
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 federal government of Switzerland has struck a deal with Moderna (NASDAQ:MRNA) to supply the country with 4.5M doses of a COVID-19 vaccine, if successfully developed. The value of the deal is not specified.
The Swiss government is also in talks with other vaccine companies and has already allocated CHF300M (nearly $330M) for purchases of COVID-19 vaccine.
Shares are up 2% premarket.
Takeda Pharmaceutical Company (NYSE:TAK) enters into an agreement with Novavax (NASDAQ:NVAX) to develop, manufacture and commercialize the latter’s COVID-19 vaccine candidate NVX-CoV2373, including its Matrix-M adjuvant, in Japan.
Japan’s Ministry of Health, Labor and Welfare will provide funding to Takeda to support technology transfer, establishment of infrastructure and manufacturing scale-up. The company plans to build capacity to make over 250M doses per year.
Takeda will be responsible for regulatory filings as well.
Novavax will receive undisclosed milestone payments and a portion of sales proceeds. Additional details remain confidential.
NVAX and TAK are both up 2% premarket on light volume.
Pfizer (NYSE:PFE) inks a multiyear agreement with Gilead Sciences (NASDAQ:GILD) to provide contract manufacturing services at its McPherson, KS facility to produce and supply COVID-19 antiviral Veklury (remdesivir).
CEO Albert Bourla says the action is part of the company’s five-point plan to commit resources to address the pandemic.
Financial terms are not disclosed.
PFE and GILD are both up 1% premarket on light volume.
Ultra-thinly traded nano cap AnPac Bio-Medical Science Co., Ltd. (NASDAQ:ANPC) rockets 114% premarket on robust volume in reaction to its announcement that it is validating its COVID-19 antibody test for commercial use in its San Jose, CA laboratory. The process should be completed in H2.
The FDA OK’d emergency use of the test last quarter.
A Phase 3 clinical trial evaluating CStone Pharmaceuticals’ (OTCPK:CSPHF) PD-L1 inhibitor CS1001 for the first-line treatment of metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC) met the primary endpoint of progression-free survival (PFS).
Specifically, median PFS in the treatment arm (CS1001 + chemo) was 7.8 months compared to 4.9 months in the control arm (placebo + chemo) with 50% less risk of cancer progression (hazard ratio = 0.50) (p<0.0001).
No new safety signals were observed.
Development is ongoing.
CS1001 is an OmniAb-derived anti-PD-L1 monoclonal antibody that the company discovered using Ligand Pharmaceuticals’ (NASDAQ:LGND) OmniRat transgenic animal platform.