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.
Merck & Co. (NYSE:MRK) says that the company is in discussions with governments and companies to help accelerate the COVID-19 vaccine production.
“Beyond our own candidates, we are actively involved in discussions with governments, public health agencies, and other industry colleagues to identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines,” Reuters quoted, a company spokesman as saying.
Yesterday, Teva Pharmaceutical (NYSE:TEVA) also announced its intention to support the COVID-19 vaccine manufacturing and distribution. Neither of the companies has revealed the parties they are in talks with.
“We have a large, worldwide network of manufacturing capabilities,” from creating underlying drug substances to putting solutions into sterile vials, known as the fill-finish process,” Teva CEO Kare Schultz has said.
The company that handles the COVID-19 vaccine distribution in its home country Israel also has the manufacturing capability to produce the active ingredients used in messenger RNA vaccines developed by Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/ BioNTech (NASDAQ:BNTX).
Last month, Merck announced its decision to discontinue the development of its COVID-19 vaccine candidates citing insufficient immune response seen in early-stage trials.
Aurora Cannabis (NYSE:ACB) shares climb nearly 9% in post market trading after the medical cannabis company posted higher second-quarter revenue, helped by a hike in high-margin international medical sales.
The Medical Cannabis business brought in revenue of C$38.9M in the quarter ended December 31, an increase of 42% from the prior-year period.
The company posted an adjusted EBITDA loss of C$16.8M in the quarter, which included termination and restructuring costs of C$2.9M.
Aurora said that it improved its cash use during the quarter by more than 74% compared with last year, and added that it had cash on hand of C$565M, as of February 10, 2021.
The company posted net revenue of C$67.67M in the quarter, an increase of 28% year over year, and said that it is continuing its progress toward positive cash flow.
The U.S. FDA has approved Regeneron Pharma’s (REGN +0.3%) Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia ((HoFH)), an ultra-rare inherited condition that affects about 1,300 patients in the U.S.
Evkeeza significantly lowered low-density lipoprotein cholesterol (LDL-C) levels in clinical trials and the treatment offers an important new option for people living with HoFH, Regeneron said.
The FDA approval is based on results from the Phase 3 ELIPSE HoFH trial, published in the New England Journal of Medicine (NEJM), where Evkeeza showed a reduction in LDL-C from baseline by 49% on average compared to placebo at week 24 (47% reduction Evkeeza, 2% increase placebo, p<0.0001).
Evkeeza is administered based on weight (15 mg/kg) once a month via intravenous infusion. The average Wholesale Acquisition Cost (WAC) per patient in the U.S. will vary based on weight, and is expected to be about $450K per year, the company said.
