XENE Loses Face As Acne Trial Flops, NBRV Awaits LEAP Data, Opdivo Scores A Nod

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) blockbuster cancer treatment Opdivo has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy. In the U.S., the drug was approved for this indication last November.

The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

This is the first CHMP positive opinion to recommend a PD-1 inhibitor for this type of treatment for squamous cell cancer of the head and neck, according to the company. Opdivo is already approved by the EC for six indications in four distinct tumor types.

Global sales of Opdivo in 2016 were $3.77 billion, up from $942 million in 2015.

BMY closed Friday's trading at $55.89, up 0.22%.

Nabriva Therapeutics AG (NBRV) expects 2017 to be a transformational year for the company.

The company is continuing to make progress in its ongoing pivotal phase III clinical trials, known as LEAP 1 and LEAP 2, evaluating Lefamulin for the treatment of patients with moderate to severe community-acquired bacterial pneumonia.

The top-line clinical data from LEAP 1 are anticipated in the third quarter of 2017 while patient enrollment for LEAP 2 is expected to be completed in the fourth quarter of 2017 - with top-line data anticipated in the first quarter of 2018.

NBRV closed Friday's trading at $10.80, down 3.14%.

Neuren Pharmaceuticals Ltd. (NURPF.OB) has reported encouraging results from its phase II trial of Trofinetide in pediatric Rett syndrome patients.

Rett syndrome is a rare, serious and life threatening condition that affects exclusively girls, affecting their speech, mobility, eating and even breathing.

According to the trial results, the highest dose of Trofinetide achieved statistically significant clinical benefit compared with placebo for each of three syndrome-specific efficacy measures, the Rett Syndrome Behaviour Questionnaire, the Clinical Global Impression of Improvement and the Rett Syndrome Domain Specific Concerns.

Neuren plans to commence a pivotal trial of Trofinetide in pediatric Rett syndrome patients next year after discussing with the FDA.

NURPF.OB closed Friday's trading at $0.07, up 6.85%.

Pfizer Inc.'s (PFE) TRUMENBA is one step closer to being approved in the European Union for the prevention of meningococcal Group B disease, following a positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The company is seeking approval of TRUMENBA for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in the E.U.

The CHMP's opinion will now be sent to the European Commission for final decision.

In the U.S., the vaccine was granted accelerated approval in October 2014 to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

PFE closed Friday's trading at $34.00, down 0.85%.

Shares of Xenon Pharmaceuticals Inc. (XENE) plunged more than 50% on Friday as its investigational drug XEN801 failed to meet efficacy endpoints in a phase II trial in patients with moderate to severe acne.

According to the trial results, XEN801 did not demonstrate a statistically significant difference from vehicle placebo in its primary endpoint of the percent change in total (inflammatory and non-inflammatory) lesion count from baseline to week 12. Moreover, XEN801 did not demonstrate statistical significance relative to key secondary efficacy endpoints.

XENE touched a 52-week low of $4.30 on Friday, before closing the day's trading at $4.65, down 52.79%.