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.
Members of the U.S. House of Representatives are expected to cast a historic vote today on the Marijuana Opportunity Reinvestment and Expungement Act, or MORE Act, which would remove pot from the U.S. list of controlled substances.
The bill would decriminalize marijuana on the federal level and create pathways for ownership opportunities in the emerging industry, allow obtaining medical cannabis recommendations and establish funding sources to reinvest in communities affected by the war on drugs.
However, the MORE Act is unlikely to become law soon because the U.S. Senate has not shown willingness to act on it. Also, the drug wouldn’t automatically become legal nationwide, as each state would ultimately determine whether pot could be sold there.
The vote would arrive roughly a month after five states — New Jersey, Arizona, Montana, South Dakota and Mississippi — voted on Election Day to legalize recreational or medical cannabis.
Rep. Earl Blumenauer, D-Ore., said last week the vote would be the first held by the full House or Senate on a measure to end federal pot prohibition since it took hold via the Controlled Substances Act of 1970.
“It is the right thing to do,” Blumenauer said.
Chief Stéphane Bancel says, “We appreciate the confidence the Government of Israel and the Ministry of Health has shown in mRNA-1273 with this second purchase. We are proud of the progress we have made to date on mRNA-1273, including the recent positive primary efficacy analysis of the Phase 3 COVE Study. We will continue our ongoing dialogue with the Ministry of Health in Israel as we seek to develop our vaccine candidate.”
The company has initiated the rolling authorization application process there.
The company says its global manufacturing ramp continues, aimed at delivering ~500M doses per year with an upside of 1B doses per annum beginning in 2021.
Shares off 1% premarket on modest volume.
Staying on script, sell-side analysts are on board with Moderna’s (NASDAQ:MRNA) mRNA-1273, expected to receive an FDA emergency use nod this month followed by a thumbs up in Europe next month.
Jefferies’ Michael Yee says antibody levels remain high beyond three months and the trajectory continues to support likely protection against SARS-Cov-2 for about a year, in line with expectations. He sees supply constraints in H1 2021 but believes most Americans who want to be vaccinated should be able to do so by the summer. Investors continue to be concerned about supply issues after Pfizer’s (NYSE:PFE) announcement yesterday that supply chain hurdles will constrain 2020 shipments of BNT162b2.
Goldman analysts concur that the vaccine’s effect is durable, noting that antibody levels have waned over time but remain higher than titers from people who have recovered from the respiratory infection.
Piper Sandler analysts expect positive opinions from the FDA panel meeting on the 17th and the meeting in Europe on January 12 by the advisory group CHMP.
Investors clearly agree. Shares are up 704% this year.
MRNA is up 1% premarket on light volume.
Clover Biopharmaceuticals announces positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either GlaxoSmithKline (NYSE:GSK) or Dynavax (NASDAQ:DVAX) induces strong immune responses as well as favorable safety and tolerability profiles in 150 adult and elderly participants.
S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.
CpG-1018/alum-adjuvanted S-Trimer induced neutralizing antibodies in 100% of adult participants at 30 µg S-Trimer dose with GMT greater than 1:1,000, and seroconversion was observed in 88% (7 out of 8) in elderly.
Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.
No serious adverse events were reported.
Preliminary results from stability studies have demonstrated that S-Trimer is stable at 2-8o C for at least six months and stable at room temperature and 40o C for at least one month, making them suitable for global distribution.
A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system is expected to begin in December 2020 funded by the Coalition for Epidemic Preparedness Innovations.
Clover intends to initiate a separate pivotal Phase 2/3 clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in H1 2021.
Bahrain has become the second nation to grant an emergency-use authorization nod to Pfizer (PFE +0.1%) and its partner BioNTech (BNTX +1.4%) coronavirus vaccine. The announcement follows an earlier announcement by the United Kingdom, making Britain the first in the world.
Though the country did not say how may vaccines it has purchased, nor when vaccinations would begin.
The mid-east nation with temperatures in the summer of ~40 degrees Celsius, says immediate challenge would be the conditions in which the vaccine must be kept. Recently, Pfizer said it expects to ship only half of the COVID-19 vaccine doses this year that it originally planned due to supply chain obstacles, a near-term problem considering its ultra-cold storage requirement of minus 70 degrees Celsius.
Bahrain had already granted emergency-use authorization for a Chinese vaccine made by Sinopharm.