FDA Calendar 2026
The complete biotech catalyst calendar: PDUFA dates (FDA decision deadlines), clinical trial readouts, and advisory committee meetings. Last updated: August 11, 2026 (v43 — evening run: removed MRK Keytruda+Padcev MIBC (approved July 10), added BLTE tinlarebant Feb 12, NVO Mim8 day 13 pending) — NVO Mim8 day 13 pending, garetosmab month-only. No new entries or approvals Aug 7-11.) A PDUFA date is the deadline Congress set for the FDA to act on a drug application — it's the most predictable catalyst in biotech.
What is a PDUFA date? The Prescription Drug User Fee Act date is the deadline by which the FDA must complete its review of a drug application (BLA or NDA).
It's not a guarantee of approval — but it's a guarantee of a decision. Binary risk, binary reward.
🗓️ Upcoming PDUFA Dates
| Date | Company | Drug / Candidate | Indication | What to Watch |
|---|---|---|---|---|
| Jul 29, 2026 | Novo Nordisk NVO | Denecimig (Mim8) | Hemophilia A (with/without inhibitors) | BLA for first FVIIIa mimetic with flexible monthly/biweekly/weekly SC dosing. FRONTIER program. Competes with the Roche drug Hemlibra. First FVIIIa mimetic for patients without inhibitors. PDUFA was July 29 — outcome STILL not announced as of Aug 11 evening run (13 days overdue, 9 business days). drugs.com unchanged (FDA Approved: No). NVO Q2 call Aug 5: management "continues to anticipate" decision. No FDA review extension publicly announced. No NVO press releases since July 31. ~80% PoA per dansfera. FDA What is New page updated Aug 10 (GDUFA) — no Mim8 entry. No new FDA novel drug approvals since Orzeyful (#30, Aug 5). MRK Keytruda+Padcev MIBC entry removed (approved July 10). Belite Bio tinlarebant STGD1 added (PDUFA Feb 12, 2027). |
| Aug 13, 2026 | Lantheus Holdings LNTH | MK-6240 (florquinitau F-18) | PET imaging — tau pathology in Alzheimer disease | F18-labeled tau-targeted PET imaging agent. Fast Track. Two pivotal Phase 3 trials met sensitivity/specificity endpoints. Would complement amyloid PET for treatment selection. |
| Aug 17, 2026 | Bristol Myers Squibb BMY | Iberdomide + daratumumab/dexamethasone | Relapsed/refractory multiple myeloma | CELMoD immunomodulatory agent + anti-CD38. Competing in crowded myeloma space with J&J and Pfizer bispecifics. |
| Aug 20, 2026 | Landos Biopharma / Ji Xing — | Omilancor | Ulcerative colitis (UC) | Oral gut-restricted LANCL2 agonist. Standard Review, Fast Track. ~85% PoA. First-in-class mechanism for mild-to-moderate UC. |
| Aug 22, 2026 | Capricor Therapeutics CAPR | Deramiocel (CAP-1002) | DMD cardiomyopathy | Allogeneic cardiosphere-derived cell therapy. FDA rescinded prior CRL. CTGTAC AdComm July 29 voted 9-3 AGAINST approval — FDA briefing docs said efficacy not demonstrated, shares crashed 65%. ~67% PoA. First-in-class for DMD cardiac disease. PDUFA leans toward rejection after negative panel vote. |
| Aug 23, 2026 | Ultragenyx Pharmaceutical RARE | DTX401 (pariglasgene breparpovec) | Glycogen Storage Disease Type Ia | AAV8 gene therapy. Priority Review, Orphan Drug. ~93% PoA. One-time treatment for rare metabolic disorder. |
| Aug 25, 2026 | Jazz Pharmaceuticals JAZZ | Ziihera (zanidatamab-hrii) | First-line HER2+ metastatic GEA | sBLA for Ziihera combinations in first-line HER2+ gastroesophageal adenocarcinoma. Priority Review. Already approved in biliary tract cancer — expanding into larger GEA market. |
