Cara Therapeutics initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Charles Duncan last night initiated coverage of Cara Therapeutics with an Overweight rating and $27 price target. The analyst, who started coverage on seven Neuro-Innovator and Platform-Enabled Therapeutic companies, believes that “biotech has entered a golden age of innovation and productivity across many therapeutic areas.”
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Friday, September 21, 2018
Cytokinetics initiated at Cantor Fitzgerald
Cytokinetics initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Charles Duncan last night initiated coverage of Cytokinetics with an Overweight rating and $14 price target. The analyst, who started coverage on seven Neuro-Innovator and Platform-Enabled Therapeutic companies, believes that “biotech has entered a golden age of innovation and productivity across many therapeutic areas.”
Zynerba initiated at Cantor Fitzgerald
Zynerba initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Charles Duncan last night initiated coverage of Zynerba with an Overweight rating and $21 price target. The analyst, who started coverage on seven Neuro-Innovator and Platform-Enabled Therapeutic companies, believes that “biotech has entered a golden age of innovation and productivity across many therapeutic areas.”
Melinta Therapeutics announces CHMP approval recommendation for Vabomere
Melinta Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending Vabomere for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms where treatment options are limited. The CHMP’s opinion will be reviewed by the European Commission, or EC, which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere’s European approval would not take effect until marketing authorization is granted by the EC.
Eli Lilly receives positive CHMP opinion for Emgality
Eli Lilly announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for Emgality for the prophylaxis of migraine in adults who have at least four migraine days per month. In June 2018, Lilly announced the intended brand name, Emgality, was conditionally accepted by the U.S. FDA.
GTx: placebo-controlled ASTRID trial did not meet primary endpoint
GTx announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm in post-menopausal women with stress urinary incontinence, did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. The percentage of patients with a greater than 50% reduction after 12 weeks of enobosarm treatment was 58.9% for 3mg, 57.7% for 1mg and 52.7% for placebo. Enobosarm was generally safe and well tolerated. Reported adverse events were minimal and similar across all treatment groups. “We are very disappointed that the ASTRID Trial did not achieve its primary endpoint,” said Robert Wills, executive chairman of GTx. “We plan to conduct a full review of all the data. We want to thank the patients, physicians, study coordinators and the entire GTx team for their support of this novel study. We have an ongoing preclinical program assessing the potential of SARDs, our novel selective androgen receptor degrader technology, to treat castration-resistant prostate cancer. We are currently on target to have development candidates by year end, which we potentially plan to take into IND-enabling studies.”
Clovis price target lowered to $71 from $87 at JPMorgan
JPMorgan analyst Cory Kasimov lowered his price target for Clovis Oncology to $71 after “reigning in” his ovarian expectations but keeps an Overweight rating on the shares. With the European Society of Medical Oncology meeting coming up in October, Kasimov is previewing the first look at data from Clovis’s Triton-2 study in prostate cancer. The analyst is “quite confident” that the company’s PARP inhibitor rucaparib should produce response rates that are well above chemotherapy and anti-androgens, at least in third line BRCA positive patients. He views the Triton-2 update as an important event for Clovis and believes “promising results could represent a step towards restoring more favorable sentiment.” A response rate of at least 30% is the lower bar for share appreciation, Kasimov tells investors in a research note. He keeps an Overweight rating on Clovis.
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