The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for Dupixent, recommending its approval in the European Union, or EU, for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment. The positive CHMP opinion is based on clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA program, including the Phase 3 QUEST and VENTURE trials. QUEST compared Dupixent vs. placebo in asthma patients inadequately controlled on a medium or high dose inhaled corticosteroid and a second controller medication. VENTURE compared Dupixent vs. placebo in oral corticosteroid dependent asthma patients. The European Commission is expected to make a final decision on the application for Dupixent in the coming months.
Friday, March 1, 2019
Amedisys price target cut to $124 from $132 at Craig-Hallum
Craig-Hallum analyst Kevin Ellich maintained a Hold rating on Amedisys and cut his price target to $124 from $132 following the company’s Q4 results. In a research note to investors, Ellich says that while CCH’s EBITDA contribution is expected to ramp from $12M-$14M in 2019 to ~$50M in 2021, and Amedisys has ample dry powder for acquisitions and share repurchases, he believes its premium valuation and the overhang attributable to PDGM will continue to weigh on the stock in the near-term.
Horizon Pharma price target raised to $34 from $28 at Jefferies
Jefferies analyst David Steinberg raised his price target for Horizon Pharma to $34 after the company announced positive Phase 3 data for teprotumumab in treating thyroid eye disease. Based on the “strong” data, teprotumumab has the potential to be a disease-modifying therapy for active thyroid eye disease, Steinberg tells investors in a research note. He sees the drug generating $500M-plus in peak sales and keeps a Buy rating on Horizon Pharma.
LHC Group price target raised to $130 from $115 at SunTrust
SunTrust analyst David MacDonald raised his price target on LHC Group to $130 and kept his Buy rating after its Q4 results. The analyst says the quarter was driven by strong organic volumes, better than expected integration of Almost Family, solid cash flow trends, and the ongoing M&A / joint venture activities.
Bio-Rad price target raised to $340 from $315 at Barclays
Barclays analyst Jack Meehan raised his price target for Bio-Rad Laboratories to $340 saying the company’s Q4 results “hit all the important marks.” The analyst views the initial 2019 guidance as better than expected and continues to believe that Bio-Rad has “substantial long-term opportunity ahead.” He also thinks the stock’s current valuation is “compelling” and reiterates an Overweight rating on the name.
Bayer’s sorafenib granted FDA orphan designation
Bayer HealthCare Pharmaceuticals’ sorafenib was granted FDA orphan designation as a treatment of desmoid tumors/aggressive fibromatosis, according to a post to the agency’s website
Ionis positive CHMP opinion for Waylivra a surprise, says Piper Jaffray
Given the prior Waylivra Complete Response Letter issued by the FDA, the positive Committee for Medicinal Products for Human Use opinion announced this morning was a surprise to many, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. The analyst anticipates a European Medicines Agency approval in the coming months and models $150M in European Waylivra sales by the late 2020s “with minimal increase in long-term operating spending.” As a result, the analyst boosted his price target for Ionis Pharmaceuticals to $63 from $60 while keeping a Neutral rating on the shares.
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