Hailed as a key growth driver for BioMarin Pharmaceuticals Inc., GALNS (N-acetylgalactosamine-6 sulfatase) came through with solid Phase III data in rare lysosomal storage disorder mucopolysaccharidosis Type IVA (MPS IVA), sending shares of the Novato, Calif.-based biotech soaring 31.2 percent Monday.
Three years after a new drug application was first submitted for leukemia drug omacetaxine mepesuccinate, during which the product moved twice into different hands via M&A transactions, the FDA granted a long-awaited nod Friday.
Three years after a new drug application was first submitted for leukemia drug omacetaxine mepesuccinate, during which the product moved twice into different hands via M&A transactions, the FDA granted a long-awaited nod Friday.
SARcode Bioscience Inc. cleared the first hurdle in its Phase III program testing dry eye candidate lifitegrast, with the drug nailing its primary endpoint in the first pivotal trial, demonstrating biologic activity against ocular surface damage.
Reata Pharmaceuticals Inc. ended a Phase III trial testing bardoxolone methyl in patients with Stage IV chronic kidney disease (CKD) and Type II diabetes after the independent data monitoring committee (IDMC) pointed to safety signals in the treatment arm, halting development of a drug that had once been hailed a potential blockbuster.
The latest biotech hoping to take advantage of the new emerging growth company category under the Jumpstart Our Business Startups (JOBS) Act of 2012, antibiotic developer Paratek Pharmaceuticals Inc. filed for an initial public offering (IPO) aiming to raise $92 million as it takes thrice partner-dumped omadacycline into Phase III testing on its own.
Drugs derived from the venom of unusual species is hardly a novelty in biotech. There's Amylin Pharmaceuticals Inc.'s Gila monster-derived diabetes drug Byetta (exenatide) and investigational drugs GxMTx4, a nontoxic peptide from spider venom from Rose Pharmaceuticals for Duchenne's muscular dystrophy, and Paion AG's recently divested desmoteplase, a plasminogen activator based on the saliva from a vampire bat.
Two weeks ago, Peregrine Pharmaceuticals Inc. was flying high. The Tustin, Calif.-based company surprised Wall Street with statistically significant interim survival data from its Phase IIb trial of cancer drug bavituximab and said it was in potentially lucrative partnering talks. But on Monday, the firm's shares lost three-fourths of their value as investors learned that those Phase II results might not turn out to be that impressive after all.
The latest firm launched by Third Rock Ventures, MyoKardia Inc., started its existence with a $38 million Series A financing, disclosed Thursday morning, to translate discoveries of mutations in the heart muscle into personalized therapeutic approaches for treating genetic cardiomyopathy.
Taking advantage of a summer stock climb on the back of its allogeneic cell therapy pipeline, Pluristem Therapeutics Inc. is nearly doubling its cash position with a $32 million public offering.
