Small-cap biotech intelligence
Daily commentary on FDA decisions, trial readouts, financings and the stocks reacting to them — plus live market, filings and news trackers.
The Briefing
Market Pulse
Spot gold (+1.24% to ~$4,424 USD/oz) and silver (+1.06% to ~$65.36 USD/oz) extended their multi-month rallies on August 12, sustaining a broadly bulli…
News Wire
Filings Watch
Ascendis Pharma A/S announced on August 25, 2026 that it will deliver an oral presentation of Week 104 data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) at the International…
Moleculin Biotech (MBRX) has interim data worth reading carefully: complete remission rates of 43% and 36% in its two Annamycin arms versus 12% in the control arm of the pivotal MIRACLE trial in…
Three complete response letters. One successful appeal. One approval.
InduPro, Inc. closed a $77 million Series B financing and dosed the first patient in its Phase 1 study of IDP-001 on August 12, 2026, per a Business Wire release that day. The Seattle-based private…
The most consequential binary event in small-cap biotech this week lands on Friday, August 22: the FDA's PDUFA decision on Capricor Therapeutics' (CAPR) deramiocel BLA for Duchenne muscular dystrophy…
Ultragenyx Pharmaceutical (NASDAQ: RARE) has a hard regulatory date on the calendar: the FDA's August 23, 2026 PDUFA decision on DTX401 (pariglasgene brecaparvovec), an AAV8 gene therapy for Glycogen…
Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) received FDA clearance on August 14, 2026 to proceed with its Lucid-MS Phase 2 clinical trial in progressive multiple sclerosis, per the…
Replimune Group (NASDAQ: REPL) cleared its hardest regulatory hurdle on August 6, 2026: FDA accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults…
Corbus Pharmaceuticals (NASDAQ: CRBP) received FDA clearance on July 28, 2026 to initiate TEMPO-1, a registrational study of CRB-701 in second-line oropharyngeal squamous cell carcinoma (OPSCC) — a…
Attovia Therapeutics priced its initial public offering on August 4, 2026, and began trading on the Nasdaq Global Market on August 5, 2026 under the symbol "ATTO" — closing its first session at…
The FDA's advisory committee delivered a lopsided verdict on Capricor Therapeutics' Deramiocel on July 29, 2026: 9 against, 3 for, 0 abstaining on whether available evidence supported the therapy's…
Thirteen biotech offerings have priced through late June, raising $5.0 billion in aggregate — a figure that already exceeds every full-year total from 2022 through 2025, according to data reported at…
One concise briefing. The movers, the filings, the FDA calendar.