ELGX Abuzz, ESPR Ahead Of Schedule, Tough Times For VIVO

(RTTNews) - AbbVie (ABBV) has initiated two phase II clinical trial programs to evaluate ABBV-8E12 in patients with early Alzheimer's disease and progressive supranuclear palsy.

ABBV-8E12 is designated an Orphan Drug by the FDA and European Medicines Agency for progressive supranuclear palsy, or PSP.

The phase II study in early Alzheimer's disease will enroll 400 patients to assess the efficacy and safety of ABBV-8E12 to delay disease progression. The phase II study in PSP will evaluate 180 adults and assess the efficacy and safety of ABBV-8E12 to slow disease progression.

ABBV closed Wednesday's trading at $61.38, up 1.32%.

Aldeyra Therapeutics Inc. (ALDX) is all set to initiate two phase III trials this year.

A phase III trial of topical ocular ADX-102 in noninfectious anterior uveitis is anticipated to begin enrollment in the second quarter of 2017. The primary endpoint is the clearing of inflammatory cells in the anterior chamber of the eye. Data from the trial are expected in late 2018.

A phase II trial of topical dermal ADX-102 in Sjögren-Larsson Syndrome (SLS) is expected to be initiated in the second half of 2017. The proposed clinical trial will enroll up to 30 SLS patients in the United States and Europe. The primary endpoint will be the severity of the dermatologic disease. Data from the trial are expected in 2019.

ALDX closed Wednesday's trading at $5.65, down 0.88%.

Shares of Endologix Inc. (ELGX) were up over 11% on Wednesday, following the reinstatement of CE Mark for its AFX and AFX2 endovascular AAA systems.

Last month, the European Union had suspended the CE Mark for the AFX system due to reports of Type III endoleaks with a prior generation of the device.

The CE Mark has been reinstated based upon low rates of reported Type III endoleaks with the current generation of AFX products, the company noted.

ELGX closed Wednesday's trading at $6.86, up 11.08%.

Esperion Therapeutics Inc. (ESPR) has completed enrollment, reaching the target of about 2,000 patients, in its global pivotal phase III long-term safety and tolerability study of Bempedoic acid in hypercholesterolemia.

The study is evaluating the long-term safety and tolerability of 180 mg of Bempedoic acid versus placebo in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) at high CVD risk whose LDL-C is not adequately controlled with current lipid-modifying therapies.

Top-line results from this study are expected by the second quarter of 2018.

ESPR closed Wednesday's trading at $11.87, up 5.89%.

Shares of Meridian Bioscience Inc. (VIVO) plunged over 20% on Wednesday as the company narrowed its profit and revenue forecasts for fiscal 2017.

For the fiscal year ending September 30, 2017, the company now expects net revenues to be in the range of $193 million to $199 million and per share earnings to be between $0.64 and $0.69. Prior guidance was for revenues in the range of $205 million to $210 million and per share earnings of $0.81 to $0.85.

VIVO closed Wednesday's trading at $12.80, down 22.19%.

Relmada Therapeutics Inc. (RLMD.OB) has been given the go-ahead by the FDA to commence a phase 2a proof of concept clinical study of d-Methadone in patients with treatment resistant depression.

The study will assess changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of REL-1017 as adjunctive treatment in patients during a seven-day dosing period and 14-day observation period.

RLMD.OB closed Wednesday's trading at $1.32, up 10%.