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With Q1 2026 already underway, here's a comprehensive look at the major biotech catalysts coming up over the next \~3 months. This post covers FDA decision dates, Phase 3 data readouts, and key events to watch.
# Quick Stats for Q1 2026
|Category|Count|
|:-|:-|
|PDUFA Dates|26|
|Phase 3 Readouts|68|
|Phase 2 Readouts|97|
|**Total Catalysts**|**192**|
# January 2026 PDUFA Dates
# January 13 - TVTX (Travere Therapeutics) - $620M
**Sparsentan** for IgA nephropathy (Priority Review)
# January 31 - AQST (Aquestive Therapeutics) - $210M
**Anaphylm** \- Epinephrine sublingual film for emergency treatment of anaphylaxis (Priority Review)
# February 2026 PDUFA Dates
|Date|Ticker|Drug|Indication|Review|
|:-|:-|:-|:-|:-|
|Feb 1|VNDA|Investigational drug|Depressive disorder|Standard|
|Feb 8|RGNX|RGX-121|Hunter syndrome (MPS II)|Priority|
|Feb 9|FBIOP|CUTX-101|Wilson's disease|Standard|
|Feb 10|AQST|AQST-109|Epinephrine nasal spray|Standard|
|Feb 12|JAZZ|JZP-458|Acute Lymphoblastic Leukemia|Priority|
|Feb 15|BHVN|\-|\-|\-|
|Feb 17|ALDX|Reproxalap|Dry eye disease|Standard|
|Feb 18|CORT|CORT125134|Cushing's syndrome|Standard|
|Feb 21|SAN.PA|Iniparib|Metastatic breast cancer|Priority|
|Feb 25|ASND|TransCon hGH|Pediatric growth hormone deficiency|Standard|
|Feb 26|PGEN|PRGN-3005|Advanced solid tumors|Priority|
|Feb 28|CRNX|Paltusotine|Acromegaly|Standard|
# Notable February Decisions
**JAZZ (Jazz Pharmaceuticals) - $6.4B market cap** \- JZP-458 for ALL could be significant given Jazz's existing oncology portfolio.
**CRNX (Crinetics) - $3.5B market cap** \- Paltusotine for acromegaly is an oral therapy that could disrupt the injectable-dominated market.
**CORT (Corcept) - $2.7B market cap** \- Second-gen Cushing's treatment with potential to expand their franchise.
# March 2026 PDUFA Dates
|Date|Ticker|Drug|Indication|Review|
|:-|:-|:-|:-|:-|
|Mar 1|SAN.PA|Efanesoctocog alfa|Hemophilia A|Priority|
|Mar 1|OTLK|ONS-5010 / LYTENAVA|Wet AMD|Standard|
|Mar 14|RYTM|IMCIVREE|Obesity (POMC/PCSK1/LEPR deficiency)|Priority|
|Mar 17|ALDX|Reproxalap|Dry eye disease|Standard|
|Mar 18|TVTX|Sparsentan|FSGS and IgA nephropathy|Priority|
|Mar 23|OTLK|ONS-5010|Wet AMD|Standard|
|Mar 25|ATHA|ATH-1017|Alzheimer's disease|Standard|
|Mar 26|GN.CO|Tisotumab vedotin|Cervical cancer|Priority|
|Mar 27|IONS|Inotersen|Transthyretin amyloidosis|Standard|
|Mar 29|LNTH|LNTH-2501|Prostate cancer imaging|Priority|
|Mar 30|OMER|OMIDRIA|Ophthalmic surgery|Standard|
|Mar 31|LENZ|LENZ-123|Alzheimer's disease|Standard|
# Notable March Decisions
**RYTM (Rhythm Pharma) - $7.4B market cap** \- IMCIVREE label expansion for rare obesity disorders. Already approved, seeking broader indications.
