Biotech Catalyst Insights
Short, evidence-backed briefings ahead of near-term biotech catalysts. Every number is sourced from verified trial, filing, and 13F data — and what is not verified is marked as unknown.
Summit Therapeutics Ivonescimab Phase 3 Bladder Cancer Trial Started September 10, 2026: HARMONi-GU1 With Enfortumab Vedotin
Summit Therapeutics' HARMONi-GU1 Phase 2/3 trial of ivonescimab plus enfortumab vedotin versus pembrolizumab plus EV in first-line bladder cancer started on its exact registered date, September 10, 2026.
Summit Therapeutics Inc. (SMMT)
Phathom Pharmaceuticals Vonoprazan Phase 3 Heartburn Trial Starts September 25, 2026: Non-Erosive GERD Study
Phathom Pharmaceuticals' Phase 3 trial of vonoprazan 10 mg versus placebo for episodic heartburn in non-erosive GERD starts September 25, 2026 per registration.
Phathom Pharmaceuticals, Inc. (PHAT)
AbbVie ABBV-1480 Phase 3 Lung Cancer Trial Starts September 22, 2026: First-Line NSCLC Study Versus Pembrolizumab
AbbVie's Phase 3 trial of ABBV-1480 plus chemotherapy versus pembrolizumab plus chemotherapy in first-line advanced NSCLC starts September 22, 2026 per registration. Design, unknowns, and pipeline context.
AbbVie Inc. (ABBV)
Novo Nordisk Zenagamtide Phase 3 Obesity Trial Starts September 22, 2026: AMAZE 7 Head-to-Head Versus Semaglutide
Novo Nordisk's AMAZE 7 Phase 3 trial of once-weekly zenagamtide versus once-weekly semaglutide in obesity starts September 22, 2026 — a direct head-to-head in the obesity indication.
Novo Nordisk A/S (NVO)
Dr. Reddy's Laboratories Pomalidomide FDA Approval August 31, 2026: Fifth PDUFA Approval of the Year
Dr. Reddy's pomalidomide application was approved on its August 31, 2026 PDUFA date — the company's fifth FDA approval of 2026 and 15th straight tracked approval since October 2024.
DR REDDYS LABORATORIES LTD (RDY)
Phase 3 Trials Starting the Week of September 21, 2026: Five Registered Studies Across Alzheimer's, Lung Cancer, Obesity, Myeloma, and Spinal Cord Injury
Five Phase 3 trials start the week of September 21, 2026: buntanetap in Alzheimer's, ABBV-1480 in lung cancer, zenagamtide in obesity, ramantamig in myeloma, and NVG-291 in spinal cord injury.
Praxis Precision Medicines PDUFA Date September 27, 2026: What the FDA Action Day Covers
Praxis Precision Medicines faces a PDUFA target action date of September 27, 2026 — the first of three FDA action dates on its calendar within four months. What the data verifies, what remains unknown.
Praxis Precision Medicines, Inc. (PRAX)
AstraZeneca Laroprovstat/Rosuvastatin Fixed-Dose Combination Phase 3 Trial Starts September 15, 2026: LDL Cholesterol Study Design
AstraZeneca's Phase 3 trial of a laroprovstat/rosuvastatin fixed-dose combination versus rosuvastatin in hypercholesterolaemia reaches its registered start date September 15, 2026. Verified design, unknowns, and pipeline context.
ASTRAZENECA PLC (AZN)
Genmab Petosemtamab Phase 3 Colorectal Cancer Trial Starts September 15, 2026: Second-Line RAS/BRAF Wild-Type Study Design
Genmab's Phase 3 second-line colorectal cancer trial of petosemtamab plus chemotherapy versus cetuximab or bevacizumab arms in RAS/BRAF wild-type disease starts September 15, 2026 per registration.
Genmab A/S (GMAB)
Jazz Pharmaceuticals JZP926 Phase 3 Juvenile Myoclonic Epilepsy Trial Starts September 18, 2026: Study Design and Pipeline Context
Jazz Pharmaceuticals' Phase 2/3 trial of JZP926 in juvenile myoclonic epilepsy, ages 10 and up, reaches its registered start date September 18, 2026. Design, 13F holdings, and the epilepsy pipeline behind it.
Jazz Pharmaceuticals plc (JAZZ)
Corbus Pharmaceuticals CRB-701 Phase 3 Head and Neck Cancer Trial Starts September 20, 2026: Oropharyngeal Carcinoma Study Design
Corbus Pharmaceuticals' Phase 3 trial of CRB-701 versus investigator's choice in platinum- and PD-(L)1-pretreated oropharyngeal cancer starts September 20, 2026 — one year after a tracked CRB-701 advisory committee record.
Corbus Pharmaceuticals Holdings, Inc. (CRBP)
ImmunityBio (IBRX) Starts Phase 1b/2 Sepsis Trial of NAI — What's Verified, What's Unknown
ImmunityBio's Phase 1b/2 trial of nogapendekin alfa inbakicept plus standard of care in critically ill sepsis adults starts Sept 15, 2026. Verified facts from BioSniper's tracked data — and what remains unknown.
ImmunityBio, Inc. (IBRX)