FDA Draft Guidance Boosts Arcellx (ACLX) and Legend Biotech (LEGN) Stock Prices
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
0mins
Source: seekingalpha
- FDA Guidance Impact: The U.S. FDA's draft guidance allows minimal residual disease and complete response as endpoints for accelerated approval in multiple myeloma treatments, leading to a stock price increase for Arcellx (ACLX) and Legend Biotech (LEGN), reflecting market optimism for new therapies.
- Collaborative Prospects: Legend Biotech's partnership with Johnson & Johnson (JNJ) on the Carvykti cell therapy has already incorporated MRD negativity as an endpoint in the CARTITUDE-6 trial, which analysts view as a positive development for its market performance.
- Market Competition Analysis: Analysts highlight that Arcellx's anito-cel therapy is also expected to enter the market based on MRD negativity, enhancing its competitiveness in the second to fourth-line treatment settings and increasing investment appeal in this sector.
- Investment Rating Changes: Jefferies maintains an Outperform rating on Legend Biotech with a target price of $66, noting that while the stock trades at a significant discount, the FDA guidance provides a clear positive signal for its future growth.
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Analyst Views on ACLX
Wall Street analysts forecast ACLX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ACLX is 113.14 USD with a low forecast of 100.00 USD and a high forecast of 130.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
18 Analyst Rating
17 Buy
1 Hold
0 Sell
Strong Buy
Current: 68.260
Low
100.00
Averages
113.14
High
130.00
Current: 68.260
Low
100.00
Averages
113.14
High
130.00
About ACLX
Arcellx Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering immunotherapies for patients with cancer and other incurable diseases. Its lead program is a BCMA-targeting ddCAR product candidate called anitocabtagene autoleucel, which is being evaluated in its pivotal Phase II iMMagine-1 and the Phase III iMMagine-3 trials in patients with relapsed or refractory multiple myeloma (rrMM). Anitocabtagene is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes its novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. It is also developing two clinical-stage ARC-SparX programs in Phase I trials: ACLX-001, which targets BCMA in rrMM, and ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
FDA Draft Guidance Boosts Arcellx (ACLX) and Legend Biotech (LEGN) Stock Prices
- FDA Guidance Impact: The U.S. FDA's draft guidance allows minimal residual disease and complete response as endpoints for accelerated approval in multiple myeloma treatments, leading to a stock price increase for Arcellx (ACLX) and Legend Biotech (LEGN), reflecting market optimism for new therapies.
- Collaborative Prospects: Legend Biotech's partnership with Johnson & Johnson (JNJ) on the Carvykti cell therapy has already incorporated MRD negativity as an endpoint in the CARTITUDE-6 trial, which analysts view as a positive development for its market performance.
- Market Competition Analysis: Analysts highlight that Arcellx's anito-cel therapy is also expected to enter the market based on MRD negativity, enhancing its competitiveness in the second to fourth-line treatment settings and increasing investment appeal in this sector.
- Investment Rating Changes: Jefferies maintains an Outperform rating on Legend Biotech with a target price of $66, noting that while the stock trades at a significant discount, the FDA guidance provides a clear positive signal for its future growth.
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