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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) reported its financial results for 2022, demonstrating a strategic shift to focus on neurologic diseases with in-licensing of AJ201, currently in a Phase 1b/2a trial for Spinal and Bulbar Muscular Atrophy (SBMA). The company completed a $12 million public offering and had cash reserves of $6.7 million as of year-end, an increase from $3.8 million in 2021. R&D expenses rose to $2.7 million from $1.3 million, and the net loss attributable to stockholders was $3.6 million, or $1.63 per share. The CEO expressed optimism about the therapeutic potential of AJ201 and ongoing development of IV Tramadol and BAER-101.

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AnnJi Pharmaceutical has entered an exclusive licensing agreement with Avenue Therapeutics (ATXI) to develop AJ201 for spinal and bulbar muscular atrophy (SBMA) in multiple regions, including the U.S., Canada, EU, Great Britain, and Israel. The deal includes an upfront payment of $3 million and potential milestone payments of up to $250 million, plus royalties from net sales. Avenue will issue shares worth 19.99% of its outstanding stock to AnnJi. AJ201 has Orphan Drug Designation from the U.S. FDA and the European Medicines Agency, with safety demonstrated in Phase 1 trials. It is currently undergoing clinical evaluation for Kennedy's Disease.

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Avenue Therapeutics (Nasdaq: ATXI) announced participation in a Type C meeting with the FDA on March 9, 2023, to discuss a study protocol assessing respiratory depression risks from IV Tramadol. The company aims to finalize this protocol based on feedback from a prior meeting on August 9, 2022, where the FDA approved the proposed study design. Additionally, on March 7, 2023, CEO Alexandra MacLean was appointed to the Board, and Dr. Jay Kranzler became Chairman. The company will hold its 2023 Annual Meeting on June 22, 2023, with stockholders needing to submit proposals by March 24, 2023.

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Avenue Therapeutics, Inc. (Nasdaq: ATXI) has announced an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for AJ201, a first-in-class therapy in clinical trials for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease. This rare disease currently lacks FDA-approved treatments. The agreement involves an upfront payment of $3 million and equity issuance, with potential royalties on net sales. AJ201 has received Orphan Drug Designation and is part of a Phase 1b/2a trial in the U.S. aimed at assessing its safety and effectiveness. The company views this asset as pivotal for enhancing its therapeutic portfolio.

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Aegis Capital Corp. has successfully facilitated a $3.25 million registered direct and private placement for Avenue Therapeutics, Inc. (NASDAQ:ATXI). Avenue Therapeutics focuses on developing therapies for central nervous system diseases and is headquartered in Miami, Florida. The company was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). This funding aims to bolster Avenue Therapeutics’ pipeline and support its growth strategy. For more details, visit Avenue Therapeutics.

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Avenue Therapeutics, Inc. (Nasdaq: ATXI) recently closed a registered direct offering and private placement with an institutional investor, raising approximately $3.25 million. The company issued 1,940,299 shares of common stock at a purchase price of $1.55 per share, alongside warrants with an exercise price also set at $1.55. The gross proceeds from this transaction will be directed towards general corporate purposes and working capital. Notably, these transactions comply with Nasdaq regulations, ensuring all offerings are priced appropriately.

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Avenue Therapeutics (Nasdaq: ATXI) has entered into a definitive agreement with an institutional investor for a registered direct offering of 1,940,299 shares of common stock and pre-funded warrants. Concurrently, the company will issue the same investor 1,940,299 warrants, each with an exercise price of $1.55. The projected gross proceeds from these transactions amount to approximately $3.25 million, expected to close by January 31, 2023. The shares and warrants are priced at $1.55 and $0.125, respectively. Avenue plans to use the net proceeds for general corporate purposes and working capital.

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Avenue Therapeutics, Inc. (Nasdaq: ATXI) reported Q3 2022 financial results, achieving key milestones in drug development for CNS diseases. The company had a fruitful FDA meeting regarding IV Tramadol, indicating a path for NDA resubmission, and it completed the acquisition of Baergic Bio, adding a novel therapy to its portfolio. Financially, Avenue's cash position decreased to $0.2 million as of September 30, 2022, but improved with $10.4 million from a public offering. The net loss was $0.7 million with a reduced loss per share of $0.45.

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Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced the acquisition of Baergic Bio, a clinical-stage company focused on CNS disorders. This acquisition aims to enhance Avenue's portfolio with BAER-101, a selective GABA-A α2/3 receptor positive allosteric modulator in development as a treatment for various CNS conditions. The acquisition aligns with Avenue's strategy to address unmet needs in CNS therapeutics and is expected to strengthen its market position following its recent capital raise.

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Avenue Therapeutics, Inc. (NASDAQ:ATXI) successfully completed a $12 million underwritten public offering, with Aegis Capital Corp. serving as the sole bookrunner on October 12, 2022. The funds raised will support the company's development of intravenous Tramadol, a dual-acting opioid currently in Phase III trials for treating post-operative acute pain. Avenue Therapeutics focuses on specialty pharmaceuticals for acute care settings and was incorporated in 2015.

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FAQ

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

The current stock price of Avenue Therapeutics (ATXI) is $2.01 as of November 22, 2024.

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

The market cap of Avenue Therapeutics (ATXI) is approximately 3.8M.

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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3.84M
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3.56%
Biotechnology
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