| Aug 25, 2026 | Xspray Pharma XSPRAY.ST | Dasynoc (dasatinib amorphous) | CML and ALL (resubmission) | Improved formulation of dasatinib (Sprycel) with 30% lower dose via better solubility. NDA resubmission after prior CRL. Swedish-listed company. Competes with original Sprycel. Compatible with proton pump inhibitors. |
| Aug 27, 2026 | Gilead Sciences GILD | Bictegravir / lenacapavir | HIV-1 treatment | Oral two-drug HIV regimen combining integrase + capsid inhibitor. Expands the Gilead HIV franchise with novel mechanism combination. |
| Aug 28, 2026 | ITM Isotope Technologies — | 177Lu-edotreotide (ITM-11) | Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) | Targeted radiopharmaceutical. Phase 3 COMPETE trial showed longer PFS and higher ORR vs everolimus. Competes in radiopharma space alongside Novartis Pluvicto. |
| Aug 30, 2026 | PharmaEssentia PCXA | BESREMi (ropeginterferon alfa-2b-njft) sBLA | Essential thrombocythemia (ET) | Label expansion from PV to ET — a rare blood cancer with no new FDA-approved therapies in 20+ years. Standard Review. Taiwan already approved in ET. SURPASS-ET Phase 3 supportive. |
| Sep 3, 2026 | Advicenne — | Sibnayal (ADV7103) | Distal renal tubular acidosis (dRTA) | Already approved in EU and GB for dRTA. US NDA submitted Nov 2025. Rare kidney disorder — no US-approved therapy specifically for dRTA. Extended-release potassium citrate formulation. 6-year safety data. |
| Sep 11, 2026 | Telix Pharmaceuticals — | Pixclara (floretyrosine F 18; TLX101-Px) | PET imaging — glioma (brain cancer) | F18-labeled amino acid PET imaging agent for glioma. NDA resubmitted. Differentiates true progression from treatment-related changes. Australian radiopharma company. |
| Sep 19, 2026 | Ultragenyx Pharmaceutical RARE | UX111 (rebisufligene etisparvovec) | Sanfilippo syndrome Type A (MPS IIIA) | AAV9 gene therapy, one-time IV infusion. Accelerated approval pathway. Addresses underlying SGSH enzyme deficiency. RMAT, Fast Track, Rare Pediatric Disease, Orphan Drug. First potential therapy for fatal pediatric neurodegenerative disease. ~$27 stock. |
| Sep 19, 2026 | IntraBio — | Aqneursa (levacetylleucine) sNDA | Ataxia-telangiectasia (A-T) | Label expansion of already-approved NPC drug into A-T. Priority Review. Phase 3 met all endpoints. Would be first FDA-approved treatment for A-T — rare progressive neurodegenerative disorder. Private company. |
| Sep 22, 2026 | Ionis Pharmaceuticals IONS | Zilganersen | Alexander disease (AxD) | RNA-targeted medicine for rare, fatal neurological condition. Priority Review, Breakthrough Therapy, Orphan Drug, Rare Pediatric Disease. No approved therapies exist for Alexander disease. ~$56 stock, ~$9B market cap. |
| Sep 26, 2026 | Mirum Pharmaceuticals MIRM | Zilurgisertib (ALK2 inhibitor) | Fibrodysplasia ossificans progressiva (FOP) | In-licensed from Incyte. Priority Review. Pivotal Phase 2 PROGRESS study positive. FOP is ultra-rare — no approved therapies. ~$113 stock, ~$7B market cap. |
| Sep 27, 2026 | Elevar Therapeutics ELEV | Lirafugratinib (RLY-4008) | FGFR2 fusion+ cholangiocarcinoma (previously treated) | Selective oral FGFR2 inhibitor. Priority Review, Breakthrough Therapy, Orphan Drug. Phase 2 ReFocus: 46.5% ORR. Licensed from Relay Therapeutics. Competes with Pemazyre and Lytgobi. ~$0.36 stock — micro-cap binary bet. |
