2026 Catalyst Calendar | BioMed Nexus

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The most comprehensive biotech catalyst calendar. Track FDA PDUFA decisions, Phase 3 readouts, patent expirations, earnings calls, and major conferences—all in one place. Updated weekly with date changes and new announcements. Trusted by 95,365+ executives, investors, and clinical leaders.

Date	Company	Ticker	Event	Drug/Product	Indication/Details	Impact	Source
Q1 2026 — JANUARY - MARCH
Jan 12-15	Multiple	—	Conference	JPM Healthcare Conference	44th Annual \| San Francisco, CA \| 8,000+ attendees \| M&A announcements expected	High	JPM
Jan 14	Fortress Biotech	FBIO	PDUFA	CUTX-101	Menkes disease (pediatric) \| Resubmission after cGMP CRL \| Rare Pediatric Disease PRV eligible	High	FDA
~Jan 30	Eli Lilly	LLY	Earnings	Q4 2025 Results	Zepbound & Mounjaro momentum \| Obesity market share vs Novo \| Orforglipron oral GLP-1 Phase 3	High	IR
~Jan 31	Pfizer	PFE	Earnings	Q4 2025 Results	Post-COVID transition \| LOE cliff prep (Eliquis 2026, Ibrance 2027) \| $7.7B cost savings progress	High	IR
~Feb 1	Moderna	MRNA	Earnings	Q4 2025 Results	COVID revenue decline \| RSV, flu combo vaccines \| Oncology pipeline (cancer vaccines)	High	IR
~Feb 4	Vertex	VRTX	Earnings	Q4 2025 Results	VX-548 (Journavx) first full quarter \| CF franchise stability \| Povetacicept IgAN path	High	IR
~Feb 5	Regeneron	REGN	Earnings	Q4 2025 Results	Eylea/Eylea HD biosimilar battle \| Dupixent franchise growth \| Linvoseltamab (MM) update	High	IR
~Feb 5	BioNTech	BNTX	Earnings	Q4 2025 Results	Post-COVID pivot \| Cancer vaccine pipeline progress \| €15.85B cash deployment strategy	Medium	IR
~Feb 6	Amgen	AMGN	Earnings	Q4 2025 Results	MariTide obesity drug Phase 3 \| Tezspire asthma growth \| Enbrel biosimilar erosion continues	High	IR
~Feb 6	Gilead Sciences	GILD	Earnings	Q4 2025 Results	HIV franchise (Biktarvy, Sunlenca) \| Veklury COVID decline \| Trodelvy oncology traction	Medium	IR
~Feb 8	Novo Nordisk	NVO	Earnings	Q4 2025 Results	Wegovy supply resolution \| Ozempic pricing \| Oral semaglutide ("Wegovy pill") filing update	High	IR
~Feb 9	Merck	MRK	Earnings	Q4 2025 Results	Keytruda continued dominance \| Animal health business \| Gardasil (HPV vaccine) growth	High	IR
~Feb 10	AbbVie	ABBV	Earnings	Q4 2025 Results	Skyrizi & Rinvoq offsetting Humira LOE \| Immunology franchise momentum \| $27B target 2027	High	IR
Q1 2026	Moleculin Biotech	MBRX	Phase 3	Annamycin + cytarabine	Relapsed/refractory AML \| MIRACLE trial interim (n=45) \| Fast Track designation	High	CT.gov
Feb 28	Ascendis Pharma	ASND	PDUFA	TransCon CNP	Achondroplasia (pediatric) \| Extended 3mo for post-marketing requirement amendment	High	FDA
Mar 2-3	Multiple	—	Conference	BIO Emerging Leaders	Miami Beach, FL \| Newly public & private biotechs \| Investment banking community	Medium	BIO
Q2 2026 — APRIL - JUNE
Apr 8	Bristol-Myers Squibb	BMY	PDUFA	Opdivo + AVD	Stage III/IV Hodgkin lymphoma (1L) \| Priority Review \| SWOG S1826 trial data	High	FDA
~Apr 29	Eli Lilly	LLY	Earnings	Q1 2026 Results	GLP-1 franchise scale \| Orforglipron Phase 3 prep (obesity filing H2 2026) \| Diabetes/obesity dominance	High	IR
~Apr 30	Pfizer	PFE	Earnings	Q1 2026 Results	Vyndaqel, Padcev growth \| Metsera obesity acquisition integration \| Cost savings execution	Medium	IR
~May 1	Moderna	MRNA	Earnings	Q1 2026 Results	RSV vaccine uptake \| Combo vaccines (flu+COVID) progress \| Cancer vaccine updates	Medium	IR
~May 4	Vertex	VRTX	Earnings	Q1 2026 Results	VX-548 market penetration \| Trikafta/Kaftrio durability \| Povetacicept IgAN regulatory timeline	High	IR
~May 5	Regeneron	REGN	Earnings	Q1 2026 Results	Dupixent expansion (new indications) \| Eylea HD vs biosimilars \| Pipeline readouts	Medium	IR
~May 6	Amgen	AMGN	Earnings	Q1 2026 Results	MariTide Phase 3 enrollment \| Obesity market positioning \| Tezspire asthma momentum	High	IR
~May 7	Novo Nordisk	NVO	Earnings	Q1 2026 Results	Wegovy demand normalization \| Amycretin Phase 3 initiation (oral GLP-1) \| Mim8 hemophilia update	High	IR
