Top Pick of the Day: AERI

Aerie Pharmaceuticals (AERI) announced positive results from its Phase 3 clinical trial, Mercury 2. The trial compared the efficacy of Roclatan against each of its components, netarsudil and latanoprost, in lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The trial showed that Roclatan lowered IOP 1 - 3 mmHg more than monotherapy with either component. The company plans to initiate a third Phase 3 registration study, Mercury 3, in Europe mid-year. It also intends to file its U.S. marketing application in the first half of 2018.
The company stock jumped over 36 percent in its premarket session, converting its Year to Date losses to 7 percent gain. The stock is now up 165 percent in the past 12 months.

Focus Ticker: RDUS

Radius Health Inc. (RDUS) announced the results from a 24-month extension study which showed the sustained treatment benefit of TYMLOS (abaloparatide) in reducing the risk of fractures in postmenopausal women. The trial, ACTIVExtend, enrolled patients who receive TYMLOS for 18 months who were transitioned to receive 24 additional months of alendronate. The trial also met all of its primary and secondary endpoints.
The stock reacted postively to the news and gained close to 2 percent in its pre-market trading session. The company stock has gained over 10 percent in the past 12 months and it lost 1 percent of its value in this year so far.

Sector News

Roche (RHHBY) announced that it is investigating a case of a German patient contracting a potential deadly brain infection called progressive multifocal leukoencephalopathy after taking one dose of MS drug Ocrevus. The company said that the  rare condition was reported as a carryover from Tysabri by the doctor treating the patient.

Medtronic (MDT) announced that it has enrolled the first patient in its study evaluating its IN.PACT AV Access Drug-Coated Balloon for the treatment of failing arteriovenous fistulas in patents with end-stage renal disease. The trial is designed to study the safety and efficacy of the device for up to two years across 30 sites in the U.S., Japan and New Zealand.

Approvals

Quidel (QDEL) announced receiving the approval of the Japanese Pharmaceuticals and Medical Devices Agency Sofia Influenza A+B Fluorescent Immunoassay (FIA) that will be performed on its automated Sofia FIA Analyzer.

Puma Biotechnology (PBYI) is reprorted to have received 12-4 approval from an FDA advisory committee for its experimental breast cancer drug. The panel concluded that Neratinib's benefits outweigh its risks.

Deals and Collaborations

Aerie Pharmaceuticals (AERI) announced inking a Controlled Equity Offering Sales agreement to sell $50 million of common stock at market prices. The agreement has been inked with Cantor Fitzgerald, which will earn 3 percent commission on the transaction.

Johnson & Johnson (JNJ) is reported to have made a $33 million multi-state settlement regarding subsidiary McNeil's promotion of certain OTC medications which were non-compliant with GMP standards between 2009 and 2011.

Earnings

Rennova Health (RNVA) announced its quarterly revenue at $1.18 million while its loss stood at $49.70 million. Its gross margins narrowed from 3.44% to -7.60% compared to the same period last year.

Revive Therapeutics (RVVTF) reported its net loss for the three and nine months ended March 31, 2017 at $452,707 and $1.08 million respectively. Its research costs for the three and nine months ended March 31, 2017 were $225,056 and $338,537, respectively.