GALE Breezes Ahead, AEGR, InVivo Hammered, AZN Gets FDA Thumbs Up, OPK To Watch

(RTTNews) - Aegerion Pharmaceuticals Inc. (AEGR) slipped more than 16 percent to $36.80 in after-hours on Tuesday as it lowered its net product sales guidance for 2014 due to purchase order delays in Brazil, the company's number two revenue-generating country.

Accordingly, Aegerion now expects global net product sales of between $180 million and $200 million for FY 2014, revised from the prior range of between $190 million and $210 million.

In the first-quarter ended March 31, 2014, non-GAAP net loss, which excludes stock-based compensation, narrowed to $7.3 million or $0.25 per share on net product sales of $27.0 million. This compared with a non-GAAP net loss of $14.6 million or $0.51 per share and net product sales of $1.2 million in the same period in 2013.

AstraZeneca plc (AZN), which is in the crosshairs of Pfizer Inc (PFE) as a takeover target, received FDA approval for EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

EPANOVA is the first FDA approved prescription omega-3 in free fatty acid form. The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day. It can be taken with or without food.

AZN closed Tuesday's trading at $79.12, down 0.12%.

Galena Biopharma (GALE) was up more than 5 percent to $2.60 in extended trading on Tuesday, following the release of its Q1, 2014 financial results.

The company's net loss for the three months ended March 31, 2014 narrowed to $2.5 million or $0.02 per share from $9.3 million or $0.11 per share in the year-ago quarter.

Net revenue from the sale of Abstral, Galena Biopharma's first commercial product approved for the treatment of breakthrough cancer pain, was $2.2 million in Q1, 2014 compared to no net revenue in the year-ago quarter.

The company anticipates completing enrollment in a phase III trial of NeuVax vaccine to prevent breast cancer recurrence, initiating a phase 2 trial with GALE-401 for the treatment of essential thrombocythemia and completing phase 2 enrollment for GALE-301 in ovarian cancer this year.

Shares of InVivo Therapeutics Holdings Corp. (NVIV.OB) cratered on Tuesday after the company priced its public offering of common stock at $1.15 per share. The offering, whose gross proceeds are expected to be approximately $14.0 million, is slated to close on or about May 9, 2014, subject to customary closing conditions.

NVIV.OB closed Tuesday's trading at $1.15, down 34.29%.

Nymox Pharmaceutical Corp.'s (NYMX) ongoing prospective phase II trial of NX-1207 for the treatment of low grade localized prostate cancer has revealed that NX-1207 has the potential to offer men with low-risk prostate cancer a significant tangible benefit in terms of avoidance of radiation and/or surgery and the related risks, discomforts, and permanent side effects.

Previously reported study results showed that patients with NX-1207 treatment had significantly less Gleason grade progression, lower average PSA levels, lower numbers of biopsy cores showing greater malignancy, and lower total volume of more malignant cancer compared to controls.

NX-1207 is also in phase III trial in the U.S. and Europe for benign prostatic hyperplasia (BPH) also referred to as prostate enlargement.

NYMX closed Tuesday's trading 2.03% higher at $5.03.

OPKO Health Inc. (OPK) has completed patient enrollment in the third phase III trial of RAYALDEE in treating secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

This third phase III trial is a 6-month open-label extension of two ongoing and identical randomized, double-blind, placebo-controlled, multi-site pivotal phase 3 studies for RAYALDEE intended to support marketing approval in the United States. The two phase III trials will end in July 2014 and the company expects to announce top-line data during the third quarter of 2014.

OPK closed Tuesday's trading at $8.16, down 2.63%.