APRI On Track, Stellar Bio Shines, FDA Nod For NVS, Study Results Heat Up HTBX

(RTTNews) - Apricus Biosciences Inc. (APRI) expects to resubmit the NDA for Vitaros, a topical vasodilator cream in development for the treatment of erectile dysfunction, in the third quarter of 2017.

Vitaros was turned down by the FDA in July 2008, with the regulatory agency questioning the results of a transgenic mouse carcinogenicity study, which were completed in 2002.

The company is also working towards regaining compliance with the minimum $2.5 million shareholder equity requirement as required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2) on or before May 30, 2017.

APRI closed Monday's trading at $2.83, up 7.20%.

Bellerophon Therapeutics Inc. (BLPH) now expects to report results from its phase II trials of INOpulse for Pulmonary Hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (PH-COPD) and PH associated with Idiopathic Pulmonary Fibrosis (PH-IPF) in mid-2017.

Originally, the company was slated to report the results this quarter.

BLPH closed Monday's trading at $1.67, down 1.76%.

Heat Biologics Inc.'s (HTBX) Phase 1b trial evaluating HS-110 in combination with Bristol-Myers Squibb's (BMY) Opdivo for the treatment of non-small cell lung cancer has achieved the efficacy endpoint.

Given the encouraging signs of synergistic efficacy, the company has decided to advance HS-110 to phase II testing.

HTBX closed Monday's trading at $0.97, up 7.79%.

The FDA has approved Novartis AG's (NVS) Kisqali, formerly known as LEE011, as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor like Letrozole (Femara).

In a pivotal phase III trial, which evaluated Kisqali plus letrozole against letrozole alone in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer, Kisqali plus letrozole reduced the risk of progression or death by 44 percent over letrozole alone.

Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.

NVS closed Monday's trading at $75.61, up 0.01%.

Shares of Peregrine Pharmaceuticals Inc. (PPHM) rose over 17% on Monday, after its wholly-owned subsidiary Avid Bioservices Inc. increased its contract manufacturing revenue guidance range for the full-year 2017 to $60 million - $65 million from its previous forecast of $50 million - $55 million range.

PPHM closed Monday's trading at $0.76, up 17.17%.

Shares of Stellar Biotechnologies Inc. (SBOT) were up more than 16% in extended trading on Monday following its technology transfer and purchase agreement with Matrivax Inc., a vaccine biotechnology company.

As per the agreement terms, Stellar will transfer its proprietary rights and know-how of immunogens and vaccine technology for a life-threatening pathogenic bacteria known as Clostridium difficile to Matrivax, and in turn, receive upfront fee and future royalties.

SBOT closed Monday's trading at $1.71, up 4.91%. In after-hours, the stock was up 16.96% to $2.00.

SCYNEXIS Inc. (SCYX) has reported financial results for the year ended December 31, 2016.

The net loss attributable to common stockholders in 2016 has narrowed to $30.0 million or $1.58 per share from $32.6 million or $2.68 per share in 2015. Analysts polled by Thomson Reuters were expecting the company to incur a loss of $1.83 per share.

SCYX closed Monday's trading at $3.03, up 13.06%. In after-hours, the stock was up another 2.31% to $3.10.

Zynerba Pharmaceuticals Inc. (ZYNE) has completed enrollment in its phase II study of ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures, dubbed STAR 1, and phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP.

The company expects to report top-line data from the STAR 1 and STOP trials in July/August of this year.

ZYNE closed Monday's trading at $20.77, up 2.47%.