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.
Sanofi (NASDAQ:SNY) intends to commence a tender offer to acquire all of the outstanding common shares of Synthorx (NASDAQ:THOR) for $68/share in cash.
The Offer will expire on January 22, 2020.
The FDA grants orphan drug status to Regeneron’s (REGN -0.3%) atoltivimab, odesivimab, and maftivimab, a post-exposure prophylaxis against Ebola virus infection.
FDA reference link.
U.S. Food and Drug Administration grants approval to Mylan Pharmaceuticals (MYL +0.7%) and Micro Labs for the first generics of Bristol-Myers Squibb’s (BMY -0.3%) Eliquis (apixaban) blood thinner for two applications.
The first application is to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
It’s also indicated to help prevent deep vein thrombosis, which may lead to pulmonary embolism, or blood clots in the lungs, in patients who have undergone hip or knee replacement surgery.
“These approvals mark the first generic approvals of a direct oral anticoagulant,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”
Previously: FDA tentatively approves Mylan’s generic Eliquis (July 10)
Allergan (AGN +0.5%) gets U.S. FDA approval for Ubrelvey (ubrogepant) for the acute treatment of migraine with or without aura in adults.
Ubrelvy is the first orally administered calcitonin gene-related peptide receptor antagonist for the treatment of migraines once they start, Allergan says.
Previously: FDA accepts Allergan application for migraine med ubrogepant (March 11)
Theravance Biopharma (NASDAQ:TBPH) enters a global license pact with Pfizer (NYSE:PFE) for Theravance’s preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized.
Theravance will get up an upfront cash payment of $10M and will be eligible for up to an additional $240M in development and sales milestone payments from Pfizer.
In addition, Theravance Biopharma will be eligible to receive royalties on worldwide net sales of any potential products emerging from the program.
Pfizer gains 0.4% in premarket trading.
“Topical JAK inhibitors that can be rapidly metabolized have potential to reach more patients with mild-to-moderate skin conditions, for whom treatment is currently limited,” said Michael Vincent, chief scientific officer, Inflammation & Immunology, Pfizer.
JAK inhibitors are currently approved for the treatment of a range of inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, myelofibrosis, and ulcerative colitis.
