FDA OKs Avadel’s Nouress; shares down 17% on launch uncertainty

The FDA approves Avadel Pharmaceuticals’ (AVDL -16.8%) Nouress (cysteine hydrochloride injection) (AV001) for neonates requiring total parenteral nutrition (TPN) (method of feeding that bypasses the GI tract).

The company says the U.S. market could be greater than $50M.

On another note, the USPTO recently issued a new patent to the company covering cysteine solutions, including Nouress.

Investors appear to be reacting to its statement that it is “evaluating” the timing and process for commercial launch, adding that a competitor’s product (Exela Pharma Service’s Elcys approved in April) was approved in the U.S. earlier this year and has also received a U.S. patent.

https://seekingalpha.com/news/3526436-fda-oks-avadels-nouress-shares-down-17-on-launch-uncertainty