Bloody Tuesday for biotech
Biotech shares dropped in the wake of Monday's news of price wars for HCV drugs, with the BioCentury 100 index falling 5% and the NYSE Arca Biotechnology (BTK) dropping 4%.
Cytokinetics, Astellas expand in neuromuscular space
Cytokinetics Inc. (NASDAQ:CYTK) added $0.62 to (13%) $5.52 on news it will receive $55 million in payments from Astellas Pharma Inc. (Tokyo:4503) to expand their skeletal muscle activation collaboration into neuromuscular indications.
Novo's Saxenda wins FDA approval
FDA approved Saxenda liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) for chronic weight management as an adjunct to diet and exercise in obese adults or in overweight adults with at least one co-morbidity. The approval comes well after Saxenda's Oct. 20 PDUFA date.
Otsuka takes Asian rights to Ariad's Iclusig
Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) licensed rights in 10 Asian territories to Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) to treat resistant and intolerant chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (ALL).
Vanda climbs on Fanapt settlement
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) rose $1.67 (14%) to $13.58 on Tuesday after it reacquired exclusive U.S. and Canadian rights to Fanapt iloperidone from Novartis AG (NYSE:NVS; SIX:NOVN). The deal settled a licensing dispute between the two companies, in which Vanda had begun an arbitration proceeding in May seeking $539 million from Novartis.
Alder proposes $115M follow-on
After completing a downsized IPO in May, Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) is proposing to raise $115 million in a follow-on underwritten by Credit Suisse; Leerink; Wells Fargo; and Sanford Bernstein.
CardioDx withdraws IPO
CardioDx Inc. (Palo Alto, Calif.) withdrew its IPO on NASDAQ, citing market conditions. In April, the company revived plans for an IPO it had postponed the previous fall, but it did not set terms (see BioCentury Extra, April 29).
POLITICS & POLICY
U.S.-China clear some air on clinical pathways
China has explicitly made clear that pharma companies can obtain waivers to avoid running domestic clinical trials after conducting multiregional clinical trials (MRCTs) that meet the government's technical requirements for use of Chinese data.
BioCentury Extra will not publish on Wednesday, Dec. 24, through Friday, Dec. 26, in observance of the Christmas holiday. BioCentury Extra will resume publishing on Monday, Dec. 29.