Pelareorep

Oncolytics Biotech seeks accelerated approval for pelareorep, its lead cancer therapy, based on positive Phase II BRACELET-1 trial data. A registrational Phase II trial is planned for 2025, evaluating pelareorep combined with paclitaxel in breast cancer patients. Oncolytics' stock rose 18.22% on the news, reflecting investor optimism. Oncolytic virus therapies are projected to see significant growth, from $114m in 2023 to $2.4bn by 2029.

Global cancer cases surge, with a 79% rise in new cases among patients under 50. The highest death tolls are linked to breast, windpipe, lung, bowel, and stomach cancers. Cancer rates are projected to increase by 77% by 2050. In response, biotech firms like Oncolytics, AbbVie, BeiGene, HUTCHMED, and Enliven Therapeutics are accelerating treatment innovations, with the FDA approving 16 new oncology treatments in 2024. Oncolytics plans to submit a clinical trial for breast cancer treatment to the FDA in early 2025.

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Cancer rates are surging globally, especially among patients under 50, with a 79% rise in new cases. The United Nations predicts a 77% increase by 2050. In response, the FDA has approved 16 new oncology treatments between July and September 2024. Oncolytics Biotech Inc. is making significant progress with its immunotherapeutic agent, pelareorep, in breast and pancreatic cancer treatments, aiming for FDA accelerated approval. The global oncology drug market is expected to grow at a CAGR of 11.5% to reach $564.50 billion by 2033, while the AI in oncology market is growing at a 35% CAGR.

Oncolytics Biotech® Inc. plans to submit a pelareorep + paclitaxel combination therapy breast cancer trial to the FDA in 2025, aiming for an accelerated approval based on strong BRACELET-1 trial results in HR+/HER2- breast cancer. The company also anticipates key milestones in gastrointestinal cancer trials, with potential for new registration-enabling studies.

Oncolytics Biotech® Inc. plans to submit a pelareorep + paclitaxel combination therapy breast cancer trial to the FDA in 2025, aiming for an accelerated approval. The BRACELET-1 trial results showed a 5.7-month PFS benefit for pelareorep + paclitaxel over chemotherapy alone. The company also anticipates key milestones in gastrointestinal cancer clinical trials in 2025.

Oncolytics Biotech (TSE:ONC) may see accelerated FDA approval for its breast cancer therapy, pelareorep, amid rising global cancer rates. Promising BRACELET-1 trial results pave the way for a large study on HR+/HER2- metastatic breast cancer patients.