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.
Eli Lilly (LLY -0.02%) reports new data from Phase 3 Blaze-1 trial, evaluating bamlanivimab and etesevimab antibody combination in critically-ill COVID-19 patients.
The treatment decreased the risk of Covid-19 hospitalizations and death by 70%, thus meeting the primary endpoint.
Study involved 1,035 patients, and there were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.
Combination also showed evidence that it reduced viral load and accelerated symptom resolution by achieving statistically significant improvements on all key secondary endpoints
Safety profile was consistent with other Phase 1, Phase 2, Phase 3 trials evaluating the antibodies.
Company submitted an Emergency Use Authorization request to the FDA in November last year, for the combination therapy, which remains under review.
Last week, the company announced that subjects receiving bamlanivimab were 80% less likely to contract COVID-19 compared to those receiving placebo at the same facility.
Johnson & Johnson (JNJ +3.2%) is trading higher today after Q4 2020 results beat analyst expectations.
With the 2021 guidance above the consensus, the earnings outlook, implying a healthy growth despite the ongoing pandemic, offers ‘further support of strong underlying sector fundamentals’ the analysts at Bank of America wrote in a research note.
Arguing that JNJ’s earnings release ‘often serves as a bellwether for the sector,’ the analysts led by Geoff Meacham think the company’s ‘generally positive updates bode well for the rest of US Biopharma heading into earnings.’
“In order to be helpful as of now” Sanofi (SNY -0.6%) has reportedly said that it will fill and pack millions of doses of Pfizer’s (PFE +0.3%) COVID-19 vaccine from July, and help meet the huge demand for shots.
Its aims to help supply over 100M doses of the vaccine this year from its plant in Frankfurt, CEO Paul Hudson told Le Figaro newspaper in an interview.
Last month, Sanofi and GlaxoSmithKline delayed the launch of its COVID-19 vaccine to late this year, as the candidate showed insufficient immune response in older people.
The company has been under pressure since to seek ways of helping with COVID-19 vaccines devised by other drugmakers as the pandemic intensifies again in Europe and elsewhere.
Sanofi is also working on another COVID-19 vaccine candidate, MRT5500, with Translate Bio which uses mRNA technology, similar to the approach of Pfizer/BioNTech. Phase 1 trials are expected to start this quarter.
In preclinical studies, MRT5500 induced dose-dependent levels of binding and neutralizing antibodies specific to the SARS-CoV-2 spike protein.
Sanofi CEO confirmed that the company remains committed to its two vaccines projects.
Earlier today, speaking to Bloomberg, Pfizer’s CEO Albert Bourla said that the company is planning to accelerate the supply of its vaccine shots.