| Sep 28, 2026 | Egetis Therapeutics EGTX.ST | Emcitate (tiratricol) | MCT8 deficiency (Allan-Herndon-Dudley syndrome) | Priority Review. Already approved in EU (Feb 2025). Breakthrough Therapy, Orphan Drug, Fast Track, Rare Pediatric Disease. Eligible for Priority Review Voucher. First US treatment for rare X-linked neurological disorder. Swedish-listed company. |
| Sep 28, 2026 | Biofrontera BFRI | Ameluz-PDT (aminolevulinic acid 10% gel) sNDA | Superficial basal cell carcinoma (sBCC) | sNDA to expand Ameluz photodynamic therapy from actinic keratosis into superficial BCC. Standard Review. sNDA accepted Feb 11, 2026 with no filing deficiencies. Would be first FDA-approved topical PDT for sBCC. German/US dermatology company. |
| Sep 30, 2026 | Scholar Rock SRRK | Apitegromab | Spinal muscular atrophy (add-on) | Anti-myostatin antibody. First-in-class add-on to SMN therapies. Breakthrough Therapy, Orphan Drug. ~67% PoA. |
| Sep 30, 2026 | Priovant / Roivant Sciences ROIV | Brepocitinib | Dermatomyositis | Dual TYK2/JAK1 inhibitor. First in class for dermatomyositis. Priority Review, Orphan Drug, BT Therapy. ~93% PoA. |
| Sep 30, 2026 | Bristol Myers Squibb BMY | Camzyos (mavacamten) sNDA | Obstructive HCM (adolescents 12-<18) | Priority Review. First cardiac myosin inhibitor for adolescents with oHCM. Phase 3 SCOUT-HCM met primary endpoint. Already approved in adults — 25K+ U.S. patients. NEJM-published. |
| Oct 4, 2026 | Merck / Eisai MRK | WELIREG (belzutifan) + LENVIMA (lenvatinib) | Advanced RCC (post-PD-1/PD-L1) | Two sNDAs for dual oral regimen. Phase 3 LITESPARK-011: 30% reduction in risk of progression or death vs cabozantinib. First HIF-2alpha + TKI combo Phase 3 win in post-immunotherapy RCC. WELIREG already approved as monotherapy in this setting. |
| Oct 10, 2026 | Daiichi Sankyo / Merck MRK | I-DXd (ifinatamab deruxtecan) | Extensive-stage small cell lung cancer (previously treated) | B7-H3-directed ADC. Priority Review, Breakthrough Therapy. Phase 2 IDEATE-Lung01 data. SCLC has low 5-year survival — significant unmet need. First-in-class B7-H3 ADC. |
| Oct 20, 2026 | Regeneron REGN | Pozelimab | VEXAS syndrome | Complement C5 inhibitor. First-in-class for VEXAS — a rare autoinflammatory disease described in 2020. BT Therapy, Orphan Drug. ~93% PoA. |
| Oct 15, 2026 | Genentech / Roche RHHBY | Enspryng (satralizumab) sBLA | Thyroid eye disease (TED) | Expanding Enspryng (already approved for NMOSD) into TED. Phase 3 SatraGO-1/2 met proptosis and diplopia endpoints. First at-home SC disease-modifying therapy for TED. Competes with Tepezza (teprotumumab, IV). Priority Review. ~155 per 100,000 prevalence. |
| Oct 17, 2026 | Opus Genetics / Viatris IRD | Ryzumvi (phentolamine 0.75%) sNDA | Presbyopia | Expanding approved Ryzumvi (mydriasis reversal) into presbyopia. Phase 3 VEGA-2/3 met all endpoints. Reduces pupil diameter via sympatholytic mechanism, preserves distance vision. 20-hour sustained effect. ~90% of US adults over 45 have presbyopia. Viatris commercializes in US. |
| Oct 24, 2026 | Pharming Group PHAR | Joenja (leniolisib) sNDA | APDS (children 4-11) | sNDA resubmission after CRL for analytical methods. Expanding approved Joenja (12+) to children 4-11 with APDS, a rare primary immunodeficiency. Phase 3 met lymphadenopathy and naive B cell endpoints. 40/50 mg dosing for patients >=27 kg. Separate sNDA for lower-weight children planned later 2026. |
