Oncolys Biopharma Inc. joined the ranks of dealmakers in the oncolytic virus therapeutic space, given a boost by last year’s FDA go-ahead for the first agent, Imlygic (talimogene laherparepvec) for melanoma from Amgen Inc.
Oncolys Biopharma Inc. joined the ranks of dealmakers in the oncolytic virus therapeutic space, given a boost by last year’s FDA go-ahead for the first agent, Imlygic (talimogene laherparepvec) for melanoma from Amgen Inc.
To win proof of concept for gene therapy in the eye previously and now in the liver, with likely read-through from results in hemophilia B with SPK-9001 to efforts in hemophilia A, are "fabulous steps for the company to have taken," Spark Therapeutics Inc. CEO Jeffrey Marrazzo told BioWorld Today.
With solid top-line phase IIb data for its oral insulin in hand, "everything is focused on taking this from where we are right now into a phase III trial," Chief Operating Officer Josh Hexter told BioWorld Today, adding that the company is still putting the results together and will schedule an end-of-phase-II meeting with the FDA when the package is ready.
The FDA "will not be happy on the cardiovascular [CV] front, short of the data from a study designed specifically to address that issue" with regard to testosterone replacement therapy (TRT), Clarus Therapeutics Inc. CEO Robert Dudley told BioWorld Today, and the agency has asked vendors of marketed products to take on such work.
Pfizer Inc.'s $5.2 billion acquisition of Anacor Pharmaceuticals Inc. to collect crisaborole sweeps one soldier off the atopic dermatitis (eczema) field, but plenty remain – with varying approaches and hard-to-handicap odds in what ISI Evercore analyst Mark Schoenebaum called a "not very developed" but potentially lucrative market.
Last September, Brean Capital LLC reflected Wall Street's generally sour sentiment by downgrading from "buy" to "hold" shares of Tetraphase Pharmaceuticals Inc. pending "a clearer path forward," after the failure of the phase III study called IGNITE2 with eravacycline as an intravenous (I.V.)-to-oral transition therapy for complicated urinary tract infection (cUTI).
An advantage specific among obese patients seen in the first phase III trial with Baxdela (delafloxacin) "didn't pan out in the second" experiment, Melinta Therapeutics Inc. CEO Eugene Sun told BioWorld Today, "but what we did end up with is a very robust study in very challenging patients, so I think we have a rich dataset now to convince physicians that Baxdela is an ideal drug" across a wide sample of subjects with acute bacterial skin and skin structure infections (ABSSSIs).
Wall Street speculation that a pending ex-U.S. partnership "could lead into something greater or bigger" helped bump shares of Celator Pharmaceuticals Inc., but CEO Scott Jackson told BioWorld Today the promise of more color than expected on Vyxeos at next month's American Society of Clinical Oncology meeting may have helped, too.
As Wall Street tossed another would-be pancreatic cancer therapy on the phase III scrap heap, Newlink Genetics Corp. CEO Charles Link said the firm is "evaluating the future" of the Hyperacute Cellular Immunotherapy platform, from which emerged algenpantucel-L, most recently to fail in patients with resected tumors.
