ATRC On Watch, BIO Gets A High Five, CORI's Study Succeeds, CYTX In Style

(RTTNews) - Shares of AtriCure Inc. (ATRC) were up more than 5% in extended trading on Tuesday after the company, which reported solid results for the second quarter, boosted its revenue outlook for 2015.

Looking ahead to 2015, the company now expects its revenue to be in the range of $127 million to $129 million compared to previous expectations of revenue in the range of $123.5 million to $125.5 million. The revised revenue outlook represents an increase of 18% to 20% over 2014.

ATRC closed Tuesday's trading at $23.24, down 0.26%. In after-hours, the stock was up 5.85% to $24.60.

Bio-Rad Laboratories Inc. (BIO) and (BIO.B) has received FDA pre-market approval for its 5th generation HIV diagnostic test - BioPlex 2200 HIV Ag-Ab assay.

In addition to offering early detection of HIV by detecting HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection), the BioPlex 2200 HIV Ag-Ab assay provides more information by specifically identifying which individual HIV-1 or HIV-2 marker is positive.

BIO closed Tuesday's trading at $149.45, up 2.05%.

Corium International Inc.'s (CORI) phase IIa study of Transdermal MicroCor PTH in post-menopausal women for the rapid delivery of a treatment for osteoporosis has yielded positive results in terms of pharmacokinetics, pharmacodynamics, safety and tolerability.

The company's MicroCor PTH delivers human parathyroid hormone, or hPTH(1-34) (known as Teriparatide), a peptide that has been clinically proven to stimulate formation of new bone and reduce the risk of fractures. Teriparatide is approved for the treatment of osteoporosis by the FDA as a daily injection.

Corium's MicroCor transdermal system uses a novel biodegradable microstructure technology capable of delivering a wide range of drugs as an alternative to daily injections.

CORI closed Tuesday's trading 2.60% higher at $13.80.

Cytori Therapeutics Inc.'s (CYTX) licensee Kerastem Technologies has received conditional approval from FDA to conduct a clinical trial studying the safety and feasibility of its technology for the treatment of female and early male pattern baldness (androgenic alopecia).

The phase II study, known as the STYLE trial, is designed to enroll 70 patients, and is expected to begin enrollment in late 2015 at up to 8 centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.

CYTX closed Tuesday's trading at $0.44, up 9.97%. In after hours, the stock was up 2.27% at $0.45.

Esperion Therapeutics Inc.'s (ESPR) phase II exploratory study evaluating the safety and efficacy of ETC-1002 in patients with both hypercholesterolemia and hypertension has met the primary endpoint of significant cholesterol reduction compared to placebo.

According to the trial results, patients treated with 180 mg of ETC-1002 achieved a 21% reduction in LDL-cholesterol from baseline, and a 24% reduction compared to placebo, which increased by 3%.

ETC-1002 also demonstrated statistically significant and clinically meaningful reductions of 25% from baseline, 44% vs placebo in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease, the company added.

ETC-1002 produced a neutral effect on blood pressure, appeared to be safe and well-tolerated and produced no muscle-related adverse events.

ESPR closed Tuesday's trading at $69.01, down 3.68%.

OPKO Health Inc.'s (OPK) New Drug Application for Rayaldee for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency has been accepted for review by the FDA.

OPK closed Tuesday's trading at $16.84, up 1.45%. In after hours, the stock was up 3.86% at $17.49.

Otonomy Inc. (OTIC) has initiated a phase II clinical trial evaluating AuriPro for the treatment of patients with acute otitis externa, also known as swimmer's ear. The study is designed to evaluate the feasibility of administering AuriPro to the ear canal in a physician's office setting.

The phase II trial is expected to enroll approximately 75 patients, ages 6 months to 80 years old, and is of 1 month duration.

The company's New Drug Application for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement, or TTP, surgery is under FDA review with a decision set for December 25, 2015.

If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.

OTIC closed Tuesday's trading at $27.28, up 1.11%.

Progenics Pharmaceuticals Inc. (PGNX) drug candidate Azedra has been granted Breakthrough Therapy designation for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.

Azedra is currently being evaluated in a pivotal phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.

The Breakthrough Therapy designation pathway was created by the FDA to expedite the development and review for a drug that treats a serious or life-threatening condition.

PGNX touched a new high of $11.15 on Tuesday before closing the day's trading at $9.42.