| Oct 26, 2026 | GSK / Ionis GSK | Bepirovirsen | Chronic hepatitis B (functional cure) | First antisense oligonucleotide for CHB. Breakthrough Therapy, Priority Review. Phase 3 B-Well 1/2: 19-20% functional cure vs 0% placebo. 26% cure in lower HBsAg subgroup. Current SOC cures <1%. GSK peak sales >2B GBP. IONS earns 10-12% royalties. 250M patients worldwide. Content team has published pre-catalyst analysis. |
| Oct 29, 2026 | Sun Pharma SUNPHARMA | ILUMYA (tildrakizumab-asmn) sBLA | Psoriatic arthritis (active) | sBLA label expansion from plaque psoriasis (approved 2018) into psoriatic arthritis. INSPIRE-1/2 Phase 3 trials supportive. Would be first IL-23 inhibitor with HCP-administered option for PsA. 1 in 3 psoriasis patients develop PsA. Priority Review. |
| Oct 30, 2026 | INOVIO Pharmaceuticals INO | INO-3107 | Recurrent Respiratory Papillomatosis (RRP) | DNA medicine under accelerated approval. Orphan Drug, Breakthrough Therapy. FDA: no AdComm planned. RRP causes airway tumors requiring repeated surgery — no approved therapies. ~$0.97 stock, ~$80M market cap binary bet. |
| Nov 1, 2026 | Agios Pharmaceuticals AGIO | Mitapivat (PYRUKYND) sNDA | Sickle cell disease (SCD) anemia | Pyruvate kinase activator. Accelerated approval pathway based on RISE UP Phase 3 transfusion burden reduction. REIGNITE Phase 3 confirmatory trial enrolling. Already approved for thalassemia. SCD market void after Oxbryta withdrawal (Sept 2024, hepatotoxicity). First PK activator in SCD if approved. ~$31 stock. |
| Nov 14, 2026 | Cytokinetics CYTK | MYQORZO (aficamten sNDA) | Obstructive HCM (monotherapy) | sNDA for aficamten as beta-blocker monotherapy alternative. Fast Track. ~92% PoA. |
| Nov 14, 2026 | Summit Therapeutics SMMT | Ivonescimab + chemo | EGFR-mutated NSCLC (post-TKI) | PD-1 x VEGF bispecific. Updated OS data (HR 0.76) de-risks PDUFA. Fast Track. ~80% PoA. |
| Nov 17, 2026 | Beren Therapeutics — | Adrabetadex | Infantile-onset Niemann-Pick disease type C (I-NPC) | Intrathecal cyclodextrin therapy. FDA extended review by 3 months. EAP ongoing. First therapy to directly target NPC pathophysiology. Private company. |
| Nov 22, 2026 | Savara SVRA | Molbreevi (molgramostim inhalation) | Autoimmune pulmonary alveolar proteinosis (aPAP) | Extended from Aug 22 to Nov 22 — FDA classified info-request responses as major amendment. No safety/efficacy concerns. First potential therapy for aPAP. ~$5.51 stock, ~$1.2B market cap. |
| Nov 25, 2026 | Sanofi SNY | Venglustat | Type 3 Gaucher disease (neurological) | Oral brain-penetrant glucosylceramide synthase inhibitor. Priority Review, Breakthrough Therapy, Fast Track, Orphan Drug. Phase 3 LEAP2MONO met primary endpoint vs imiglucerase. First disease-modifying therapy for GD3 neurological manifestations. |
| Nov 27, 2026 | Nuvalent / GSK GSK | Neladalkib (NVL-655) | ALK-positive NSCLC (TKI-pretreated) | Brain-penetrant ALK-selective inhibitor. Priority Review, Breakthrough Therapy. ALKOVE-1 Phase 1/2 data. Nuvalent acquired by GSK (July 2026). Competes with Pfizer Lorbrena. |
| Nov 27, 2026 | BridgeBio Pharma BBIO | BBP-418 (povelvertide) | Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) | Oral therapy. Priority Review. Phase 3 FORTIFY positive. First treatment for LGMD2I/R9 — progressive muscle disease with no approved therapies. ~$84 stock, ~$13.5B market cap. |
