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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
AI platform for regulated clients. Q4 2025 pivot built on a top-10 pharma engagement project, the Skye Salud sovereign healthcare JV in Mexico and a first step of balance-sheet clean-up with Nasdaq compliance restored.
NRx has licensed a nationwide Real-World Evidence dataset from Osmind covering more than 70,000 patients treated with IV ketamine or intranasal esketamine for major depression with suicidal ideation. The full analysis will be submitted to the FDA in support of an Accelerated Approval application for NRX-100, the preservative-free ketamine IV formulation already under Fast Track Designation for suicidal ideation in depression and bipolar depression.
Briefing Space-AI-Defence stocks Jan 14
Daily overview on defence, space and AI-linked military names: Grok enters Pentagon networks, MBDA strengthens its position in Brazil and space small caps swing between rational euphoria and technical risk.
Travere confirmed that the PDUFA date for the FILSPARI sNDA in FSGS is January 13, 2026. In the latest corporate update (press release) and at the JPM conference, management explained that the FDA recently sent a series of additional information requests “to further characterize the clinical benefit of FILSPARI” and that Travere has now submitted complete responses, which are under review.
Beyond Air (XAIR) – Nitric Oxide Platform, NeuroNOS Deal and LungFit PH Expansion | Merlintrader trading Blog IT EN Beyond Air (XAIR) – Nitric oxide platform, NeuroNOS deal and a 170% day Beyond Air (XAIR) is a commercial-stage medtech/biopharma company…
Ocugen has been rallying on rising price and volume, trading close to its 52-week high. The key trigger is the official announcement of a January 15, 2026 webcast to discuss 12-month data from the Phase 2 ArMaDa trial of OCU410 in GA, as outlined in the company’s press release
In its January 13, 2026 press release, BriaCell announced the durable and sustained complete resolution of a lung metastasis in a patient treated with Bria-OTS™ (off-the-shelf personalized immunotherapy). The release describes a 78-year-old woman with metastatic breast cancer who achieved complete resolution after four doses of Bria-OTS monotherapy, with confirmation out to 11 months.
NEAT is clearly positive, Quince can be re-rated as a near-launch rare-disease company with credible billion-dollar potential and strategic appeal. If NEAT fails or is weak, equity value could be severely impaired given the single-asset focus, limited cash and EIB debt.
Focus: FDA approval of Zycubo (copper histidinate, ex CUTX-101) as first treatment for Menkes disease in children – monetisation of milestones, royalties and potential PRV for Fortress/Cyprium.
Today is about one thing: uncertainty around the FDA decision timing/outcome for the FILSPARI FSGS sNDA. The company explicitly highlighted FDA information requests right before the target date.
Focus: multi-year low 9-figure Satellite Services contract with the Swedish Armed Forces – third sovereign-space deal in 12 months, >$500M combined.
Tenax Therapeutics (TENX) – Deep Dive / Analisi Approfondita (Jan 2023 – Oggi) Tenax Therapeutics (TENX) – Deep Dive / Analisi Approfondita (Jan 2023 – Oggi) Full deep dive on TENX: financials, pipeline, catalysts, shareholder structure, insider activity, dilution, analyst…
Precision oncology company built around synthetic lethality, with darovasertib in uveal melanoma and a broad pipeline (MAT2A, PRMT5, PARG, ADCs) backed by more than 1.1 billion dollars in cash and a guided runway into 2030.
Focus: FDA PDUFA for KRESLADI™ (LAD-I) on March 28, 2026 – gene therapy, rare pediatric disease.
Yesterday’s report framed ATRA around a PDUFA-window setup, with the assumption that the 2025 CRL was primarily a CMC/GMP story and that the ALLELE trial remained acceptable as the pivotal efficacy dataset. Today that premise is broken: the FDA has issued a second Complete Response Letter (CRL) for tabelecleucel/tab-cel in EBV+ PTLD.
Biotech catalysts, small-cap rotation, space & defence names already on the Merlintrader radar, Trump factor, geopolitics (Ukraine, Red Sea, Venezuela, Greenland) and J.P. Morgan Healthcare Conference 2026.
As of January 10, 2026, Sana Biotechnology (NASDAQ: SANA) stands as a clinical-stage pioneer focused on the development of engineered cells as a new modality of medicine. Founded on the belief that cell therapy will follow small molecules and biologics as the "third pillar" of therapeutics, Sana has built a platform to address the two primary bottlenecks of the industry: Immune Evasion and Scalable Manufacturing.
Madrigal (MDGL) is a commercial-stage biopharma focused on metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH). Its lead product, Rezdiffra (resmetirom), received FDA accelerated approval on March 14, 2024 as the first treatment for adults with noncirrhotic MASH with moderate to advanced fibrosis (F2–F3), to be used with diet and exercise.
CorMedix Inc. has crossed a line that many small biotechs never reach. It is no longer a binary, pre-revenue story waiting for a single FDA decision. With DefenCath approved, the Melinta acquisition closed and several hundred million dollars of revenue on the board, CRMD now behaves like a small-cap specialty pharma focused on preventing and treating serious infections linked to vascular access.
Summit Therapeutics Inc. (NASDAQ: SMMT) has effectively transformed itself into a single-asset, late-stage oncology company centered on ivonescimab (SMT112), a PD-1 × VEGF bispecific antibody licensed from Akeso in January 2023 (FY2024 PR). Ivonescimab is already approved in China (Akeso) and is now in a broad, global Phase III program led by Summit in NSCLC and colorectal cancer.