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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 completes enrollment in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy, with topline data expected in Q2 2024. Positive preclinical data for BAER-101 presented at key medical meetings. Final agreement with FDA on Phase 3 safety study of IV tramadol.
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Avenue Therapeutics, Inc. (ATXI) has been granted an extension by the Nasdaq Hearings Panel to evidence compliance with listing criteria, including bid price and stockholders' equity requirements, until May 20, 2024. The company is exploring options to meet these criteria but cannot guarantee compliance.
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Avenue Therapeutics, Inc. announced that BAER-101 fully suppressed seizure activity in SynapCell's GAERS model of absence epilepsy, demonstrating high efficacy in anti-seizure drug development. The preclinical data showed full seizure suppression with a minimal effective dose of 0.3 mg/kg, PO, supporting its advancement to a Phase 2a trial.
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Avenue Therapeutics, Inc. announces promising preclinical data on BAER-101 for treating absence epilepsy. The data highlights the compound's ability to suppress seizures effectively with minimal side effects, targeting specific GABAA subtypes. BAER-101 shows significant potential as a safe and potent treatment option for epilepsy patients.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced that CEO, Dr. Alexandra MacLean, will present a corporate update at the Sidoti January Micro-Cap Investor Conference on January 18, 2024. The company will also host virtual one-on-one meetings with investors. A webcast and archived replay will be available on Avenue's website.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced the entry into warrant exercise agreements with existing accredited investors for the immediate exercise of certain outstanding warrants to purchase an aggregate of 16.5 million shares of the Company’s common stock. The gross proceeds to Avenue from the exercise of the warrants are expected to be approximately $5.0 million.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) has finalized an agreement with the FDA for the Phase 3 safety study protocol of IV tramadol for the treatment of acute post-operative pain. The study aims to address the theoretical risk of opioid-induced respiratory depression and is expected to be completed within 12 months. The company plans to initiate the study soon, potentially leading to FDA approval and improving the current treatment paradigm for U.S. patients.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) has announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (SBMA), with topline data anticipated in the second quarter of 2024. The 12-week trial enrolled 25 patients, randomly assigned to AJ201 (600 mg/day) or placebo, with the primary endpoint being the assessment of safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include various biomarkers addressing proof of target engagement, including changes in mutant androgen receptor protein levels in skeletal muscle and changes in fat and muscle composition as seen on MRI scans.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced that Dr. Amy Chappell will present preclinical data for BAER-101 at the AES 2023 Annual Meeting. The data demonstrate the molecule's potential to significantly suppress seizures in a translational animal model of absence epilepsy. BAER-101 selectively targets GABAA α2 and α3 subtypes, potentially improving anticonvulsant and anxiolytic activity while minimizing the risk of tolerance and abuse. The molecule underwent preclinical evaluation in the GAERS model, demonstrating full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO. The safety, tolerability, and efficacy data support BAER-101's continued development in a Phase 2a trial.
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Avenue Therapeutics, Inc. (Nasdaq: ATXI) reported financial results and recent corporate highlights for the third quarter ended September 30, 2023. The company's Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (SBMA) remains on track to report topline data in the second quarter of 2024. Positive BAER-101 preclinical data has been accepted for presentation at the American Epilepsy Society Annual Meeting. Avenue also reached an agreement with the U.S. FDA on the study design and analysis approach for the Phase 3 safety study of IV tramadol. The company raised $5 million in gross proceeds from a public equity offering.
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FAQ
What is the current stock price of Avenue Therapeutics (ATXI)?
The current stock price of Avenue Therapeutics (ATXI) is $1.1 as of February 28, 2025.
What is the market cap of Avenue Therapeutics (ATXI)?
The market cap of Avenue Therapeutics (ATXI) is approximately 2.6M.
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
ATXI Rankings
ATXI Stock Data
2.57M
1.51M
9.85%
10.33%
3.56%
Biotechnology
Pharmaceutical Preparations
United States
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