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

ACRS

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

ACRS gets FDA Fast Track for modzatinib, accelerating LP program timeline

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  <section data-block="information">
    <h3>Information</h3>
    <p>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</p>
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  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>ACRS announced FDA Fast Track designation for modzatinib (ATI-2138) to treat moderate-to-severe LP, including oral erosive LP, cutaneous LP, and lichen planopilaris. The program will begin a phased, multi-part Phase 2b trial in Q4 2026, with rolling review and potential Priority Review under Fast Track. This milestone could de-risk the program and support earlier data-driven valuation, though clinical outcomes remain uncertain.</p>
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  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>FDA grants Fast Track for modzatinib in LP. Aclaris aims Phase 2b in LP in Q4 2026.</li><li>Fast Track enables rolling review and potential Priority Review. Could shorten path to potential approval.</li><li>Lichen planus has no approved therapies. Represents a significant unmet medical need.</li><li>Phase 2b initiation planned Q4 2026. Readouts may inform valuation.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Aclaris Therapeutics, Inc. (ACRS)</strong>: FDA Fast Track designation for modzatinib in LP; potential near-term clinical and stock impact.</li><li><strong>FDA (NA)</strong>: Regulatory authority granting designation; not a direct stock mover but influences development timeline.</li></ul>
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  <section data-block="category">
    <h3>Industry News</h3>
    <p>Industry News: regulatory milestone for a clinical-stage biotech; supports development timeline and potential valuation uplift if phase data are favorable.</p>
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  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>FDA Fast Track designation may accelerate data readouts and potential approval.</li><li>Phase 2b initiation planned for Q4 2026 provides near-term visibility.</li><li>LP has no approved therapies, creating unmet-need backdrop.</li><li>Possible Priority Review if criteria met; could lift valuation.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Date of release: Aug 6, 2026.</li><li>Ticker: ACRS (NASDAQ).</li><li>Drug: Modzatinib (ATI-2138).</li><li>Indication: Moderate to severe LP including oral erosive LP, cutaneous LP, and lichen planopilaris.</li><li>Phase 2b trial planned to begin in Q4 2026; Fast Track enables rolling review and potential Priority Review.</li></ul>
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  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Positive near-term catalyst; expect upside as Phase 2b advances and rolling reviews shorten timelines (3–9 months).</p>
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><p>WAYNE, Pa., Aug.  06, 2026  (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ACRS">ACRS</a>), 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 &#34;FDA&#34;) 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.</p>  <p>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 <a href="https://www.globenewswire.com/Tracker?data=7C6n0-eVArvSUWfAelq1-ml_h0a3FdQvMIgVlblquCeqFnEGcgXQRWfYAY3H-RZPuhbjcPCB0zLvtHSctr9bMOmpbRx73aanBKo5F6vf9phLKlf47alEehQYZ8PugCfq2yn7x6E0uW4kXLpvrmWHCa3EBh8f81yYsQgV4J5UESLA0xKjmsjGgunUzbF-ixpRZ9OrsqHvx0LOblo3na0Xsg==" rel="nofollow" target="_blank">FDA&#39;s official website</a>.</p>  <p>"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."</p>  <p><strong>About Aclaris Therapeutics, Inc.</strong></p>  <p>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&amp;D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on <a href="https://www.globenewswire.com/Tracker?data=FRwp-HVhw3JhUt4iExJ9wH8A43SV-6Cooq5kI8zMcrHQjZB5mm5V3JJf3u4c7ERGK3MZsQWf6fpQWgTDQ1ITMp5W2qBtaJ71NlXwI1TPD7xVzeVaT2h_2HISkp_64Mth" rel="nofollow" target="_blank">LinkedIn</a>.</p>  <p><strong>Cautionary Note Regarding Forward-Looking Statements</strong></p>  <p>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.</p>  <p><strong>Aclaris Therapeutics Contacts:</strong></p>  <p><strong>Will Roberts</strong><br></br>Senior Vice President<br></br>Corporate Communications and Investor Relations<br></br>(484) 329-2125<br></br>wroberts@aclaristx.com</p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTgwNTQ4NSM3NzYzNjE3IzIwMjAxODM="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/M2VjMmNhMzctZTFjMy00MGE1LTg1M2EtMDlkZTc3MThjOTNmLTEwMzE3NTUtMjAyNi0wOC0wNi1lbg==/tiny/Aclaris-Therapeutics-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/de2bcb21-de59-4226-bc8b-b1b747461f51"><img src="https://ml.globenewswire.com/media/de2bcb21-de59-4226-bc8b-b1b747461f51/small/aclaris-logo-clr-jpg.jpg" border="0" width="150" height="63" alt="Primary Logo"></img></a></p>

ACRS announced FDA Fast Track designation for modzatinib (ATI-2138) to treat moderate-to-severe LP, including oral erosive LP, cutaneous LP, and lichen planopilaris. The program will begin a phased, multi-part Phase 2b trial in Q4 2026, with rolling review and potential Priority Review under Fast Track. This milestone could de-risk the program and support earlier data-driven valuation, though clinical outcomes remain uncertain.

News insight

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

AI summary

Sentiment rationale

Key facts

Industry News