Mycovia Pharmaceuticals Inc. is prepping to launch its first commercial product following U.S. FDA approval of oral antifungal oteseconazole for use in recurrent vulvovaginal candidiasis (RVVC). Branded Vivjoa, the drug is expected to be available to patients during the second quarter.
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines.
Shares of Eliem Therapeutics Inc. fell 56% on the company’s announcement that it would end development of its non-opioid palmitoylethanolamide prodrug, ETX-810, in diabetic peripheral neuropathic pain following a phase IIa failure. It was part of a double dose of bad news reported by Seattle-based Eliem, which also is delaying phase II development of depression candidate ETX-155 to resolve issues of lower-than-expected drug exposure in a phase I study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy.
By January 2022, 12 billion COVID-19 vaccine doses had been manufactured and, to date, roughly 20 vaccines have received either full approval or emergency use authorization in countries around the world. In places such as Europe and the U.S., most of the people who want vaccinations have gotten their jabs. And the vaccines continue to show efficacy, with the latest CDC data showing consistently less risk for testing positive for COVID-19 or dying from the infection for those who are vaccinated and boostered. Yet the development of new COVID-19 vaccines remains surprisingly robust, with BioWorld tracking 258, the majority of which are in preclinical development.
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
Neuron23 Inc. came out of stealth mode in late 2020 with a $113.5 million combined series A and B round to support its AI-enabled drug discovery effort aimed at bringing a precision medicine approach to neuroimmunology. Now it has added another $100 million in a series C financing as it gears up to move into clinical testing with lead programs targeting LRRK2 and TYK2.
Zogenix Inc.’s Fintepla (fenfluramine) cleared the U.S. FDA hurdle shortly after its March 25 PDUFA date, expanding the drug’s use in patients with Lennox-Gastaut syndrome (LGS) and validating UCB SA’s $1.9 billion acquisition of Emeryville, Calif.-based firm, which closed earlier this month.
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
