Pliant Therapeutics Receives FDA Fast Track Designation for PLN-101095 in Combination with Pembrolizumab for the Treatment of ICI-Refractory Solid Tumors

Rhea-AI Summary

Pliant Therapeutics (Nasdaq: PLRX) reported that the U.S. FDA has granted Fast Track designation to PLN-101095, an oral dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential treatment of solid tumors resistant to immune checkpoint inhibitors (ICIs).

PLN-101095 is being studied in the Phase 1a/1b FORTIFY trial (NCT06270706), with data expected in 2027. According to Pliant Therapeutics, Fast Track status may allow more frequent FDA interactions, rolling New Drug Application submissions and eligibility for priority review if criteria are met.

Positive

• FDA Fast Track status for PLN-101095 plus pembrolizumab in ICI-refractory tumors
• FORTIFY Phase 1a/1b trial ongoing with data expected in 2027

Negative

• Program remains in early-stage Phase 1a/1b development
• Key clinical data for PLN-101095 not expected until 2027

Argus Aug 18 session 9 alerts

+4.09% close to close 92.7x rel. volume Open Argus

Details

Market move: PLRX +4.09% in the Aug 18 session. Fast Track designation

+6.1% Peak in 1 hr 3 min

$75.54M Market Cap

On Aug 18, the day this news came out, PLRX closed 4.09% above the previous close. Argus tracked a peak move of +6.1% during that session. Our momentum scanner recorded 9 alerts for this stock that day. Relative volume reached 92.7x the daily average during tracking.

Data tracked by StockTitan Argus for the Aug 18 session.

Key Figures

Trial Phase: Phase 1a/1b Expected Data Year: 2027

Trial Phase

Phase 1a/1b

FORTIFY trial evaluating PLN-101095

Expected Data Year

2027

FORTIFY trial data expected

Previous Clinical trial Reports

5 past events · Latest: May 15

Same Type 5 events

1. May 15

   Phase 1 trial advance

   24h Move

   -1.3%

   Lead candidate advanced into multiple ascending dose cohorts with safety demonstrated

2. May 21

   Clinical data presentation

   24h Move

   +0.8%

   Company presented clinical and preclinical data across three integrin-related studies

3. Mar 17

   Phase 1 clinical data

   24h Move

   +10.4%

   Interim PLN-101095 data showed responses and tumor-size reductions across three cohorts

4. Mar 03

   Trial discontinuation

   24h Move

   -59.9%

   BEACON-IPF was discontinued following safety concerns and an unfavorable risk-benefit profile

5. Feb 13

   Trial enrollment pause

   24h Move

   +21.0%

   Enrollment and dosing were paused after a DSMB recommendation for external review

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

Key Terms

fast track designation, ici-refractory, immune checkpoint inhibitors, new drug application

4 terms

fast track designation regulatory

"today announced the receipt of Fast Track designation from the U.S. Food and Drug Administration"

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.

ici-refractory medical

"for the potential the treatment of solid tumors that are resistant to immune checkpoint inhibitors"

A disease described as ici-refractory no longer responds to treatment with immune checkpoint inhibitors (ICIs), a class of cancer drugs that help the immune system attack tumors. It means prior ICI therapy failed to shrink or control the cancer, similar to how a lock stops responding to a key that once worked. This designation matters to investors because it defines a patient group with ongoing medical needs, impacts clinical trial design, potential market size for new therapies, and regulatory pathways.

immune checkpoint inhibitors medical

"solid tumors that are resistant to immune checkpoint inhibitors (ICIs)"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

new drug application regulatory

"the ability to submit a New Drug Application (NDA) on a rolling basis"

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.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SOUTH SAN FRANCISCO, Calif., Aug. 18, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential the treatment of solid tumors that are resistant to immune checkpoint inhibitors (ICIs). PLN-101095 is currently being evaluated in the Phase 1a/1b FORTIFY trial (NCT06270706) with data expected in 2027.

