A black-box warning, confusion about postmarketing requirements and the third-to-market status of Orexigen Therapeutics Inc.'s obesity therapy Contrave (naltrexone and bupropion) extended-release tablets may have been responsible for weakening of the stock, but the company and partner Takeda Pharmaceuticals U.S.A. sounded upbeat during a morning conference call with investors.
Almost exactly four years after partnering with Genmab A/S on an antibody-drug conjugate (ADC) that targets tissue factor antigen, Seattle Genetics Inc. (Seagen) has inked another deal with its Danish partner, this time worth as much as $200 million in milestone payments and bringing a $11 million payment up front.
Following up the early U.S. approval of in-licensed Beleodaq (belinostat) for peripheral T-cell lymphoma, Spectrum Pharmaceuticals Inc. offered good news from another deal, making public the plans to push SPI-2012, a long-acting granulocyte stimulating factor (GCSF), into phase III trials next year.
With its stock recovering nicely from a low-ball initial public offering (IPO) in April, Vital Therapies Inc. said its phase III trial with VTI-208 in alcohol-induced liver decompensation (AILD) is progressing on schedule and has enrolled 150 of the planned 200 patients.
Merck & Co. Inc.'s FDA clearance, almost two months earlier than expected, of PD-1-targeting Keytruda (pembrolizumab) for melanoma holds the title for gaining the first U.S. approval of a drug in the class, but restrictions in the label have meant "a lot of head-scratching," said Robert Pierce, formerly director of Merck's anti-PD-1 development team.
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.
