The oft-cited "favorable trends" in otherwise failed phase II/III data with Kamada Ltd.'s inhaled alpha-1 antitrypsin therapy (AAT) may just be adequate to win European Union (EU) marketing approval, and the company is forging ahead.
Infinity Pharmaceuticals Inc.'s hefty deal with Abbvie Inc. provides $275 million up front and the potential for $530 million more if milestones are met with duvelisib, also known as IPI-145, already in phase III trials as a blood cancer monotherapy and ripening for combination use.
Exelixis Inc. will downsize by 70 percent in the wake of the pivotal phase III failure by Cometriq (cabozantinib) in prostate cancer (PC), and awaits results that are due next year from the late-stage experiment in renal cell carcinoma (RCC).
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.
