Avenue Therapeutics Inc. (ATXI) shares plunged 5.29% in after-hours on Monday, November 29, 2021, and closed the daily trading at $1.61. However, in the regular trading on Monday, ATXI’s stock gained 53.15%. ATXI shares have fallen 50.15% over the last 12 months, and they have moved up 39.34% in the past week. Over the past three months, the stock has lost 1.16%, while over the past six months, it has declined 64.95%.
Let’s have a look at its recent news.
FDA upcoming meeting for ATXI IV tramadol
On November 29, 2021, FDA informed Avenue Therapeutics, Inc. about a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committee is scheduled for February 15, 2022. The committees will discuss the IV tramadol New Drug Application.
Earlier, on October 25, 2021, ATXI received a written interim response from the Office of New Drugs (OND) of the U.S. Food and Drug Administration, stating that the OND needs additional input from an Advisory Committee to decide on the Formal Dispute Resolution Request which was filed by the company.
In the second Complete Response Letter (CRL) on June 14, 2021, FDA identified that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population.
ATXI public offering of common stock
On November 17, 2021, Avenue Therapeutics, Inc. exercised its previously announced underwritten public offering. the company offered an additional 292,018 shares of common stock at $1.34 per share. the gross proceeds from the offer are approximately $3 million.
Earlier on November 12, 2021 (ATXI), closed its public offering of 1,946,787 shares of common stock at a public offering price of $1.34, for the gross proceeds of approximately $2.6 million.
The recent news about the coming FDA meeting may or may not be the reason behind its top-notch early gains on Monday. There is no clear picture yet whether FDA will approve the tramadol or not. We have to wait and see what happens on the meeting day in February 2022.