ATXI Stock: Over 15% Decrease Pre-Market Explanation

By Amit Chowdhry ● Apr 13, 2021
  • The stock price of Avenue Therapeutics, Inc. (Nasdaq: ATXI) fell by over 15% pre-market. This is why it happened.

The stock price of Avenue Therapeutics, Inc. (Nasdaq: ATXI) – a company focused on the development of intravenous (“IV”) tramadol for the U.S. market – fell by over 15% pre-market. Investors appear to be responding to the company announcing that the U.S. Food and Drug Administration (FDA) was still reviewing its New Drug Application (“NDA”) for IV tramadol and had not provided a decision regarding the NDA.

And an acknowledgement letter from the FDA in February 2021 stated that the Company’s resubmission of its NDA for IV tramadol was a complete class 1 response to the Complete Response Letter (“CRL”) dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of April 12, 2021.

The NDA for IV tramadol was resubmitted after the receipt of official minutes from a Type A meeting with the FDA – which was conducted following a CRL issued by the FDA in October 2020. And the resubmission package included revised language relating to the proposed product label and a report relating to terminal sterilization validation.

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