FDA Gives Thumbs Down To ADMP, OHRP Blacked Out, HTBX Heating Up

(RTTNews) - Shares of Adamis Pharmaceuticals Corp. (ADMP) were down more than 34% in extended trading on Friday after the company's New Drug Application for Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe product for the emergency treatment of acute anaphylaxis was sent back to the drawing board by the FDA. Anaphylaxis is a potentially life-threatening allergic reaction.

The NDA for Epinephrine Pre-Filled Syringe was filed under 505 (b)(2) regulatory pathway last May. In the complete response letter issued on Friday, the FDA has raised several items, including clarifying the product delivery volume specifications, and the company is planning to request a meeting with the regulatory agency to discuss the letter.

ADMP closed Friday's trading at $5.39, down 2.71%. In after-hours, the stock was down 34.69% at $3.52.

Heat Biologics Inc. (HTBX), which has completed enrollment in a phase 1 clinical trial of its investigational drug HS-410, for the treatment of non muscle invasive bladder cancer, expects an immune response analysis of the first 10 patients in the first half of 2015.

A phase 2 clinical study of HS-410 for the treatment of non muscle invasive bladder cancer is also underway - with patient enrollment of the first three arms of the study in combination with BCG (Bacillus Calmette-Guérin) scheduled for completion in the third quarter of 2015 and topline results anticipated in the second half of 2016.

HTBX closed Friday's trading 5.25% higher at $6.21.

Shares of Ohr Pharmaceutical Inc. (OHRP) cratered more than 68% on Friday following disappointing topline data from a phase II study of its investigational drug OHR-102 for the treatment of the wet form of age-related macular degeneration.

The study, dubbed IMPACT, involved two arms - OHR-102 drops administered twice daily plus Lucentis PRN versus placebo eye drops administered twice daily plus Lucentis PRN. According to the study results, the mean number of injections between the treatment arms, the primary endpoint of the study, was not meaningfully different.

OHRP closed Friday's trading at $2.74, down 68.61%.

RXi Pharmaceuticals Corp. (RXII) and privately-held MirImmune LLC have entered into an exclusive licensing agreement for RXi's Self-Delivering RNAi technology to develop cell-based immunotherapies to treat cancer.

The agreement entitles RXi to receive an annual licensing fee, clinical milestone payments, sub-licensing income and single digit royalties from MirImmune. Pending MirImmune's achievement of a few gating milestones, RXi will have the right to acquire a double-digit equity stake in MirImmune.

RXII closed Friday's trading at $0.76, up 1.43%. In after-hours, the stock was up another 3.95% at $0.79.