Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%. Read More
Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday. Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%. Read More
BEIJING – Antibody developer Akeso Biopharma Inc., from China's Guangdong province, closed a $150 million series D financing round to advance its pipeline, especially the two PD-1-based bispecific antibodies, AK-104 and AK-112, aimed to help it stand out in the fierce PD-1 space in China. "A significant portion of the proceeds will go to AK-104 and AK-112, which are both first-in-class drug candidates," Akeso CEO Michelle Xia told BioWorld. This year is a big one for Akeso, as AK-104 and AK-112 received IND approvals from the FDA in March and July, respectively. Read More
DUBLIN – Evotec SE is taking a further crack at kidney disease, through a 50-50 joint venture with Vifor Pharma Group, which is funding an initial drug discovery and preclinical development phase with €25 million (US$27.6 million). The as-yet-unnamed venture aims to capitalize on Evotec's participation in a large-scale U.K. biobank, which is tracking about 4,000 patients with either chronic kidney disease or idiopathic nephrotic syndrome. Read More
LONDON – It used to be called junk DNA, but now Ervaxx Ltd. has shown the noncoding parts of the genome are a treasure trove of novel cancer antigens. Two years after spinning out of the Francis Crick Institute in London, the company has emerged with a $17.5 million series A funding and a fully formed platform for systematically discovering coding sequences for what it refers to as "dark antigens." (The name is trademarked.) Read More
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). Read More
Whether prescription drug prices are skyrocketing in the U.S. is a question of perspective and context. Patients needing regular refills of insulin or certain other brand drugs with no generics are seeing their out-of-pocket costs going up, sometimes with every trip to the pharmacy. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
