Axsome Therapeutics Reports Strong Growth with 88% Revenue Increase in 2024, Advances CNS Pipeline
• Axsome Therapeutics achieved remarkable financial performance in 2024, with total net product revenue reaching $385.7 million, representing an 88% year-over-year growth driven by strong Auvelity and Sunosi sales.
• The company secured FDA approval for Symbravo for acute migraine treatment in adults and successfully completed Phase 3 trials for AXS-05 in Alzheimer's disease agitation, with NDA submission planned for late 2025.
• Multiple late-stage clinical programs are advancing, including trials for solriamfetol in ADHD and depression, with key data readouts expected in Q1 2025.
OncoZenge Secures $2.9 Million Investment to Advance Phase 3 Trial of BupiZenge for Oral Mucositis Pain
• OncoZenge AB secures a SEK 30.2 million ($2.9 million) investment from Sichuan Yangtian Bio-Pharmaceutical Co, Ltd to fund the Phase 3 clinical trials of BupiZenge.
• The investment will be executed through four share issues, potentially granting Yangtian Pharma a 28.5% ownership stake in OncoZenge upon completion.
• Funds will primarily support a multi-country Phase 3 trial for BupiZenge, a novel oral lozenge formulation of bupivacaine for treating oral mucositis pain in cancer patients.
• The strategic partnership aims to leverage Yangtian Pharma's expertise to explore further market opportunities, including potential expansion into the United States and Asian markets.
Catumaxomab Receives European Marketing Authorization for Malignant Ascites Treatment
• Catumaxomab, a first-in-class trifunctional antibody, has been granted European Commission marketing authorization for malignant ascites.
• The approval makes catumaxomab the only approved drug therapy for malignant ascites, a complication of advanced-stage cancers.
• Pharmanovia has secured exclusive rights from Lindis Biotech to commercialize and launch catumaxomab across Europe.
• Catumaxomab targets EpCAM-positive carcinomas, offering a novel approach by engaging T-cells to destroy cancer cells.
Lindis Biotech and Pharmanovia Partner to Relaunch Catumaxomab for Malignant Ascites
• Lindis Biotech has partnered with Pharmanovia to relaunch Catumaxomab, a bifunctional antibody therapy, following a positive review from the EMA's Committee for Medicinal Products for Human Use.
• Catumaxomab is poised to become the first approved treatment for malignant ascites, a condition frequently associated with advanced cancers such as ovarian and pancreatic cancer.
• The drug targets EpCAM-positive carcinomas, aiming to enhance patient quality of life by decreasing reliance on paracentesis and potentially prolonging survival.
• Pharmanovia will lead the marketing efforts for Catumaxomab, with both companies expressing optimism about alleviating the burden of malignant ascites on patients.
Pharmanovia In-Licenses Catumaxomab for Malignant Ascites Treatment
• Pharmanovia has secured exclusive rights to commercialize catumaxomab, a trifunctional bispecific monoclonal antibody, for treating malignant ascites.
• Catumaxomab targets EpCAM-positive carcinomas and enhances the patient's immune system to kill tumor cells, offering a novel approach.
• The EMA's CHMP issued a positive opinion on catumaxomab in October 2024, potentially making it the only approved drug for malignant ascites.
• Pharmanovia aims to reintroduce catumaxomab to the market, pending regulatory approval, to address the unmet needs in cancer supportive care.
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