Having results in primates with its ricin toxin vaccine Rivax is "almost like you've got phase II data," Soligenix Inc.'s chief scientific officer Oreola Donini told BioWorld Today, which is probably why shares of the Princeton, N.J.-based company (NASDAQ:SNGX) skyrocketed 43.6 percent, or $1.12, to close Wednesday at $3.69.
Prometic Life Sciences Inc.'s president and CEO, Pierre Laurin, told BioWorld Today that "anything can happen here," as the company pursues work with the oral antifibrotic PBI-4050, but for now the FDA has agreed on the design of the first of the Laval, Quebec-based firm's pair of planned phase II/III trials in idiopathic pulmonary fibrosis (IPF).
"These are tough-to-treat cancers and we knew they were tough-to-treat cancers going in," Oncomed Pharmaceuticals Inc. CEO Paul Hastings said, but results "all the way back to our xenograft data, as well as our phase Ib data, gave us every indication that these were indications which we should go forward with," and the company "did the right thing" by pursuing them, he said.
Hoping to succeed where pharma giant Novartis AG failed in a late-stage trial, KPI Therapeutics Inc. is "working on closing out an investment round" to enable a phase II experiment with lead compound dalazatide in inclusion-body myositis (IBM), CEO Charles Magness told BioWorld Insight. "We hope to get that [financing] rolling in the summer-ish time frame," he said.
Bad news came on Good Friday for Incyte Corp. and Eli Lilly and Co. in the form of a complete response letter (CRL) from the FDA related to once-daily, oral baricitinib for moderate to severe rheumatoid arthritis (RA).
As the company unveiled positive topline phase II results with topical gel SB-208, Novan Inc. CEO Nathan Stasko told BioWorld Today that "we're really at the infancy of this platform and the nitric-oxide era," with more news due about other compounds this year.
"It's a lab-ready system – that's really critical," Geraldine Hamilton, president and chief scientific officer of Emulate Inc., told BioWorld Today, detailing the firm's cooperative research and development agreement with the FDA for use of the Boston-based firm's Organs-on-Chips technology, which will be placed "in [the FDA's] lab, so they can get first-hand experience" with it.
Investors may not have cherished high hopes for Allergan plc's phase II effort with Botox (onabotulinumtoxin type A) in major depressive disorder (MDD), nor are the results uniformly positive, but the company is forging ahead anyway with plans for a phase III experiment.
