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Avenue Therapeutics, Inc. - ATXI STOCK NEWS

Welcome to our dedicated page for Avenue Therapeutics news (Ticker: ATXI), a resource for investors and traders seeking the latest updates and insights on Avenue Therapeutics stock.

Avenue Therapeutics, Inc. (NASDAQ: ATXI), a subsidiary of Fortress Biotech (NASDAQ: FBIO), is a specialty pharmaceutical company headquartered in Miami, FL. Avenue focuses on developing and commercializing therapies for the treatment of neurologic diseases. The company's core product pipeline includes AJ201 for spinal and bulbar muscular atrophy (SBMA), BAER-101 for epilepsy and panic disorders, and IV tramadol for moderate-to-moderately-severe postoperative pain management. Avenue is currently engaged in a pivotal Phase 3 program for IV tramadol, which aims to fill a therapeutic gap in the acute pain market between IV acetaminophen/NSAIDs and conventional narcotics. AJ201, designed for SBMA or Kennedy’s Disease, is in the Phase 1b/2a clinical trial stage, with topline data expected in mid-2024. Additionally, BAER-101 has shown promising preclinical results in epilepsy models and is slated for further development contingent on financing. The company continues to advance its innovative drug pipeline while maintaining strategic partnerships and exploring new opportunities for growth in the pharmaceutical market. Recent achievements include completion of patient enrollment for AJ201’s Phase 1b/2a trial, FDA alignment on the Phase 3 safety study for IV tramadol, and multiple public equity offerings raising substantial gross proceeds. Avenue's commitment to providing impactful therapies to patients with unmet medical needs underscores its significance in the specialty pharmaceutical sector. For more information, visit www.avenuetx.com.

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Avenue Therapeutics (Nasdaq: ATXI) has priced an underwritten public offering of 3,636,365 common and pre-funded units, each at $3.30 per common unit, aiming for gross proceeds of approximately $13.8 million if the underwriter's over-allotment option is fully exercised. The offering is set to close on October 11, 2022. Proceeds will be used to repurchase shares held by InvaGen Pharmaceuticals and fund general corporate purposes, including drug development. The SEC declared the related registration statement effective on October 6, 2022.

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Avenue Therapeutics (Nasdaq: ATXI) announced a 1-for-15 reverse stock split effective September 23, 2022. Approved by shareholders, the split aims to comply with Nasdaq's $1.00 minimum bid price requirement. Post-split, outstanding shares will decrease from approximately 22.7 million to about 1.5 million. Additionally, Avenue discussed regulatory updates regarding its intravenous Tramadol product, receiving positive feedback from the FDA on a proposed safety study design to mitigate risks associated with opioid stacking. The company plans to submit a detailed protocol based on FDA suggestions.

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Avenue Therapeutics (NASDAQ: ATXI) announced the outcome of the FDA joint meeting concerning its IV tramadol development for acute pain management. The Advisory Committee voted 8-14 against whether the benefits of IV tramadol outweigh its risks in inpatient settings. The FDA requires this input for a decision on Avenue's formal dispute resolution request, expected within 30 days. Avenue aims to provide an alternative to conventional opioids for acute pain relief in the U.S.

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Avenue Therapeutics announced that the FDA Advisory Committee will review the New Drug Application for IV tramadol on February 15, 2022. The meeting will involve the Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Committees. This review is crucial as it influences the Office of New Drugs' decision regarding Avenue's formal dispute resolution request. Trading of Avenue's stock on NASDAQ has been suspended pending this event.

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Avenue Therapeutics has successfully completed a $2 million public offering of common stock, with Aegis Capital Corp. acting as the sole bookrunner. The funds raised will support the company’s ongoing development of IV tramadol, an alternative aimed at reducing opioid use for patients with acute pain in the U.S. Avenue Therapeutics is headquartered in New York City and is focused on innovative solutions for pain management.

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Avenue Therapeutics (NASDAQ: ATXI) has successfully closed its public offering of 1,910,100 shares of common stock at a price of $1.07, raising approximately $2.0 million in gross proceeds. Aegis Capital Corp. acted as the sole book-running manager for this offering and has a 45-day option to purchase an additional 286,430 shares to cover over-allotments. The registration statement for the offering was declared effective by the SEC on December 10, 2021. Avenue Therapeutics aims to develop IV tramadol as a potential alternative to conventional opioids for acute pain management.

