Allergan announced that the U.S. FDA has accepted for review the company’s supplemental New Drug Application for VRAYLAR, seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder in adults in the current product label. The sNDA is supported by data from three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. In all three pivotal studies, cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression.
Wednesday, September 26, 2018
Aldeyra to host conference call
Conference call to discuss results from phase 2b Dry Eye Disease Clinical Trial will be held on September 26 at 8 am. Webcast: http://ir.aldeyra.com/
RA Pharmaceuticals announces results from Phase 1b study of renal med
Ra Pharmaceuticals announced positive results from the Company’s Phase 1b pharmacokinetic study evaluating zilucoplan in patients with renal impairment. The Company has received International Nonproprietary Names clearance for use of the name zilucoplan from the World Health Organization. The Phase 1b, multi-center, open-label trial was designed to evaluate the PK profile of zilucoplan in patients with severe renal impairment as a lead-in to studying zilucoplan in complement-mediated renal disorders. The trial enrolled 16 subjects, including eight patients with severe renal impairment matched with eight healthy control subjects with normal renal function. Each patient received a single, subcutaneous dose of 0.3 mg/kg of zilucoplan. The PK profile of zilucoplan was consistent across both groups, with exposures similar in renally-impaired patients and healthy volunteers. There were no adverse events reported. Overall, the data indicate that zilucoplan can be used in clinical studies of patients with renal impairment without any need for dose adjustment. Zilucoplan is currently being studied in a Phase 2 study in generalized myasthenia gravis with a top-line data read-out expected around year-end 2018. The Company also recently completed interactions with regulators, including the U.S. Food and Drug Administration, for its global Phase 3 program of zilucoplan for the treatment of paroxysmal nocturnal hemoglobinuria. Based on these interactions, Ra Pharma plans to initiate a global, pivotal, single-arm Phase 3 trial in treatment-naive PNH patients during the first half of 2019.
JMP Securities ‘optimistic’ on Madrigal following Amarin’s Vascepa data
JMP Securities analyst Liisa Bayko said she feels “optimistic” regarding MGL-3196’s potential cardiovascular benefit following Amarin’s (AMRN) announcement that Vascepa reduced the risk of major adverse CV events in the REDUCE-IT long-term outcomes study. The REDUCE-IT data lays an argument that Madrigal’s MGL-3196, which has a similar impact on cardiometabolic parameters, may also provide a CV benefit, contends Bayko. She maintains an Outperform rating and $300 price target on Madrigal Pharmaceuticals shares.
https://thefly.com/landingPageNews.php?id=2795673
Clementia Pharmaceuticals announces data from Phase 2 trial
Clementia Pharmaceuticals announced updated data from the open label extension of its ongoing Phase 2 clinical trial of palovarotene in fibrodysplasia ossificans progressiva, or FOP. “These updated data continue to support the potential for palovarotene in FOP, an ultra-rare and devastating bone condition,” said Clarissa Desjardins, founder and CEO of Clementia. “Twelve-week flare-up outcomes for patients treated with palovarotene in our Phase 2 trial indicate a consistent treatment effect of approximately 73 percent reduction in mean new bone growth, or heterotopic ossification, and palovarotene was generally tolerated in both adult and pediatric patients. However, we observed that nearly half of the patients in Part B had flare-ups that went untreated mainly due to the criteria for flare-up treatment specified in the Part B protocol. The flare-up treatment criteria in the MOVE Trial, on the other hand, are expected to result in more frequent use of flare-up up dosing in response to flare-up symptoms. First and second interim analyses from the MOVE Trial are expected to occur in the second and third quarters of 2019, respectively, and are designed to assess new HO in treated patients as compared to external natural history study controls. We look forward to those data readouts next year and anticipate that they’ll reflect the true potential of palovarotene in patients who urgently need a treatment option.”
https://thefly.com/landingPageNews.php?id=2795795
Obalon Therapeutics gets approval of PMA-S application for Obalon Touch
Obalon Therapeutics announced approval of a premarket approval supplement, or PMA-S, application for the Obalon Touch Inflation System from the FDA. The Obalon Touch Inflation System is an automated system utilized to inflate the Obalon Balloon. The Obalon Touch is intended to be commercialized in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in Q3 and is pending a decision by the FDA.
https://thefly.com/landingPageNews.php?id=2795817
TG Therapeutics price target lowered to $30 from $35 at SunTrust
SunTrust analyst Peter Lawson lowered his price target on TG Therapeutics to $30 after the announcement that the independent Data Safety Monitoring Board for the ongoing Phase 3 UNITY-CLL trial in chronic lymphocytic leukemia, or CLL, patients advised that the data “was not mature enough” to read out the overall response rate. The analyst says the company has decided to not seek accelerated approval, which could delay market entry, focusing instead on the Progression-Free Survival endpoint to support approval. While Lawson remains bullish on the stock and maintains his Buy rating, he notes that his revised price target reflects the lower probability of success in the CLL program.
https://thefly.com/landingPageNews.php?id=2795823
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