AEON Biopharma | MedPath

AEON Biopharma Appoints Rob Bancroft as New CEO to Lead ABP-450 Therapeutic Development

2 months ago

• AEON Biopharma has appointed industry veteran Rob Bancroft as Chief Executive Officer to lead the company's development of ABP-450 for therapeutic applications. • ABP-450 (prabotulinumtoxinA) is the same botulinum toxin complex marketed for cosmetic use as Jeuveau, with AEON focusing on its potential for debilitating medical conditions in neurosciences. • The company is pursuing a 351(k) biosimilar pathway with the FDA, aiming to position ABP-450 as a biosimilar to BOTOX for both current and future therapeutic indications.

Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD

6 months ago

• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025. • The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus. • Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1. • Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.

Cervical Dystonia Therapeutic Pipeline Shows Promise with Novel Therapies

7 months ago

• The cervical dystonia therapeutics market is poised for growth, driven by advancements in R&D and the emergence of novel treatment options. • Key pipeline drugs, including Daxibotulinumtoxin A from Revance Therapeutics and ABP-450 from AEON Biopharma, are expected to enter the market soon. • Current treatments focus on symptom management, but new therapies aim to address the underlying disease mechanisms for improved outcomes. • Several companies, including Ipsen and Allergan, are actively involved in developing innovative medications and devices for cervical dystonia.

AEON Biopharma Achieves Positive Outcome in FDA Biosimilar Advisory Meeting for ABP-450

8 months ago

• AEON Biopharma is aligned with the FDA on the 351(k) regulatory pathway for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). • Comparative analytical studies are scheduled to begin in Q4 2024 to demonstrate biosimilarity between ABP-450 and BOTOX®. • A Biosimilar Biological Product Development (BPD) Type 2 meeting with the FDA is planned for 2025 to review study results. • AEON aims for a single approval to market prabotulinumtoxinA for all of BOTOX's approved and future therapeutic indications in the U.S.