Monday, January 14, 2019
Lipocine granted Priority Motion by USPTO in Clarus interference case
Lipocine announced that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, or USPTO, granted Lipocine’s Priority Motion in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics U.S. Patent No. 8,828,428 and Lipocine, U.S. Patent Application No. 14/713,692, and entered adverse judgment against Clarus. The PTAB ruling cancels all claims of the Clarus ‘428 patent.
https://thefly.com/landingPageNews.php?id=2848107
Pfizer announces FDA acceptance of NDAs filings for tafamidis
Pfizer announced today that the FDA accepted for filing the company’s New Drug Applications, or NDAs, for tafamidis for the treatment of transthyretin amyloid cardiomyopathy, or ATTR-CM. Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition. The tafamidis meglumine form has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The target Prescription Drug User Fee Act action date for a decision by the FDA is in July 2019. The tafamidis free acid form will be under Standard Review. This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration. The target PDUFA action date for a decision by the FDA is in November 2019.
https://thefly.com/landingPageNews.php?id=2848109
Baird upgrades Teladoc to Outperform on valuation, UnitedHealth deal potential
Baird analyst Matthew Gillmor upgraded Teladoc (TDOC) to Outperform from Neutral. The analyst believes it remains an attractive secular growth story as plan sponsors are reconfiguring benefit designs for “virtual first” healthcare. He also believes its valuation is looking more attractive and the Street estimates appear achievable. Gillmor also believes the company is working on a contract with UnitedHealth (UNH) to serve a large patient population within the latter, which would be a positive catalyst. Gillmor has an $80 price target on Teladoc shares.
https://thefly.com/landingPageNews.php?id=2848115
https://thefly.com/landingPageNews.php?id=2848115
La Jolla upgraded to Hold from Underperform at Jefferies
Jefferies analyst Eun Yang upgraded La Jolla Pharmaceutical to Hold while lowering her price target for the shares to $6 from $13.
https://thefly.com/landingPageNews.php?id=2848159
Inspire Medical announces first BCBS coverage policy after positive report
Inspire Medical announced that Blue Cross of Idaho has issued a positive coverage policy of Inspire therapy. This is the first coverage policy issued following BCBS Evidence Street’s January 7 report, which stated there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. In addition to Blue Cross of Idaho, an additional positive coverage policy became effective January 1 with Ascension Smart Health. These positive coverage decisions are a result of the large and growing body of clinical evidence supporting the use of Inspire therapy for the treatment of moderate to severe obstructive sleep apnea.
Intercept upgraded to Buy from Hold at Laidlaw
Laidlaw analyst Francois Brisebois upgraded Intercept Pharmaceuticals to Buy and raised his price target for the shares to $130 from $99. The company recently announced that its “highly anticipated” Phase 3 Regenerate topline interim analysis in nonalcoholic steatohepatitis with advanced fibrosis is anticipated in Q1 versus the prior guidance of second half of 2019, Brisebois tells investors in a research note. A readout at the earlier part of guidance is a “significant positive” as it represents management’s ability to deliver on timelines for their main value driver, says the analyst. Brisebois sees Intercept’s upcoming date readout as “relatively de-risked.” He’s also encouraged by Intercept’s acquisition of Aralez Pharmaceuticals’ license to develop and commercialize bezafibrate in the U.S.
Sunday, January 13, 2019
JPMorgan healthcare analysts to hold a dinner
Healthcare Analysts hold a JPMorgan Healthcare Conference Wrap-Up Dinner which will feature short presentations from senior healthcare analysts, as well as a Buy-Side Stock Picking Contest, in New York on January 15.
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