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Tag: ATXI Stock Price

  • Here You Would Find Why Avenue Therapeutics, Inc. (ATXI) Stock is on a Continuous Rally

    Avenue Therapeutics, Inc. (ATXI), a specialty pharmaceutical company, has declined 5.29% in aftermarket trading session. Consequently, ATXI stock is trading at $1.61 at the time of the writing. The decline could be attributed to the profit-taking factor after the stock soared 53.15% during the regular trading session on Monday and closed the day at $1.70. The rise appears to be due to announcements regarding FDA advisory committee meetings.

    Why ATXI Rallying?

    On Monday, ATXI announced that it has been informed by FDA that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee is scheduled for 22nd February 2022. The meeting would be held to discuss the IV tramadol New Drug Application. The FDA had also stated it before that the input from the advisory committee is required for the Office of New Drugs to decide on the company’s formal dispute resolution request. OND would respond within 30 days after the advisory committee meeting to the company’s appeal.

    Q3 2021 Operational Results

    On 15th November, ATXI released the operational results for the third quarter of the fiscal year 2021, which ended on 30th September 2021. The research and development expenses bore by the company during the period were $278,000 against $466,000 for the same period of 2020. The general and administrative expenses for the period were $594,000 against $1.03 million for the same period of 2020. The net loss suffered by the company during the period was $871,000 against $1.02 million for the same period of 2020. The net loss per basic and diluted share for the quarter was $0.05 against $0.06 for the same quarter of 2020.

    Executive Commentary

    Lucy Lu, M.D., President, Chief Executive Officer and Director of ATXI, while commenting on the results said that the company would continue to incur the research and development costs as it develops and looking out for the regulatory approval of IV Tramadol in the U.S. He hoped that the recent developments would cause a positive impact over the company’s performance in near future.

    Future Outlook for ATXI

    The last month has seen ATXI stock jump up by a steady 5%. Before that, the stock performance was abysmal throughout the last 12 month period. ATXI stock plunged 71% during the last 9 months. But the recent developments have stirred a positive movement for ATXI stock. It is hoped that it would continue to be the case in the long run for the company.

  • ATXI Stock Is Down Today Before Market Open. Why?

    Avenue Therapeutics Inc. (ATXI) shares fell -45.84% to $2.28 in premarket trade today. Last trading session, Avenue stock has fallen -3.44% to $4.21. ATXI stock retreated even more -8.17% in the last five days but gained 2.93% over the past month. Before market open this morning, ATXI stock fell after the US Food and Drug Administration (“FDA”) rejected its new drug application (NDA).

    The NDA was for which drug?

    The mission of Avenue Therapeutics is to develop IV tramadol. US patients suffering from acute pain may be able to decrease their reliance on conventional opioids with IV tramadol. Avenue was formed by the Fortress Biotech Corporation in New York City.

    Today, Avenue announced that the FDA has sent a second Complete Response Letter (“CRL”) in connection with its application for approval of IV tramadol.

    • The CRL concluded that IV tramadol’s delayed and unpredictable onset of analgesia does not support its use as a monotherapy to treat acute pain.
    • Furthermore, the CRL stated that there is not enough information to support the combination of ATXI’s painkiller with other analgesics being safe and effective for the intended population.
    • In this CRL, the FDA highlighted no Chemistry, Manufacturing, and Controls (“CMC”) issues in ATXI’s candidate.
    • An October decision by the health regulator had rejected approval for the ATXI’s painkiller due to its unsuitability for the intended users.

    ATXI’s stance:

    The FDA’s interpretation of the data in the NDA is not consistent with Avenue (ATXI)’s position, said the company in its statement. ATXI once again committed to continue seeking regulatory approval for IV tramadol.