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) is close to an agreement with the Trump administration in which the company would bolster the supply of its coronavirus vaccine for the U.S. by at least tens of millions of doses next year in exchange for a government directive giving it better access to manufacturing supplies, New York Times reports.
A deal, which could be announced as early as tomorrow, would help the U.S. at least partly offset a potential vaccine shortage that could leave as many as 110M adult Americans uncovered in H1 2021.
The government is asking for 100M additional doses from Pfizer from April through June; the company has indicated it should be able to produce at least 70M doses and possibly more if it can gain more access to supplies and materials.
Pfizer and partner BioNTech (NASDAQ:BNTX) as well as rival Moderna are the only two groups that have won U.S. emergency use authorization for their respective COVID-19 vaccine candidates.
As UK health authorities warn of a new highly transmissible variant of COVID-19, the COVID-19 vaccine makers on the other side of the Atlantic are trading lower as the companies start to investigate its impact on vaccine efficacy.
While the NASDAQ Biotechnology Index has risen +0.4%, the firms with FDA-approved COVID-19 jabs are in negative territory: Moderna (NASDAQ:MRNA) is down -9.5%, and American Depository Receipts of BioNTech (NASDAQ:BNTX) have lost -6.1% reaching the lows seen in November-end.
The CEO of BioNTech, Ugur Sahin, thinks the chances of its vaccine working against the new variant, called B.1.1.7, as ‘relatively high.’ An experiment will take about two weeks to yield data and confirm it, he added.
Meanwhile, Morgan Stanley analyst, David Risinger, predicts mRNA-based vaccines like those from Moderna and Pfizer (NYSE:PFE)/BioNTech should protect against new COVID strains.
Arguing that the new strain “only carry sporadic point mutations in the spike protein that are believed to be unlikely to disrupt the full immunogenicity,” the analyst, however, does not rule out the possibility of future strains requiring new vaccine development.
Another mRNA-based COVID-19 vaccine developer, CureVac (NASDAQ:CVAC), has said it does not think its product will be less effective against the new variant, adding it could come up with a new version within weeks. Yesterday, the company announced the initiation of its Phase 3 trial for its COVID-19 vaccine candidate.
The FDA has signed off investigational new drug application for Hepion Pharmaceuticals’ (HEPA -2.4%) CRV431, a cyclophilin inhibitor for the treatment of COVID-19, and the candidate is poised to move directly into Phase 2 study.
“Although Hepion’s focus and lead indication remain squarely on the treatment of NASH, this IND may allow us opportunities to seek collaboration partnerships to support the initiation of Phase 2 studies of CRV431 for COVID-19, and to explore sources of non-dilutive external funding for our COVID-19 program.”, said Robert Foster, Hepion’s CEO.
In preclinical study, CRV431 demonstrated positive antiviral activity against SARS-CoV-2, and showed to inhibit production of infectious virus with almost five-times greater potency than the positive control compound in the study.
The Department of Justice files a lawsuit against Walmart (WMT -1.5%) in which it accuses the retail giant in essence of illegally distributing opioids.
The lawsuit claims that Walmart aimed to increase profits by understaffing its 5K pharmacies and pressuring employees to fill prescriptions quickly. That action said to have made it difficult for pharmacists to reject invalid prescriptions and contributed to widespread drug abuse in the U.S. Walmart’s compliance department is identified as a weak link by the DOJ in preventing the issue.
Shares of Walmart are still up more than 20% YTD and the retail stock is one of top picks for 2021 at both RBC Capital and Bank of America.
The news comes after a November settlement with a variety of distributors, and in late October, the retailer looked to try and get ahead of this lawsuit by launching a preemptive attack against the U.S. Government in a lawsuit of its own.
CytoDyn (OTCQB:CYDY) announces that a treating physician has received authorization from the FDA to administer leronlimab for a COVID-19 patient under emergency IND (eIND).
In recent months, leronlimab has received more than 60 eIND authorizations from the FDA.
FDA’s decision will enable the company to respond to ongoing requests for leronlimab until Phase 3 trial data is unblinded.
CytoDyn has completed enrollment in its Phase 3 trial.
Leronlimab has become a debate topic over its ability to help COVID-19 patients, or even become a “cure” for this terrible pandemic.
CYDY has rallied around 63% over the past six months.