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.
Pfizer (NYSE:PFE) and development partner BioNTech (NASDAQ:BNTX) announce a deal with the U.S. Department of Health and Human Services for up to 600M doses of their COVID-19 vaccine, currently dubbed BNT162 (BNT162b1 and BNT162b2 have Fast Track status).
The feds have placed an initial order of 100M doses for $1.95B ($19.50/dose) and may acquire up to 500M additional doses under the Operation Warp Speed program.
People will receive the vaccine at no cost per the government’s commitment for free access.
The company’s believe that they can make 100M doses by year-end and potentially more than 1.3B doses by the end of 2021.
PFE is up 2% premarket and BNTX is up 5%, both on average volume.
Pfizer has outperformed the broader market in the last month. See more stats on performance and momentum for Pfizer and for BioNTech.
In a U.S. House Energy and Commerce Oversight and Investigations Subcommittee hearing yesterday conducted by remote video, representatives of COVID-19 vaccine developers disclosed a range of planned approaches to pricing.
AstraZeneca (NYSE:AZN) and Johnson & Johnson (NYSE:JNJ) indicated that they would price their offerings, if approved, at the cost of production, at least until the pandemic ebbs.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) said that they would set prices exceeding manufacturing costs, although Moderna added that it planned to price it “reasonably” to ensure broad access.
Pfizer (NYSE:PFE), developing its candidate with BioNTech (NASDAQ:BNTX), indicated that it expects to make a profit but it wouldn’t “charge too much” considering the “extraordinary times” of the pandemic. Individuals should not have to pay anything.
For comparison purposes, flu shots typically cost $16-25 per dose, according to the CDC. Jefferies’ Michael Yee believes that COVID-19 vaccines will cost $50-100 per course, adding that Moderna’s offering could generate up to $2B in sales in the first year.
Following up on its first announcement two months ago, Roche (OTCQX:RHHBY +0.3%) reports detailed results from its successful Phase 3 clinical trial, ARCHWAY, evaluating its Port Delivery System (PDS) with ranibizumab in patients with neovascular age-related macular degeneration (wet AMD). The data will be presented virtually on Sunday, July 26, at the American Society of Retina Specialists Annual Meeting.
98.4% of PDS patients were able to go six months without additional treatment while achieving vision outcomes equivalent to those receiving monthly eye injections, implying twice-yearly treatment, 83% less frequent than current standard of care.
PDS is a permanent refillable eye implant about the size of a grain of rice that continuously delivers a customized formulation of ranibizumab (branded as Lucentis in the injectable format) over a period of months.
PDS is being assessed in another Phase 3, PAGODA, in patients with diabetic macular edema.
Marketing applications in the U.S. and Europe for wet AMD are next up.
American Green (OTCPK:ERBB) achieved three complete growth cycles within its newly created 11th grow room at the Arizona-based Sweet Virginia cannabis grow facility.
With additional 240 plants, the company’s overall canopy space increased by 12%+.
“Coupling our expansion in capacity with our previously announced reductions in labor costs, I believe we can expect an improvement in our Y/Y bottom line by about 23%. This could translate into $350K annually, or more,” VP cultivation Bryan Croteau commented.
This new room will allow for just over 6 harvests every year, a significant increase in return for a minimal investment.
Reuters reports that Novavax (NASDAQ:NVAX) CEO Stanley Erck and three other executives may earn stock options worth up to $101M if its COVID-19 vaccine candidate enters a Phase 2 study regardless of the outcome according to a regulatory filing. The incentive plan, not previously reported, allows the execs to start exercising the options a year after the start of the mid-stage study, expected to launch soon.
The company, sporting a market cap of over $8B, has not advanced a vaccine into the marketplace in its 33-year history.
In a statement to Reuters, Novavax stated that the options were awarded to retain top talent and recognize their intense effort.
Mr. Erck’s options would be worth almost $49M if exercised at yesterday’s close of $140.69.
Shares down 5% premarket on light volume.
