Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study.
Testing Nuplazid (pimavanserin) against major depressive disorder (MDD), Acadia Pharmaceuticals Inc. became the latest to fail in the indication as the company unveiled top-line results from the 298-patient phase III effort called Clarity.
Chief Business Officer David McNinch told BioWorld that South San Francisco-based Encoded Therapeutics Inc.’s $135 million from an oversubscribed series D financing follows by about a year the hefty series C round that “helped us get the [lead gene therapy] program poised to its current stage, which is IND-enabling studies.” The asset, ETX-101 for SCN1A-positive Dravet syndrome (DS), is expected to enter human trials next year.
The two-year standstill provision in Assembly Biosciences Inc.’s potential $540 million pact with Beigene Ltd. to advance hepatitis B virus (HBV) therapies was “highly negotiated,” said Jason Okazaki, Assembly’s chief legal and business officer.
The two-year standstill provision in Assembly Biosciences Inc.’s potential $540 million pact with Beigene Ltd. to advance hepatitis B virus (HBV) therapies was “highly negotiated,” said Jason Okazaki, Assembly’s chief legal and business officer.
Armata Pharmaceuticals Inc.’s recent $15 million award for a three-year program from the U.S. Department of Defense to partially fund a phase Ib/II study added to the already growing resurgence of notice for phage-based therapeutics, with even big pharma starting to take heed.
Robust financial markets continue to fuel the industry despite gloom over the COVID-19 pandemic, with Relay Therapeutics Inc. pricing its upsized, 20 million-share IPO at $20 per unit to reap $400 million.
An editorial yesterday in The New England Journal of Medicine (NEJM) marveled that “the world has now witnessed the compression of six years of work into six months,” and went on to ask the question that’s on everyone’s pandemic-wrenched mind: “Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious COVID-19 vaccine for the most vulnerable in the next six [months]?”
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
Inmune Bio Inc. CEO Raymond Tesi told BioWorld his firm is taking an “oncology-style” approach to Alzheimer’s disease (AD) as the firm tests next-generation tumor necrosis factor (TNF) inhibitor XPro-1595 against neuroinflammation.
