Universal Health downgraded to Neutral on valuation at JPMorgan

JPMorgan analyst Gary Taylor downgraded Universal Health Services to Neutral from Overweight with an unchanged price target of $147. The analyst says that while he does not have a “new active negative thesis” on the shares, he finds the stock “relatively fairly valued with limited catalysts.” Universal Health’s valuation continues to reflect a stronger secular EBITDA growth outlook than the company has been able to deliver over the last three years or is implied in 2019 guidance, Taylor tells investors in a research note.

https://thefly.com/landingPageNews.php?id=2873495

Merck: CHMP recommends approval for new dosing schedule for Keytruda

Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended the approval of a new extended dosing schedule for Keytruda, Merck’s anti-PD-1 therapy, for all approved monotherapy indications in the European Union, or EU. In the EU, Keytruda as monotherapy is currently approved for eight indications across five tumor types. The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks delivered as an intravenous infusion over 30 minutes for Keytruda monotherapy. If approved by the European Commission, the new dose would be available in addition to the currently approved dose of Keytruda 200 mg every three weeks infused over 30 minutes. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected in Q2.

https://thefly.com/landingPageNews.php?id=2873501

Prothena initiated at Cantor Fitzgerald

Prothena assumed with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Charles Duncan assumed coverage of Prothena with an Overweight rating and raised his price target for the shares to $20 from $18. Prothena’s lead candidate prasinezumab for the treatment of Parkinson’s disease is a potential first-in-class anti-alpha-synuclein antibody, targeting an evidence-based mechanism of disease pathology, Duncan tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2873519

Verastem says COPIKTRA demonstrates progression free-survival of 16.4 months

Verastem announced a poster highlighting clinical data from the Phase 3 DUO study evaluating COPIKTRA in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies was presented at the 23rd Annual International Congress on Hematologic Malignancies, which took place February 28 – March 3, 2019, in Miami, FL. COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval from the U.S. Food and Drug Administration for this same indication in September 2018. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. The accelerated approval was based on overall response rate and continued approval for this indication may be contingent upon confirmatory trials. The randomized, multicenter, open-label, Phase 3 DUO study, compared COPIKTRA versus ofatumumab in 319 adult patients with CLL or SLL after at least one prior therapy. The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25mg twice daily until disease progression or unacceptable toxicity, or ofatumumab, an approved standard of care treatment for use in CLL/SLL, for 7 cycles. The approval of COPIKTRA was based on efficacy and safety analysis of patients with at least 2 prior lines of therapy, where the benefit:risk appeared greater in this more heavily pretreated population compared to the overall trial population. In this subset, the median patient age was 69 years, 59% were male, and 88% had an ECOG performance status of 0 or 1. Forty-six percent received 2 prior lines of therapy, and 54% received 3 or more prior lines. At baseline, 52% of patients had at least one tumor greater than or equal to 5 cm, and 22% of patients had a documented 17p deletion. During randomized treatment, the median duration of exposure to COPIKTRA was 13 months, with 80% of patients receiving at least 6 months and 52% receiving at least 12 months of COPIKTRA. The median duration of exposure to ofatumumab was 5 months. Efficacy was based on progression-free survival as assessed by an Independent Review Committee. Other efficacy measures included overall response rate.
https://thefly.com/landingPageNews.php?id=2873527

Axsome Therapeutics initiates MOMENTUM Phase 3 trial

Axsome Therapeutics enrolled the first patient in its MOMENTUM study, a Phase 3, randomized, controlled trial assessing the efficacy and safety of AXS-07 in the acute treatment of migraine. MOMENTUM will enroll only patients with a history of inadequate response to prior migraine treatments. Topline results from this trial are expected in Q1 of 2020.
https://thefly.com/landingPageNews.php?id=2873537

Teladoc price target raised to $75 from $70 at SunTrust

SunTrust analyst Sandy Draper raised his price target on Teladoc to $75 and kept his Buy rating, saying the review of his financial model and conversations with the company management suggest that its FY19 guidance has been set too conservatively. The analyst believes that Teladoc’s two key metrics – paying members and utilization – will exceed his prior expectations and also offers a more positive outlook on the “wide-scale telehealth adoption” given the company’s “strong sales pipeline and an increasingly more favorable legislative environment.”
https://thefly.com/landingPageNews.php?id=2873539

Hutchison China MediTech initiated with a Buy at Deutsche Bank

Deutsche Bank analyst Richard Parkes started Hutchison China MediTech with a Buy rating and $35 price target. The analyst believes the shares offer “significant upside potential” as the company leverages its pipeline of cancer-focused drugs in both domestic and global markets.
https://thefly.com/landingPageNews.php?id=2873559