
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.
PhaseBio Pharmaceuticals (NASDAQ:PHAS) +81% after-hours as the Food & Drug Administration authorized the company to proceed with VANGARD, “a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.”
PB1046 is an injected vasoactive intestinal peptide receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems; VIP has been observed to have potent bronchodilatory and immunomodulatory effects in the respiratory system.
Based on FDA feedback, the company believes “positive, clearly interpretable and clinically meaningful trial results may enable PhaseBio to submit a Biologics License Application.”
The continued selloff in Moderna (MRNA -11.4%) is weighing on other COVID-19 vaccine developers as investors bag profits in a group that may be overextended.
Selected tickers: Vir Biotechnology (VIR -7.5%), Novavax (NVAX -7.7%), Dynavax (DVAX -4.4%), Inovio Pharmaceuticals (INO -9.4%), Vaxart (VXRT -7.2%), iBio (IBIO -4.3%), Johnson & Johnson (JNJ -0.8%), Sanofi (SNY -0.7%), GlaxoSmithKline (GSK -0.4%), Pfizer (PFE -0.5%), Soligenix (SNGX -7.5%), AstraZeneca (AZN -3.1%), Arcturus Therapeutics (ARCT -22.7%), GeoVax Labs (OTCPK:GOVX -5.0%), BioNTech (BNTX -4.4%), Altimmune (ALT -23.1%)
Novavax (NASDAQ:NVAX) has acquired Cyrus Poonawalla Group’s Praha Vaccines a.s. for $167M in cash. The deal includes a biologics manufacturing facility and related assets in Bohumil, Czech Republic that, it says, should be able to produce over 1B doses of antigen for its COVID-19 vaccine candidate, NVX-CoV2373, in 2021.
Shares up 1% premarket on modest volume.
BioCryst Pharmaceuticals (NASDAQ:BCRX) initiates a $100M public offering of common stock. Price, volume and terms have yet to be announced.
Shares down 5% after hours.
Mesoblast (NASDAQ:MESO): Q3 GAAP EPS of -$0.0284 beats by $0.13.
Revenue of $12.2M (+876.0% Y/Y) beats by $1.67M.
Shares -0.08% AH.