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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
NRX-100 was supposed to be one of those year-end catalysts that keep biotech traders awake at night: fast-track status, fee waivers, a new FDA voucher program, and a decision “by year-end 2025”. Yet, as the calendar runs out, the line between guidance and reality still looks blurry.
Instead of a sterile list of dates, this piece focuses on context: how Corcept Therapeutics (CORT), Vanda Pharmaceuticals (VNDA) and Outlook Therapeutics (OTLK) are approaching their regulatory events, what their cash situation looks like, what the retail chatter is, and what kind of narrative one can realistically expect in a positive or negative outcome.
The FDA has accepted a new BLA resubmission for ONS-5010 and set a Class 1 PDUFA goal date on 31 December 2025, after a second CRL in August that focused on lack of substantial evidence of efficacy.
KALA BIO has gone from Phase 2b hope story to distressed nano-cap in a few months: KPI-012 failed, the lender swept cash after a default, and the company survived via a rescue deal with David Lazar plus a $10M registered direct offering priced at-the-market. Here’s what that actually means for the equity.
News of the day – FDA approval
The FDA has approved YARTEMLEA (narsoplimab-wuug) for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children 2 years and older. YARTEMLEA is the first and only approved inhibitor of the lectin complement pathway and the only FDA-approved therapy for TA-TMA.
Sanofi has announced a definitive agreement to acquire Dynavax Technologies Corporation for 15.50 dollars per share in cash, representing a total equity value of approximately 2.2 billion dollars. The offer implies a 39 percent premium to Dynavax’s closing price on December 23, 2025, and the transaction is expected to close in the first quarter of 2026, subject to customary conditions
Dermata Therapeutics (DRMA) – 58% Rally, Low Float and OTC Pivot Deep Dive 2025 | Merlintrader trading Blog Dermata Therapeutics (DRMA) – 58% Rally, Low Float and OTC Pivot Deep Dive 2025 Independent research note on Dermata’s +58% move: financing…
Wall Street comes into Christmas Eve with the S&P 500 at fresh record highs after several strong sessions driven mainly by mega-cap tech. Today’s session is shortened, volumes are thin and the mood is a mix of “Santa Claus rally” and “better not break anything before the holidays”.
From FDA approval of AQVESME in alpha/beta-thalassemia to the next catalysts in sickle cell and MDS: a filings-based look at where Agios really stands now.
On 23 December 2025, reviva confirmed in an 8-K and a press release that the FDA, after the pre-NDA meeting, is strongly encouraging a second Phase 3 trial (RECOVER-2) before any NDA submission for brilaroxazine in schizophrenia.
As of late 2025, Cassava is a small-cap CNS company trading in the low-single-digit USD range after its lead Alzheimer’s drug, simufilam, failed in Phase 3 and the program was discontinued.
Over the last weeks of 2025, several themes have dominated coverage on TBPH: a clearly positive Q3 2025 earnings print (revenue up high-teens percent year-on-year, earnings swinging to a small profit), a sizeable analyst re-rating with average price targets in the mid-to-high twenties per share, and a steady drumbeat of commentary framing Theravance as a “growth” or “momentum” stock again rather than a restructuring situation.
Viridian Therapeutics is trying to become the second major commercial player in thyroid eye disease after Amgen’s Tepezza, with a TED franchise built around veligrotug (IV) and VRDN-003 (subcutaneous), plus an FcRn platform (VRDN-006/008) that targets broader autoimmune indications.
ProKidney is a late clinical-stage cellular therapeutics company focused on a single lead product: rilparencel, also known as REACT (Renal Autologous Cell Therapy).
Deep dive on Moleculin Biotech, Inc. (NASDAQ: MBRX), a Phase 3 oncology company built around Annamycin (AnnAraC) in relapsed/refractory AML, with additional programs in STS lung metastases, brain tumors and viral indications. We walk through MIRACLE’s design and timelines, Phase 1b/2 AML data, the latest December 2025 updates, the balance sheet and why the stock still trades like a distressed nano-cap.
Adagio Medical is not a biotech but a medical device company developing catheter-based ultra-low temperature cryoablation (ULTC) systems for cardiac arrhythmias: atrial fibrillation (AF), atrial flutter and ventricular tachycardia (VT). Its technology uses near-critical nitrogen to reach temperatures as low as −196°C in a linear catheter system, aiming to create rapid, continuous, transmural lesions.
Processa Pharmaceuticals is a clinical-stage company built around a simple idea: instead of discovering entirely new oncology molecules, it re-engineers existing, FDA-approved chemotherapies to improve their therapeutic index. The Next Generation Cancer (NGC) platform aims to keep the same cancer-killing mechanism, while changing metabolism and distribution to reduce toxicity and potentially increase efficacy.
Mustang Bio is a clinical-stage biotech focused on CAR-T and oncolytic virus approaches for hard-to-treat cancers and rare diseases. The science is interesting (especially around MB-106 and MB-101), but cash is tight, dilution is heavy and the going-concern risk is real. Here we lay out numbers, pipeline, sentiment and risk without any promotional angle.
SELLAS Life Sciences is a late-stage oncology biotech whose near-term equity story is dominated by a single survival-driven Phase 3 trial (REGAL with GPS in AML maintenance) and a rapidly de-risking CDK9 program (SLS009 in AML-MR).
Beam Therapeutics is one of the purest listed plays on base editing. Its pipeline spans ex vivo and in vivo programs: risto-cel (BEAM-101) for sickle cell disease, BEAM-201 for aggressive T-cell malignancies, BEAM-301 for glycogen storage disease type Ia (GSD1a) and BEAM-302 for severe alpha-1 antitrypsin deficiency, plus an engineered stem-cell antibody-paired evasion (ESCAPE) platform aimed at non-genotoxic conditioning.