The efficacy supplement for the radioligand therapy Pluvicto was approved with a status date of July 31, 2026.
Drugs@FDA
The company also disclosed a partial response in a RAD 204 trial patient and a quarterly cash outflow that leaves under one quarter of runway before recent raises.
SEC filing
Interim blinded data from 62 evaluable subjects show remission rates holding steady even as more venetoclax-failure patients enter the pivotal trial.
SEC filing
The European Commission cleared AstraZeneca and Daiichi Sankyo's Datroway for patients with metastatic triple-negative breast cancer who cannot receive immunotherapy, citing a survival benefit.
SEC filing
AbbVie announced a definitive deal for Apogee's immunology pipeline, adjusted its full-year adjusted EPS range, and reported a string of regulatory approvals across its portfolio.
SEC filing
Tenax says topline Phase 3 LEVEL results are expected in August 2026 and will be presented at the ESC Congress, while enrollment continues in a second pivotal trial, LEVEL-2.
SEC filing
The July 30, 2026 agreement ends Kyorin's license and hands aTyr full rights to develop and commercialize efzofitimod worldwide.
SEC filing
The Melbourne, Florida biotechnology company reported $350,000 sold so far from one investor, with a first sale date of July 17, 2026.
SEC filing
The company disclosed in a July 31, 2026 filing that Professor Peled stepped down for personal reasons, effective August 1, 2026.
SEC filing
The Zurich-based biopharmaceutical company will sell shares and warrants to fund its lead type 1 diabetes program after a recent FDA Pre-IND meeting.
SEC filing
Werewolf said it expects to report strategic-review and clinical trial updates in the second half of 2026 after closing its JZP898 sale to Jazz and repaying its K2 loan.
SEC filing
The moves are tied to stockholder approval of proposals needed to complete Quince's acquisition of Orphai Therapeutics and related financing.
SEC filing
The company set terms for a previously announced offering, with underwriters exercising their warrant option in full, expected to close July 31, 2026.
SEC filing (3)
The neuroscience drug development veteran joins as Vistagen advances its pherine pipeline, including Phase 3 fasedienol for social anxiety disorder.
SEC filing
The company is offering 12 million shares as its lead sleep apnea drug candidate awaits FDA decision by February 28, 2027.
SEC filing
The filing shows Armistice Capital already holds 31.18% of VivoSim before the offering, with warrant terms tied to a stockholder-approval trigger.
SEC filing
The company said mRNA-1403 did not clear a Phase 3 interim efficacy threshold as it awaits an August 5 FDA decision on flu vaccine mFLUSIVA.
SEC filing