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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
Mereo BioPharma is now a concentrated bet on setrusumab (UX143), an anti-sclerostin monoclonal antibody partnered with Ultragenyx for osteogenesis imperfecta (OI), plus a back-up program in respiratory alpha-1 antitrypsin deficiency (alvelestat) and an earlier-stage bone asset (vantictumab) licensed to āshibio for autosomal dominant osteopetrosis type 2, where Mereo retains European commercial rights.
Abivax SA is a French biotech now focused almost entirely on chronic inflammatory diseases, with obefazimod as its lead – and effectively only late-stage – asset. Originally developed for HIV, obefazimod was repositioned in ulcerative colitis after mid-stage virology data underwhelmed but immune-modulation readouts looked promising. Over time, the company abandoned its older infectious disease and oncology projects and concentrated resources on inflammatory bowel disease.
Cytokinetics enters 2026 in a very different position from just a year ago. After years as a development-stage muscle biology company – including the high-profile failure of omecamtiv mecarbil in chronic heart failure – the company now has its first approved product: MYQORZO (aficamten) for symptomatic obstructive HCM.
CRISPR Therapeutics enters 2026 as a hybrid story: part royalty-like partner on a first-in-class commercial gene therapy (Casgevy for SCD/TDT), part high-risk platform company pushing CRISPR into autoimmune disease, oncology, cardiovascular disease and regenerative medicine.
On December 18, 2025, Altimmune announced 48-week data from the IMPACT Phase 2b trial of pemvidutide for MASH (metabolic dysfunction-associated steatohepatitis). While the company highlighted “key measures of success” including improvements in non-invasive fibrosis markers (ELF, LSM, cT1), sustained weight loss, and favorable safety, the stock fell by more than 20% in the following sessions.
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company (no products on the market yet) headquartered in Purchase, New York (USA). The company develops orally available therapies for age-related neurodegenerative disorders, primarily Alzheimer’s disease and Dementia with Lewy bodies (DLB).
Reviva Pharmaceuticals is a small late-stage clinical company built almost entirely around one asset: brilaroxazine (RP5063), a serotonin-dopamine modulator for schizophrenia and other CNS / inflammatory indications. The company has successfully completed one large global Phase 3 trial (RECOVER-1) and a 1-year open-label extension and is now preparing for a pre-NDA meeting with the FDA in Q4 2025, targeting a full NDA submission in Q2 2026 for schizophrenia.
Christmas week: lower liquidity, but often faster and more technical moves. Below you’ll find market movers, Europe/commodities, and a “Biotech Special” built on calendar catalysts (RVPH, ARGX, AARD, plus technical notes on ZLAB and HALO).
CUTX-101 (copper histidinate) – Copper replacement therapy for Menkes disease, an ultra-rare pediatric condition. Developed by Cyprium Therapeutics (a Fortress subsidiary), it is the flagship program right now: clinical data showed meaningful survival benefits when treatment is initiated early in life. The NDA has been filed with the FDA and granted Priority Review, now in the final regulatory phase.
The week’s backdrop for biotech and small caps sits at the intersection of interest rates, portfolio positioning, US politics and geopolitics. None of these elements decides a trade alone, but together they define the risk corridor in which individual catalysts play out.
In early December 2025 Castellum’s CEO Glen Ives released a year-end shareholder letter summarizing a step-change year: record Q3 revenue, the company’s first GAAP net profit, significant debt reduction, and a contract backlog that more than doubled year-on-year. The letter also highlights a 103.3 million dollar NAVAIR Special Missions contract (via GTMR), a 66.2 million dollar NAWCAD Lakehurst prime contract for the SSI subsidiary, and fresh awards under the Missile Defense Agency’s SHIELD IDIQ program.
On 18 December 2025, law firm Bragar Eagel & Squire announced a new investigation into certain officers and directors of Unicycive Therapeutics. The investigation follows the securities class action already filed in August 2025 over the company’s public statements around the OLC New Drug Application and the June 2025 FDA Complete Response Letter.
In practical terms this does not change day-to-day operations, but it reinforces a clear message: the OLC NDA path and related communication are now under legal as well as regulatory scrutiny.
Tradipitant (motion sickness) is under NDA review with an unchanged PDUFA action date on December 30, 2025. FDA has started formal labeling discussions.
The FDA has lifted the partial clinical hold on long-term tradipitant studies, accepting that motion sickness is acute, so a 6-month dog tox study is no longer required.
Full dossier on Sangamo Therapeutics (NASDAQ: SGMO) as of 18 December 2025: Fabry gene therapy ST-920, neurology pivot, cash and dilution, Nasdaq listing risk, analyst and retail sentiment, and scenario analysis including a hypothetical bullish path if the Fabry BLA is accepted for review.
This guide is the core pillar of the Run-Up Biotech 2026 framework. It is designed as a reference map for event-driven traders who want to follow biotech catalysts in a more structured way: from calendar building and candidate selection to timing, risk management and post-event review.
NRx has announced the conversion of the remaining 5.4M USD owed to Anson Funds into common equity, with no additional warrants or repricing features disclosed. Management states that, following this transaction, the year-end 2025 balance sheet is expected to show no remaining convertible debt and a “debt-free” capital structure.
This article is built around one simple idea: before the label is public, you can only discuss “expectations” seriously if you anchor them to official sources, peer-reviewed evidence, and observable regulatory patterns. This is not a “tip.” It is a disciplined reading exercise.
Omeros Corporation is approaching a binary regulatory event: the U.S. Food and Drug Administration (FDA) is scheduled to decide on the Biologics License Application (BLA) for narsoplimab (to be marketed as Yartemlya) in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) on December 26, 2025. This is the company’s most important near-term catalyst and one of the most closely watched PDUFAs into year-end.
J.P. Morgan upgraded Recursion Pharmaceuticals (RXRX) from Neutral to Overweight and increased its price target from 10 to 11 USD after reviewing new Phase 1b/2 data for REC-4881 in familial adenomatous polyposis (FAP). At a spot price around 4.20 USD, the new target implies more than 160 percent upside versus the current quote
On December 17, 2025, PMGC’s subsidiary NorthStrive Biosciences announced the initiation of Phase III of its AI-driven drug discovery program in partnership with Yuva Biosciences:contentReference[oaicite:5]{index=5}. This stage is intended to experimentally validate multiple candidate compounds prioritized by YuvaBio’s MitoNova™ AI platform during Phase II, focusing on enhancing mitochondrial function and preserving muscle mass in obese patients