On Wednesday, H.C. Wainwright increased the price target on shares of Arcellx Inc. (NASDAQ: ACLX) to $95 from $80, while maintaining a Buy rating on the stock. This adjustment comes after the release of abstracts for ASH 2024 on November 5, where Arcellx disclosed that it would present initial data from the iMMagine-1 trial and updated results from the Phase 1 trial of anito-cel in patients with relapsed/refractory multiple myeloma (r/r MM).
The iMMagine-1 trial included 58 patients as of June 1, 2024, who had a minimum of two months of follow-up. The median follow-up time was reported to be 10.3 months. The trial achieved an impressive overall response rate (ORR) of 95% with 55 out of 58 patients responding to the treatment. Furthermore, the complete response (CR) and stringent complete response (sCR) rate was 62%.
In the subset of patients eligible for minimal residual disease (MRD) assessment (n=39), 92% achieved MRD-negative status at a sensitivity level of one tumor cell per 100,000 white cells (10^-5). The estimated six-month progression-free survival (PFS) and overall survival (OS) rates were 90% and 95%, respectively, with neither median PFS nor median OS being reached at the time of reporting.
The analyst noted that these results are very similar to the initial Phase 1 data for anito-cel, presented at ASH 2021, where 19 patients had an ORR of 100% and a CR/sCR rate of 68%. Comparatively, in the latest dataset, the CR/sCR rate was 79% among 38 patients. It is expected that with additional follow-up, the CR/sCR rate will continue to rise.
The six-month PFS rate from the trial was also compared to the CARTITUDE-1 study, which had a six-month PFS rate of 87%, underscoring the competitive performance of anito-cel. There were no delayed neurotoxicities reported, such as parkinsonism, cranial nerve palsies, or Guillain-Barre syndrome.
Cytokine release syndrome (CRS) of any grade was observed in 84% of patients with no Grade 3 cases, and immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was seen in 9% of patients, with 2% being Grade 3. These rates of Grade 3 events were consistent with those observed in the Phase 1 study.
Arcellx is expected to present a more comprehensive dataset at the next month's ASH meeting. The anticipation of further positive results has led to the reaffirmation of the Buy rating and the increase in the price target for Arcellx's stock.
In other recent news, Arcellx Inc. has been at the forefront of significant developments in the biotechnology sector. BofA Securities raised the price target for Arcellx to $100, maintaining a Buy rating, following the release of promising data on the company's leading drug candidate, anito-cel™, for the treatment of multiple myeloma.
Similarly, Evercore ISI, Stifel, and Redburn-Atlantic also increased their price targets, maintaining positive ratings based on the potential safety profile and market prospects of anito-cel™.
Arcellx's clinical studies on anito-cel™ for relapsed or refractory multiple myeloma (RRMM) have shown promising results, with a median progression-free survival of 30.2 months and a 95% overall response rate. The treatment has also received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.
Moreover, Arcellx is collaborating with Kite, a Gilead (NASDAQ:GILD) Company, to co-develop and co-commercialize anito-cel™ for RRMM. The company's innovative D-Domain technology, which enables the discovery and development of small-sized binders, has also gained attention for its potential in Arcellx's early-stage ARC-SparX program. These recent developments highlight Arcellx's efforts to advance CAR-T cell therapy, especially for blood cancers.
InvestingPro Insights
Arcellx Inc. (NASDAQ: ACLX) has been demonstrating strong financial performance, aligning with the positive clinical trial results highlighted in the article. According to InvestingPro data, the company's revenue growth is impressive, with a 349.34% increase in the last twelve months as of Q2 2024. This substantial growth reflects the potential market enthusiasm for Arcellx's innovative treatments, particularly anito-cel for multiple myeloma.
The company's gross profit margin stands at a remarkable 91.7%, indicating highly efficient operations and potentially strong pricing power for its novel therapies. This aligns with one of the InvestingPro Tips, which notes Arcellx's "impressive gross profit margins."
Despite these positive indicators, it's important to note that Arcellx is not yet profitable, with an operating income of -$80.67 million in the last twelve months. This is consistent with another InvestingPro Tip stating that "analysts do not anticipate the company will be profitable this year." However, this is not uncommon for biotech companies in the development stage of breakthrough therapies.
The market seems to be pricing in future growth potential, as evidenced by the stock's performance. InvestingPro data shows a strong 92.32% price return over the past year, and a 68.41% return in the last three months, reflecting investor optimism about the company's pipeline and recent clinical trial results.
For investors seeking a more comprehensive analysis, InvestingPro offers 13 additional tips for Arcellx, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.