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Fly News Breaks for January 15, 2020
Jan 15, 2020 | 09:33 EDT
Gabelli analyst Kevin Kedra said the unanimous FDA Advisory Committee vote of 27-0 against Nektar's (NKTR) oxycodegol reinforces his belief that the FDA will not be approving any new long-acting opioids in the near term and eliminates a potential opioid competitor to Collegium Pharmaceutical's (COLL) Xtampza. The current FDA AdCom is also reviewing Intellipharmaceutics' (IPCIF) Aximris XR, another new long-acting opioid formulation, and Kedra expects "a similar overwhelmingly negative vote this afternoon." Xtampza remains the most recently approved extended-release/long-acting opioid for pain on the U.S. market and he expects the status quo to remain for the intermediate future, said the analyst, who keeps a Buy rating on Collegium shares.
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