With its protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab showing strong anti-cholesterol results across patient populations and dosing schedules (monthly as well as every two weeks) in phase III trials, Amgen Inc. held fast against data provided thus far by Regeneron Pharmaceuticals Inc. with alirocumab, also targeting PCSK9.
It’s only $5 million in series A funding, but enough to move start-up Kindex Pharmaceuticals Inc. into a phase II trial with lead compound KDT 501, a hops-derived candidate for type 2 diabetes that regulates the cross-talk between macrophages and adipocytes to influence the complex of proteins that regulate inflammation, also known as the inflammasome.
With a label warning about weight loss that might actually help sales, Celgene Corp.’s oral phosphodieasterase-4 (PDE4) inhibitor Otezla (apremilast) was approved by the FDA on its Friday PDUFA date for adults with active psoriatic arthritis (PsA).
Right on time, the FDA approved Celgene Corp.’s phosphodieasterase-4 inhibitor Otezla (apremilast) for adults with active psoriatic arthritis (PsA), a drug that could sell in the range of $1.5 billion to $2 billion by 2017, the company said.
Wall Street hailed Endocyte Inc.’s double play – a positive opinion from European regulators on vintafolide in platinum-resistant ovarian cancer (PROC) and good news from a phase IIb trial in non-small-cell lung cancer (NSCLC) with the same compound – by sending its stock through the roof.
Akebia Therapeutics Inc. beat the target amount raised in its initial public offering to raise about $100 million, and started off trading with a bang, closing Thursday (NASDAQ:AKBA) at $26.70, up 57 percent.
Still enrolling a pivotal trial of its own Factor Xa inhibitor betrixaban, Portola Pharmaceuticals Inc. launched a new phase III study, this one testing andexanet alfa, designed to reverse the action of the anticoagulant class.
Medivation Inc. and partner Astellas Pharma Inc. made the latest move in the battle for prostate cancer marketing share by submitting a supplemental new drug application (sNDA) seeking a label for Xtandi (enzalutamide) in chemotherapy-naïve men.
Five Prime Therapeutics Inc. is getting $20 million up front, selling a premium-priced equity stake, and “learning from the masters, as it were,” in its three-year cancer immunotherapy deal with Bristol-Myers Squibb Co. (BMS), an agreement centered on two undisclosed pathways that could generate a couple of targets each, said Five Prime CEO Lewis Williams.
Already trading weakly as a public entity thanks to its reverse merger in the fall of last year, Ignyta Inc. priced an initial public offering (IPO) of about 5.2 million shares at $9.15 each, for gross proceeds of about $48 million and a net haul of about $44.5 million.