| Nov 27, 2026 | Zydus Lifesciences ZYDU.NS | Saroglitazar | Primary Biliary Cholangitis (PBC) | Priority Review. Phase 3: 56.7% biochemical response vs 9.8% placebo. Already approved in India. Competes with Intercept Ocaliva. Indian-listed company (NSE: ZYDU). U.S. launch planned by March 2027 if approved. |
| Nov 30, 2026 | Vertex Pharmaceuticals VRTX | Povetacicept | IgA nephropathy | Dual BAFF/APRIL inhibitor. Accelerated approval pathway. Phase 3 showed meaningful proteinuria reductions. VRTX diversifies into IgAN — competes with Vera Trutakna (atacicept, approved July 2026). |
| Nov 30, 2026 | Cogent Biosciences COGT | Bezuclastinib + sunitinib | GIST (imatinib-pretreated) | Selective KIT D816V inhibitor + sunitinib for second-line GIST. Phase 3 PEAK: mPFS 16.5 vs 9.2 months (HR 0.50, p<0.0001). ORR 46% vs 26%. First treatment to beat an active comparator in GIST. Breakthrough Therapy, RTOR. No AdComm planned. Separate NDA from NonAdvSM (PDUFA Dec 30). First new second-line GIST therapy in 20+ years. |
| Dec 12, 2026 | Vanda Pharmaceuticals VNDA | Imsidolimab | Generalized Pustular Psoriasis (GPP) | Anti-IL-36 receptor antibody. Vanda licensed from AnaptysBio. GPP is a rare, potentially fatal autoinflammatory skin condition. GEMINI trials showed no disease flares. Would compete with Boehringer Spevigo (approved Sep 2022). ~$5.18 stock, ~$312M market cap. |
| Dec 18, 2026 | Deciphera / ONO Pharmaceutical — | Tirabrutinib | Relapsed/refractory primary CNS lymphoma (R/R PCNSL) | Selective second-generation BTK inhibitor. Accelerated approval pathway. Already approved in Japan as Velexbru. No FDA-approved therapies specifically for R/R PCNSL. Deciphera acquired by ONO Pharmaceutical (June 2024). |
| Dec 22, 2026 | Mineralys Therapeutics MLYS | Lorundrostat | Resistant hypertension | Aldosterone synthase inhibitor. First-in-class for resistant hypertension. Fast Track. ~85% PoA. |
| Dec 23, 2026 | Gilead Sciences / Arcellx GILD | Anito-cel (anitocabtagene autoleucel) | Relapsed/refractory multiple myeloma (4L+) | BCMA-directed CAR-T cell therapy. Phase 2 iMMACE-1 pivotal. Gilead acquiring Arcellx for up to $7.8B. Competes with J&J Carvykti, BMS Abecma. Gilead/Kite positioning as potential best-in-class BCMA CAR-T. |
| Dec 27, 2026 | Praxis Precision Medicines PRAX | Relutrigine | SCN2A/SCN8A developmental epileptic encephalopathies | Sodium channel blocker for rare severe genetic epilepsies. Priority Review, Breakthrough Therapy, Orphan Drug. ~93% PoA. FDA extended review by 3 months from Sept 27 to Dec 27, 2026. No approved therapies specifically target these sodium channel epilepsies. |
| Dec 30, 2026 | Cogent Biosciences COGT | Bezuclastinib | NonAdvanced Systemic Mastocytosis | Selective KIT D816V inhibitor. Pivotal SUMMIT trial: 95.4% achieved >=50% tryptase reduction. FDA: no AdComm planned, no review issues identified. GIST NDA also filed (PDUFA Nov 30). |
| Dec 30, 2026 | Saol Therapeutics — | SL1009 (sodium dichloroacetate / DCA) | Pyruvate dehydrogenase complex deficiency (PDCD) | NDA resubmission (Class 2) after prior CRL. Priority Review, Orphan Drug, Rare Pediatric Disease. Anticipates Priority Review Voucher. Companion diagnostic (510k) with Medosome Biotec. No FDA-approved therapies for PDCD — ultra-rare life-threatening mitochondrial disease. Private company. |
