In a world more familiar with the 30% to 70% efficacy rates of seasonal flu vaccines, news of 95% efficacy rates for two of the major late-stage COVID-19 vaccines in development seems thrilling. But do such robust-sounding numbers, the product of relatively early analyses, really merit the enthusiasm they’ve garnered?
Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell 66.3% to $4.02 on Nov. 17 following news that its autologous cell therapy candidate, Nurown, missed the primary efficacy endpoint of a phase III amyotrophic lateral sclerosis (ALS) study.
Olema Pharmaceuticals Inc., a company looking to improve on current endocrine therapies with an oral estrogen receptor antagonist and degrader of its own, has filed for a $170 million IPO on Nasdaq. The offering follows an $87.4 million series C round, closed in September and a $54 million series B financing closed not long before in July.
Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market.
Shares of Five Prime Therapeutics Inc. (NASDAQ:FPRX) shot 237% higher to $18 Nov. 11 on new top-line results for its targeted antibody, bemarituzumab, in gastric cancer.
Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021.
Assembly Biosciences Inc., a company testing the limits of sustained virologic response in people with chronic hepatitis B virus infection after they discontinue treatment, said nearly all participants in an ongoing phase II study returned to having detectable viral loads after going off a regimen featuring the company's core inhibitor, vebicorvir.
New updates from a dynamic late-phase systemic lupus erythematosus pipeline shared at this week's American College of Rheumatology annual meeting and beyond showed a robust field of potential new treatments nearing the finish line.
An earlier-than-intended release of abstracts for the American Society of Hematology annual meeting spilled multiple market-moving updates Nov. 4, though with no apparent shocks so far. Shares of Allogene Therapeutics Inc. sunk 8% on Nov. 4 over some metered disappointment around initial data for ALLO-715, a potential medicine for relapsed/refractory (r/r) multiple myeloma. By contrast, shares of Global Blood Therapeutics Inc. climbed nearly 15%, buoyed by new data supporting the long-term use of its sickle cell disease therapy, Oxbryta (voxelotor).
Aurinia Pharmaceuticals Inc. is suspending further development of voclosporin ophthalmic solution (VOS) for dry eye syndrome after a dose-ranging trial of the candidate failed to meet its primary endpoint of improving a measure of the condition after four weeks of treatment.
