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.
In an interview on CNBC this morning, Moderna (NASDAQ:MRNA) CEO Stephane Bancel said that he expects the 30K-subject study assessing mRNA-1273 should be fully enrolled in 4-6 weeks.
Preliminary efficacy data may be available as early as September/October/November depending on the event rate.
Safety is top concern. On the efficacy front, he is confident that mRNA-1273 can meet the FDA threshold of 50% effectiveness compared to control.
Data from non-human primate study will provide additional color on potential efficacy.
Neutralizing antibody data from Phase 2 trial should be available in late August/early September.
Shares up 9% premarket on robust volume.
Moderna announced a nearly $500M contract modification over the weekend, and detailed its Phase 3 efforts. Read more here.
Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have begun their late-stage human trials for their lead mRNA COVID-19 vaccine candidate.
Pfizer is up 1.9% postmarket; BioNTech is up 6%.
The candidate, BNT162b2, a nucleoside-modified messenger RNA vaccine that encodes an optimized SARS-Cov-2 full-length spike glycoprotein, is starting a 2-dose regimen in a phase 2/3 safety/efficacy study.
The study is worldwide, except for China.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far,” says Pfizer’s Head of Vaccine Research and Development Kathrin U. Jansen.
Assuming clinical success, the companies claim they are on track to seek regulatory review as soon as October, and pending approval, to supply up to 100M doses by the end of 2020 (and 1.3B doses by the end of 2021).
Amyris (AMRS +4.7%) and Infectious Disease Research Institute (IDRI) has signed a binding term for a planned COVID-19 RNA (ribonucleic acid) vaccine technology program.
The program combines IDRI’s RNA vaccine platform with Amyris’ fermentation platform technology, with the goal to create semi-synthetic squalene-based vaccine adjuvants at scale.
Amyris expects first commercial supply of vaccine adjuvant by the end of this year and, assuming successful trials, could have a successful vaccine platform next year.
Additional details of the proposed program will be disclosed
Reuters reports that negotiations between the Europe Union (EU) and COVID-19 vaccine developers Pfizer (PFE -0.8%), Sanofi (SNY +2.0%) and Johnson & Johnson (JNJ -0.1%) have bogged down due to disagreements over price, payment method and potential liability costs.
The EU is in talks with at least six vaccine makers to secure upfront supplies of vaccines if and when available, including Moderna (MRNA +7.3%) and Germany’s CureVac AG (CVAC).
Sanofi is negotiating to supply 300M doses of the candidate it is developing with GlaxoSmithKline (GSK +1.2%) and wants an immediate upfront payment for the entire stock according to two officials, a demand that has caused some “hurdles.”
Pfizer and development partner BioNTech (BNTX -1.1%) want the EU to pay for 500M doses only if their vaccine is authorized for sale, a move that would mitigate the risk if the vaccine proves unsuccessful but could substantially raise the cost if it works.
Further complicating matters are doubts from certain EU negotiators about mRNA (Moderna, CureVac).
By comparison, the U.S. has already inked supply agreements with AstraZeneca (AZN +0.5%) and Pfizer among its funding deals. The agreed-upon $40 per treatment course it too bullish for Europe say officials.
AZN’s initial deal with Germany, France, Italy and the Netherlands specified the delivery of 300M doses for 750M euros (2.5 euros per dose) with an option to buy an additional 100M doses.
Morgan Stanley has upgraded Biogen (NASDAQ:BIIB) to Overweight from Underweight citing a favorable risk profile on Alzheimer’s candidate aducanumab. Analyst Matthew Harrison also upped his price target to $357 (31% upside) from $263 saying the current price reflects “less than a 25% chance” for an FDA nod.
The agency’s action date is in March 2021.
On the negative side, he believes that there is at least 10% downside risk from generic encroachment on MS med Tecfidera (dimethyl fumarate) which accounts for almost 1/3 of sales.
Shares up 3% premarket on light volume.
