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Tuesday, March 5, 2019

Adamas Pharmaceuticals downgraded to Hold from Buy at Needham

Needham analyst Serge downgraded Adamas Pharmaceuticals to Hold after the management pulled its forecast for 2% Rx market share for the company’s Gocovri given its reported weakness in Q4 and expectations for Q1. The analyst states that the seasonal factors related to early-year insurance plan resets and pharma industry changes, along with the timing of Osmolex launch, have further disrupted Gocovri performance. Belanger notes that the lack of visibility on the product takes his rating to neutral until he sees some signs that the Gocovri launch ramp can re-accelerate.
https://thefly.com/landingPageNews.php?id=2874309

Marinus Pharmaceuticals initiated at Jefferies

Marinus Pharmaceuticals initiated with a Buy at Jefferies. Jefferies analyst Andrew Tsai started Marinus Pharmaceuticals with a Buy rating and $10 price target. Marinus is an inexpensive name that offers a favorable setup at current price levels, Tsai tells investors in a research note. The stock’s risk/reward for is “skewed heavily towards the upside” as the Street appears to underappreciate the company having multiple shots on goal, adds the analyst. He believes the Phase II postpartum depression readout in the first half of 2019 could rally stock up to 50% if positive.
https://thefly.com/landingPageNews.php?id=2874319

Uncertain future of PBMs creating cloud over MCO group, says Morgan Stanley

Morgan Stanley analyst Zack Sopcak noted that managed care stocks he covers are down an average of 10% since February 22 and “theories abound” as to why. In talks with investors, he has heard Medicare for All, drug pricing hearings and cuts to insulin prices all mentioned as potential reasons for the pressure, though “none have really stuck,” Sopcak stated. However, he does believe a lack of understanding or agreement on the future of PBMs and contributions to earnings in light of HHS’ proposals have “created a cloud” over the MCO group, Sopcak said. The analyst, who calls out the magnitude of the move in UnitedHealth (UNH) in particular as unwarranted, points to three potential upcoming catalysts that can “break the group’s malaise” prior to earnings: Anthem’s (ANTM) investor day on March 7, Humana’s (HUM) investor day on March 19 and the Medicare Advantage final rate setting announcement on April 1. Other MCOs include Cigna (CI), Centene (CNC), Molina Healthcare (MOH) and WellCare (WCG).
https://thefly.com/landingPageNews.php?id=2874347

XBiotech presents Phase 2 bermekimab data

XBiotech released findings for its Phase 2 clinical study for bermekimab presented at the American Academy of Dermatology’s annual meeting The company provided the results for 42 Hidradenitis Suppurativa, or HS, patients that received 12 weekly injections of bermekimab therapy. Aside from “excellent” safety, a major finding of the study was that patients achieved significant therapeutic benefit from bermekimab therapy regardless of whether or not they had previously failed treatment with the only existing FDA-approved biological drug treatment for HS. In what the company believes to be a breakthrough for the disease, patients having previously failed as well as those who never received anti-TNF therapy had significant reduction in pain. Pain is a hallmark of HS that has so far not been adequately addressed by any therapy. Data showed that by week 12 of treatment, 63% of patients who have previously failed anti-TNF therapy achieved a positive HiSCR; similarly, 61% of patients with no prior anti-TNF therapy achieved positive HiSCR. These results translated into a 46% and 60% reduction in the number of abscesses and inflammatory nodules, respectively, for the two groups. A breakthrough finding was that 67% and 72% of patients achieved a clinically meaningful reduction in pain by week 12.The existing FDA-approved biological therapy was only shown to reduce pain when used in combination with oral antibiotic. No antibiotics were used as part of the clinical study with bermekimab. The study enrolled 42 patients, each receiving 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen. There were two treatment groups: those who had failed prior anti-TNF therapy and those with no prior anti-TNF treatment history. The study was conducted at eleven different dermatology research centers across the U.S. An intravenous infusion formulation of bermekimab was previously used in a randomized, double-blind, placebo controlled Phase 2 study for patients with HS, where bermekimab treated patients had a significantly higher rate of HiSCR compared to placebo. However, this was the first study of bermekimab in HS using a new subcutaneous formulation that is administered from pre-filled syringes. XBiotech invested in new filling equipment and developed the pre-filled syringe manufacturing process to provide a more convenient subcutaneous bermekimab product candidate.
https://thefly.com/landingPageNews.php?id=2874367

Bluebird Bio downgraded to Market Perform from Outperform at SVB Leerink

https://thefly.com/landingPageNews.php?id=2874153

Gossamer Bio initiated at BofA/Merrill

Gossamer Bio initiated with a Buy at BofA/Merrill. BofA/Merrill analyst Ying Huang initiated Gossamer Bio with a Buy and $30 price target.
https://thefly.com/landingPageNews.php?id=2874173

Catalent price target raised to $49 from $46 at First Analysis

First Analysis analyst Steven Schwartz raised his price target for Catalent to $49 and maintains an Outperform rating on the shares following meetings with management. . The company has a “relatively modest” organic growth profile, but there is additional growth potential from margin expansion driven by business mix improvement and leverageable acquisitions, Schwartz tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2874177