Rocket Lights Up AERI, GALT Awaits Data In 3Q 2016, ITCI On Fire

(RTTNews) - Shares of Aerie Pharmaceuticals Inc. (AERI) climbed more than 77% in extended trading on Wednesday after the company reported positive results from its second phase III glaucoma trial, dubbed Rocket 2.

In the Rocket 2 study, the company's investigational product Rhopressa was found to be non-inferior to Timolol, the most widely used comparator, in lowering intraocular pressure (IOP) in patients with glaucoma.

The first phase III trial of Rhopressa, dubbed Rocket 1, the results of which were announced in April of this year, failed to demonstrate non-inferiority of IOP lowering compared to Timolol. The baseline IOPs tested in the study ranged from above 20 to below 27 mmHg.

However in the Rocket 1 study, Rhopressa demonstrated non-inferiority compared to Timolol for patients with IOP below 26 millimeters of mercury (mmHg) and numerical superiority over Timolol.

Therefore, in consultation with the FDA, Aerie revised the primary endpoint range of the Rocket 2 trial also to above 20 mmHg (millimeters of mercury) but below 25 mmHg, which has been successfully met.

The company expects Rocket 2 safety results by the end of 2015 or early 2016, and filing of Rhopressa NDA is scheduled for mid-2016.

AERI closed Wednesday's trading at $18, up 0.17%. In after-hours, the stock surged 77.39% to $31.93.

AbbVie (ABBV) and Neurocrine Biosciences Inc.'s (NBIX) phase 2b clinical trial evaluating product candidate Elagolix alone or in combination with add-back therapy compared to placebo in women with heavy menstrual bleeding associated with uterine fibroids has met the composite primary efficacy endpoint.

The composite primary efficacy endpoint was to achieve a menstrual blood loss volume (MBL) of less than 80 mL as well as a 50% or greater reduction in MBL volume from baseline at the final study month as measured by the alkaline hematin method.

The phase III Evaluation of Elagolix in patients with uterine fibroids is expected to begin in the first quarter of 2016 and will include two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study.

NBIX closed Wednesday's trading 1.63% higher at $54.29.

Galectin Therapeutics Inc. (GALT) has commenced its phase II clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis with advanced fibrosis.

The trial, dubbed NASH-FX, will enroll 15 NASH (non-alcoholic steatohepatitis) patients with advanced fibrosis (stage 3) to receive 8 mg/kg of GR-MD-02 and 15 to receive placebo every other week for 16 weeks, for a total of nine doses. Top-line data is expected to be available in the third quarter of 2016.

GALT closed Wednesday's trading 2.42% higher at $2.12.

Shares of Intra-Cellular Therapies Inc. (ITCI) were up more than 86% on Wednesday as the company reported positive top-line results from its first phase III trial of ITI-007 in patients with schizophrenia.

In the trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 as measured by the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score. Moreover, ITI-007 60 mg showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entire study, according to the company.

Intra-Cellular also announced top-line data from a separate clinical study using positron emission tomography in patients with schizophrenia, which showed that ITI-007 60 mg was associated with a mean of approximately 40% striatal dopamine D2 receptor occupancy. This meant that ITI-007 demonstrated antipsychotic effect at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs.

Unlike any existing schizophrenia treatment, ITI-007's special working mechanism likely contributes to its favorable safety profile, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motoric side effects, added the company.

ITCI touched a new high of $49.75 on Wednesday before closing the day's trading at $48.79, up 86.686%.

In a head-to-head phase III study, Merck & Co. Inc.'s (MRK) investigational Omarigliptin for adults with type 2 diabetes has been found to be non-inferior to its top-selling Januvia at reducing patients' A1C* levels from baseline. (*a person's average levels of blood glucose, also called blood sugar, over the past 3 months).

Januvia had sales of $6 billion in 2014, up 3% over the prior year.

The company plans to submit for regulatory approval of Omarigliptin in the U.S. by the end of 2015.

MRK closed Wednesday's trading at $53.87, up 0.60%.

Ocera Therapeutics Inc. (OCRX) has initiated a phase I clinical trial of oral prototype solid-dose, extended-release formulations of OCR-002 in healthy subjects to study the pharmacokinetics, safety and tolerability of the compound.

OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the FDA for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease.

The phase I trial is an open-label, five-treatment, five-period crossover study expected to be completed by the end of 2015.

OCRX closed Wednesday's trading at $3.60, down 0.28%.