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CureVac Receives U.S. FDA IND Clearance to Initiate Phase 1 Clinical Trial for Novel mRNA-Based Precision Immunotherapy in Squamous Non-Small Cell Lung Cancer

1. FDA approved IND application for CureVac's CVHNLC therapy targeting lung cancer. 2. Clinical treatment expected to begin in 2025, marking pipeline advancement.

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Why Bullish?

FDA clearance often boosts biotech stocks. Historical examples show price increases following similar approvals.

How important is it?

The FDA clearance is a critical milestone that can significantly impact investor sentiment and stock price.

Why Long Term?

The significance of new therapies often leads to sustained investor interest over time.

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Significant Regulatory Milestone: U.S. FDA cleared IND application for CVHNLC, CureVac's investigational therapy targeting squamous non-small cell lung cancer Proprietary Epitopes: CVHNLC encodes novel tumor epitopes identified through proprietary whole genome-based discovery platform Enhanced Combination Therapy: CVHNLC to be tested in combination with pembrolizumab, aiming to amplify targeted anti-tumor immune responses Clinical Progress: Patient treatment anticipated to start in the second half of 2025 Pipeline Advancement: IND clearance highlights CureVac's continued oncology pipeline growth, with more candidates planned to enter the clinic in 2026 TÜBINGEN, GERMANY AND BOSTON, MA / ACCESS Newswire / April 7, 2025 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small cell lung cancer (sqNSCLC).

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