On January 7, 2026 Immuneering will host a conference call and webcast to present 12-month overall survival (OS) from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) + modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer. This is the logical follow-up to the 6- and 9-month data that have already attracted significant attention.

Travere Therapeutics has transitioned in 2025 from a “promising rare-disease biotech” into a genuine kidney franchise story. Filspari is fully approved in IgAN and ramping quickly, while the January 13, 2026 PDUFA on FSGS could make it the first FDA-approved therapy in that indication.

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.

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.

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…

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.

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.