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0 -0.0121739130434783 -0.0010230179028133 0.00030690537084407 -0.00808184143222508 -0.00751918158567772 0.0485933503836319 0.0485933503836319
Stock impact report

Cancer Drug Developers Secure Regulatory Clarity as FDA Reshapes Approval Standards

Oncolytics Biotech Inc. - Common Shares (ONCY) 
Last oncolytics biotech inc. - common shares earnings: 11/12 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.oncolyticsbiotech.com
Company Research Source: GlobeNewswire
VANCOUVER, British Columbia, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – The FDA is moving to require just one clinical trial for new drug approvals, signaling a dramatic shift toward faster regulatory pathways that could accelerate oncology breakthroughs[1]. This momentum is already materializing, with five major oncology approvals secured in November across multiple cancer indications, demonstrating regulators' willingness to green-light promising therapies when supported by compelling clinical data[2]. Against this backdrop of regulatory evolution, several clinical-stage biotechs are advancing toward definitive registration studies and commercial readiness, positioning themselves at exactly the right moment in the approval cycle. These companies include Oncolytics Biotech Inc. (NASDAQ: ONCY), Immunome, Inc. (NASDAQ: IMNM), Prelude Therapeutics Incorporated (NASDAQ: PRLD), Context Therapeutics Inc. (NASDAQ: CNTX), and Relay Therapeutics, Inc. (NASDAQ: RL Show less Read more
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