FDA Nod For NEOS, One Step Closer To EU Approval Are GSK, TSRO, On Watch Is MTFB

(RTTNews) - Today's Daily Dose brings you news about Biohaven's collaboration with Alzheimer's Disease Cooperative Study; CHMP positive opinion on GlaxoSmithKline's Trelegy Ellipta and TESARO's ZEJULA; Orphan Drug designated Motif's investigational drug candidate, Iclaprim, and FDA approval of Neos' third extended release product for the treatment of ADHD.

Read on...

Biohaven Pharmaceutical Holding Co. Ltd. (BHVN) and Alzheimer's Disease Cooperative Study have entered into a collaboration to undertake a phase II clinical trial of Trigriluzole in patients with mild-to-moderate Alzheimer's Disease.

Trigriluzole, a glutamate modulating candidate, is being developed by Biohaven for use in the symptomatic treatment of patients with Alzheimer's disease and other neurological disorders.

A phase II/III trial with Trigriluzole in spinocerebellar ataxia is underway - with topline results expected in 4Q 2017.

The most advanced product in the pipeline is Rimegepant, which is under two pivotal phase III trials for the acute treatment of patients with migraine.

The Company went public on the New York Stock Exchange on May 4, 2017, offering its shares at a price of $17.00 each.

BHVN closed Friday's trading at $37.86, up 0.11%.

GlaxoSmithKline plc (GSK) and Innoviva Inc.'s (INVA) Trelegy Ellipta, a once-daily single inhaler triple therapy, has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for use in appropriate adult patients with moderate to severe chronic obstructive pulmonary disease.

Trelegy Ellipta is a combination of Fluticasone furoate, an inhaled corticosteroid; Umeclidinium, a long-acting muscarinic antagonist and Vilanterol, a long-acting beta2-adrenergic agonist, delivered once daily in GSK's Ellipta dry powder inhaler. A final decision by the European Commission is anticipated by around the end of 2017.

Innoviva retains a 15% economic interest in future payments made by GSK for Trelegy Ellipta.

Trelegy Ellipta is under FDA review - with a decision reportedly expected on September 21, 2017.

GSK closed Friday's trading at $40.24, down 0.27%.

Motif Bio plc.'s (MTFB) investigational drug candidate, Iclaprim has been granted Orphan Drug Designation by the FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis.

Iclaprim has been studied in an animal model of chronic pulmonary methicillin resistant Staphylococcus aureus infection, which mimics the pathophysiology observed in the lungs of patients with cystic fibrosis, according to the Company.

Iclaprim is also under two phase III trials in Acute Bacterial Skin & Skin Structure Infections, dubbed REVIVE-1 and REVIVE-2.

The Company reported positive results from the REVIVE-1 trial in April of this year. Results from the REVIVE-2 trial are due in the fourth quarter of this year.

MTFB closed Friday's trading at $8.01, up 4.73%.

The FDA has approved Neos Therapeutics Inc.'s (NEOS) Adzenys ER oral suspension, previously referred to as NT-0201, for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 years and older.

Adzenys ER is the third Neos extended release product for the treatment of ADHD, and the other two being Adzenys XR-ODT Extended-Release Orally Disintegrating Tablets and Cotempla XR-ODT Extended-Release Orally Disintegrating Tablets.

Adzenys ER is expected to be launched in early 2018.

NEOS closed Friday's trading at $9.20, up 2.22%.

The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion on TESARO Inc.'s (TSRO) ZEJULA.

ZEJULA has been recommended for approval in Europe as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy. The drug now awaits final decision by the European Commission.

ZEJULA was approved by the FDA on March 27, 2017.

TSRO closed Friday's trading at $117.16, up 1.67%.