**LNTH (Lantheus) - $4.2B market cap** \- LNTH-2501 is their next-gen PSMA imaging agent, following success of Pylarify.
**IONS (Ionis) - $5.7B market cap** \- Inotersen for TTR amyloidosis adds to their antisense oligonucleotide portfolio.
# Major Phase 3 Data Readouts
# January 2026
|Date|Ticker|Drug|Indication|Market Cap|
|:-|:-|:-|:-|:-|
|Jan 12|MRK|Pembrolizumab|NSCLC|$245.9B|
|Jan 15|TBPH|TD-8236|Asthma|$330M|
|Jan 15|TBPH|Ampreloxetine|Neurogenic Orthostatic Hypotension|$330M|
|Jan 19|AZN|Tozorakimab|COPD|\-|
|Jan 27|ROCHE|Fenebrutinib|Relapsing Multiple Sclerosis|\-|
|Jan 30|MRTX|MRTX849 (Adagrasib)|Advanced Cancer|\-|
|Jan 31|KOD|Tarcocimab|Diabetic Retinopathy|$76M|
# February 2026
|Date|Ticker|Drug|Indication|Market Cap|
|:-|:-|:-|:-|:-|
|Feb 3|UCBJY|Bimekizumab|Chronic Plaque Psoriasis|\-|
|Feb 15|CMPS|Psilocybin|Treatment Resistant Depression|$350M|
|Feb 15|DAWN|Tovorafenib|Low-grade Glioma|$970M|
|Feb 15|AVDL|FT218|Narcolepsy|$1.3B|
|Feb 18|PFE|Talazoparib + Enzalutamide|Prostate Cancer|$142.7B|
|Feb 20|NVO|Semaglutide|Obesity|\-|
|Feb 20|NVO|Cagrilintide|Obesity|\-|
|Feb 25|INCY|Povorcitinib|Vitiligo|$9.9B|
# March 2026
|Date|Ticker|Drug|Indication|Market Cap|
|:-|:-|:-|:-|:-|
|Mar 5|MRK|Pembrolizumab|NSCLC|$245.9B|
|Mar 11|ARGX|Efgartigimod|POTS|\-|
|Mar 14|INSM|Treprostinil Palmitil|Pulmonary Hypertension|$11.0B|
|Mar 15|NBIX|Valbenazine|Tardive Dyskinesia|$10.5B|
|Mar 15|MDGL|Resmetirom|NASH|$5.1B|
|Mar 15|LLY|Orforglipron|Obesity|$769.8B|
|Mar 15|RNA|AOC 1001 (del-desiran)|DM1|$10.8B|
|Mar 15|KRYS|KB801|Neurotrophic Keratitis|$4.6B|
|Mar 22|PFE|Ritlecitinib|Vitiligo|$142.7B|
|Mar 27|MLTX|Sonelokimab|Hidradenitis Suppurativa|$1.1B|
|Mar 31|URGN|UGN-104|Upper Tract Urothelial Carcinoma|$680M|
# Key Phase 2 Readouts to Watch
# High Market Cap Companies
* **Jan 15 - LLY ($770B)** \- Tirzepatide for overweight (Phase 2 dose-finding)
* **Jan 17 - REGN ($114B)** \- Vonsetamig for CKD
* **Jan 28 - REGN ($114B)** \- REGN7544 for POTS
* **Jan 31 - MRNA ($42B)** \- mRNA-3927 for Propionic Acidemia
* **Feb 1 - REGN ($114B)** \- Multiple readouts (Sarilumab, Cemiplimab, Tocilizumab)
# Smaller Cap Movers
* **Jan 15 - ANAB ($490M)** \- Rosnilimab for Rheumatoid Arthritis
* **Jan 15 - TNGX ($860M)** \- TNG260 for NSCLC
* **Jan 15 - FDMT ($1B)** \- 4D-310 for Fabry Disease
* **Jan 31 - CGEM ($1B)** \- CLN-081 for NSCLC
# Conference
# January 12-15 - JPM Healthcare Conference 2026
The biggest healthcare investor conference of the year. Expect pipeline updates, M&A rumors, and guidance from major players.
# Top Companies by Catalyst Count (Q1 2026)
|Ticker|Company|Catalysts|Market Cap|
|:-|:-|:-|:-|
|PFE|Pfizer|12|$142.7B|
|REGN|Regeneron|10|$113.8B|
|INCY|Incyte|6|$9.9B|
|LLY|Eli Lilly|4|$769.8B|
|MRK|Merck|4|$245.9B|
# Disclaimer & Data Source
All data in this post comes from [CatalystAlert.io](https://catalystalert.io), a biotech catalyst tracking platform that I built.
**I'm the creator of this platform and we're currently in beta.** Premium features are completely free during the beta period.
If you spot any errors, incorrect dates, or missing catalysts, I'd really appreciate the feedback:
* **DM me** on Reddit
* **Email:** [info@catalystalert.io](mailto:info@catalystalert.io)
* **Twitter/X:** [@catalystalert](https://twitter.com/catalystalert)
We aggregate data from SEC filings, FDA, ClinicalTrials.gov, and other public sources. Accuracy matters to us, so any corrections help improve the platform for everyone.
*Not financial advice. Do your own DD. Dates are subject to change based on FDA/company decisions.*