Aclaris Therapeutics Receives Fast Track Designation for Modzatinib (ATI-2138) for Moderate to Severe Lichen Planus (LP)

Rhea-AI Summary

Aclaris Therapeutics (NASDAQ: ACRS) announced that the U.S. FDA has granted Fast Track Designation for its investigational therapy modzatinib (ATI-2138) for moderate to severe lichen planus (LP), including oral erosive LP, cutaneous LP, and lichen planopilaris.

According to Aclaris, Fast Track status enables more frequent FDA interactions, the possibility of rolling New Drug Application review, and potential eligibility for Priority Review if criteria are met. The company expects to initiate a phased, multi-part Phase 2b LP trial in the fourth quarter of 2026 as it advances its immuno-inflammatory pipeline.

Positive

• Fast Track Designation granted by FDA for modzatinib (ATI-2138) in moderate to severe LP
• Planned phased multi-part Phase 2b trial in LP starting in the fourth quarter of 2026

Negative

• None.

News Explained

Fast Track is a regulatory-process milestone for investigational modzatinib: it can increase FDA interaction and allow rolling review, but the release describes a path toward registration rather than a completed approval or Phase 2b result.

Market Context

ACRS's tag-specific clinical-news record showed an average 24-hour move of -3.08%. That history adds...

Analysis

ACRS's tag-specific clinical-news record showed an average 24-hour move of -3.08%. That history adds context to this Fast Track designation, while the planned Phase 2b trial and absence of efficacy data remain key items to watch.

Key Figures

Planned trial timing: Q4 2026

1 metrics

Planned trial timing Q4 2026 Phased multi-part Phase 2b trial of modzatinib in lichen planus

Previous Clinical trial Reports

5 past events · Latest: Apr 28 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 28	Phase 1a clinical data	Positive	-4.3%	Positive ATI-052 results and lichen planus selection for ATI-2138
Mar 18	Phase 2 enrollment	Positive	-5.7%	Completed bosakitug enrollment with 109 patients
Jan 06	Phase 1a clinical data	Positive	+0.0%	Interim ATI-052 data showed favorable safety and pharmacodynamic activity
Jul 29	Phase 2a clinical data	Positive	-1.3%	ATI-2138 met primary and key secondary endpoints in atopic dermatitis
Jun 23	Phase 1a/1b initiation	Positive	-4.1%	Initiated ATI-052 program targeting TSLP and IL-4R

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific clinical-trial news events were followed by negative or flat 24-hour reactions, with an average move of -3.08%.

Key Terms

fast track designation, rolling review, new drug application, priority review, +1 more

5 terms

fast track designation regulatory

"the FDA has granted Fast Track Designation for modzatinib"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

rolling review regulatory

"Fast Track designation also allows for rolling review of a New Drug Application"

A rolling review is a regulatory process where health authorities examine data on a drug or vaccine as it becomes available instead of waiting for a complete file at the end. For investors, this can speed up the timeline to approval and reduce uncertainty because regulators assess progress in real time—think of reading and approving chapters of a book as they’re finished rather than waiting for the whole manuscript, which can bring forward potential market access and revenue.

new drug application regulatory

"rolling review of a New Drug Application (NDA)"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

priority review regulatory

"may also be eligible for Priority Review if relevant criteria are met"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

phase 2b medical

"initiate a phased multi-part Phase 2b trial"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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WAYNE, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (the "FDA") has granted Fast Track Designation for modzatinib (ATI-2138) for moderate to severe lichen planus (LP) including oral erosive LP, cutaneous LP, and lichen planopilaris. Aclaris expects to initiate a phased multi-part Phase 2b trial of modzatinib in LP in the fourth quarter of 2026.

Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and fill an unmet medical need. The designation provides for more frequent interactions with the FDA regarding the development plan and clinical trial design, supporting a potentially more efficient path to registration. Fast Track designation also allows for rolling review of a New Drug Application (NDA), meaning completed sections may be submitted and reviewed on an ongoing basis rather than waiting until every section of the NDA is completed before the entire application can be reviewed. Additionally, Fast Track-designated programs may also be eligible for Priority Review if relevant criteria are met. For more information on the Fast Track designation, visit the FDA's official website.

“Lichen planus is a serious, clinically concerning disease with debilitating symptoms that can affect the quality of life of patients suffering from this disorder; unfortunately, there are currently no approved therapies,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris “This is an important milestone for our company; we look forward to more frequent interactions with the FDA as we move modzatinib into a Phase 2b trial later this year.”

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding the initiation of a Phase 2b trial of modzatinib in LP in the fourth quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks related to Aclaris’ ability to maintain Fast Track designation for modzatinib for LP and realize the potential benefits associated with such designation, uncertainties inherent in the conduct of preclinical and clinical studies, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the “Risk Factors” section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2025, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contacts:

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

FAQ

What did the FDA grant Aclaris Therapeutics (NASDAQ: ACRS) for modzatinib in August 2026?

The FDA granted Fast Track Designation to modzatinib (ATI-2138) for moderate to severe lichen planus. According to Aclaris, this status is intended to facilitate development and expedite review for investigational therapies that address serious conditions with unmet medical needs.

Which lichen planus indications are covered by modzatinib’s Fast Track Designation for ACRS?

Fast Track Designation for modzatinib covers moderate to severe lichen planus, including oral erosive LP, cutaneous LP, and lichen planopilaris. According to Aclaris, this reflects the program’s focus on multiple serious LP manifestations lacking approved treatment options.

When will Aclaris Therapeutics start the Phase 2b trial of modzatinib for lichen planus?

Aclaris expects to initiate a phased multi-part Phase 2b trial of modzatinib in lichen planus in the fourth quarter of 2026. According to Aclaris, this trial is the next development step following Fast Track Designation by the FDA.

What does FDA Fast Track Designation mean for Aclaris Therapeutics’ modzatinib program?

Fast Track Designation allows more frequent FDA interactions and potential rolling review of a New Drug Application. According to Aclaris, completed NDA sections for modzatinib may be submitted as they are ready, potentially supporting a more efficient path to registration.

Could Aclaris Therapeutics’ modzatinib (ACRS) become eligible for Priority Review?

Fast Track-designated programs like modzatinib may be eligible for FDA Priority Review if specific criteria are met. According to Aclaris, this is an additional potential benefit of Fast Track, though Priority Review is not automatic and depends on future regulatory assessment.

Why is Fast Track Designation important for patients with lichen planus treated by modzatinib?

Fast Track can speed development and review of therapies targeting serious diseases with unmet needs. According to Aclaris, lichen planus has debilitating symptoms and currently no approved therapies, so the designation supports a potentially faster path to an investigational treatment option.