Pharmaceuticals News

Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027 Two abstracts accepted for presentation at the European Respiratory...

Completed pre-IND meeting with the FDA for CNTY-813, an iPSC-derived islet replacement therapy with functional cure potential in type 1 diabetes (T1D); IND submission on track for 4Q 2026CNTY-813...

Received FDA clearance of IND application for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2 Advancing IND-enabling studies for potential first-in-class multi-specific, masked T cell...

FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance Exclusive U.S. and Canada Commercialization...

Randomized Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) ongoing, with results expected in 1H 2027; potential registration trial expected in 2027 once recommended dose regimen has...

Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash,...

Maintained strong financial position with cash, cash equivalents and marketable securities of $92.6M as of June 30, 2026 Received first payment of approximately $178M from Moderna settlement in...

COPENHAGEN, Denmark, August 12, 2026 – Novonesis today announced the launch of Optiva® Triticum, a new biosolution that helps pasta manufacturers increase flexibility in wheat sourcing while...

Over 50% of commercially insured lives in the U.S., representing a recent and significant increase, now have coverage for CARDAMYST® (etripamil) nasal spray Phase 3 registrational trial of etripamil...

– Newly granted patent extends protection for ATH434 to at least 2045, significantly enhancing its strategic value and long-term commercial potential – – Strengthens ATH434’s intellectual property...