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 company announces an agreement with Alliance Global Partners to offer up to $250M worth of common stock. Sorrento (NASDAQ:SRNE) is under no obligation to sell any shares and can suspend the offer at any time.Shares are down 3.5% after hours.
Moderna (NASDAQ:MRNA) says it’s submitted an Investigational New Drug application to the FDA for its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus.
The company has received initial feedback from the FDA on the design of the planned Phase 2 trial, which is seen beginning this quarter. The study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
CVS Health (NYSE:CVS) says it will join other pharmacy chains and retailers at the White House today to announce the next phase in COVID-19 testing.
Beginning in May, it will offer self-swabs to people meeting CDC criteria for testing in parking lot sites or via drive-through windows. It expects to have up to 1,000 locations in the U.S. operating as collection sites with a goal of processing up to 1.5M tests/month subject to supplies. No testing will be done in stores.
It currently operates large-scale collection sites in five states. Most can collect up to 1,000 tests/day.
Update: Walgreens (NASDAQ:WBA) plans to open collection sites in 49 states and Puerto Rico with a focus on underserved communities. It expects to test more than 50K people per week using LabCorp’s (NYSE:LH) collection kit, approved by the FDA last week. Currently, it has 18 drive-through sites across 11 states and plans to have 23 sites across 15 states by the end of this week, all by appointment only.
LH is up 1% after hours.
CytoDyn (OTCQB:CYDY +10.1%) has completed the rolling submission of its U.S. marketing application seeking approval to use leronlimab, combined with highly active antiretroviral therapy (HAART), in treatment-experienced HIV patients, a Fast Track-tagged indication.
The company is also testing the viral entry inhibitor in COVID-19. A Phase 2 study in mild-to-moderately ill patients and a Phase 2b/3 trial in severely and critically ill patients are in process in the U.S.
The company says leronlimab inhibits (binds to) a protein on the surface of certain immune cells called Cysteine-Cysteine Chemokine Receptor 5 (CCR5) which plays a key role in modulating immune cell trafficking in sites of inflammation, so it may have potential to treat COVID-19.
Cresco Labs (OTCQX:CRLBF): Q4 Net loss of $45.22M.
Revenue of $41.38M (+144.0% Y/Y) misses by $2.64M.