| Jan 4, 2027 | Nuvation Bio NUVB | IBTROZI (taletrectinib) sNDA | ROS1-positive NSCLC (updated data) | sNDA with updated TRUST-I and TRUST-II data. TKI-naive mDOR and mPFS exceeding 4 years. Already approved — sNDA adds updated duration of response data. ~$6.42 stock. |
| Jan 21, 2027 | Dyne Therapeutics DYN | Zeleciment rostudirsen (DYNE-251) | DMD amenable to exon 51 skipping | PMO-Fab conjugate for muscle-targeted delivery. Priority Review, BT Therapy, Fast Track, Rare Pediatric Disease, Orphan Drug. Accelerated approval based on dystrophin surrogate. DELIVER trial: 5.46% dystrophin (~10x eteplirsen). Functional improvement across 6 endpoints. ~$24 stock. |
| Jan 29, 2027 | Praxis Precision Medicines PRAX | Ulixacaltamide (PRAX-944) | Essential tremor (adults) | T-type calcium channel inhibitor. First therapy specifically designed for essential tremor. Priority Review, BT Therapy, Fast Track. Essential3 Phase 3 program. No AdComm planned. ~90% PoA. |
| Feb 12, 2027 | Belite Bio BLTE | Tinlarebant (LBS-008) | Stargardt Disease Type 1 (STGD1) | Oral RBP4 inhibitor. Priority Review, Breakthrough Therapy, Fast Track, Rare Pediatric Disease, Orphan Drug. First-ever treatment for STGD1 if approved — rare inherited retinal disease affecting ~53K US patients. Reduces bisretinoid toxin accumulation. ~$178 stock. |
| Feb 27, 2027 | Cullinan / Taiho CGEM | Zipalertinib (CLN-081) | EGFR exon 20 insertion NSCLC (previously treated) | Oral EGFR TKI designed for ex20ins mutations. Breakthrough Therapy. Phase 2b REZILIENT1 met ORR primary endpoint. Competes with J&J Rybrevant and Exkivity (withdrawn). First targeted ex20ins therapy if approved. ~$17 stock. |
| Feb 28, 2027 | BioMarin Pharmaceutical BMRN | Voxzogo (vosoritide) sNDA | Achondroplasia (full approval conversion) | sNDA to convert accelerated approval to full approval. Largest long-term efficacy/safety dataset in achondroplasia. Already approved — sNDA fulfills postmarketing requirement. ~$59 stock. |
| Feb 28, 2027 | Sarepta Therapeutics SRPT | Amondys 45 + Vyondys 53 (sNDAs) | DMD exon 45/53 skipping (accelerated-to-full approval) | sNDAs to convert accelerated approvals to traditional approvals. ESSENCE Phase 3 missed primary endpoint; supported by real-world evidence. Already approved drugs — conversion removes accelerated-approval contingency. 1800+ patients treated worldwide. ~$16 stock, ~$1.7B market cap. |
| Feb 28, 2027 | Apnimed APMD | AD109 / Oxnimbi (aroxybutin + atomoxetine) | Obstructive sleep apnea (OSA) | Fixed-dose oral combination targeting neuromuscular root cause of upper airway collapse. Fast Track. First potential oral pharmacotherapy for OSA — no FDA-approved oral drug exists. Phase 3 SynAIRgy and LunAIRo both met primary AHI reduction endpoint (1300+ patients). ~80M US patients. APMD IPO priced July 30, 2026 at $16/share. Major shareholder: Shionogi. |
| Mar 22, 2027 | Merck MRK | ENFLONSIA (clesrovimab) sBLA | RSV (children <2 at increased risk) | sBLA expanding already-approved ENFLONSIA from infants in first RSV season to children under 2 at increased risk through second RSV season. SMART trial supported. sBLA accepted Aug 6, 2026. |
| Apr 23, 2027 | Pharvaris PHVS | Deucrictibant IR | Hereditary angioedema (on-demand) | Oral bradykinin B2 receptor antagonist for on-demand treatment of HAE attacks. Priority Review. RAPIDe-3 Phase 3 positive. First oral on-demand HAE therapy if approved. ~$34 stock. |
