Opdivo In The Headlines, Lightlake On Course, FDA Approves 2 Diabetes Drugs

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) cancer drug Opdivo has demonstrated long term survival benefit in patients with previously treated non-squamous non-small cell lung cancer - with an estimated 39% of patients alive at 18 months compared to 23% for Docetaxel, based on a minimum follow-up of 17.1 months, in a phase III trial dubbed CheckMate -057.

The supplemental Biologics License Application for Opdivo in previously treated non-squamous non-small cell lung cancer patients is under FDA review, with a decision slated for January 2, 2016.

Opdivo is already approved as a monotherapy in two cancer indications - for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy and for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

In a separate press release, the company announced that its supplemental Biologics License Application for the Opdivo plus Yervoy regimen in patients with previously untreated advanced melanoma has been accepted for Priority Review - with a target action date of January 23, 2016.

The company generated $122 million from Opdivo sales in Q2-2015 compared to $40 million in Q1-2015.

BMY closed Friday's trading at $60.24, down 2.52%.

The New Drug Application for Narcan Nasal Spray, intended to treat opioid overdose, which was submitted by Lightlake Therapeutics Inc.'s (LLTP) partner Adapt Pharma Ltd., on July 27, 2015, has been accepted for priority review by the FDA.

The FDA's Priority Review status accelerates the review time from 10 to 6 months from the day of NDA acceptance.

LLTP.OB closed Friday's trading at $9.49, down 9.45%.

The FDA, on Friday, approved two new drug treatments for diabetes mellitus developed by Novo Nordisk (NVO) - Tresiba and Ryzodeg 70/30.

Tresiba is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. Tresiba is expected to be launched in the U.S. during the first quarter of 2016. Tresiba has already been launched in 30 countries.

Ryzodeg 70/30 contains insulin degludec in a soluble co-formulation with insulin aspart, and can be administered once or twice daily with any main meal.

NVO closed Friday's trading at $54.93, down 0.18%.

OncoSec Medical Inc.'s (ONCS) phase II trial of investigational therapy ImmunoPulse IL-12 in patients with Merkel cell carcinoma has demonstrated that it promotes tumor-specific, systemic anti-tumor immune responses.

In the phase II trial, 79% of patients showed an increase in IL-12 protein levels in tumor biopsy samples obtained approximately 22 days after treatment compared to baseline, according to the trial results.

ImmunoPulse IL-12 is currently in phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck, and triple-negative breast cancer.

ONCS closed Friday's trading at $6.73, down 0.44%.