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Avenue Therapeutics Announces Reverse Stock Split, Regulatory Update For Lead Its Pain Candidate

  • Avenue Therapeutics Inc ATXI received the official meeting minutes from the FDA regarding a meeting conducted for IV Tramadol in combination with other opioid analgesics to manage moderate-to-moderately severe pain.
  • At the meeting, Avenue presented a study design for a single safety clinical trial that the company believes could address the concerns regarding risks related to opioid stacking.
  • The FDA stated that the proposed study design appears reasonable and agreed with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol. 
  • The company intends to submit a detailed study protocol that could form the basis for submitting a complete response to the second Complete Response Letter for IV Tramadol.
  • In February, FDA’s adComm said that Avenue Therapeutics submitted insufficient data.
  • In June 2021, Avenue Therapeutics received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
  • Concurrently, Avenue Therapeutics announced that it would effect a 1-for-15 reverse stock split.
  • After the reverse stock split, the number of shares will be reduced from 22.7 million to 1.5 million.
  • Price Action: ATXI shares are down 29.5% at $4.65 during the premarket session on the last check Friday.

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