Avenue Therapeutics Inc. (NASDAQ: ATXI) stock declined by 28.27% at last close while the ATXI stock price falls during pre-market as well, by 8.94%. Avenue Therapeutics is a pharmaceutical firm whose objective is to produce IV tramadol for patients diagnosed with severe pain in the United States as a viable alternative to conventional opioids. Avenue was created by Fortress Biotech and is based in New York City.
The ATXI stock price dropped because,
ATXI has got a second Detailed Response Letter from the US Food and Drug Administration (“FDA”) in regard to its New Drug Application for IV tramadol approval.
According to the CRL, IV tramadol’s delayed and variable onset of analgesia does not justify its use as a monotherapy to treat individuals in acute pain, and there is inadequate evidence to support its use in conjunction with other analgesics for the target patient group. In this CRL, the FDA found no concerns with Chemistry, Manufacturing, or Controls.
However, Avenue does not agree with the FDA’s analysis of the NDA data and plans to pursue regulatory approval for IV tramadol.
About Fortress Biotech,
Fortress Biotech is a cutting-edge biopharmaceutical company that was named to Deloitte’s Technology Fast 500 for 2019 and 2020, which ranks the strongest North American companies in the technology, media, telecommunications, life sciences, and energy tech departments relying on percentages of fiscal year sales growth over three years.
Fortress is aimed at securing, developing, and promoting high-potential pharmaceuticals and drug candidates, both commercialized and in development. Fortress, its majority-owned and majority-controlled partners, including companies it formed and in whom it maintains substantial minority ownership positions, have seven marketed prescription pharmaceutical drugs and over 25 initiatives in development. Such product prospects cover six large market segments, including cancer, rare disorders, and gene therapy, allowing it to generate value for shareholders.