As Pfizer Inc. and Biontech SE start their massive phase II/III safety and efficacy trial evaluating a single nucleoside-modified messenger RNA candidate from their BNT-162-based vaccine program against SARS-CoV-2, smaller, privately held Codagenix Inc. plans a different approach.
The bad cohort 1 news from Spectrum Pharmaceuticals Inc. in late April with poziotinib in the phase II Zenith20 study turned itself around in a stock-boosting way as the Henderson, Nev.-based firm unveiled data from cohort 2.
HONG KONG – Mumbai, India-headquartered Glenmark Pharmaceuticals Ltd. have released statistically significant top-line results from a phase III trial showing that Fabiflu (favipiravir), an antiviral pyrazine RNA polymerase inhibitor, can treat cases of mild to moderate COVID-19 in four days.
HONG KONG – Tokyo-based Daiichi Sankyo Co. Ltd. has hit its goals in a phase III study testing the use of prasugrel hydrochloride in thrombotic stroke patients.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Amgen, Chi-Med, Cytomx, Northwest, Noxxon, Polarityte, Theratechnologies, UCB.
Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Ampio, Aravive, Clarity, Corcept, Genfit, Incyte, Pipeline, Quadriga.
Testing Nuplazid (pimavanserin) against major depressive disorder (MDD), Acadia Pharmaceuticals Inc. became the latest to fail in the indication as the company unveiled top-line results from the 298-patient phase III effort called Clarity.
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