Novo Nordisk reinstated with an Outperform at Exane BNP Paribas
Tuesday, January 29, 2019
Aldeyra acquires Helio Vision
Aldeyra Therapeutics announced that it has acquired Helio Vision, a privately held biotechnology company. The acquisition adds to Aldeyra’s pipeline a Phase 3-ready product candidate for the treatment of proliferative vitreoretinopathy, a serious sight-threatening condition with no approved treatment. ADX-2191 has received Orphan Drug Designation from the FDA. Under the terms of the agreement, Aldeyra has acquired Helio Vision for an upfront payment of approximately $10M in common stock, subject to a six-month lock-up period, and an additional $2.5M payment in common stock two years from the date of closing, subject to certain terms and conditions of the agreement. Helio Vision shareholders will also be eligible to receive up to an additional $12.5M in Aldeyra stock upon achievement of certain regulatory milestones. Eliott and the other co-founders of Helio Vision will continue to work with Aldeyra on ADX-2191 as consultants under the terms of the acquisition.
Momenta reports first subject dosed in Phase 1/2 trial of M254
Momenta Pharmaceuticals announced the dosing of the first subject in the Phase 1/2 clinical trial of M254, hypersialylated Immunoglobulin G. The Phase 1/2 study will enroll normal healthy volunteers and patients with Immune Thrombocytopenic Purpura. The multi-part study includes single and multiple dose parts, and a placebo-controlled, randomized double-blinded cross-over study comparing M254 to IVIg. The four part study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of intravenous M254 in approximately 65 subjects, including healthy volunteers and patients with ITP. Parts A and B are double-blind, placebo-controlled, single ascending dose cohort studies in healthy volunteers and ITP patients, respectively. In Part C, ITP patients will receive M254 or IVIg in a cross-over dosing design, while in Part D, ITP patients will receive multiple doses of M254. The primary efficacy endpoint is an assessment of platelet response.
Allakos announces results from two cohorts of Phase 2 AK002 trial
Allakos announced “positive” Phase 2 results from two additional chronic urticaria cohorts: patients with cholinergic urticaria and symptomatic dermographism. Earlier this month, Allakos reported that 12 of 13 patients in the Xolair-naive chronic spontaneous urticaria, or CSU, cohort achieved a complete response with AK002. Top-line results for the remaining urticaria cohort, patients with chronic spontaneous urticaria who failed to respond to Xolair, are expected later in Q1. The study is being conducted at four sites in the U.S. and Germany. The cholinergic urticaria and symptomatic dermographism cohorts enrolled 11 and 10 patients, respectively, with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to four times the labeled antihistamine dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test, or UCT, were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12, indicative of poorly-controlled urticaria, were enrolled in the study and treated with up to six doses of AK002 given once monthly. Patients received an initial dose of 0.3 mg/kg at baseline, followed by a dose of 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg, depending on response, for a total of six doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002. AK002 was generally well tolerated. The most common adverse event was mild to moderate infusion-related reactions which occurred mostly during the first infusion.
HCA Healthcare reports Q4 same facility equivalent admissions up 1.9%
Same facility admissions and equivalent admissions increased 1.9 percent in the fourth quarter of 2018 compared to the prior year period. Same facility emergency room visits declined 2.1 percent in the fourth quarter of 2018, compared to the prior year period. Same facility inpatient surgeries increased 0.1 percent, while same facility outpatient surgeries increased 0.8 percent in the fourth quarter of 2018 compared to the same period of 2017. Same facility revenue per equivalent admission increased 4.4 percent in the fourth quarter of 2018, compared to the fourth quarter of 2017.
Allergan says anti-infectives unit ‘more likely than not to be sold’
https://thefly.com/landingPageNews.php?id=2855142
HCA Healthcare sees FY19 EPS $9.60-$10.20, consensus $10.17
https://thefly.com/landingPageNews.php?id=2855144
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