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.
The European Commission has approved the proposed merger between Mylan N.V. (MYL +3.1%) Pfizer’s (PFE +1.5%) Upjohn unit. The nod is contingent on Mylan divesting certain generic medicines. The parties expect the transaction to close in H2.
The combined company will do business as Viatris.
BioCryst Pharmaceuticals (BCRX -8.7%) plunges on increased volume, triggering a volatility halt, in sympathy with the drop in Gilead Sciences (GILD -5.0%) on reports that a China-based study testing antiviral remdesivir failed to demonstrate a treatment benefit.
BioCryst is testing its own antiviral, galidesivir, for the same use. A Phase 1 study in Brazil is in process.
Eli Lilly (NYSE:LLY): Q1 Non-GAAP EPS of $1.75 beats by $0.27; GAAP EPS of $1.60 beats by $0.25.
Revenue of $5.86B (+15.1% Y/Y) beats by $380M.
Shares -1.09% PM.
A survey from the WSJ has found at least 10,700 COVID-related deaths at long-term care facilities among more than 35 states that either report data online or responded to requests for information.
That’s almost a quarter of all U.S. deaths, with the virus hitting at least 4,800 facilities nationwide.
Currently, the federal Centers for Medicare and Medicaid Services requires nursing homes to tightly restrict who can enter, though limited testing and asymptomatic cases means staffers could have brought infections inside.
Sanofi (NASDAQ:SNY) announces positive results from a Phase 2b clinical trial evaluating brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor SAR442168 in patients with relapsing forms of multiple sclerosis (MS).
The study met the primary endpoint demonstrating significantly reduced disease activity as measured by the number of new Gd-enhancing T1 hyperintense lesions detected by brain magnetic resonance imaging (MRI).
Four doses were tested (5 mg-60 mg) for 12 weeks compared to placebo. Participants receiving 60 mg showed an 85% relative reduction in new Gd-enhancing T1 hyperintense lesions and an 89% relative reduction in T2 hyperintense lesions (secondary endpoint).
No new safety signals were observed.
The company plans to initiate four Phase 3 trials in relapsing and progressive forms of MS.
Sanofi in-licensed global rights to the candidate from Principia Biopharma (NASDAQ:PRNB) under a November 2017 agreement.
