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CureVac Receives FDA Clearance for Phase 1 Trial of mRNA Immunotherapy

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CureVac Receives FDA Clearance for Phase 1 Trial of mRNA Immunotherapy

An update from CureVac ( (CVAC) ) is now available.

On April 7, 2025, CureVac announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of CVHNLC, a novel mRNA-based precision immunotherapy for squamous non-small cell lung cancer (sqNSCLC). This significant regulatory milestone allows CureVac to begin testing CVHNLC in combination with pembrolizumab, aiming to enhance anti-tumor immune responses. The trial will assess the safety and tolerability of the treatment, with patient treatment expected to start in the second half of 2025. This development underscores CureVac’s continued growth in its oncology pipeline, with more candidates anticipated to enter clinical trials in 2026.

Spark’s Take on CVAC Stock

According to Spark, TipRanks’ AI Analyst, CVAC is a Outperform.

CureVac’s strong financial recovery, positive earnings call sentiment, and solid technical indicators contribute to a favorable outlook. Key strengths include significant revenue growth and strategic partnerships. However, historical financial volatility and potential legal challenges warrant caution.

To see Spark’s full report on CVAC stock, click here.

More about CureVac

CureVac is a pioneering multinational biotech company founded in 2000, specializing in the development of transformative medicines based on messenger RNA (mRNA) technology. The company has been instrumental in advancing mRNA technology for medical applications, including the production of mRNA vaccines against COVID-19. CureVac focuses on designing and developing off-the-shelf and personalized cancer immunotherapy product candidates, as well as prophylactic vaccines and treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac operates in several countries, including the Netherlands, Belgium, Switzerland, and the U.S.

YTD Price Performance: -24.93%

Average Trading Volume: 716,574

Technical Sentiment Signal: Strong Buy

Current Market Cap: $581M

Learn more about CVAC stock on TipRanks’ Stock Analysis page.

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