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Avenue Therapeutics (NASDAQ: ATXI) announced a public offering priced at $1.07 per share, aiming for gross proceeds of approximately $2.0 million. The offering will consist of 1,910,100 shares and is set to close on December 15, 2021, pending typical closing conditions. With a 45-day underwriters' option, the total could reach up to $2.3 million. The net proceeds will support working capital and corporate purposes. Avenue specializes in developing intravenous tramadol as an alternative to opioids for acute pain management in the U.S.

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Avenue Therapeutics (NASDAQ: ATXI) announced that the FDA has tentatively scheduled a joint meeting for February 15, 2022, involving the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting will address the New Drug Application for intravenous tramadol. The FDA previously indicated that this committee input is essential for the Office of New Drugs to make a decision regarding Avenue's formal dispute resolution request, with a response due within 30 days post-meeting.

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Avenue Therapeutics (NASDAQ: ATXI) announced the full exercise of an underwriter’s option to purchase an additional 292,018 shares of common stock at $1.34 per share. This action brings total gross proceeds from the public offering to approximately $3 million, before expenses. The offering was conducted under a registration statement declared effective by the SEC. Avenue Therapeutics focuses on developing IV tramadol as an alternative to conventional opioids for acute pain management.

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Aegis Capital Corp. has successfully completed a $2.6 million public offering of common stock for Avenue Therapeutics (NASDAQ: ATXI). The funds raised through this offering are aimed at advancing Avenue's mission to develop IV tramadol, a potential alternative to conventional opioids for acute pain management in the U.S. Avenue Therapeutics was founded by Fortress Biotech (NASDAQ: FBIO) and is positioned to address the growing need for effective pain relief solutions.

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FAQ

What is the current stock price of Avenue Therapeutics (ATXI)?

The current stock price of Avenue Therapeutics (ATXI) is $2.195 as of November 4, 2024.

What is the market cap of Avenue Therapeutics (ATXI)?

The market cap of Avenue Therapeutics (ATXI) is approximately 3.2M.

What is Avenue Therapeutics, Inc.'s primary focus?

Avenue Therapeutics, Inc. focuses on developing and commercializing therapies for the treatment of neurologic diseases, including SBMA, epilepsy, and acute postoperative pain.

What are the main products in Avenue Therapeutics' pipeline?

The main products are AJ201 for spinal and bulbar muscular atrophy (SBMA), BAER-101 for epilepsy and panic disorders, and IV tramadol for moderate-to-moderately-severe postoperative pain.

What is the current status of AJ201?

AJ201 is in Phase 1b/2a clinical trials for the treatment of spinal and bulbar muscular atrophy. Topline data from this trial are expected in mid-2024.

What recent achievements has Avenue Therapeutics made?

Recent achievements include completing patient enrollment for AJ201’s Phase 1b/2a trial, reaching FDA agreement on the Phase 3 safety study for IV tramadol, and raising substantial funds through public equity offerings.

How does IV tramadol fit into the acute pain market?

IV tramadol aims to fill a gap in the acute pain market by providing a pain management option that falls between IV acetaminophen/NSAIDs and conventional narcotics.

What are the future plans for BAER-101?

BAER-101, which has shown promising preclinical results, is planned to enter Phase 2a clinical trials to further study its anti-seizure properties in patients with epilepsy, pending additional financing.

Who founded Avenue Therapeutics, Inc.?

Avenue Therapeutics, Inc. was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).

Where is Avenue Therapeutics headquartered?

Avenue Therapeutics is headquartered in Miami, FL.

How does Avenue Therapeutics aim to enhance shareholder value?

Avenue Therapeutics aims to enhance shareholder value by advancing its clinical pipeline, securing regulatory approvals, and providing impactful therapies to patients with neurologic diseases.

Where can I find more information about Avenue Therapeutics' clinical trials?

More detailed information about Avenue Therapeutics’ clinical trials can be found on their official website at www.avenuetx.com.

Avenue Therapeutics, Inc.

Nasdaq:ATXI

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3.17M
1.43M
13.16%
8.9%
1.91%
Biotechnology
Pharmaceutical Preparations
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