FDA Grants Fast Track for Flex Pharma Inc (NASDAQ:FLKS) ALS Drug

Flex Pharma Inc (NASDAQ:FLKS)

Flex Pharma Inc (NASDAQ:FLKS)

Flex Pharma Inc (NASDAQ:FLKS) gained over 11%, ending the day at $4.33, after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track (FT) designation for the development of FLX-787, Flex Pharma’s co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS).

Flex Pharma Inc (NASDAQ:FLKS)
1Month Daily Candle Graph for $FLKS

Importantly, reports indicate that there are currently no drugs approved to treat ALS in the U.S. The Fast Track designation is used to accelerate the clinical development and review of drugs to treat serious diseases that have an unmet medical need. The Fast Track designation also allows for more frequent communication with the FDA’s Neurology Division throughout the drug development and review process, with the goal of getting important new drugs to patients more rapidly.

William McVicar, Ph.D., Flex Pharma’s interim President and CEO, stated “With Phase 2 clinical trials in both ALS and CMT expected to initiate this quarter in the US, FLX-787 will be amongst the most advanced, novel compounds in the clinic for these degenerative neurological diseases. The R&D team is focused on the execution of these new Phase 2 IND studies, as well as completion of the ongoing exploratory Phase 2 spasticity study in MS in Australia. These studies are expected to yield several important data readouts in 2018.”

FLKS shares are well below their 52-week high of $12.68 but almost 50% above their 52-week low of $3.01. During the past year shares of Flex Pharma Inc (NASDAQ:FLKS) have fallen over 63%, and are down 18% YTD. Last year they posted their forst sales – totaling $1 million. However, the company has posted increasing losses from the beginning. In 2014 the per share loss was (-$0.45), that was followed by a loss of (-$2.08) in 2015 and a (-$2.43) loss in 2016. Of the five investment analysts that follow Flex Pharma Inc (NASDAQ:FLKS), four rate the shares as a “Strong Buy” and one rates the shares a “Hold”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Author: James Marion

James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

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