CareDx expands into hematology oncology with new trial

Published 11/12/2024, 13:20
CareDx expands into hematology oncology with new trial
CDNA
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BRISBANE, Calif. - CareDx, Inc. (NASDAQ:CDNA), a $1.29 billion market cap precision medicine company known for its transplant patient solutions, has announced a partnership with TC BioPharm to utilize its AlloCell solution in the ACHIEVE clinical trial. According to InvestingPro data, CareDx's stock has surged over 100% year-to-date, reflecting strong investor confidence in its strategic initiatives. This collaboration marks CareDx's strategic move into hematology oncology, focusing on pharmacokinetic and monitoring assays for cell therapy patients.

The ACHIEVE trial is a phase II study aimed at assessing the efficacy of TCB008, an allogeneic gamma-delta T-cell therapy, for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). AlloCell, previously used in ten cell therapy clinical trials, will now be employed to monitor the expansion and persistence of TCB008 in patients. The company maintains a strong financial position with a current ratio of 4.1, indicating robust liquidity to support its clinical initiatives.

Marica Grskovic, PhD, Chief Strategy Officer at CareDx, expressed excitement about the company's progression in the science of allogeneic cell therapy for AML. Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm, highlighted the significance of the partnership in advancing TCB008 as a potential therapy for blood cancers.

The use of CareDx's AlloCell test is expected to provide valuable data on the behavior of TCB008 gamma-delta T-Cells in rebuilding the immune systems of trial participants. This information will be critical in understanding the treatment's duration and effect.

CareDx, headquartered in Brisbane, California, is at the forefront of genomics-based information for transplant patients, offering a range of testing services, products, and digital healthcare solutions. InvestingPro analysis indicates the company is currently undervalued, with analysts setting price targets ranging from $28 to $40. Get deeper insights into CareDx's financial health and growth prospects with InvestingPro's comprehensive research report, available alongside 1,400+ other detailed company analyses.

The press release also contains forward-looking statements regarding the potential benefits of the strategic partnership and the ACHIEVE trial. However, these statements are subject to risks and uncertainties that could cause actual results to differ from expectations. This information is based on a press release statement from CareDx, Inc.

In other recent news, CareDx, Inc. demonstrated robust growth in its third quarter of 2024, with a notable year-over-year revenue increase of 23% to $82.9 million. The company's gross margins improved, and it achieved a positive adjusted EBITDA of $6.9 million, exceeding expectations. CareDx also revised its full-year 2024 revenue guidance upward, now expecting a 17% growth at the midpoint.

The company further outlined a three-year growth strategy aiming to reach $500 million in revenue by 2027 with 20% adjusted EBITDA profitability. Other recent developments include the closure of investigations by the DOJ and SEC with no findings of wrongdoing, and the withdrawal of patent infringement claims against CareDx's AlloSure testing method by a competitor.

CareDx anticipates 17% year-over-year revenue growth for fiscal year 2024, potentially lowering to 12-13% when accounting for one-time revenues. The company plans to enhance its commercial team and billing operations to support higher growth rates by 2027. CareDx also expects mid-single-digit growth in the transplant market for 2025, driven by advancements in perfusion technologies.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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