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Tag: Avenue Therapeutics

  • $2.0M Public Offering: Avenue Therapeutics Inc. (ATXI) in the Red Pre-market

    Following the announcement of a $2.0M public offering, Avenue Therapeutics Inc. (ATXI) was down by 15.9% at the last check, in the premarket today. In the previous session, the stock traded in the green, closing the session at $1.32 with a 5.60% increase. At the time of writing, ATXI stock was in the red at $1.11 in the premarket on December 13.

    The specialty pharmaceutical company, Avenue Therapeutics Inc. (ATXI) was founded in 2015. Currently, its 18.99 million outstanding shares trade at a market capitalization of $25.07 million.

    The Public Offering

    On December 12, the company announced an underwritten public offering of its common stock. As per the offerings, 1,910,100 shares of the company’s common stock would be offered to underwriters. Moreover, the per-share price of the common stock as disclosed is to be $1.07 in the offering. Further, the expected gross proceeds from the offering are $2.0 million approx., less discounts, and commissions.

    Furthermore, a 45-day option of buying up to 15% additional shares was also granted to the underwriters. Subsequently, the gross proceeds would increase to $2.3 million, if the option is exercised in full.

    As per the closing conditions, the expected close date of the offering is December 15, 2021. In addition, the net proceeds of the offering will be used for working capital and general corporate purposes.

    Furthermore, the sole book-running manager for the offering is Aegis Capital Corp.

    ATXI’s Tramadol’S NDA

    On November 29, the company announced the details of its Tramadol’s New Drug Application. As per the details, the FDA informed ATXI about a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. As per the announcement, the joint meeting is supposed to take place on February 15, 2022. Both the committees will discuss the New Drug Application for ATXI’s tramadol.

    ATXI’s Previous Developments

    On November 17, the company announced the exercise and closing of the underwriter’s over-allotment option. As per the details, the underwriter of the previously announced public offering had fully exercised its option for buying additional 292,018 shares. The price of the additional shares of the common stock was $1.34 per share. Further, the gross proceeds of the option along with the original offering were $3.0 million approx. This amount excludes the underwriter’s discounts and commissions offered.

    In addition, the sole book-running manager of the offering was also Aegis Capital Corp.

  • 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.