| Apr 24, 2027 | Organogenesis ORGO | ReNu | Knee osteoarthritis pain | Cryopreserved amniotic suspension allograft. BLA with RMAT designation. Three large RCTs (1300+ patients). First regenerative medicine therapy for knee OA if approved. ~$2.39 stock. |
| Apr 28, 2027 | Immunome IMNM | Varegacestat | Desmoid tumors (adults) | Oral gamma-secretase inhibitor. NDA accepted July 8, 2026. No FDA-approved therapies specifically for desmoid tumors. First targeted oral therapy for this rare tumor type if approved. ~$23 stock, ~$2.6B market cap. |
| May 1, 2027 | Axsome Therapeutics AXSM | AXS-12 (reboxetine) | Cataplexy in narcolepsy | Oral selective norepinephrine reuptake inhibitor. Orphan Drug. Phase 3 SYMPHONY met primary endpoint. FDA not planning AdComm. First targeted cataplexy therapy if approved. N/A stock price (Polygon free tier). |
| May 8, 2027 | BridgeBio Pharma BBIO | Encaleret | Autosomal dominant hypocalcemia type 1 (ADH1) | Oral calcium-sensing receptor modulator. Phase 3 CALIBRATE met all primary and key secondary endpoints. First and only therapy specifically for ADH1 if approved. FDA not planning AdComm. ~$84 stock, ~$16B market cap. |
| May 13, 2027 | Bristol Myers Squibb BMY | Mezigdomide + carfilzomib/dexamethasone (MeziKd) | Relapsed/refractory multiple myeloma | Oral CELMoD agent. Phase 3 SUCCESSOR-2: mPFS 18.0 vs 8.3 months (HR 0.48). Second CELMoD NDA from BMS alongside iberdomide (PDUFA Aug 17, 2026). N/A stock price (Polygon free tier). |
🔬 Clinical Trial Milestones
Upcoming clinical data readouts. Phase 3 is the make-or-break stage; Phase 1 data can move stocks if safety and early efficacy surprise.
| Company | Drug / Candidate | Phase | Indication | Expected Data | What to Watch |
|---|---|---|---|---|---|
| Editas Medicine EDIT | EDIT-301 (reni-cel) | Phase 1/2 | Sickle cell disease | Q3 2026 | Updated hematopoietic stem cell data. Quick comparison vs. Casgevy (Vertex/CRISPR). |
| Moderna MRNA | mRNA-1345 (mRESV) | Phase 3 | RSV (pediatrics) | Q3 2026 | First RSV vaccine for infants under 2. mRESV showed 83.7% efficacy in adults. |
| Vertex Pharmaceuticals VRTX | Vanzacaftor triple combo | Phase 3 | Cystic fibrosis (F508del non-GM) | Q4 2026 | Would expand eligible CF population by ~5%. Potential blockbuster label expansion. |
| Alnylam Pharmaceuticals ALNY | Nucapsiran | Phase 2 | Hypertension | Q4 2026 | RNAi targeting angiotensinogen. Quarterly dosing could disrupt the hypertension market. |
| CRISPR Therapeutics CRSP | CTX131 (CAR-T) | Phase 1 | Solid tumors | Q4 2026 | First-in-human data for solid tumor CAR-T. Early signal on safety and trafficking is key. |
| Regeneron REGN | Linvoseltamab | Phase 3 | Relapsed/refractory multiple myeloma | Q3 2026 | BCMAxCD3 bispecific. Competing with J&J Tecvayli and Pfizer Elrexfio. BLA filed. |
| Gilead Sciences GILD | Lenacapavir | Phase 3 | HIV PrEP (twice-yearly) | Q4 2026 | Twice-yearly injectable for HIV prevention. PURPOSE 2 trial showed 100% efficacy. |
🏛️ Advisory Committee Meetings
FDA advisory committees are panels of outside experts who vote on whether a drug should be approved. The FDA usually follows their recommendation — but not always.
| Date | Committee | Drug | Ticker | Key Questions |
|---|
Calendar compiled from FDA filings, company press releases, and ClinicalTrials.gov. Dates are subject to change — companies can announce delays or extensions at any time. Not investment advice.