Biotech Catalysts This Week: FDA Decisions, Readouts & Earnings (Sep 27–Oct 4, 2026)

· 2 min read

This week’s docket skews toward late-stage oncology follow-through rather than binary regulatory drama, with no PDUFA dates on the calendar and ARV’s involvement in three separate trials, including the ERADICATE prostate cancer study and a hepatocellular carcinoma combination readout, the throughline worth watching. IBRX’s bladder cancer combination and BIIB’s observational pregnancy safety data round out a quieter, data-generation-heavy week rather than a decision-heavy one.

🧪 Trial Catalysts & Milestones

  • ARV — 2026-09-28: Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That H
  • IBRX — 2026-09-30: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasi
  • BIIB — 2026-09-30: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women Durin
  • ARV — 2026-09-30: Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [AD
  • ARV — 2026-09-30: A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Be
  • ARWR — 2026-09-30: Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
  • JAZZ — 2026-09-30: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Pati
  • ARV — 2026-09-30: Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Trea
  • EWTX — 2026-09-30: Defining Endpoints in Becker Muscular Dystrophy
  • SMMT — 2026-09-30: Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Ca
  • IBRX — 2026-10-01: A Study to Assess Anktiva in Patients With Long Covid-19.
  • IBRX — 2026-10-01: A Study to Assess Anktiva in Patients With Long Covid-19.
  • CORT — 2026-10-01: Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
  • BHVN — 2026-10-01: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset
  • ARV — 2026-10-01: Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Ef

📡 Run-up Radar Highlights

Stocks entering the pre-catalyst window with the strongest setups (full radar is a Premium feature):

  • SLDB — Phase 1, Phase 2 — Active Trial in 18 days, score 62/100
  • EWTX — N/A — Active Trial in 3 days, score 52/100
  • SNDX — Phase 1 — Recruiting in 4 days, score 50/100

💸 Dilution Watch: New Financing Filings

  • VKTX: convertible notes $275M (424B5, 2026-09-25) EDGAR
  • IMCC: registered direct offering (424B5, 2026-09-24) EDGAR
  • BMRA: shelf registration (S-3, 2026-09-24) EDGAR
  • GRML: ATM program (424B5, 2026-09-23) EDGAR
  • GRML: registered direct offering (424B5, 2026-09-23) EDGAR

Full Dilution Watch table →

📈 Last Week’s Biggest Gainers

  • VKTX +35.67% (volume 17.9x average)
  • TWST +16.11% (volume 2.0x average)
  • TNGX +14.33% (volume 2.4x average)
  • IBRX +9.94% (volume 2.1x average)
  • BRVE +8.90% (volume 0.7x average)

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This digest is for informational purposes only and is not investment advice. Always do your own research.

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.