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
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…
Attovia Therapeutics, Inc. (Nasdaq: ATTO) priced its initial public offering at $17.00 per share on August 4, 2026 — the top of its targeted range — raising $289.0 million in gross proceeds before…
Zhengye Biotechnology Holding Limited (Nasdaq: ZYBT) regained compliance with Nasdaq's minimum bid price rule on August 5, 2026 — and the stock responded with a violent move the following session.
Three distinct small-cap biotech catalysts set the agenda for the week of August 4, against a backdrop where the Russell 2000 has already returned 22.93% in the first half of 2026 — its best…
Medicus Pharma Ltd. (NASDAQ: MDCX) received a 'Study May Proceed' letter from the FDA on July 27, 2026, clearing the company to launch SKNJCT-005 — an NDA-enabling, open-label, multicenter Phase 2b…
One concise briefing. The movers, the filings, the FDA calendar.