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.
Exero Medical Ltd. aims to improve monitoring the gastrointestinal system after surgery with a wireless, biodegradable anastomotic leak sensor implant. It has started a tiny five-patient, first-in-human study as a proof of concept for its technology.
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year.
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business. The company is now developing three therapeutic products, one diagnostic and a vaccine.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I. The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results.
LONDON – There were encouraging results from trials of three COVID-19 vaccines on July 20, with Astrazeneca plc, Biontech SE/Pfizer Inc. and Cansino Biologics Inc. all reporting T-cell responses in ongoing phase I/II studies of their respective products.
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