Eloxx Pharmaceuticals Inc. (NASDAQ:ELOX) jumped 10% after the US FDA granted the company Fast track designation for its drug candidate, ELX-02, to treat patients with cystic fibrosis with nonsense alterations.
Currently, the drug candidate is in second phase clinical studies in cystic fibrosis patients with the nonsense mutation in the CF transmembrane conductance regulator (CFTR) gene who don’t have any available efficient disease-modifying treatments available. Most importantly, the second phase studies are meant to assess ELX-02’s safety and evaluate its biological activity. The company anticipates top present findings from the initial four treatment arms in Q4 2021.
CEO Sumit Aggarwal said they are pleased to receive Fast Track Designation for ELX-02, considering the need for patients is significant. Aggarwal said that the ability to have enhanced access to the FDA and guidance for ELX-02’s regulatory pathway would offer a chance to expedite the development of the drug to meet the needs of CF patients having nonsense mutations. ELOX is worth keeping an eye on.
On Thursday, ELOX stock moved up 10% at $1.53 with more than 4.60 million shares, compared to its average volume of 1.25 million shares. The stock has moved within a range of $1.4400 – 1.6800 after opening the trade at $1.47.