Aquestive Therapeutics, Inc. (NASDAQ: AQST) shares jumped on Monday after the firm announced that its treatment of amyotrophic lateral sclerosis (ALS), Exservan, received early-action approval from the U.S. Food and Drug Administration (FDA).
For some quick background, ALS is a debilitating and rare disease affecting as many as 30,000 Americans and 52,000 Europeans. It is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. More famously, this is known as Lou Gehrig’s disease.
Exservan is now approved for the treatment of ALS and will fill a critical need in the fight for ALS patients because it can be administered safely and easily, twice daily, without water where many patients have trouble swallowing.
Previously, Exservan received FDA orphan drug designation in January 2018.
Keith J. Kendall, CEO of Aquestive Therapeutics, commented:
We received full FDA approval for Exservan in advance of our PDUFA action date. We appreciate the ongoing feedback from the FDA and its early-action approval. We anticipate that Exservan, via our orally administered PharmFilm® dosage form, will bring meaningful treatment to patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication. In line with our stated objectives, we licensed this product to Zambon S.p.A. for development and commercialization in the EU. We are continuing the dialogue with potential licensees for the US commercial rights.
Shares of Aquestive Therapeutics closed Friday at $6.43, with a 52-week range of $2.95 to $11.03. The consensus analyst price target is $18.33. Following the announcement, the stock was up about 18.5% at $7.62 in early trading indications Monday.