Oncomed Pharmaceuticals Inc.'s stoppage in June of phase Ib trials because of bone-related adverse events with a pair of candidates did little to dampen the enthusiasm of analysts for the firm, and last week's lift of the partial clinical hold on vantictumab (OMP-18R5) only made the picture brighter.
Some investor confusion over the results from Repros Therapeutics Inc.'s first of two identical, pivotal phase III trials with Androxal (enclomiphene), its oral secondary-hypogonadism treatment, did not stop shares of the company from enjoying an uplift based on the data, which could enable a new drug application (NDA) before 2014 is over.
With its inhaled levodopa product for Parkinson's disease (PD) gearing up for a phase III trial and $55 million just gained in a series C financing, Civitas Therapeutics Inc. filed to raise up to $86.2 million in an initial public offering (IPO).
Given a lift by phase I/IIa data with KTE-C19, its anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for aggressive non-Hodgkin's lymphoma, Kite Pharma Inc. plans a pivotal study early next year in diffuse large B-cell lymphoma (DLBCL).
Entering the marketplace battle for HIV-1 share with a new fixed-dose pill is Viiv Healthcare Ltd., the joint venture between Glaxosmithkline plc and New York-based Pfizer Inc., which won the go-ahead from U.S. regulators last week for Triumeq.
With $24 million in series B financing, Aldea Pharmaceuticals Inc. will gather more safety data this year and in the second half of 2015 start a phase II trial in acute alcohol intoxication with its lead candidate, AD-6626, based on technology licensed from Stanford University.
Baxter International Inc. unveiled favorable phase III data from the pivotal trial with BAX 855, an extended half-life recombinant factor VIII (rFVIII) antagonist for hemophilia A. The follow-on for Baxter's gold standard Advate (octocog alfa) is partnered with Nektar Therapeutics Inc., and analysts say the latest results put the companies on solid footing in the space.
First to market with an all-oral first-line therapy for adults with Gaucher disease type 1, the most common form, is the Genzyme unit of Paris-based Sanofi SA, which gained FDA marketing clearance for Cerdelga (eliglustat), giving patients an option to the infused enzyme replacement therapy (ERT) Cerezyme (imiglucerase), also developed by Genzyme.
Globavir Biosciences Inc. formally threw its hat into the Ebola ring, making known the firm's plan to develop the preclinical candidate GBV006 as a potential remedy for the virulent outbreak in West Africa.
Biogen Idec Inc. is keeping its injectable bases covered in relapsing multiple sclerosis (RMS) with the approval Friday of Plegridy (peginterferon beta-1a), given by an auto-injector pen or prefilled syringe every two weeks, a significant half-life advantage over the firm's Avonex (interferon beta-1a) for RMS, given weekly.
