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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.
Avenue Therapeutics (ATXI) reported Q3 2024 financial results and pipeline updates. The company expects topline data from its Phase 1b/2a trial of AJ201 for spinal and bulbar muscular atrophy around year-end 2024. The trial enrolled 25 patients to evaluate safety and tolerability. Cash position was $2.6M as of September 30, 2024. Q3 R&D expenses increased to $2.3M from $0.9M year-over-year, while G&A expenses decreased to $0.8M from $1.2M. Net loss was $(3.1)M or $(1.92) per share. The company also plans Phase 2a trials for BAER-101 in epilepsy and a Phase 3 safety study for IV tramadol, both pending additional financing.
Avenue Therapeutics, Inc. (Nasdaq: ATXI), a specialty pharmaceutical company focusing on neurologic disease treatments, has announced its participation in Maxim Group's 2024 Healthcare Virtual Summit. The company's CEO, Alexandra MacLean, M.D., will engage in a fireside chat on Tuesday, October 15, 2024, at 1:30 PM ET.
The event will be accessible to registered attendees, and investors can sign up or log in to the conference through a provided link. This participation highlights Avenue Therapeutics' commitment to engaging with the investment community and sharing insights about their developments in the neurologic disease treatment sector.
Avenue Therapeutics (Nasdaq: ATXI), a specialty pharmaceutical company focusing on neurologic disease treatments, has announced its participation in two upcoming investor conferences. Dr. Alexandra MacLean, the company's CEO, will represent Avenue at these events:
1. H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, in New York, featuring a company presentation and one-on-one meetings.
2. Lake Street Capital Markets BIG8 Conference on September 12, 2024, in New York, offering one-on-one meetings.
The H.C. Wainwright presentation will be available for on-demand viewing by conference attendees starting September 9, 2024, at 7:00 a.m. ET. These conferences provide Avenue Therapeutics with opportunities to showcase their progress and engage with potential investors.
Avenue Therapeutics (NASDAQ: ATXI) reported Q2 2024 financial results and corporate highlights. Key points:
- Last patient visit completed in Phase 1b/2a trial of AJ201 for spinal and bulbar muscular atrophy (SBMA); topline data expected in H2 2024
- Raised $4.4 million from warrant exercise in May 2024
- Cash position: $4.9 million as of June 30, 2024
- Q2 2024 net loss: $2.7 million ($6.43 per share)
- R&D expenses: $1.4 million, down from $3.0 million in Q2 2023
- G&A expenses: $1.5 million, up from $0.9 million in Q2 2023
Avenue continues to advance its pipeline for neurologic diseases, with AJ201 being the most advanced investigational treatment for SBMA in the U.S. The company also plans to initiate a Phase 2a trial of BAER-101 for epilepsy, subject to additional financing.
Avenue Therapeutics (Nasdaq: ATXI), a specialty pharmaceutical company, will participate in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The company's CEO, Dr. Alexandra MacLean, will present at the event. The presentation will be accessible to registered attendees on-demand starting on Thursday, June 27, 2024, at 7:00 a.m. ET. Avenue Therapeutics focuses on developing and commercializing therapies for neurologic diseases.
Avenue Therapeutics announced the completion of the last patient visit in its Phase 1b/2a clinical trial of AJ201, aimed at treating spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.
The company anticipates reporting topline results by mid-2024. The 12-week, multicenter, randomized, double-blind trial included 25 patients, focusing on assessing the safety and tolerability of AJ201, with secondary endpoints examining pharmacokinetic and pharmacodynamic data.
CEO Alexandra MacLean expressed gratitude to all stakeholders involved and highlighted the drug's promising preclinical efficacy and safety profile. The trial is critical, as there are currently no approved treatments for SBMA.
Further study details are available on ClinicalTrials.gov under the identifier NCT05517603.
Avenue Therapeutics (Nasdaq: ATXI) reported its first-quarter 2024 financial results and recent corporate highlights. The company raised $9.4 million in gross proceeds from warrant exercises since January 2024 and increased its cash position to $3.2 million by March 31, 2024. Avenue has made significant progress with its lead clinical program AJ201 for spinal and bulbar muscular atrophy (SBMA) and presented promising preclinical data for BAER-101 in epilepsy treatment. The company plans to initiate a Phase 2a trial for BAER-101 pending necessary financing. Additionally, Avenue reached an agreement with the FDA on the Phase 3 study design for IV tramadol. Research and development expenses rose to $2.4 million, and general and administrative expenses increased to $1.3 million for the first quarter of 2024. Net loss narrowed to $4.3 million from $7.5 million in the same period last year.
Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced the immediate exercise of outstanding warrants for $4.4 million in gross proceeds. The warrants were issued with varying exercise prices and will result in the purchase of 689,680 shares of common stock at a reduced price of $6.20 per share. The proceeds are expected to be used for general corporate purposes, and the transaction is set to close on or about May 1, 2024.
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