With just four full weeks remaining in the first quarter of 2021, we count down remaining clinical and regulatory catalysts slated for the quarter. During the following three weeks we will publish an updated list, replacing completed catalysts with new entries of interest.
First, lets review the week that was with a selection of price-moving events and notable news.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) met Friday to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from (Janssen Biotech) Johnson & Johnson (NYSE:JNJ). The committee voted unanimously 22-0 that the benefits outweighed the risks in people over the age of 18 years. The vaccine becomes the third to be given a positive vote by the committee, following in the steps of Moderna and Pfizer. The FDA is likely to issue a EUA within the next few days. The company expects to deliver the U.S. 20 million doses of its single-dose vaccine candidate by the end of March and 100 million doses by the end of June.
In clinical trials, the vaccine was shown to be 66% effective in preventing moderate to severe COVID-19. Broken down into regions, the efficacy rate was 72% in the U.S. and 57% in South Africa. The vaccine was 85% effective in preventing severe disease. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C).
Otonomy, Inc. (NASDAQ:OTIC) announced its Phase 3 clinical trial of Otividex in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. Shares slumped to close the week down 46% to $2.92.
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares closed the week down 41% to $4.06 on news the FDA has advised the company that data from its Phase 3 trial of NurOwn in patients with Amyotrophic lateral sclerosis does not provide the threshold of substantial evidence to support a Biologics License Application (BLA). The FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission. The company announced in November 2020 that the trial did not meet the primary endpoint.
Merck (NYSE:MRK) announced the acquisition of Pandion Therapeutics, Inc. (NASDAQ:PAND) for $60 per share in cash or an approximate total equity value of $1.85 billion. Shares of Pandion closed Thursday up 133% to $59.81.
Tricida, Inc. (Nasdaq: TCDA) shares closed Friday down 31% to $5.11 following news it received an Appeal Denied Letter from the FDA in response to its Formal Dispute Resolution Request (FDRR) submitted in December 2020. The company received a Complete Response Letter in August last year for TRC101 in patients with chronic kidney disease (CKD) and filed the FDRR hoping that certain data from previous trials could be used to accelerate their resubmission.
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Selection of biotech earnings next week (15) – full list for premium members
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