AKAO Abuzz, AAAP Gets FDA Blessing, CORT Under Close Watch, Big Day For MBRX

(RTTNews) - Shares of Achaogen Inc. (AKAO) rose nearly 13% on Thursday, following a $20 million contract option awarded by BARDA to support the development of the company's lead product candidate Plazomicin.

Plazomicin is under a phase III pivotal clinical trial in complicated urinary tract infections. Achaogen expects to release top-line results from this trial, dubbed EPIC, in the first quarter of 2017, and plans to submit a New Drug Application to the FDA in the second half of 2017.

AKAO closed Thursday's trading at $3.61, up 12.99%.

Advanced Accelerator Applications S.A. (AAAP) has secured FDA approval for NETSPOT, previously known as Somakit-TATE, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients.

NETSPOT, which is a kit for the preparation of gallium Ga 68 dotatate injection, is the first approved drug using Ga 68 as a positron emitter.

The company intends to commercialize NETSPOT in the US in two forms - as a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.

NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler.

AAAP closed Thursday's trading at $30.41, up 3.22%.

Corcept Therapeutics Inc. (CORT) is on track to report final efficacy results from its phase 1/2 trial of Mifepristone plus Eisai's Halaven in patients with triple-negative breast cancer in mid-2016.

The preliminary efficacy results reported from the phase 1/2 trial by the company on Thursday were encouraging. According to the trial results, 3 patients exhibited a partial response, defined as a 30 percent or greater reduction in tumor size, 8 had stable disease and 11 had progressive disease. One patient is too early in treatment to be assessed, noted the company.

The company has begun dosing patients in a phase 1/2 trial of CORT125134 plus Celgene's Abraxane to treat a range of solid-tumor cancers. Initial results from this study are expected in 2017.

CORT closed Thursday's trading at $6.25, up 3.82%.

The Medicines Co. (MDCO) has completed patient enrollment in its phase II trial of PCSK9si in patients with atherosclerotic cardiovascular disease, or ASCVD, or ASCVD-risk equivalents like diabetes and familial hypercholesterolemia, and elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies.

The study, dubbed ORION-1, has randomized 501 patients with high cardiovascular risk and high LDL-C ("bad cholesterol") despite current treatment. Interim three-month and six-month effectiveness and safety data are expected to be available by year-end 2016.

MDCO closed Thursday's trading at $37.79, up 0.69%.

Shares of Moleculin Biotech Inc. (MBRX) gained more than 33% in their market debut on Thursday.

The IPO was priced at $6.00 per share, the upper end of the previously-filed $5.00 to $6.00 pricing range. The stock opened at $8.99 and rose as high as $9.49 during mid-day trading.

The company's lead product candidate is Annamycin, a phase II compound for the treatment of relapsed or refractory acute myeloid leukemia.

MBRX closed Thursday's trading at $8.00, up 33.33%.