Biotech catalyst, news and analysis PDUFA tracker
December 2025 is the densest FDA decision month of the year. In only 26 days the agency is expected to rule on fourteen key dossiers across oncology (Breyanzi), cardiology (Aficamten), ophthalmology (EYLEA HD, LYTENAVA), rare diseases (Narsoplimab, Mitapivat), endocrine disorders (Relacorilant), infectious diseases (Zoliflodacin) and more.
On December 3, 2025, PDS Biotech announced via an official 8-K filing that the FDA has granted a Type C Meeting to discuss a potential accelerated approval pathway based on PFS for PDS0101 + pembrolizumab in first-line HPV16+ HNSCC.
The market reaction was immediate: the stock gained roughly +18% on Dec 3 and closed at $0.899 on Dec 4, about +12% across 48 hours.
Hoth Therapeutics is a micro-cap, clinical-stage biotech focused on oncology-supportive care, mast-cell–driven diseases, neurodegeneration and metabolic/obesity indications. The company just issued a comprehensive pipeline update covering four core programs: HT-001 (topical therapy for EGFR-inhibitor rash), HT-KIT (KIT-driven mast-cell diseases, Orphan Drug Designation), HT-ALZ (Alzheimer’s / CNS inflammation) and a newly launched GDNF-based metabolic program in collaboration with the Atlanta VA Medical Cente
2025, Ondas Holdings transformed from a marginal wireless communications company into an emerging leader in autonomous defense, driven by strategic acquisitions, record government contracts, and a rapidly expanding global customer pipeline. With Q3 2025 revenue of $10.1 million, a record backlog of $23.3 million, and an ultra-strong cash position of $840 million, Ondas is exceptionally positioned to capitalize on the boom in the counter-UAS market.
Polyrizon Ltd is an early-stage biotech leveraging proprietary Capture & Contain (C&C) hydrogel technology for nasal barriers against allergens/viruses and Trap & Target (T&T) for enhanced intranasal drug delivery
LONDON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ:MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the third quarter ended September 30, 2025, and provided recent corporate highlights.
Altimmune is entering a pivotal phase with several bullish drivers converging through Q4 2025 and into 2026
ADC Therapeutics announced updated LOTIS-7 Phase 1b trial results on December 3, 2025, showing highly encouraging efficacy and manageable safety for ZYNLONTA + glofitamab combination in relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Janux Therapeutics has gone from market darling to high-risk story stock in 2025:
52-Week High (early 2025): around US$71–72 per share (after strong early JANX007 data and sector momentum).
Price after December 2–3, 2025 update: mid-teens (≈US$16–17), following a two-day collapse of ~50% after the latest Phase 1 JANX007 update.
Positive Phase 3 HOPE-3 topline results in Duchenne muscular dystrophy cardiomyopathy with statistically significant skeletal and cardiac benefit, reopening the regulatory path after the 2025 CRL.
Fractyl Health (NASDAQ: GUTS) is emerging as one of the most interesting names in the metabolic space thanks to its flagship device Revita®, a duodenal mucosal resurfacing (DMR) procedure designed to maintain weight loss after stopping GLP-1 drugs.
VERA Therapeutics is a biopharmaceutical company in advanced clinical stage focused on serious immunological diseases. The company achieved its most important milestone in November 2025 with the submission of a Biologics License Application (BLA) to the FDA for atacicept, its lead candidate for the treatment of IgA Nephropathy (IgAN).
Complete Verastem Oncology VSTM Stock Hub updated through Q2 2026 earnings: AVMAPKI FAKZYNJA launch, VS-7375, RAMP 301, RAMP 205, cash, dilution, risks and future catalysts.
Veritone is a small-cap AI/software company that has struggled for several years with dilution, weak fundamentals, and high volatility. Today’s ~12% move appears more like a speculative rebound than a structural change
PharmaCyte has successfully monetized its equity stake in Femasys Inc. (FEMY), increasing its cash and marketable securities to roughly ~20 million USD, up from about 13.3 M USD as of July 31, 2025, according to the company’s press release and BusinessWire distribution.
FDA approval secured June 2024 with orphan drug exclusivity through 2031
$8.27M inventory ready for immediate commercialization
Strong clinical efficacy: 36.2% ORR, 84.4% tumor burden reduction
MicroCloud Hologram Inc. (HOLO) is a Chinese technology company specializing in holographic LiDAR technology, autonomous driving ADAS systems, and holographic digital twin solutions. The company represents a **recovery play** from a post-reverse-split penny stock to a **profitable, cash-rich operation** with significant exposure to the autonomous vehicle and advanced driver assistance systems (ADAS) market
FDA Pre-NDA Meeting (Schizophrenia)
TIMEFRAME: Q4 2025 (IMMINENT)
The Event: Reviva has a scheduled meeting with the FDA in Q4 2025 to discuss submitting a New Drug Application (NDA) for Brilaroxazine based solely on existing data (RECOVER-1 Phase 3 + OLE Long-term data).
AGIO, BCRX, MIST: December 2025 PDUFA Deep Dive | Analyst Targets & Timeline
The week of November 24-29 closed with continued volatility as investors digested stretched AI valuations, mixed macro signals, and elevated geopolitical tensions. Major indexes ended modestly lower: S&P 500 [finance:S&P 500] -1.9%, Nasdaq [finance:Nasdaq Composite] -2.7%, Dow [finance:Dow Jones Industrial Average] -1.9%.