“While immune checkpoint inhibitors have fundamentally changed the oncology treatment landscape, primary or acquired resistance remains a significant barrier for the majority of patients,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “This Fast Track designation underscores the urgent need for innovative therapies for immune checkpoint inhibitor-refractory solid tumors and recognizes the potential of PLN-101095. We look forward to working closely with the FDA as we advance this program.”

FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and non-clinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. Pliant’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of ICI-refractory advanced or metastatic solid tumors. PLN-101095 is being investigated in FORTIFY, a Phase 1b indication expansion trial enrolling patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Pliant’s preclinical research is focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules with programs focused on delivering siRNAs to skeletal muscle cells, adipocytes, and renal cells. For additional information, please visit: www.PliantRx.com. Follow Pliant on social media at X, LinkedIn and Facebook.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include express or implied statements regarding ongoing clinical trial development of PLN-101095, including timing of enrollment and data; the potential benefits of PLN-101095; receipt of Fast Track designation and implications thereof; and Pliant’s plans for the continued development of PLN-101095 among others, including its integrin-based drug delivery platform. Because such statements deal with future events and are based on Pliant’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of Pliant’s product candidates, including any delays in Pliant’s ongoing or planned preclinical or clinical trials; the risks inherent in the drug development process, including obtaining regulatory approval, even with Fast Track Designation; the impact of current macroeconomic, geopolitical and marketplace conditions on Pliant’s business, operations, clinical supply and plans; Pliant’s reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of Pliant development operations; risks regarding the accuracy of Pliant’s estimates of expenses and timing of development, its capital requirements and the sufficiency of its cash to support planned operations; and Pliant’s ability to obtain and maintain intellectual property protection for Pliant’s product candidates; among others. These and additional risks are discussed in the sections titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Pliant’s Quarterly Report on Form 10-Q for the period ended June 30, 2026, as filed with the Securities and Exchange Commission (SEC) and available on the SEC's website, as may be amended or supplemented with future SEC filings. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What Fast Track designation did PLN-101095 receive and how does it impact Pliant Therapeutics (PLRX)?

PLN-101095 received FDA Fast Track designation for use with pembrolizumab in ICI‑refractory solid tumors. According to Pliant Therapeutics, this may enable more frequent FDA meetings, rolling New Drug Application submissions and potential priority review if eligibility criteria are satisfied.

What is PLN-101095 being developed for by Pliant Therapeutics (NASDAQ: PLRX)?

PLN-101095 is being developed to treat solid tumors resistant to immune checkpoint inhibitors when combined with pembrolizumab. According to Pliant Therapeutics, it is an oral small molecule dual selective inhibitor of αvβ8 and αvβ1 integrins now under evaluation in the FORTIFY trial.

What stage is the FORTIFY clinical trial (NCT06270706) for PLN-101095 and when is data expected?

FORTIFY is a Phase 1a/1b clinical trial evaluating PLN-101095 with pembrolizumab in ICI‑refractory solid tumors. According to Pliant Therapeutics, data from this study are expected in 2027, reflecting the program’s current early clinical development stage.

How could FDA Fast Track benefits support the PLN-101095 program for PLRX investors?

Fast Track may support PLN-101095 by enabling frequent FDA meetings, rolling NDA submission and eligibility for priority review. According to Pliant Therapeutics, these mechanisms are designed to facilitate and potentially expedite review for drugs addressing serious conditions with unmet medical needs.

Why did the FDA grant Fast Track designation to PLN-101095 in August 2026?

Fast Track was granted because available clinical and non‑clinical data suggested PLN-101095 could address an unmet need in ICI‑refractory solid tumors. According to Pliant Therapeutics, Fast Track is reserved for serious or life‑threatening conditions where improved therapies are needed.

What cancer patients could potentially benefit from PLN-101095 if approved, according to Pliant Therapeutics (PLRX)?

PLN-101095 targets patients with solid tumors that are primary or acquired resistant to immune checkpoint inhibitors. According to Pliant Therapeutics, this group represents a substantial unmet medical need despite the broad impact of checkpoint inhibitors on the oncology treatment landscape.