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 time frame in which most Americans will be eligible for a coronavirus vaccine keeps moving up.
Just two weeks ago, Dr. Moncef Slaoui, head of Operation Warp Speed, said the U.S. could immunize one-third of its population within three months, but it now looks like most of America could get a vaccine by that date.
“Depending on the decisions by our governors… but I believe we’ll have enough supply out there to be reaching out to the general public for administration – at your CVS (NYSE:CVS), Walgreens (NASDAQ:WBA), Kroegers (NYSE:KR) – by the end of February into March,” said Health and Human Services Secretary Alex Azar.
That timeline could be even earlier if the approval of the AstraZeneca (NASDAQ:AZN) and Johnson & Johnson (NYSE:JNJ) vaccine comes soon, he added.
On Tuesday, the FDA said that that a jab developed by Moderna (NASDAQ:MRNA) was “highly effective,” setting the stage for an emergency authorization later this week. (NYSE:PFE) and BioNTech (NASDAQ:BNTX) began shipping their vaccine nationwide on Sunday.
Looking to the stocks, Shock Exchange writes today on Seeking Alpha that Moderna’s COVID-19 upside looks priced in.
The European Commission has granted conditional marketing authorization Kite’s Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Kite is a Gilead (NASDAQ:GILD) company.
Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy.
Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional authorization after the submission and assessment of additional confirmatory data.
Under terms of the deal, Aphria (NASDAQ:APHA) owners will receive 0.8381 shares of Tilray (NASDAQ:TLRY) for each Aphria share they own, while Tilray owners will continue to hold their shares. Aphria will own about 62% of the combined company at close at about a 23% premium to Tilray’s close yesterday.
The merged company will be called Tilray and continue to trade under the symbol TLRY.
From the PR: “The Combined Company, supported by low-cost, state-of-the-art cultivation, processing, and manufacturing facilities, will have a complete portfolio of branded Cannabis 2.0 products in Canada. Internationally, the Combined Company will be well-positioned to pursue growth opportunities with Aphria’s medical cannabis and distribution footprint in Germany, and Tilray’s European Union Good Manufacturing Practices (“EU-GMP”) low-cost cannabis production facility in Portugal, which has export capabilities and tariff-free access to the European Union (“EU”) to meet increasing global demand for medical cannabis. In the United States, the Combined Company will have a strong consumer packaged goods presence and infrastructure with two strategic pillars, including SweetWater Brewing Company (“SweetWater”), a cannabis lifestyle branded craft brewer, and Manitoba Harvest, a leading hemp food manufacturer and a pioneer in branded CBD and wellness products.”
The deal is seen closing in Q2 of 2021.
A conference call is set for 8:30 ET.
APHA +10%, TLRY +28% premarket.
Peers: Canopy Growth (NYSE:CGC) +3%, Cronos Group (NASDAQ:CRON) +3.2%, Aurora Cannabis (NYSE:ACB) +4.4%,
This morning’s announcement was leaked last night.
Despite favorable views from FDA scientists on its COVID-19 vaccine efficacy, the analysts at Jefferies have downgraded Moderna (NASDAQ:MRNA) citing ‘elevated expectations in the wake of a 653% rally this year.’
After falling -5.1% in value yesterday, the stock is trading -3.8% in pre-market trading ahead of a possible emergency authorization later this week for the company’s mRNA-based vaccine against COVID-19.
Noting that the ‘company’s pipeline has been de-risked by success for its Covid-19 vaccine’ and projecting Covid sales to reach $10B this year, the analyst Michael Yee writes ‘stock is among the industry’s best this year ‘compared to 54% gain for the SPDR S&P Biotech ETF (NYSEARCA:XBI).’
Highlighting ‘2021 guidance parameters and Phase 3 data from competitors like AZN, JNJ, and NVAX in the start of next year’ as key events, Yee, however, argues ‘the investor focus will be on 2021 execution.’
The recommendation is cut to ‘Hold’ from ‘Buy’ with a price target at $150, equal to that set by Morgan Stanley which has also downgraded the stock to equal-weight from overweight.
Noting that the ‘sustainable opportunity in 2022E and beyond’ for the company’s COVID-19 vaccine is ‘far from clear’, RBC Capital Markets downgrades Pfizer (NYSE:PFE) to ‘Sector Perform’ from ‘Outperform’ with a price target of $42.00, an upside of ~8.5% to yesterday’s close. The shares trade -1.8% lower, adding to the -1.2% loss in value in the year so far.
Last week, the company made headlines when it’s COVID-19 vaccine candidate co-developed with BioNTech SE (NASDAQ:BNTX) became the first to win the emergency use authorization in the U.S.
Despite the approval, the analysts led by Randall Stanicky argue, ‘a bull case vaccine scenario is largely in the stock’ ahead of ‘competitive vaccine updates possibly with superior dosing/logistics.’
However, the analysts keep the core ‘2021E–25E “Biopharma” (ex-vaccine) revenue and EPS CAGRs’ unchanged, noting any upward revision should come from the pipeline.
The rival vaccine candidate from Moderna (NASDAQ:MRNA) is set to undergo an expert panel review, potentially leading to a EUA nod later this week. Unlike Pfizer/BioNTech shot, Moderna’s jab, based on similar technology with a comparable efficacy level, does not require rigorous ultracold storage requirements.
Moderna was also downgraded today, cut to Hold by Jefferies.