UPDATED WEEKLY

FDA Drug Approval Calendar 2026

AI-powered catalyst tracking for biotech traders. Every upcoming PDUFA date, advisory committee meeting, and Phase 3 readout — with conviction scores, insider analysis, and filing history insights.

Upcoming catalysts

PDUFA dates

Advisory meetings

Phase 3 readouts

Filter:All Events13PDUFA Date5Advisory Committee3Phase 3 Readout5

This FDA drug approval calendar tracks every major biotech catalyst for Q1–Q2 2026, including PDUFA target action dates, FDA advisory committee (AdCom) meetings, and Phase 3 clinical trial data readouts. Each event is analyzed by BioAlpha's AI, which scores conviction based on regulatory filing history, SEC insider trading filings (Form 4), and institutional 13-F accumulation patterns. Bookmark this page — we update it weekly as new catalysts are announced.

Mar 30, 2026PDUFA Date

VRTX

Suzetrigine (VX-548)

Vertex Pharmaceuticals · $VRTX

Indication: Acute pain (non-opioid analgesic)

Strong regulatory signals and insider buying suggest high approval probability. First-in-class non-opioid mechanism addresses major unmet need.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction91%

HIGH

Filing History

Complete Response Letter unlikely — FDA accepted filing with Priority Review. Manufacturing inspection completed with no Form 483 issues. Advisory committee voted 10-3 in favor.

Insider Activity

CEO purchased $2.1M in shares over last 90 days. No insider sales detected. Institutional ownership increased 4.2% this quarter.

Apr 3, 2026Advisory Committee

BMRN

Voxzogo (vosoritide)

BioMarin Pharmaceutical · $BMRN

Indication: Achondroplasia (expanded age range)

AdCom discussion will focus on benefit-risk in youngest age group. Prior approval for 5+ age range is positive precedent, but vote outcome is uncertain.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction74%

MODERATE

Filing History

sNDA for expanded age indication (0-5 years). Pivotal Phase 3 met primary endpoint with p<0.001. However, FDA has requested additional safety data on very young patients.

Insider Activity

Mixed signals: CFO sold $800K in planned 10b5-1 trades, but two board members initiated new purchases totaling $1.4M.

Apr 8, 2026PDUFA Date

ALNY

Amvuttra (vutrisiran)

Alnylam Pharmaceuticals · $ALNY

Indication: ATTR cardiomyopathy (expanded indication)

Landmark mortality data in cardio-myopathy. No AdCom is a positive signal. Expansion into ATTR-CM could triple the addressable market.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction87%

HIGH

Filing History

sNDA filed based on HELIOS-B Phase 3 data showing 33% reduction in all-cause mortality. No advisory committee scheduled — FDA review appears straightforward.

Insider Activity

Minimal insider transactions. Institutional accumulation detected across 12 major funds per latest 13-F filings. Short interest declined 18% over 60 days.

Apr 14, 2026Phase 3 Readout

PFE

Padcev + Keytruda

Seagen / Pfizer · $PFE

Indication: Muscle-invasive bladder cancer (neoadjuvant)

High-conviction readout. Positive data would validate Pfizer's $43B Seagen acquisition and expand Padcev into earlier treatment lines.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction79%

MODERATE

Filing History

EV-304 trial interim analysis expected. Prior EV-302 showed 53% reduction in death vs. chemo in metastatic setting. Neoadjuvant data could expand label significantly.

Insider Activity

Pfizer has been actively repurchasing shares ($3.8B buyback program). Seagen integration synergies tracking ahead of guidance per Q4 earnings call.

Apr 21, 2026Phase 3 Readout

MRNA

mRNA-1083

Moderna · $MRNA

Indication: Flu + COVID combination vaccine

Readout could go either way — combo vaccines have historically faced immunogenicity challenges. Market already pricing in moderate success probability.

AI SIGNAL ANALYSIS

◆ NEUTRAL

Conviction68%

MODERATE

Filing History

Phase 3 ORCHID trial enrolling 8,000+ participants. Primary immunogenicity endpoints due Q2 2026. Prior Phase 2 showed non-inferiority vs. separate vaccines.

Insider Activity

CEO Bancel sold $45M in scheduled dispositions (consistent with prior quarters). Two VP-level insiders purchased small positions ($150K total).

Apr 27, 2026PDUFA Date

REGN

Dupixent (dupilumab)

Regeneron Pharmaceuticals · $REGN

Indication: COPD with type 2 inflammation

Near-certain approval. COPD indication could add $4B+ in peak annual sales. Breakthrough designation and Priority Review signal FDA alignment.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction93%

HIGH

Filing History

sBLA filed with breakthrough therapy designation. BOREAS and NOTUS Phase 3 trials both met primary endpoints with 30%+ exacerbation reduction. FDA granted Priority Review.

Insider Activity

Sanofi partner increased Dupixent sales projections by 15% in latest investor presentation. Regeneron insiders have been net buyers for 3 consecutive quarters.

May 1, 2026Advisory Committee

BIIB

Tofersen (Qalsody)

Biogen · $BIIB

Indication: ALS (SOD1 mutation, full approval)

High uncertainty. FDA must weigh biomarker data vs. marginal clinical benefit. AdCom vote could split. Conversion from accelerated to full approval is contested.

AI SIGNAL ANALYSIS

◆ NEUTRAL

Conviction62%

LOW

Filing History

Currently approved under accelerated approval based on neurofilament biomarker. Confirmatory Phase 3 ATLAS trial showed clinical benefit trends but did not meet statistical significance on primary endpoint.

