Arcellx Shares Surge on Strong Multiple Myeloma Drug Data
FDA & Biotech

Arcellx Shares Surge on Strong Multiple Myeloma Drug Data

Updated Phase 2 results for anito-cel show a 96% response rate, positioning the therapy as a potential best-in-class treatment and challenging established rivals.

Shares of Arcellx Inc. (NASDAQ: ACLX) jumped more than 9% on Monday after the clinical-stage biotechnology company presented highly encouraging data for its experimental multiple myeloma therapy, anito-cel. The results, unveiled at the American Society of Hematology (ASH) 2025 annual meeting, bolster the case for the drug's potential as a leading treatment in a competitive market, sending the company's stock up to $76.00 in afternoon trading.

The updated data from the pivotal iMMagine-1 Phase 2 study showed that anito-cel achieved an impressive 96% overall response rate (ORR) in patients with relapsed and/or refractory multiple myeloma. According to the company's official announcement, the treatment also led to a 74% complete response rate, a deep level of response that is critical for long-term patient outcomes.

The durability of the response was also a key highlight. At the 12-month mark, 82.1% of patients remained progression-free, with that figure at a robust 61.7% after 24 months. "These data are compelling and are an important advancement for patients living with multiple myeloma," said Dr. Krina Patel, an Associate Professor at The University of Texas MD Anderson Cancer Center and a study investigator.

Beyond the strong efficacy, analysts are pointing to anito-cel's safety profile and manufacturing efficiency as key differentiators. Unlike some other CAR-T therapies, there were no observed cases of delayed neurological events or Parkinsonism-like symptoms in the trial. William Blair analyst Sami Corwin noted this favorable risk-benefit profile could make anito-cel more suitable for outpatient treatment, a significant advantage for both patients and healthcare systems, according to reporting by MedCity News.

Arcellx is developing anito-cel in a strategic partnership with Gilead Sciences' Kite Pharma, a leader in cell therapy. This collaboration is crucial as it allows Arcellx to leverage Kite's extensive and sophisticated manufacturing infrastructure. The companies have reported a 17-day median turnaround time from cell collection to infusion, a critical logistical factor in the patient treatment journey.

The positive data positions anito-cel to compete directly with established BCMA-targeting CAR-T therapies, including Bristol Myers Squibb's Abecma and Johnson & Johnson's Carvykti. With its combination of high efficacy, a clean safety profile, and efficient manufacturing, Arcellx aims to capture a significant share of the multi-billion dollar multiple myeloma market.

Wall Street has taken note of the potential, with the consensus analyst price target for ACLX sitting at over $113 per share, suggesting significant upside from its current valuation of approximately $4 billion. The company has already completed a pre-BLA (Biologics License Application) meeting with the FDA and is on track for a planned commercial launch in 2026.

Rami Elghandour, Arcellx's Chairman and CEO, expressed confidence in the therapy's future. "The data from iMMagine-1 continue to reinforce our belief that anito-cel is poised to become a category leader in treating multiple myeloma patients," he stated, reaffirming the company's focus on bringing the treatment to market.