December 31, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (24th Dec - 30th Dec): TEVIMBRA & RYBREVANT Approvals, Major Private Placements


  1. Microtech begins human trials of implantable microsensor for Heart Failure management.
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  2. Avid Bioservices' acquisition by GHO and Ampersand progresses with Hart-Scott-Rodino waiting period expiration.
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  3. CEL-SCI announces $5 million public offering to fund Multikine development for Head and Neck Neoplasms.
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  4. FDA approves TEVIMBRA for first-line treatment of HER2-negative Gastric and Gastroesophageal Junction Cancers with chemotherapy.
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  5. EC approves amivantamab and lazertinib for first-line treatment of EGFR-mutated advanced non-small cell lung cancer.
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  6. NRx Pharmaceuticals submits NDA for NRX-100 (IV Ketamine) to FDA for Suicidal Depression treatment.
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  7. CARsgen's Claudin18.2 CAR-T shows positive results in Phase II trial for Gastric Cancer in China.
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  8. Vor Bio secures $55.6M in private placement to advance trials for Acute Myeloid Leukemia therapies.
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  9. KALA BIO secures $10.75M in private placement to advance KPI-012 for Persistent Corneal Epithelial Defect.
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  10. Takeda's HYQVIA approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia, offering less frequent dosing for patients.
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  11. Microbot Medical submits FDA 510(k) for LIBERTY® Endovascular Robotic System, aiming for 2025 U.S. commercial launch.
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  12. AusperBio secures $73M to advance Phase 2 trials for chronic Hepatitis B therapy AHB-137.
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  13. BeiGene secures global rights for Duality Biologics' B7H4 ADC, achieving a milestone in solid tumor therapy development.
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  14. IDEAYA licenses SHR-4849 ADC for Small Cell Lung Cancer and Neuroendocrine Tumors, targeting US IND filing in 2025.
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  15. Precigen submits BLA for PRGN-2012, seeking FDA priority review for Recurrent Respiratory Papillomatosis treatment.
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  16. Chimerix submits NDA for dordaviprone to FDA for recurrent H3 K27M-mutant diffuse glioma, seeking accelerated approval.
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  17. Citius Oncology receives FDA approval for LYMPHIR to treat Cutaneous T-Cell Lymphoma and reports increased financial losses for 2024.
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  18. Vincerx Pharma announces strategic merger with Oqory, focusing on ADCs for oncology indications.
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  19. Immedica to acquire Marinus Pharmaceuticals, enhancing rare disease portfolio with FDA-approved seizure treatment ZTALMY.
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  20. Radiopharm partners with Lantheus for Phase 1 trial of radiopharmaceuticals targeting solid tumors in Australia.
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  21. Novartis' Phase III trial shows efficacy of OAV101 IT in Spinal Muscular Atrophy patients.
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  22. Traws Pharma secures $72.6M funding to advance Tivoxavir Marboxil for H5N1 Bird Flu treatment.
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  23. ADC Therapeutics completes Phase 3 trial enrollment for ZYNLONTA in Diffuse Large B-Cell Lymphoma.
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  24. Huadong Medicine and SynerK partner to develop siRNA drug SNK-2726 for Hypertension treatment in Greater China.
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  25. Axsome's AXS-05 shows efficacy in Phase 3 trials for Alzheimer's Disease agitation, with NDA submission planned for 2025.
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