Insider Activity

Biogen insiders have been net sellers. However, multiple ALS patient advocacy groups have submitted citizen petitions supporting full approval.

May 7, 2026Phase 3 Readout

LLY

Tirzepatide

Eli Lilly · $LLY

Indication: MASH/NASH (metabolic liver disease)

Tirzepatide in MASH could be a $10B+ opportunity. Phase 2 data was among the best ever seen in liver disease. High conviction on positive readout.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction85%

HIGH

Filing History

SYNERGY-NASH Phase 3 top-line readout. Prior Phase 2 showed 74% MASH resolution rate vs. 13% placebo. If Phase 3 confirms, Lilly would file sNDA by Q3 2026.

Insider Activity

Eli Lilly insiders have maintained positions. Company recently announced $5B manufacturing expansion for incretin-class drugs, suggesting confidence in pipeline.

May 12, 2026PDUFA Date

GILD

Lenacapavir

Gilead Sciences · $GILD

Indication: HIV prevention (twice-yearly PrEP)

Strongest approval signal in current pipeline. 100% efficacy is unprecedented in HIV prevention. Twice-yearly injection could reshape PrEP market globally.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction95%

HIGH

Filing History

PURPOSE 1 trial: 100% efficacy in women (zero infections). NDA filed with Priority Review and Breakthrough Therapy designation. No safety signals in 5,000+ patients.

Insider Activity

Gilead initiated $5B accelerated share repurchase. Senior leadership team has been accumulating shares. No insider sales in 180 days.

May 15, 2026Phase 3 Readout

ABBV

Emraclidine

AbbVie (via Cerevel) · $ABBV

Indication: Schizophrenia (muscarinic agonist)

Binary event. Success validates the $8.7B Cerevel deal and creates a potential blockbuster. Failure would pressure AbbVie's growth narrative. Phase 2 dose selection adds uncertainty.

AI SIGNAL ANALYSIS

◆ NEUTRAL

Conviction58%

LOW

Filing History

EMPOWER Phase 3 registrational trial. Novel M4 muscarinic agonist mechanism — first potential new schizophrenia MOA in decades. Phase 2 showed mixed results with dose-response questions.

Insider Activity

AbbVie acquired Cerevel for $8.7B in 2024 largely on emraclidine potential. Recent patent filings suggest confidence, but no insider buying detected.

May 19, 2026Phase 3 Readout

AMGN

MariTide (maridebart cafraglutide)

Amgen · $AMGN

Indication: Obesity (monthly injectable GLP-1/GIP)

Monthly dosing could differentiate MariTide in the crowded GLP-1 space. Key question: can efficacy match Lilly/Novo weekly injectables? Market is pricing in moderate probability.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction76%

MODERATE

Filing History

Phase 2 showed 14.5% weight loss at 52 weeks with monthly dosing (vs. weekly for competitors). Phase 3 MARITIME program readout will determine competitive positioning.

Insider Activity

Amgen has guided MariTide as top pipeline priority. R&D spend allocation increased 22% for obesity program. Two executive officers purchased shares in Q1.

May 22, 2026Advisory Committee

NVAX

CIC (COVID-Influenza Combination)

Novavax · $NVAX

Indication: Combined COVID + Influenza protein vaccine

AdCom convening suggests FDA has concerns. Novavax's manufacturing track record introduces additional risk. Protein-based approach may struggle vs. mRNA competitors on immunogenicity.

AI SIGNAL ANALYSIS

▼ BEARISH

Conviction45%

LOW

Filing History

FDA has convened an advisory committee, which typically indicates questions about the data package. Phase 3 non-inferiority margin was narrow. Manufacturing scale-up concerns remain from prior COVID vaccine production issues.

Insider Activity

CEO and CFO have both been net sellers in recent quarters. Short interest at 22% of float — elevated but declining from 30% peak.

May 28, 2026PDUFA Date

IONS

Donidalorsen

Ionis Pharmaceuticals · $IONS

Indication: Hereditary angioedema (HAE) prevention

Clean regulatory path. No AdCom and strong Phase 3 data point toward approval. HAE market is well-defined with established commercial playbook.

AI SIGNAL ANALYSIS

▲ BULLISH

Conviction82%

MODERATE

Filing History

NDA filed based on OASIS-HAE Phase 3 showing 90% reduction in HAE attacks vs. placebo. Monthly subcutaneous dosing. FDA accepted filing without Refuse to File letter. No advisory committee scheduled.

Insider Activity

Ionis announced partnership expansion with AstraZeneca. Insider purchases detected from CMO and VP of Clinical Development ($650K combined).

How We Generate AI Signals for FDA Events

BioAlpha's AI analyzes three categories of public data for each FDA catalyst: (1) Regulatory filing history — including FDA acceptance letters, Refuse to File decisions, Complete Response Letters, and advisory committee voting patterns; (2) SEC insider trading filings — Form 4 transactions from company officers and directors, analyzed for unusual buying or selling patterns near catalyst dates; (3) Institutional accumulation — 13-F filings from major biotech funds to detect smart money positioning.

The conviction score reflects the AI's assessment of how strongly these signals align. A score above 85 indicates strong directional alignment across all three data sources. Scores between 65–85 suggest mixed signals, and below 65 indicates high uncertainty or conflicting data.

Disclaimer: This calendar contains illustrative AI-generated analysis for educational purposes. It does not constitute financial advice. Always conduct your own due diligence before making investment decisions. PDUFA dates and clinical trial timelines are subject to change.