Oncolytics Biotech Inc. CEO Brad Thompson told BioWorld Today that the FDA's approval of the first oncolytic virus agent, Amgen Inc.'s Imlygic (talimogene laherparepvec) for melanoma, should make raising capital easier for his firm and clear the way for others working with "very complicated agents" in the space.
Science or technology that fails to measure up and weak leadership make for sure-fire deal-killers in the venture capital (VC) world, but there's more to it, said Jay Lichter, managing partner with Avalon Ventures in San Diego.
With seven new-indication or product approvals possibly ahead through 2018, Alexion Pharmaceuticals Inc. should have no problem using the priority review voucher gained via the FDA's clearance Friday of Strensiq (asfotase alfa) for perinatal-, infantile- and juvenile-onset bone disorder hypophosphatasia (HPP), a high-cost, breakthrough therapy that shouldn't feel any pain during this election year's storm over drug profiteering.
A pair of top-line datasets from what analysts called a successful phase III trial in allergic conjunctivitis and a phase IIb study said to have done its job in glaucoma/ocular hypertension (OH) apparently didn't convince investors in Ocular Therapeutix Inc., who took shares (NASDAQ:OCUL) down 52.3 percent Friday, or $7.88, to close at $7.18.
Relypsa Inc. CEO John Orwin told BioWorld Today it’s “probably not appropriate” to make comparisons between his firm’s just-approved Veltassa (patiromer) for high blood potassium and the FDA-pending compound from ZS Pharma Inc., since no head-to-head trials have been done.
The surprise phase III blow-up of Synta Pharmaceuticals Corp.’s heat-shock protein 90 (HSP90) inhibitor ganetespib, disclosed Tuesday night, sent shares into the basement and dealt what one analyst called “a major blow to confidence in the drug,” still in four trials sponsored by investigators and cooperative groups that are testing the compound against other indications.
Off to a strong start with $102 million in series A money, Gritstone Oncology Inc.'s research with immunotherapies based on tumor-specific neoantigens (TSNAs) will first try the vaccine strategy in non-small-cell lung cancer (NSCLC) – a "big idea that merits some detailed attention and effort," CEO, president and co-founder Andrew Allen told BioWorld Today.
Once viewed as a potential blockbuster destined to face off against Pfizer Inc.’s Prevnar 13, Genocea Biosciences Inc.’s pneumococcus vaccine, GEN-004, fizzled in top-line data from a phase IIa trial, performing better than placebo but not well enough to hit statistical significance.
Cempra Inc.’s stock (NASDAQ:CEMP) lost 28 percent of its value Friday to close at $19.29, down $7.49, as investors balked at infusion-site pain reactions reported in the otherwise successful, second phase III trial with solithromycin for community-acquired bacterial pneumonia (CABP).