The final part of our first quarter preview of biotech stock events to watch rounds out this week with Phase 1/2 catalysts. Previously a list of PDUFA dates for small and mid-cap companies and Phase 3 data readouts were published.
First, let’s review the week that was with notable price-moving news.
Eli Lilly and Company (NYSE:LLY) shares closed Monday up 12% to $185.94 following the release of data from its Phase 2 trial of Donanemab for the treatment of Alzheimer's Disease. The trial met the primary endpoint, slowing the decline of patients on the Integrated Alzheimer's Disease Rating Scale (iADRS) by 32% relative to placebo.
Biogen Inc (NASDAQ:BIIB) shares followed the move made by Lilly, closing the week up 9% to $275.84. The FDA is currently reviewing its regulatory application for marketing approval of its candidate for Alzheimer’s, Aducanumab, with a decision due by March 7. An FDA Advisory Committee voted last year in November that the treatment was not effective.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced it will sell its Inbrija manufacturing operations to Catalent for $80m in cash. Catalent will manufacture Inbrija for Acorda. The company expects that combined savings from the sale, restructuring and other operating cost reductions will reduce annual operating expenses by approximately $40m. Shares closed the week up 63% to $6.70.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. government will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. Under the new agreement, the government will purchase all finished doses, up to 1.25m, of antibody cocktail delivered by June 30, 2021, in addition to the current supply of doses to treat 300,000 people under a previous agreement. Shares closed the week up 4% to $517.93.
Cardiff Oncology, Inc. (NASDAQ:CRDF) shares fell Friday 31% to $13.46 following the release of updated data from its Phase 1b trial of Onvansertib in patients with colorectal cancer. Of the 12 Phase 1b patients evaluable for efficacy 5 (42%) achieved a partial response (PR) and 8 (67%) have shown a durable response ranging from 6.1 to 13.7 months. At a previous update at the ESMO conference in September the company noted a partial response rate of 45% (5/11 patients).
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Phase 1 and 2 data readouts to watch for the first quarter: