RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
The single-dose vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) appears to have generated a promising immune response with a reasonable safety profile, according to mid-stage trial data published in the New England Journal of Medicine. The company shares are up 1.2% in postmarket after trading flat during the day.
The phase 1/2a study has evaluated 805 participants after the first vaccine dose in two cohorts and after two doses in a single cohort. The most frequent systemic adverse event was fever, and the adverse effects were more common in those who received both shots and a higher dose.
Data indicated the presence of neutralizing-antibody titers in 90% or more of all participants on day 29 after the first dose and 100% by day 57 with a further increase in titers.
The scientists have concluded that the safety and immunogenicity of trial results support further development of the vaccine candidate.
The results of the company’s late-stage trial involving 45K subjects are likely to arrive by late January.
Evolus (NASDAQ:EOLS) is trading 5.9% higher in apparent reaction to yesterday’s agreement between Allergan Aesthetics of AbbVie (NYSE:ABBV) and Cypris Medical following which Allergan will have an option to acquire the Chicago-based medical device company.
Evolus is a performance beauty company focused on delivering products in the self-pay aesthetic market. Its first product Jeuveau® (prabotulinumtoxinA-xvfs) has FDA clearance for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults.
On a forward EV/Sales basis, Evolus is trading at ~3.1x, less than half the sector median, and for the past year, the shares have lost ~62.1% until last week.
Cypris Medical’s Xact device is designed to allow for lifting and suturing of the superficial muscular aponeurotic system. As part of the deal, Allergan Aesthetics will have the right to exercise an option to acquire Cypris Medical including the Xact device, following the completion of a clinical trial for Xact.
The trial set to start in 2021 will evaluate the safety and effectiveness of Xact in treating midface descent as well as for neck lifts.
Esperion (NASDAQ:ESPR) announces it has entered into a definitive agreement with Serometrix to in-license its oral, small molecule PCSK9 inhibitor program, and says it expects Q4 2020 U.S. net product revenue to be between $8M and $8.5M.
The small molecule PCSK9 inhibitor program is intended for development of a convenient, oral medicine. There are currently no oral PCSK9 inhibitors available to patients.
The Company expects FY 2021 operating expenses to be about $320M to $340M, inclusive of $30M of non-cash stock-based compensation.
Also highlights cash, cash equivalents, and investment securities available-for-sale totalled about $305M as of December 31, 2020.
Esperion plans to report its full financial results for Q4 and FY 2020 in late February.