BIIB & ALKS Team Up For MS Drug, REGN's Eylea Combo Fails Again, AEZS Rises

(RTTNews) - Today's Daily Dose brings you news about regulatory progress of Aeterna's Macrilen; BioTelemetry's collaboration with Onduo; Catalyst Pharma's Lambert-Eaton myasthenic syndrome study results and stock offering; Dova's near-term catalyst, and Regeneron's setback in Eylea combo therapy.

Read on...

Aeterna Zentaris Inc.'s (AEZS) (AEZS.TO) Marketing Authorization Application for the use of Macrilen for the evaluation of adult growth hormone deficiency has been accepted for review by the European Medicines Agency.

The NDA for Macrilen is also under FDA review, with a decision expected on December 30, 2017. In the U.S., this is Macrilen's second go-around with the FDA. It was turned down in November 2014 due to failed primary analysis and data deficiencies.

If approved, Macrilen will be the only FDA-approved drug for assessing AGHD, a condition which arises when pituitary gland is missing or does not function correctly.

AEZS closed Monday's trading at $2.06, down 1.90%. In after-hours, the stock was up 4.37% to $2.15.

Biogen (BIIB) and Alkermes plc (ALKS) have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, which is under phase III development for the treatment of relapsing forms of multiple sclerosis.

Biogen will receive an exclusive, worldwide license to commercialize ALKS 8700, and pay Alkermes an upfront payment of $28 million. Alkermes is also entitled to receive a mid-teens royalty on worldwide net sales of ALKS 8700, if approved.

A head-to-head study evaluating the gastrointestinal tolerability of ALKS 8700 compared to Biogen's FDA-approved TECFIDERA, dubbed EVOLVE-MS-2, is underway. Initial data from EVOLVE-MS-2 are expected in the first half of 2018.

ALKS closed Monday's trading at $50.36, down 1.35%.

BioTelemetry Inc.'s (BEAT) division Telcare has entered into a strategic collaboration with Onduo to supply remote blood glucose systems and the resulting data for patients enrolled in Onduo's groundbreaking diabetes management program.

Onduo is a joint venture created by Verily, an Alphabet company, and Sanofi (SNY).

BEAT closed Monday's trading at $25.40, down 2.12%.

Shares of Catalyst Pharmaceuticals Inc. (CPRX) plunged over 8% in extended trading on Monday after the Company announced that it has commenced an underwritten public offering of 11 million shares of its common stock.

Catalyst also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

Earlier in the day, the Company announced positive top-line results from a second phase III trial of Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome.

In the study, treatment with Firdapse achieved statistical significance for co-primary endpoints and secondary endpoint.

The Company is planning to submit its NDA for Firdapse to the FDA in the first quarter of 2018.

CPRX closed Monday's trading at $3.61, up 3.14%. In after-hours, the stock was down 8.03% to $3.32.

Dova Pharmaceuticals Inc.'s (DOVA) New Drug Application for Avatrombopag has been accepted for filing, and has been granted Priority Review by the FDA, with a decision date set for May 21, 2018.

Avatrombopag is proposed for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

DOVA closed Monday's trading at $28.63, down 0.45%.

Regeneron Pharmaceuticals Inc. (REGN) is not advancing its experimental eye drug combo of investigational Nesvacumab and approved Eylea into phase III development. The decision was taken based on results of two phase II studies, dubbed RUBY and ONYX.

The RUBY study evaluated patients with diabetic macular edema, and the ONYX study evaluated patients with wet age-related macular degeneration.

The addition of Nesvacumab to Eylea in the phase II trials did not provide sufficient differentiation to warrant Phase 3 development, the Company noted.

This is the Company's second setback in its attempt in evaluating a combination therapy involving Eylea.

Last September, the Company's phase II study, which evaluated Eylea co-formulated with Rinucumab showed no benefit over Eylea alone in neovascular age-related macular degeneration.

Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA.

REGN closed Monday's trading at $374.53, down 2.68%.