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AEON Biopharma, Inc. (symbol: AEON) is a clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, targeting multiple debilitating medical conditions. The company initially concentrates on the neurosciences market and aims to leverage ABP-450 in treating conditions such as cervical dystonia, migraine, and potentially post-traumatic stress disorder (PTSD). This biopharmaceutical entity was listed on the NYSE following a merger with a special purpose acquisition company (SPAC) designed to merge with healthcare-related businesses.
Recent developments include positive data from the 52-week open-label extension (OLE) Phase 2 study of ABP-450 in treating cervical dystonia, showing peak efficacy within four weeks and a durability of effect between 12 to 16 weeks post-treatment. AEON also presented pre-clinical data at the TOXINS 2024 conference highlighting the promising results of ABP-450 in conjunction with lidocaine for treating PTSD in a rat model via image-guided Stellate Ganglion Block (SGB).
Financially, AEON recently closed a $15 million Private Placement with Daewoong Pharmaceutical, bolstering its resources for further clinical development of ABP-450. Despite a recent interim analysis from the Phase 2 chronic migraine study not achieving its primary endpoint, the company remains optimistic about advancing other late-stage programs such as cervical dystonia and gastroparesis.
ABP-450 is manufactured under stringent guidelines by Daewoong, ensuring compliance with regulatory standards including cGMP. AEON holds exclusive rights for ABP-450's therapeutic applications across key territories including the USA, Canada, and the EU.
Management Team: AEON's leadership includes highly experienced professionals, with Marc Forth serving as President and CEO, alongside other key figures like Dr. Chad Oh and Chief Financial Officer Jennifer Sy. Their combined expertise is instrumental in navigating the company through its clinical milestones and regulatory approvals.
AEON Biopharma (NYSE: AEON) announced a positive outcome from its FDA Biosimilar Advisory Meeting for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). The company is aligned with the FDA on the 351(k) regulatory pathway for approval. Key points include:
1. Comparative analytical studies are expected to start in Q4 2024.
2. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to review results and confirm the proposed study package.
3. AEON aims to bring prabotulinumtoxinA to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single approval.
4. The company anticipates conducting a Phase 3 program, subject to funding, to compare ABP-450 with BOTOX®.
AEON Biopharma (NYSE: AEON), a clinical-stage biopharmaceutical company developing a botulinum toxin complex for multiple therapeutic indications, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York, NY. The event is scheduled for September 11, 2024.
Key points:
- Marc Forth, AEON's President and CEO, will present a corporate overview at 1:30 PM ET
- One-on-one meetings with institutional investors will be available
- A live webcast of the conference event will be accessible through the conference host
This participation provides AEON an opportunity to showcase its progress and engage with potential investors, potentially impacting its market position and future funding prospects.
AEON Biopharma (NYSE: AEON) reported its Q2 2024 financial results and provided a corporate update. The company is progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar to BOTOX®. AEON is scheduled to hold a biosimilar initial advisory meeting with FDA in Q3 2024. The 351(k) regulatory pathway offers potential for a single approval for all of BOTOX's current and future therapeutic indications.
Key highlights include:
- Plans to initiate a single pivotal clinical study in cervical dystonia (CD)
- Submitted a briefing package to FDA with extensive data
- Expects to start a Phase 3 CD study with ~400 patients
- Aims to demonstrate non-inferiority to BOTOX
The biosimilar approach may offer a potential regulatory pathway to bring ABP-450's differentiated economic model to the U.S. market efficiently.
AEON Biopharma has announced a strategic shift to pursue a biosimilar pathway for ABP-450, its lead candidate for treating cervical dystonia (CD). The company plans to conduct a Phase 3 study comparing ABP-450 directly with BOTOX® via the FDA's 351(k) regulatory pathway. This move follows promising Phase 2 trial results and aims to secure approval for all of BOTOX’s current and future therapeutic indications. An in-person FDA meeting is scheduled for Q3 2024 to discuss this plan. If successful, the Phase 3 study could pave the way for a Biologics License Application (BLA) filing.
AEON Biopharma announced a strategic reprioritization and cost reduction plan, aiming to extend its cash runway into Q4 2024 while evaluating funding options for its late-stage clinical pipeline. Key actions include a workforce reduction of approximately 55%, termination of CFO Peter Reynolds, and the appointment of CEO Marc Forth and Corporate Controller Jennifer Sy to additional roles as principal financial officer and principal accounting officer, respectively. The company will discontinue the Phase 2 study of ABP-450 for chronic migraine prevention due to unmet endpoints, focusing instead on analyzing interim data and maintaining patient safety.
AEON Biopharma reported its Q1 2024 financial results, revealing ongoing analysis of interim data from its Phase 2 study of ABP-450 in chronic migraine, which did not meet primary or secondary endpoints. The company is evaluating the next steps for ABP-450 across its late-stage clinical pipeline, targeting multiple indications. Key developments include a productive end-of-Phase 2 meeting with the FDA for episodic migraine, despite not achieving the primary endpoint, and a $15 million private placement agreement with Daewoong Pharmaceutical. The funds will be used for general working capital.
AEON Biopharma, Inc. provided an update on its development pipeline, highlighting late-stage and early-stage clinical programs. The company focuses on a botulinum toxin complex for treating medical conditions. While ABP-450 did not show superiority over placebo in chronic migraine, the company remains optimistic about its migraine program and other indications. The portfolio includes studies on episodic migraine, cervical dystonia, gastroparesis, and PTSD.
AEON Biopharma announced that the preliminary results from the Phase 2 trial with ABP-450 for chronic migraine prevention did not meet the primary endpoint of mean reduction in monthly migraine days. The trial showed no statistical significance in reduction compared to placebo, leading to the company initiating cash preservation measures and reviewing strategic options.
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