Amgen Inc.'s bid to get approved an I.V. replacement for its oral Sensipar hit choppy seas in the form of a complete response letter from the FDA on its PDUFA date regarding the NDA for Parsabiv (etelcalcetide), designed to treat secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis.
In September 2015, when Galapagos NV lost its partnership with Abbvie Inc. for Janus kinase (JAK) 1 inhibitor filgotinib in rheumatoid arthritis (RA) – but kept intact their agreement for cystic fibrosis (CF) – the search for a new tie-up began right away, even as the spurning entity moved ahead with its own late-stage, oral JAK1 candidate in RA, ABT-494.
As the day went on and Wall Street heard further details, out-of-the-gate skepticism calmed among onlookers about the $14 billion price tag on Pfizer Inc.'s buyout of Medivation Inc.
Clovis Oncology Inc.'s publicly known showing with oral PARP inhibitor rucaparib in advanced ovarian cancer turned up in platinum-sensitive patients, which makes comparisons tough with Astrazeneca plc's same-class Lynparza (olaparib).
Cerulean Pharma Inc.'s top-line phase II blowup with lead candidate CRLX101 in advanced renal cell carcinoma (RCC) put the kibosh on the idea that targeting hypoxia inducible factor (HIF) in combination with a vascular endothelial growth factor inhibitor might work, so the company is narrowing its focus to topoisomerase-1-sensitive tumors.
In January, after Eleven Biotherapeutics Inc. disclosed mixed phase III data in severe allergic conjunctivitis with the interleukin-1 (IL-1) signaling inhibitor EBI-005 (isunakinra) – which also proved a dud in the late-stage experiment for dry eye disease in May 2015 – the stock took a 77 percent hit and Wall Street retreated.
With the second phase III failure of antisense oligonucleotide custirsen in castrate-resistant prostate cancer (CRPC), Oncogenex Pharmaceuticals Inc. investors have turned their eyes to non-small-cell lung cancer (NSCLC), where the clusterin inhibitor is undergoing late-stage tests in combination with docetaxel.
Even if Wall Street scratches off the soon-to-report, longshot phase III SEAMLESS trial in acute myeloid leukemia (AML), Cyclacel Pharmaceuticals Inc. may have value aplenty in an early stage pair of other clinical programs. But home-run hopes die hard and biotech is full of surprises – such as Vyxeos, the late-stage AML winner in March for Celator Pharmaceuticals Inc.
Protagonist Therapeutics Inc.‘s $90 million IPO sold 7.5 million shares at $12 each, after the Milpitas, Calif.-based firm had first planned for $70 million by offering 5.84 million shares with insiders buying as much as $40 million. The upsized win bodes well not only for the company’s efforts in oral vs. injectable therapies but also for others hoping to find their places on the public market, though shares (NASDAQ:PTGX) didn’t see much action Thursday, closing at $11.70, down 30 cents.
Adelene Perkins, CEO of Infinity Pharmaceuticals Inc., told BioWorld Today that her firm's "going-in assumption is that we will be successful" in selling rights to PI3K inhibitor duvelisib despite Abbvie Inc.'s pullout from their partnership, which followed Gilead Sciences Inc.'s trial-death woes related to Zydelig in the same class and put the jitters into investors even as they hold out hope from the promising approach.
