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.
Following positive efficacy data, Moderna (NASDAQ:MRNA) reports that its COVID-19 vaccine candidate, mRNA-1273 remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days.
mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
Stability testing supports this extension from an earlier estimate of 7 days.
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer.
The vaccine will not require onsite dilution or special handling.
When compared to peers, Pfizer’s (NYSE:PFE) vaccine must be stored frozen at negative 94 degrees Fahrenheit (-70° C), most likely needing dry ice (-109 degrees Fahrenheit) for shipment.
Johnson & Johnson’s (NYSE:JNJ) vaccine, if successful, is expected to be stable at refrigerated temperatures of 35.6 – 46.4 degrees Fahrenheit (2°C – 8°C) for at least three months and for two years at -20 °C.
CureVac’s (NASDAQ:CVAC) CVnCoV, is stable for at least three months at +41 degrees Fahrenheit (+5 Celsius) which is standard refrigerator temperature. It is also stable for up to 24 hours at room temp in a ready-to-use setting.
EC President Ursula von der Leyen also says she hopes to finalize a deal soon with Moderna (MRNA +6.2%) for its coronavirus vaccine.
CureVac’s CVnCoV is stable for at least three months at +41 degrees Fahrenheit – standard refrigerator temperature – and is stable for up to 24 hours at room temp in a ready-to-use setting.
CVnCoV, an mRNA vaccine, is being tested in a Phase 1 study in 284 healthy adult volunteers and in a Phase 2 trial in 691 healthy adults, but a large-scale pivotal trial has not begun.
FDA has signed-off investigational new drug application (IND) filed by Eli Lilly (LLY +0.3%) for LY3561774, the first candidate to emerge from licensing collaboration between Dicerna (DRNA -3.8%), and Eli Lilly.
The event has triggered a milestone payment of $10M from Eli Lilly, and Phase 1 trial for the candidate is expected to commence by the end of this year, for the treatment of an undisclosed cardiometabolic disease.
Pfizer (NYSE:PFE) completes the deal to spin off its Upjohn business and combine it with Mylan NV (NASDAQ:MYL) to form Viatris (VTRS), which will start trading tomorrow under the ticker symbol VTRS.
Pfizer stockholders received ~0.124079 shares of Viatris common stock for every one share of Pfizer common stock held as of Nov. 13 and they retain the same number of Pfizer shares they held before the transaction.
As contemplated under the agreement, Pfizer stockholders own ~57% of Viatris common stock and Mylan shareholders own ~43% of Viatris common stock.
In light of the distribution of the Upjohn business and its combination with Mylan to form Viatris, the Pfizer’s 2020 financial guidance provided in its Q3 earnings release overstates expected total company results.
After the transaction, historical contributions from the Upjohn business will be treated as a discontinued operation.
Pfizer intends to provide its initial 2021 financial guidance in conjunction with its Q4 2020 earnings release.
Jefferies cools on Tilray (NASDAQ:TLRY) with a downgrade to an Underperform rating after having the cannabis stock set at Hold. The firm has concerns over valuation after the recent share price runup.
“At the same time, not reflecting fundamentals, the share price has run up on retail US market FOMO around the US election. With question marks on international, the valuation unfairly inflated, and CEO share sales of $20mn on election run up, we d/g to underperform… We’ve always argued the Tilray thesis is largely tied to the international outlook where Tilray is seemingly set up to do very well when international markets accelerate.”
Shares of Tilray are down 1.44% in premarket action.
Aurora Cannabis (NYSE:ACB) was also cut at Jefferies, which noted the recent re-rating in the stock price was “unjustified.” Shares have more than doubled from their levels in early November.