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.
Eagle Pharmaceuticals (EGRX +2.5%) has settled all patent issues with Eli Lilly (LLY -0.3%) related to the latter’s chemo drug Alimta (pemetrexed for injection).
Under the terms of the settlement agreement, Eagle will be allowed to initially enter the U.S. market with its alternative offering, Pemfexy, on February 1, 2022 followed by full commercial launch on April 1, 2022.
Monopar Therapeutics (MNPR) has filed a preliminary prospectus for an IPO of ~1.1M common shares at $8-10 per share.
Underwriters’ over-allotment will be an additional ~167K shares.
In September, it filed for an offering of ~4.4M shares at the same price range.
The FDA grants 510(k) clearance to Boston Scientific’s (BSX +0.7%) EXALT Model D, a single-use duodenoscope (a hollow lighted tube for inspecting the small intestine) for use in endoscopic retrograde cholangiopancreatography procedures (aimed at diagnosing issues in the liver, gallbladder, bile ducts and pancreas).
The company says it is the first such single-use device available in the U.S. (other duodenoscopes are reusable which carries an infection risk if not cleaned thoroughly).
Limited commercial launch will commence next quarter.
Tenet Healthcare (THC +0.6%) has agreed to sell two hospitals, including its associated physician practices, and six MedPost urgent care centers in the Memphis area to Methodist Le Bonheur Healthcare for an undisclosed sum.
The hospitals are St. Francis in Memphis and St. Francis in Bartlett.
The transaction should be completed in 2020.
The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Vyndaqel (tafamidis) for the once-daily treatment of wild-type or hereditary transthyretin amyloidosis in adults with cardiomyopathy.
A different formulation of the transthyretin stabilizer is currently approved in Europe for transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy (ATTR-PN) to delay peripheral neurologic impairment.
A final decision from the European Commission usually takes ~60 days but has trended closer to 30 days recently.
