Both items of news today are good for MNOV.
FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis
MediciNova, Inc.
LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-001 (tipelukast) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with fibrosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases and demonstrate the potential to address unmet medical needs for such diseases. An important feature of the FDA's Fast Track program is that it emphasizes frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
In January 2015, MediciNova announced an open Investigational New Drug (IND) application for MN-001 in NASH. Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.
LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that the Tokyo Stock Exchange (TSE) has announced a new rule affecting the trading of dual-listed stocks on the Tokyo Stock Exchange, including the stock of MediciNova. Under the old rule, the TSE had used the previous day's closing price of MediciNova's stock on the TSE as the base price to determine the daily limit of the stock price movement on the TSE (also known as the "circuit breaker" rule). Under the new rule that will become effective on April 20, 2015, if (1) the difference between the previous day's closing price of MediciNova's stock on NASDAQ converted to Japanese yen and the previous day's closing price of MediciNova's stock on the TSE ("the price divergence") is greater than the daily limit of the stock price movement on the TSE and (2) the price divergence is greater than 20%, then the TSE will use the previous day's closing price of MediciNova's stock on NASDAQ converted to Japanese yen as the base price to determine the daily limit of the stock price movement on the TSE.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with this rule change as our stock price movements on NASDAQ and TSE should now occur in a more synchronized fashion than has occurred previously."
All I say is IMHO and not to be construed as investment advice. I know nothing, as informed frequently by my wife.
