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.
Thinly traded Translate Bio (TBIO +20.5%) is up on a 4x surge in volume on the heels of bullish comments from COVID-19 vaccine collaborator Sanofi (SNY +2.8%) during its Q1 earnings call that it expects to launch in-human studies in Q4 and, if all goes well, a regulatory nod could happen as early as H2 2021.
The companies are partnering on an mRNA vaccine against SARS-CoV-2 under an original 2018 agreement. TBIO has already begun producing multiple mRNA constructs for the project and will use its mRNA platform to design and manufacture a range of candidates. They expect to have the capacity to produce as many as 360M doses by H1 2021 (CEO Paul Hudson stated earlier that the company is aiming to make up to 600M doses next year).
A key U.S. governmental trial for Gilead’s (GILD +1.8%) remdesivir, could report results as early as mid-May, lead researcher Dr. Andre Kalil tells Reuters.
Preliminary findings could come even sooner for the randomized trial, which was launched in February by the National Institute of Allergy and Infectious Diseases.
Enrollment in the trial closed Sunday and exceeded its goal of 400-500 patients. The trial is designed to show whether the antiviral can improve outcomes like hospitalization length and survival for patients with a range of COVID-19 severity.
Doctors at Houston Methodist Hospital say they’ve treated 41 mostly severely ill COIVD-19 patients since March 23 – none have died and half have returned home.
Related: Yesterday, the WHO mistakenly posted draft documents of a Chinese study that showed remdesivir failed to improve patients’ conditions. Gilead countered that the study was underpowered for efficience since it was terminated early for low enrollment.
Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an 83% (n=10/12) survival rate in ventilator-dependent COVID-19 patients who were treated with its allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. Nine of the 10 were weaned off ventilator support after a median of 10 days, while seven have been discharged from the hospital.
By comparison, 9% (n=38/445) of ventilator-dependent COVID-19 patients at a major New York City hospital who received standard-of-care treatment were able to discontinue ventilator support. The survival rate was only 12% (n=38/320) in ventilator-dependent COVID-19 patients at another major hospital in the city.
A Phase 2/3 study is in process.
Eli Lilly (NYSE:LLY) and collaboration partner Innovent Biologics (OTCPK:IVBIY) announce that the China National Medical Products Administration has accepted for review the supplemental marketing application seeking approval to use the combination of Tyvyt (sintilimab), Alimta (pemetrexed) and platinum-based chemo for the first-line treatment of non-squamous non-small cell lung cancer.
Tyvyt, a PD-1 inhibitor, was approved in China in December 2018 for patients with relapsed/refractory classical Hodgkin lymphoma who have received at least two prior lines of chemo.
Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies has filed two supplemental marketing applications in the U.S. seeking approval to use Simponi Aria (golimumab) to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two years old (in combination with methotrexate).
Simponi Aria is an intravenously administered formulation of Simponi (administered via subcutaneous injection).
