BDSI Hoping To Deliver, MDCO Gets FDA Nod, TXMD On Watch, Busy Days Await NVAX

(RTTNews) - BioDelivery Sciences International Inc. (BDSI) has completed a pre-specified interim analysis of the ongoing initial pivotal phase III trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy, and anticipates having top-line results by the end of the first quarter of 2015.

BDSI closed Wednesday's trading at $13.02, up 3.09%.

BioLineRx (BLRX) expects final data from its phase II trial of BL-8040 in the treatment of acute myeloid leukemia in early 2015. The company will commence a phase 1 trial for BL-8040 as a novel stem cell mobilization agent during the next 4-6 weeks, with results expected in late 2014 or early 2015.

BLRX closed Wednesday's trading at $1.77, down 1.12%.

Cubist Pharmaceuticals Inc. (CBST) is voluntarily recalling certain lots of CUBICIN to the due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.

CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections.

CBST closed Wednesday's trading at $61.47, down 1.11%.

Novavax Inc. (NVAX) has a busy time ahead with a number of events lined up for the coming months.

This quarter, the company expects to release top-line data from a recently initiated phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with its Matrix-M adjuvant.

The company also plans to initiate 4 clinical studies before the end of 2014 - a phase II clinical trial of its RSV F-protein vaccine candidate for protection of infants via maternal immunization in pregnant women; a phase I clinical trial of its RSV F-protein vaccine candidate for protection of pediatrics; a phase II clinical trial of its RSV F-protein vaccine candidate for protection of elderly; a phase 2 clinical trial of its quadrivalent VLP seasonal influenza vaccine.

NVAX closed Wednesday's trading at $4.58, up 3.15%. However, in after-hours, the stock was down 4.15% to $4.39.

Shares of TherapeuticsMD Inc. (TXMD) were up 1.05% in after-hours Wednesday following better-than expected Q2 results.

This women's health pharmaceutical company, which is focused on the development and commercialization of advanced hormone replacement therapies, is continuing recruitment in the ongoing REPLENISH phase III study for its combination hormone therapy pill.

The company is also expected to advance its investigational product TX-004HR (VagiCap), the first softgel vaginal suppository for treatment of vulvar vaginal atrophy, in phase III testing this quarter.

TXMD closed Wednesday's trading 5.56% higher at $4.75. In after-hours, the stock was up 1.05% to $4.80.

Shares of The Medicines Co.'s (MDCO) surged more than 10 percent in extended trading Wednesday after the company announced that its antibiotic - ORBACTIV - has been approved by FDA for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria.

ORBACTIV, administered intravenously, becomes the first and only single dose antibiotic approved for the treatment of ABSSSIs, and is expected to be launched this year.

The product is also under review in Europe, where the company is seeking approval for the treatment of complicated skin and soft tissue infections, or cSSTI. (cSSTI is known as acute ABSSSIs in the US). A decision from the European Commission is expected during the first half of 2015.

Durata Therapeutics' Dalvance, which is administered intravenously, having a once-a-week dosing for two weeks, and Cubist Pharmaceuticals' Sivextro, which is given once daily for 6 days either orally or intravenously, are the other approved drugs for ABSSSIs.

Vital Therapies, Inc. (VTL) expects to deliver preliminary phase III trial results of its lead product candidate - ELAD System - an extracorporeal bio-artificial liver therapy, in alcohol-induced liver decompensation in the first half of 2015.

The company went public on the NASDAQ Global Market on April 17, 2014, offering its shares at a price of $12 each.

VTL closed Wednesday's trading at $21.90, down 3.23%.