A Happy New Year and a warm welcome to 2021 to all readers of BioPharmCatalyst.
Over the next few weeks, we preview upcoming biotech stock catalysts slated for the first quarter of this year, commencing this week with PDUFA dates for small and mid-cap companies, before moving onto key clinical trial readouts in following weeks.
First, let's review the week that was. With the holiday period seeing much quieter news flow than normal, just a few notable price-moving clinical data readouts and regulatory decisions are noted.
REGULATORY:
Osmotica Pharmaceuticals plc (NASDAQ:OSMT) shares closed Wednesday down 20% to $4.23 following news the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis. The FDA has recommended the company conduct a new trial in order to provide evidence of efficacy of arbaclofen.
CLINICAL DATA:
Aprea Therapeutics, Inc. (Nasdaq: APRE) shares slumped to close the week down 80% to $4.92 on news data from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS), did not meet the predefined primary endpoint of complete remission (CR) rate. The CR rate in the eprenetapopt with AZA arm was 33.3% compared to 22.4% in the AZA alone arm (p= 0.13).
COVID-19 VACCINE:
AstraZeneca Plc (NASDAQ: AZN) and the University of Oxford won approval from U.K. regulators for their COVID-19 vaccine, making it the third vaccine to be approved in the U.S/U.K/Europe. While efficacy levels have shown to be lower in clinical trials compared with the two other approved vaccines (Moderna and Pfizer), it can be stored at refrigerator temperature unlike the other aforementioned vaccines which require super freezing storage.
Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) shares closed Tuesday down 54% to $42.36 following the release of pre-clinical and Phase 1/2 data from its COVID-19 vaccine trial of ARCT-021.
OTHER
Myovant Sciences (NYSE:MYOV) and Pfizer Inc. (NYSE:PFE) announced a collaboration to develop and commercialize relugolix in the U.S. and Canada. Myovant will receive up to $4.2b, including an upfront payment of $650m, $200m in potential regulatory milestones for FDA approvals for relugolix and tiered sales milestones. Myovant and Pfizer will equally share profits for relugolix. Shares of Myovant closed the week up 21% to $27.62.
Small and mid-cap biotech stocks assigned first quarter PDUFA dates: