GLPG Awaits SAPHIRA Data, VTAE Vaults, CBLI Hits A Snag

(RTTNews) - Cerus Corp. (CERS) has received expanded FDA approval for its INTERCEPT Blood System for treatment of platelets suspended in 100% plasma. The extended label claim further enhances compatibility with commonly used platelet collection methods, noted the company.

The INTERCEPT Blood System was initially approved by the FDA in December 2014 for treatment of platelets collected in a commercially available platelet additive solution, InterSol.

CERS closed Wednesday' trading at $5.79, down 3.34%.

It looks like the progress of regulatory review of Cleveland BioLabs Inc.'s (CBLI) pre-Emergency Use Authorization submission for Entolimod as a radiation countermeasure is going to be delayed.

The FDA has determined that an in vivo study will be necessary to establish bio-comparability between the Entolimod drug formulation proposed for use under the pre-EUA and the drug formulation used in previously conducted preclinical and clinical studies. So, until these bio-comparability data have been evaluated by the Agency, further review of the pre-EUA dossier is not going to proceed.

CBLI closed Wednesday's trading at $2.95, down 19.40%.

Galapagos NV (GLPG) has dosed the first patient in a phase II trial of its investigational drug GLPG1837 in cystic fibrosis patients with a G551D mutation. This study is named as SAPHIRA 1.

Another phase II study is evaluating GLPG1837 in cystic fibrosis patients with a S1251N mutation, dubbed SAPHIRA 2. Topline results from both SAPHIRA 1 and 2 phase II studies are expected in the second half of this year.

GLPG closed Wednesday's trading at $42.95, up 0.56%.

Shares of Vitae Pharmaceuticals Inc. (VTAE) were up over 58% in extended trading on Wednesday, following positive top-line results from the company's 4-week phase 2a proof-of-concept clinical trial of VTP-43742 in psoriatic patients.

According to the trial results, VTP-43742 demonstrated a clear signal of efficacy, with patients in the 350 mg dose group achieving a 24% reduction in the Psoriasis Area Severity Index (PASI) score relative to placebo. In the 700 mg dose group, patients achieved a 30 percent placebo-adjusted PASI score reduction.

The company plans to advance VTP-43742 into a larger scale 16 week trial in the second half of 2016 to continue to assess the efficacy, safety and tolerability of the compound.

VTAE closed Wednesday's trading at $4.11, down 7.64%. In after hours, the stock was up 58.15% to $6.50.