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SAN DIEGO/CALGARY - Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), a biotechnology company with a market capitalization of nearly $35 billion and impressive revenue growth of 51% over the last twelve months, announced Tuesday it has initiated regulatory discussions with the U.S. Food and Drug Administration regarding a potential registration-enabled pivotal study for its pelareorep therapy in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
The company expects to commence study start-up activities before the end of 2025, pending favorable FDA discussions. The planned trial would evaluate pelareorep’s effectiveness in combination with chemotherapy with or without checkpoint inhibition, using overall survival as the primary endpoint. According to InvestingPro data, analysts maintain a strong buy consensus on the stock, which is currently trading near its 52-week high of $300.
"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics, according to the company’s press release.
Pelareorep has already received Fast Track and Orphan Drug designations from the FDA for mPDAC treatment. The therapy works by converting immunologically "cold" tumors into "hot" ones through activation of immune responses.
The company indicated it is considering proposing an adaptive study design in collaboration with a third party. Oncolytics stated it believes this program creates value for shareholders while positioning the company as a potential partner for pharmaceutical companies interested in immunotherapy treatments for pancreatic and other gastrointestinal cancers.
Pancreatic cancer remains one of the most lethal and difficult-to-treat solid tumors, with limited effective immunotherapy options currently available.
The company plans to provide additional information on study design, timelines, and next steps following regulatory feedback from the FDA.
In other recent news, BeOne Medicines announced a positive recommendation from the European Medicines Agency for its cancer drug TEVIMBRA in early-stage lung cancer. The Committee for Medicinal Products for Human Use recommended approval of TEVIMBRA in combination with chemotherapy for patients with resectable non-small cell lung cancer, based on results from the Phase 3 RATIONALE-315 study. Additionally, RBC Capital raised its price target for BeOne Medicines to $349, citing the company’s leadership in hematologic oncology. Citizens JMP also reiterated a Market Outperform rating and a $348 price target, highlighting the potential of BeOne’s clinical data.
Meanwhile, Oncolytics Biotech has regained compliance with Nasdaq’s listing requirements after previously failing to maintain the minimum bid price. The company reported that its immunotherapy treatment, pelareorep, showed significant survival benefits in cancer studies. Pelareorep demonstrated a two-year survival rate of 21.9% for metastatic pancreatic cancer patients, compared to a 9.2% historical benchmark. Oncolytics also noted a 62% objective response rate when pelareorep was used with chemotherapy and a checkpoint inhibitor.
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