FDA Panel Backs REGN's Cholesterol Drug, SAGE Cheered Up, Keep Watch Over TXMD

(RTTNews) - CytoDyn Inc. (CYDY.OB) has initiated its first phase III study for PRO 140, a novel self-injectable antibody, for the treatment of HIV. The first patient in the trial is expected to be dosed in the third quarter of this year.

CYDY.OB closed Tuesday's trading 5.85% higher at $0.99.

Dermira Inc. (DERM), which initiated a phase 2b dose-finding trial for DRM01 in patients with acne vulgaris in April 2015, plans to enroll approximately 400 patients. Based on current enrollment projections, the company anticipates announcing topline data from this study in the first half of 2016.

DERM closed Tuesday's trading at $15.59, down 1.33%.

IGI Laboratories Inc. (IG) has submitted its fourth abbreviated new drug application of this year to the FDA, which brings the total number of ANDA submissions now pending at the FDA to twenty-six.

IG closed Tuesday's trading at $6.36, down 2.30%.

Prothena Corp. plc (PRTA) has successfully dosed the first human in a phase I, single ascending dose study of its proprietary protein immunotherapy, PRX003, designed to enroll up to 40 subjects in the U.S.

PRX003 is a monoclonal antibody targeting melanoma cell adhesion molecule (MCAM) for the potential treatment of psoriasis and other inflammatory diseases.

The company expects to initiate a multiple ascending dose study in patients with psoriasis in 2016.

PRTA closed Tuesday's trading at $45.14, down 0.09%.

The FDA panel has recommended approval of Sanofi (SNY) and Regeneron Pharmaceuticals Inc.'s (REGN) investigational therapy Praluent for patients with hypercholesterolemia.

The Committee voted 13 to three (with no abstentions) that the benefit of Praluent exceeds its risks to support approval in one or more patient populations. The Biologics License Application on Praluent is under priority review by the FDA with a decision scheduled for July 24, 2015. The regulatory agency usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved by the FDA, Praluent is expected to be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the U.S. The Marketing Authorization Application for Praluent in the European Union is currently under review by the European Medicines Agency.

REGN closed Tuesday's trading at $526.09, unchanged from the previous day's close. In after-hours, the stock was down 2.70% to $511.90.

SAGE Therapeutics Inc.'s (SAGE) epilepsy candidate SAGE-547 has demonstrated a statistically significant improvement from baseline in depression in four women with postpartum depression within 24 hours after administration in an exploratory clinical trial in postpartum depression.

Postpartum depression is a type of depression some women experience after giving birth. It is estimated that 11% to 20% of women who give birth each year have postpartum depression symptoms.

According to the exploratory trial results, all four patients rapidly achieved remission, as measured by the Hamilton Rating Scale for Depression, and also demonstrated consistent improvement as measured by the Clinical Global Impression-Improvement scale during the SAGE-547 treatment period.

SAGE-547 is expected to enter phase III clinical trial for super-refractory status epilepticus, or SRSE, in mid-2015. An epileptic seizure that lasts more than 5 minutes is known as status epilepticus, and it affects about 150,000 people each year in the U.S.

When we alerted our premium subscribers to SAGE on February 3, 2015, it was trading around $39. The stock closed Tuesday's trading 15.38% higher at $86.71.

TherapeuticsMD Inc. (TXMD) has completed patient enrollment in a phase III clinical trial of TX-004HR for the treatment of pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy, due to menopause.

TX-004HR is an investigational bio-identical estradiol softgel capsule administered vaginally without the need for an applicator.

The company looks forward to disclosing topline results from the phase III trial, dubbed Rejoice, later this year.

TXMD closed Tuesday's trading at $8.16, up 0.37%.