AUXL Gives Bleak Outlook, IG Reverses Loss, ENDP Opens Wallet, BOTA Stops Work

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) dropped more than 21 percent to $21.44 in after-hours on Tuesday as the company lowered its financial guidance for full year 2014 due primarily to lower-than-expected revenues from Testim testosterone gel.

Accordingly, the company now expects full year 2014 revenue to range between $380 million and $420 million, down from the initial forecast range of $450 million to $490 million.

For the first quarter of 2014, the company expects to record worldwide Testim revenues of approximately $11 to 13 million, compared to $45.5 million in the first quarter of 2013.

Worldwide Testim revenues for full-year 2014 are now expected to be less than $85 million.

Biota Pharmaceuticals Inc. (BOTA) plunged more than 33 percent on Tuesday to close at $3.68 after being issued a Stop-Work Order by the Biomedical Advanced Research and Development Authority (BARDA) for the company's contract for the development of its drug candidate laninamivir octanoate.

Laninamivir Octanoate is a second generation, long-acting neuraminidase inhibitor, delivered by a TwinCaps inhaler in adults with symptomatic influenza A or B infection.

Laninamivir Octanoate is under phase II testing, and the trial referred to as IGLOO trial is being conducted under the company's contract with the BARDA. The IGLOO trial was initiated in the Southern Hemisphere last June and in the Northern Hemisphere last December.

Now that the Stop-Work Order has been issued and the phase 2 IGLOO trial has exceeded the original recruitment target of 636 patients, the company said it has concluded enrollment in the Northern Hemisphere and will not enroll patients in this trial during the upcoming Southern Hemisphere influenza season.

Endo International plc (ENDP) (ENL.TO) is all set to acquire Mexico-based privately-owned specialty pharmaceuticals company Grupo Farmaceutico Somar for cash consideration. Endo expects the transaction to be immediately accretive to adjusted earnings per share.

ENDP closed Tuesday's trading at $63.25, up 4.44%.

Flamel Technologies (FLML) lost more than 9 percent on Tuesday to close at $11.91, following the receipt of a complete response letter from the FDA for its second New Drug Application from the Éclat portfolio.

The regulatory agency refused to approve the product candidate from the Éclat portfolio citing issues at the facility of the supplier of the active ingredient.

Globus Medical Inc. (GMED) said it has executed well on both the top and bottom lines while delivering strong cash flow in the first quarter of 2014. Looking ahead, the company is optimistic that it has the momentum to maintain and expand its industry leading product portfolio.

In Q1, 2014, the company's non-GAAP net income, which excludes the provision for litigation, was $22.8 million or $0.24 per share compared to $19.9 million or $0.21 per share in the year-ago quarter. First quarter net sales were $114.2 million, up 8.8% from $105.0 million last year.

GMED closed Tuesday's trading at $22.75, down 1.13%. In after-hours, the stock gained 2.20% to $23.25.

IGI Laboratories Inc. (IG) announced strong Q1 results - posting quarterly profit, reversing year-ago loss, on 86% revenue growth. Net income was $0.2 million on total revenues of $6.9 million in the first quarter of 2014. This compared to a net loss of $0.3 million and total revenues of $3.7 million in the same period in 2013.

IG closed Tuesday's trading at $5.02, down 2.90%.

Lipocine Inc. (LPCN) has completed enrollment in its pivotal phase 3 clinical study evaluating LPCN 1021 in hypogonadal men with low testosterone. In the study, dubbed SOAR, a total of 315 subjects were randomized at 40 active sites in 2:1 ratio, such that 210 are being treated with LPCN 1021 and 105 with Androgel 1.62% (the leading gel product by sales) for 52 weeks.

The company expects top-line efficacy data for the trial to be available in the third quarter of 2014, with a New Drug Application filing with the FDA anticipated in the second half of 2015.

LPCN closed Tuesday's trading at $7.50, unchanged from the previous day's close.

RXi Pharmaceuticals Corp. (RXII) has initiated its second phase 2a study of RXI-109 to prevent recurrence of keloids in patients undergoing keloidectomy (removal of keloid). The first phase 2a study of RXI-109 in patients who had pre-existing hypertrophic scars present on their lower abdomen for at least one year was started late last year.

RXII closed Tuesday's trading 5.01% down at $3.41.