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Monday, August 13, 2018

Cerner (CERN) Added as Short Idea at Hedgeye


with 20% Downside – Bloomberg

Mylan launches generic Adcirca in U.S. for pulmonary arterial hypertension


Mylan N.V. (MYL +1%commences the U.S. commercial launch of its generic version of Eli Lilly’s (LLY +0.1%) Adcirca (tadalafil) for patients with pulmonary arterial hypertension.
Per IQVIA, the U.S. market is ~$510M.

Aytu BioScience announces accelerated launch of ZolpiMist sleep aid in the U.S.


Aytu BioScience announces accelerated launch of ZolpiMist in the U.S.  Earlier today, Aytu announced the accelerated launch of ZolpiMist, an oral spray formulation of zolpidem tartrate and the only FDA-approved oral spray prescription sleep aid. The Aytu BioScience sales force begins promoting ZolpiMis to U.S. clinicians in the domestic $1.8B non-benzodiazepine prescription sleep aid market. The earlier than expected launch of ZolpiMist was made possible by the company taking early delivery of an initial supply of commercial ZolpiMist inventory. Josh Disbrow, Aytu BioScience Chief Executive Officer stated, “We are pleased to be launching ZolpiMist this week ahead of schedule, following the signing of our exclusive license agreement just two months ago. Our sales force has completed a rigorous training program, and initial inventory has been purchased and received. Additionally, U.S. wholesalers have been stocked, and now we are well positioned to effectively promote ZolpiMist alongside Natesto, our FDA-approved nasally-administered testosterone replacement therapy. ZolpiMist is a novel product, offering distinct benefits to patients with short-term insomnia, and we look forward to introducing ZolpiMist to the U.S. market.”

Medtronic upgraded to Strong Buy with $119 price target at Needham


Needham analyst Mike Matson upgraded Medtronic to Strong Buy from Buy and raised his price target for the shares to $119 from $103. The company’s product cycle remains robust and it has a number of major products in its pipeline, Matson tells investors in a research note. The analyst sees potential to upside to consensus in fiscal 2019 and finds the stock’s current valuation as attractive. Further, Matson believes the new long-term financial targets given at Medtronic’s investor day in June “seem more realistic.”

Genentech announces FDA Breakthrough Therapy Designation granted for Xolair


Genentech, a member of the Roche Group (RHHBY), announced that the FDA has granted Breakthrough Therapy Designation for Xolair for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval as soon as possible. Genentech and Novartis Pharmaceuticals are working closely with NIAID and the Consortium of Food Allergy Research, or CoFAR, to initiate a potentially pivotal study evaluating the efficacy and safety of Xolair in multiple food allergies and will disclose details at a later date. In the U.S., Genentech and Novartis Pharmaceuticals work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals is an affiliate of Novartis (NVS).

Piper says be long Evolent, Cerner on new CMS proposal


Piper Jaffray analyst Sean Wieland says the Centers for Medicare & Medicaid Services last week unveiled its proposal to get accountable care organizations to take on risk and eliminate the one-sided risk programs. Federal mandates to migrate providers toward two-sided risk should increase demand for such implementation services, because most providers aren’t currently equipped to implement these programs on their own, Wieland tells investors in a research note. He believes enactment of this proposal could drive a $1.3B opportunity to these services companies over the next three years. The analyst recommends being long shares of Evolent Health (EVH) and Cerner (CERN) to invest in this theme.

Mylan upgraded to Outperform from Sector Perform at RBC Capital


https://bit.ly/2KPLDdf