AXSM - Axsome slips as Teva seeks generic for depression therapy
- Axsome Therapeutics ( NASDAQ: AXSM ) traded lower in the morning hours Monday after announcing that Teva Pharmaceuticals ( NYSE: TEVA ) has filed for a generic version of its newly FDA-approved depression therapy Auvelity in the U.S.
- In a regulatory filing, Axsome ( AXSM ) said that Teva ( TEVA ) communicated its filing of the Abbreviated New Drug Application (ANDA) through a Paragraph IV Certification Notice Letter on Feb. 10.
- Teva ( TEVA ) has argued in the letter that its ANDA filing will not infringe several Auvelity patents, which are set to expire in 2040 and listed on FDA’s Orange Book. Teva ( TEVA ) does not challenge other Orange Book-listed Auvelity patents with expiries in 2034.
- After the FDA greenlighted Auvelity extended-release tablets for adults with major depressive disorder (MDD), Cantor Fitzgerald raised the price target on Axsome ( AXSM ) in November, citing its market launch.
- The company launched Auvelity with an annual price tag of $13.5K, twice its previous guidance. Seeking Alpha contributor Avisol Capital Partners argued recently, upgrading the stock to Buy.
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Axsome slips as Teva seeks generic for depression therapy