MediciNova Rises on FDA's Nod on MN-166 Study Initiation - Analyst Blog

MediciNova, Inc.'s (MNOV) shares have gained 7.7% ever since the company announced that it will be starting a clinical study on MN-166 for treating amyotrophic lateral sclerosis (ALS). Earlier in the week, the company announced that the FDA has given the green signal to the start of the clinical study.

The randomized, double-blind, placebo-controlled study will be evaluating several efficacy endpoints including functional activity, respiratory function, muscle strength and non-invasive ventilation utilization of patients being treated with MN-166. Moreover, MediciNova will assess the safety and tolerability of the candidate in combination with riluzole versus placebo in patients suffering from ALS.

MediciNova will be funding the study with support from Carolinas HealthCare System. The company intends to start patient enrolment for the study this fall.

We note that several companies have struggled in the past in developing candidates for the treatment of ALS. Cytokinetics, Inc.'s (CYTK) tirasemtiv, being developed for the treatment of ALS, failed to meet the primary objectives in a phase IIb study earlier in the year (read more: Cytokinetics' Tirasemtiv Misses Primary Endpoint).

Similar setbacks for MN-166 may weigh heavily on MediciNova. Meanwhile, MN-166 is also being developed for the treatment of opioid dependence and progressive multiple sclerosis. MediciNova also has MN-001 (nonalcoholic steatohepatitis), MN-029 (solid tumor) and MN-221 (asthma) in its pipeline. We expect investor focus to stay on MediciNova's pipeline going forward.

Presently, some better-ranked stocks in the sector include Amgen Inc. (AMGN) and Gilead Sciences Inc. (GILD). Both the stocks hold a Zacks Rank #1 (Strong Buy).