AERI's Rocket-1 Crashes, ACT Launches Avycaz, DRNA Extends Gain After Hours

(RTTNews) - Actavis plc (ACT) has launched its antibacterial drug AVYCAZ in the U.S. The drug was approved by the FDA in February of this year to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

ACT closed Thursday's trading at $298.36, up 1.06%.

Aerie Pharmaceuticals Inc. (AERI) plunged more than 65% in after-hours on Thursday as its first phase 3 registration trial of glaucoma treatment, Rhopressa, failed to meet the primary endpoint.

The trial, dubbed Rocket 1, failed to demonstrate non-inferiority of IOP (intraocular pressure) lowering for once-daily Rhopressa compared to twice-daily timolol, the most widely used comparator in registration trials for glaucoma. The baseline IOPs tested in the study ranged from above 20 to below 27 mmHg.

However, Rhopressa demonstrated non-inferiority compared to timolol for patients in the study with IOP below 26 millimeters of mercury (mmHg) at all nine measured time points and numerical superiority over timolol at the majority of measured time points, said the company.

A second phase 3 registration trial of Rhopressa, dubbed Rocket 2 is underway, with efficacy results expected in the third quarter and twelve month safety results expected by the end of 2015.

It remains to be seen if the Rocket 2 will be able to put Aerie's stock price back on track.

AERI closed Thursday's trading at $35.39, up 2.82%. In after-hours, the stock lost 65.50% of its value and was down at $12.21.

CymaBay Therapeutics Inc. (CBAY) has initiated a phase II study of drug candidate MBX-8025 in patients with homozygous familial hypercholesterolemia, or HoFH.

Homozygous Familial Hypercholesterolemia is a rare genetic lipid disorder resulting in an accumulation of low-density lipoprotein, often referred to as bad cholesterol, in the blood.

The phase 2 trial is designed to enroll 8 patients at sites in Europe and North America. Following enrollment, patients will initially receive a 50 mg dose of MBX-8025 once daily that will be increased first to 100 mg and eventually 200 mg of MBX-8025 over the course of 3 months.

The company expects the outcome of this study to be available around the end of this year.

CBAY closed Thursday's trading at $4.88, down 2.40%.

Shares of Dicerna Pharmaceuticals Inc. (DRNA) rose more than 6% on Thursday, following the FDA's Orphan Drug Designation for DCR-PH1, the company's therapeutic candidate for the treatment of primary hyperoxaluria type 1, or PH1.

PH1 is a severe, rare, inherited disorder of the liver that often results in kidney failure, and for which there are no approved therapies.

The company expects to initiate a phase I trial of DCR-PH1 in 2015, with initial clinical data to be released by late 2015.

DRNA went public on January 30, 2014, priced at $15.00 per share. The stock closed Thursday's trading at $24.43, up 6.59%. In after-hours, the stock was up another 3.97% at $25.40.

Quidel Corp. (QDEL) has reported better-than-expected earnings for the first quarter ended March 31, 2015.

Net income on a non-GAAP basis was $10.8 million or $0.30 per share on total revenue of $61.3 million in Q1, 2014. This compared with non-GAAP net income of $2.9 million or $0.08 per share and total revenue of $46.7 million in the year-ago quarter. Analysts polled by Thomson Reuters expected the company to earn $0.12 per share and revenue of $61.22 million.

QDEL closed Thursday's trading at $23.81, up 0.04%.