May 29-Jun 2	Multiple	—	Conference	ASCO Annual Meeting	Chicago, IL \| 40,000+ oncology professionals \| Practice-changing trial results	High	ASCO
Jun 2-5	Multiple	—	Conference	BIO International Convention	Boston, MA \| Largest biotech partnering \| BD deals, licensing agreements	High	BIO
H1 2026	Moleculin Biotech	MBRX	Phase 3	Annamycin + cytarabine	Relapsed/refractory AML \| MIRACLE Part A complete (n=~75-90) \| Dose optimization	High	CT.gov
Q3 2026 — JULY - SEPTEMBER (SELECT EVENTS)
~Jul 30	Eli Lilly	LLY	Earnings	Q2 2026 Results	Obesity franchise scale \| Orforglipron Phase 3 data (Q3 expected) \| Donanemab Alzheimer's uptake	High	IR
~Aug 1	Moderna	MRNA	Earnings	Q2 2026 Results	Mid-year pipeline assessment \| Combo vaccine traction \| mRNA platform expansion	Medium	IR
~Aug 4	Vertex	VRTX	Earnings	Q2 2026 Results	VX-548 adoption trajectory \| CF franchise sustainability \| Type 1 diabetes cell therapy	Medium	IR
~Aug 4	Regeneron	REGN	Earnings	Q2 2026 Results	Dupixent growth \| Linvoseltamab (MM) regulatory path \| Eylea biosimilar impact assessment	Medium	IR
~Aug 5	Amgen	AMGN	Earnings	Q2 2026 Results	MariTide Phase 3 interim potential \| Weight loss competitive landscape \| Tezspire momentum	High	IR
Nov 21, 2026	Pfizer / BMS	PFE / BMY	Patent LOE	Eliquis (apixaban)	Blood thinner \| $7K/year list price \| Generic entry expected Q4 2026 \| ~$10B annual sales	High	Patents
Q4 2026 — OCTOBER - DECEMBER (SELECT EVENTS)
Dec 6-9	Multiple	—	Conference	ASH Annual Meeting	San Diego, CA \| Hematology data \| Leukemia, lymphoma, sickle cell breakthroughs	High	ASH
2026 WATCHLIST — DATES TBD
2026	Regeneron	REGN	Patent LOE	Eylea (aflibercept)	Macular degeneration \| $5.9B sales 2023 \| Sandoz, Viatris biosimilars ready \| Eylea HD competition	High	Patents
2026	Bayer / J&J	BAYRY	Patent LOE	Xarelto (rivaroxaban)	Anticoagulant \| Best-selling drug 2022 US \| Generic entry expected 2026	High	Patents
Mar 2026	Novo Nordisk	NVO	Patent LOE	Ozempic (semaglutide)	Type 2 diabetes \| Key patent expires March 2026 BUT follow-on patents to 2031-2033 \| Generics not expected until 2032+	Medium	Patents
2026	Novo Nordisk	NVO	PDUFA	Mim8	Hemophilia A \| FDA approval decision expected 2026	High	LaBiotech
2026	Novo Nordisk	NVO	Phase 3	Amycretin (GLP-1/amylin)	Obesity \| Oral & injectable \| 22% weight loss in trials \| Next-gen after semaglutide	High	LaBiotech
2026	Vertex	VRTX	PDUFA	Povetacicept	IgA nephropathy \| Approval expected amid Journavx & Casgevy launch headwinds	High	BioSpace
2026	Intellia Therapeutics	NTLA	Phase 3	NTLA-2002 (CRISPR)	Hereditary angioedema \| HAELO Phase 3 \| In vivo gene editing breakthrough	High	CGTlive
Mid-2026	MaaT Pharma	MAAT	Regulatory	MaaT013 (microbiome therapy)	Graft-versus-host disease \| EMA decision \| First microbiome therapy in EU	High	LaBiotech
2026	Abivax	ABVX	Regulatory	Obefazimod	Ulcerative colitis \| Post-Phase 3 success (all endpoints met) \| Stock +500% in 2025	High	LaBiotech
2026	Aspen Neuroscience	Private	Phase 1/2	ANPD001 (iPSC therapy)	Parkinson's disease \| Autologous dopamine neurons \| $115M Series C \| Potential IPO 2026	High	LaBiotech

📊 Calendar Guide

PDUFA: FDA Prescription Drug User Fee Act date—the deadline for drug approval decisions

Phase 3: Late-stage clinical trial data readout—make-or-break efficacy results

Earnings: Quarterly financial results with management guidance and pipeline updates

Conference: Major industry event with data presentations, BD deals, and networking

Patent LOE: Loss of Exclusivity—when generic/biosimilar competition can begin

Impact: High = Stock moving >10% or industry-wide significance

Impact: Medium = Material for company or relevant to sector

⚠️ Important: This calendar is updated weekly. PDUFA dates can shift due to FDA amendments or Complete Response Letters (CRLs). Phase 3 timelines are estimates based on company guidance. Earnings dates are projected from historical patterns. Patent expirations may be extended through legal settlements or additional patents. Always verify critical dates through official SEC filings or company IR pages before making investment decisions.

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