBLA
1L HER2+ GEAJazz Pharmaceuticals. sBLA PDUFA for Ziihera combination use in first-line HER2-positive gastroesophageal adenocarcinoma.
$GILDBIC/LENAug 27NDA
Once-daily HIV regimenGilead. NDA PDUFA for bictegravir/lenacapavir in virologically suppressed adults. Strategic HIV franchise catalyst.
$PTGXrusfertideQ3PDUFA
Polycythemia veraProtagonist / Takeda. Priority Review NDA window for rusfertide in polycythemia vera. Exact date not pinned in this compact board.
$NUVLzidesamtinibSep 18NDA
ROS1+ NSCLCNuvalent. NDA PDUFA for zidesamtinib in ROS1-positive non-small-cell lung cancer. Important targeted-oncology regulatory event.
$RAREUX111Sep 19Risk
Sanfilippo A gene therapyUltragenyx. Resubmitted BLA PDUFA for UX111 in Sanfilippo syndrome type A. CMC and facility risk remain the key swing factors.
$IONSzilganersenSep 22NDA
Alexander diseaseIonis. NDA PDUFA for zilganersen in Alexander disease. Rare neurological disease Priority Review event.
$BFRIAmeluz PDTSep 28sNDA
Superficial BCC expansionBiofrontera. PDUFA for Ameluz photodynamic therapy sNDA seeking expansion into superficial basal cell carcinoma. Small-cap liquidity can amplify reaction.
$SRRKapitegromabSep 30BLA
Spinal muscular atrophyScholar Rock. BLA PDUFA for apitegromab in spinal muscular atrophy. Manufacturing and fill-finish facility status remain key watch items.
$ROIVbrepocitinibQ3NDA
DermatomyositisPriovant / Roivant. NDA Priority Review window for brepocitinib in dermatomyositis. Company has pointed to potential launch timing by end-September if approved.
$QUREAMT-130Q3BLA
Huntington’s AA pathuniQure. Planned BLA submission for AMT-130 in Huntington’s disease. Not a PDUFA, but one of the most important regulatory-pathway events in the quarter.
$SLNdivesiranAugData
SANRECO Phase 2 PVSilence Therapeutics. SANRECO Phase 2 topline data for divesiran in polycythemia vera. Important read-through alongside $PTGX / Takeda rusfertide.
$IMMXNXC-201Q3Data
AL amyloidosisImmix Biopharma. NEXICART-2 topline data for NXC-201 in relapsed/refractory AL amyloidosis. BLA-enabling study, high-volatility small-cap setup.
$KPTIselinexorNearData
Endometrial cancer Ph3Karyopharm. XPORT-EC-042 Phase 3 topline data for selinexor in endometrial cancer. Treat as near-term until released or formally delayed.
$KODDAYBREAKQ3Data
Wet AMD Phase 3Kodiak Sciences. DAYBREAK Phase 3 topline data for tarcocimab / KSI-501 in wet AMD. Watch efficacy, durability, dosing interval and safety.
$ALMSenvudeucitinibQ3Data
SLE Phase 2bAlumis. LUMUS Phase 2b readout for envudeucitinib in systemic lupus erythematosus. Autoimmune data can be noisy; dose response matters.
$IVVDVYD2311Q3Data
DECLARATION pivotalInvivyd. DECLARATION pivotal / Phase 3 topline data for VYD2311. COVID-antibody sentiment can be unstable, but pivotal data can still move the name.
$MPLTML-007C-MAMid-AugData
ZEPHYR schizophrenia Ph2MapLight Therapeutics. Phase 2 ZEPHYR topline results for ML-007C-MA in schizophrenia. CNS readout with potentially sharp binary reaction.
$AMLXavexitideQ3Ph3
PBH pivotal LUCIDITYAmylyx. Phase 3 LUCIDITY topline results for avexitide in post-bariatric hypoglycemia. One of the clearest Phase 3 clinical binaries of the quarter.
$PHVSdeucrictibant ERQ3Ph3
HAE prophylaxis Ph3Pharvaris. Phase 3 CHAPTER-3 data for extended-release deucrictibant as prophylaxis for hereditary angioedema. Major HAE readout.
$SYRESPY003Q3Data
IBD / UC Phase 2Spyre Therapeutics. Phase 2 SKYLINE Part A topline data for SPY003 in inflammatory bowel disease and ulcerative colitis.
$VERATrutakna / ataciceptQ3eGFR
ORIGIN 3 follow-upVera Therapeutics. ORIGIN 3 eGFR analysis following accelerated approval. Not another approval decision, but important for durability and confirmatory confidence.
$OCGNOCU410STQ3Data
Stargardt interim analysisOcugen. Interim OCU410ST analysis after 24 patients complete eight months of follow-up in Stargardt disease. Small-cap ophthalmology catalyst.
$XENEazetukalnerQ3NDA
Focal-onset seizures filingXenon. Expected NDA submission for azetukalner in focal-onset seizures. Filing confirmation would set up future FDA acceptance and PDUFA timing.
$BBIOinfigratinibQ3NDA
Achondroplasia filingBridgeBio. Expected NDA submission for infigratinib in achondroplasia. Submission timing and acceptance will define the next regulatory leg.
$CLNNCNM-Au8Q3NDA
ALS accelerated pathwayClene. Targeted NDA submission for CNM-Au8 in ALS through an accelerated pathway. Very high regulatory strategy risk because submission does not guarantee acceptance.
$OCGNOCU400Q3BLA
Rolling BLA startOcugen. Expected start of rolling BLA submission for OCU400 in retinitis pigmentosa. Filing progress, manufacturing and future acceptance are the next watch items.
$MLTXsonelokimabLate SepBLA
HS filing watchMoonLake. Planned BLA submission for sonelokimab in hidradenitis suppurativa around the end of September. Acceptance would create the next formal FDA calendar item.
Most attention-worthy watchlist
Board rule
Only July–September catalysts are shown. October and later events are intentionally excluded from this compact homepage widget. Resolved decisions are removed from the active board: $SNY Sarclisa SC was approved on July 10, ahead of its original July 23 target date. Events with only Q3 guidance are included, but should be rechecked against company filings before trading around them.
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.
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