Biotech Analysis
Source-checked deep dives into biotech companies, FDA decisions and clinical trials: what the filings and data show, the scenarios they leave open and what to watch next.
Our analyses take no bull or bear side, make no buy or sell calls and are never paid for. Read our editorial policy.
Ivonescimab Before the FDA’s November 14 Decision: What Summit’s HARMONi Data Show
Ivonescimab faces an FDA decision on November 14, 2026. What Summit’s HARMONi data show, the FDA’s survival bar, the market, AstraZeneca’s $2B and the risks.
How Big Can Anktiva Get? ImmunityBio’s Market After the Papillary Approval
How big can Anktiva get after the FDA’s papillary approval? ImmunityBio’s US sales, a step-by-step market estimate, competitors and financing risks.
PDS Biotech (PDSB) After the Soon-Shiong PIPE: What the Filings and Trials Show About PDS0301, and What Could Come Next
What PDS Biotech’s filings and trials show about PDS0301 (IL-12), Patrick Soon-Shiong’s 19.9% stake and the talked-about Anktiva combination.
What a New 2,610-Patient AML Registry Study Does and Does Not Tell Us About SELLAS’s REGAL Control Arm
A 2,610-patient PETHEMA registry study shows how venetoclax and HMA therapy fare in real-world AML, and what it does not tell us about SELLAS’s REGAL trial.
Inovio’s INO-3107 PDUFA Date (October 30, 2026): What the Filings Show and What They Leave Open
Inovio’s INO-3107 for RRP has an FDA decision due Oct 30, 2026. The review record, the accelerated approval question, Papzimeos and Inovio’s cash runway.
The Ghost PDUFA Date: Zidesamtinib Was Approved Two Months Early, After Nuvalent Was Already Sold
The September 18, 2026 PDUFA date on many calendars is a ghost: GSK closed its Nuvalent buyout on July 15 and the FDA approved zidesamtinib on July 22. What calendar traders should take from it, and what we fixed.
What the Public Data Can and Cannot Tell Us About SELLAS’s Galinpepimut-S in AML
A statistical analysis of SELLAS’s Phase 3 REGAL trial of galinpepimut-S (GPS) in AML — what the blinded, pooled event data can and cannot tell us.
Why SELLAS Might Fail: The Hidden Risks Behind GPS, REGAL, and the AML CR2 Bull Case
Ticker: SLSCompany: SELLAS Life Sciences GroupLead asset: Galinpepimut-S, also known as GPSKey catalyst: Phase 3 REGAL trial in acute myeloid leukemia patients in second remissionCore question: Is the delayed REGAL readout evidence that GPS is working, or could the market be overreading blinded survival data? Summary SELLAS Life Sciences has become one of the more debated small-cap biotech catalyst stories. […]