ALIM, PSDV Rally After Iluvien News, GILD Lays Out Plan, REGN Gets FDA Date

(RTTNews) - Alcobra Ltd.'s (ADHD) proprietary drug candidate MG01CI has been granted "Orphan Drug" designation by FDA in the treatment of Fragile X Syndrome. The drug candidate is under pre-clinical testing in the indication of Fragile X Syndrome.

Earlier this week, the company reported highly statistically significant positive results from a phase IIb clinical trial with MG01CI in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder.

ADHD closed Wednesday's trading 2.96% higher at $18.43.

Alimera Sciences Inc. (ALIM) and pSivida Corp (PSDV), which suffered a setback in October after being told by FDA to conduct new clinical trial in order for their diabetic macular edema drug Iluvien to be approved, rallied in extended trading on Wednesday after good news on the drug.

Iluvien is an intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for the treatment of diabetic macular edema. Alimera licensed the Iluvien technology from pSivida Corp.

Alimera received a Complete Response Letter for Iluvien from the FDA for the third time on Oct.18, 2013, and was asked to submit results from a new clinical trial to address the clinical and statistical deficiencies identified. The same day - Oct.18, 2013, Alimera was notified by the FDA that an Advisory Committee meeting would be convened on January 27, 2014, which would be of assistance in addressing the deficiencies identified in the Complete Response Letter.

However, following labeling discussions with the FDA yesterday, it has been concluded that Alimera need not conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval. It has also been decided that the Advisory Committee meeting is no longer necessary.

Accordingly, Alimera will be addressing the remaining issues that were raised in the Complete Response Letter and will submit its response in the first quarter of 2014, which will include recent safety data gathered from patients in Europe.

Iluvien is being sold in Germany and is expected to launch in France in 2014. The drug is also approved in Austria, Portugal and Spain and has been recommended for approval in Italy.

ALIM closed Wednesday's trading at $2.55. In after-hours, the stock surged 84.31% to $4.70. PSDV also gained more than 58% to $4.70 in extended trading on Wednesday.

Gilead Sciences Inc. (GILD) is planning to submit a New Drug Application for its investigational once-daily fixed-dose combination of Sofosbuvir and Ledipasvir for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in the first quarter of 2014.

In phase III trials, the single tablet regimen of Sofosbuvir/ Ledipasvir with and without Ribavirin has been evaluated for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. According to top-line results of the trials announced today, single tablet regimen of Sofosbuvir/Ledipasvir can provide high cure rates among patients with genotype 1 HCV infection, while eliminating the need for both Interferon and Ribavirin.

Sofosbuvir was approved as Sovaldi in the United States as recently as December 6 and in Canada on December 13, 2013. Applications for Sofosbuvir are pending in the European Union, Australia and New Zealand, Switzerland and Turkey.

GILD closed Wednesday's trading at $73.59, up 5.01%.

Omeros Corp.'s (OMER) drug candidate OMS721 has received orphan drug designation from FDA for prevention of complement-mediated thrombotic microangiopathies. The company expects to report additional phase I clinical data of OMS721 in early 2014. The phase II clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in the first quarter of 2014.

OMER closed Wednesday's trading 18.05% higher at $10.53.

Regeneron Pharmaceuticals Inc.'s (REGN) supplemental Biologics License Application for EYLEA Injection for the treatment of Diabetic Macular Edema has been accepted for standard review by the FDA.

The regulatory agency's decision on EYLEA for the expanded indication is set for August 18, 2014.

EYLEA is already approved in the United States and European Union for the treatment of neovascular (wet) Age-related Macular Degeneration and for Macular Edema following Central Retinal Vein Occlusion (CRVO).

In the first nine months of 2013, EYLEA U.S. net product sales were up 79% to $1.01 billion. For full year 2013, the company expects sales of EYLEA to range between $1.35 billion and $1.375 billion.

REGN closed Wednesday's trading 3.76% higher at $271.72.

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