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Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Category Reports Biotech
Tickers reports and analysis
VNDA Vanda Pharmaceuticals Inc
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.
SGMO Sangamo Therapeutics Inc
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.
NRXP NRX Pharmaceuticals Inc
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.
OMER Omeros Corp Yartemlya (narsoplimab)
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.
OMER Omeros: The Finish Line Approaches
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.
RXRX Recursion Pharmaceuticals Inc
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
PMGC’s subsidiary NorthStrive Biosciences
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
ADTX Sparked Aditxt
Deep dive on Aditxt Inc. (ADTX), a highly distressed micro-cap trying to build an ecosystem around immune tolerance, precision diagnostics and women’s health, while struggling with going concern warnings, heavy dilution and a very fragile balance sheet.
ALDX Aldeyra Therapeutics Inc Update dec 16
On December 16, 2025, the FDA formally extended the PDUFA target action date for reproxalap in dry eye disease from December 16, 2025 to March 16, 2026, after Aldeyra submitted the Clinical Study Report (CSR) for its dry-eye field trial to the NDA at the FDA’s request.
CUE Emergency Deep Dive
Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells using its Immuno-STAT platform, targeting both autoimmune disease and cancer.
FBIO Fortress Biotech
Fortress Biotech has evolved into a hybrid model: part commercial dermatology company (via Journey Medical), part royalty/affiliate platform with exposure to multiple late-stage assets developed by partners and subsidiaries.
RCKT Rocket Pharmaceuticals Inc
Rocket Pharmaceuticals is a gene therapy-focused company with disclosed programs across lentiviral (hematology) and AAV (cardiovascular) platforms, as described in SEC-filed materials.
GRCE Grace Therapeutics
Grace Therapeutics has disclosed that it submitted an NDA for GTx-104 (intravenous nimodipine) on June 25, 2025, and that the FDA accepted the application for review with a PDUFA target date of April 23, 2026.
Biotech Weekly Recap
This week delivered a clear “biotech reality check” mix: multiple FDA decisions (including a first-in-class gene therapy), two new oral options for gonorrhea, and several high-visibility clinical readouts across obesity/metabolic and rare disease. The flow of headlines was “event-driven”, with market attention concentrating on hard endpoints, safety/tolerability, and execution quality.
TENX Tenax Therapeutics
Tenax Therapeutics is advancing oral levosimendan for pulmonary hypertension associated with HFpEF (PH-HFpEF), with a registrational path built around the LEVEL Phase 3 program and a planned second global Phase 3 study (LEVEL-2) accepted by FDA in 2025.
SANA Biotechnology
SANA Biotechnology is often framed as a high-risk / high-reward cellular engineering story. The core thesis revolves around its proprietary hypoimmune (HIP) platform: engineered cells designed to evade immune rejection, with the long-term goal of enabling allogeneic cell therapies without chronic immunosuppression.
VKTX Viking Therapeutics Inc
Viking Therapeutics is one of the most watched “metabolic” biotechs because it is trying to build a two-lane story: (1) obesity with VK2735 (the same molecule in injectable and oral tablet forms), and (2) MASH/NASH with VK2809 (thyroid receptor beta agonist with histology data).
ALT Altimmune Update dec 12
Altimmune announced a succession plan under which Jerry Durso will assume the role of President & CEO on January 1, 2026, while outgoing CEO Vipin Garg remains an advisor through June 30, 2026.
CYTK Cytokinetics
Cytokinetics is a late-stage cardiovascular biotech whose investment case now turns almost entirely around aficamten, a next-generation cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (oHCM). The clinical package in oHCM is strong: the pivotal SEQUOIA-HCM trial versus placebo and the active-control MAPLE-HCM trial versus metoprolol both met their primary endpoints with clinically meaningful gains in peak oxygen uptake (pVO₂), improved symptoms and a safety profile that appears manageable so far.
ACIU AC Immune
AC Immune’s ACI-7104.056 is an active peptide vaccine designed to raise antibodies against misfolded α-synuclein in early Parkinson’s disease (PD). The ongoing Phase 2 VacSYn trial is the first randomized, double-blind study to show that such an approach can consistently drive very high antibody titers that reach the CNS and are associated with stabilization of multiple disease-relevant biomarkers.