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
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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
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ONCY
News
- Cancer Drug Developers Secure Regulatory Clarity as FDA Reshapes Approval Standards [Canadian Business Journal (Canada)]Canadian Business Journal
- Oncolytics Biotech® Announces Promising Efficacy and Translational Data Supporting Pelareorep in KRAS-Mutant Metastatic Colorectal CancerBusiness Wire
- THE VISIBILITY INDEX: 5 Companies Solving the Invisible Crisis [Canadian Business Journal (Canada)]Canadian Business Journal
- THE VISIBILITY INDEX: 5 Companies Solving the Invisible CrisisGlobeNewswire
- GI Cancer Immunotherapy Breakthroughs Signal New Treatment Era [Canadian Business Journal (Canada)]Canadian Business Journal
ONCY
Earnings
- 11/12/25 - Miss
ONCY
Sec Filings
- 12/16/25 - Form 6-K
- 12/10/25 - Form EFFECT
- 12/10/25 - Form 6-K
- ONCY's page on the SEC website