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Pliant Therapeutics gets FDA Fast Track for PLN-101095 in solid tumors

Tue, 18 Aug 2026 08:30:12 -0400

Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate PLN-101095 in combination with pembrolizumab for the treatment of solid tumors resistant to immune checkpoint inhibitors.

PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins. The designation covers its use in patients whose tumors are refractory to immune checkpoint inhibitor therapy.

The drug is currently being evaluated in a Phase 1a/1b clinical trial called FORTIFY, which is enrolling patients with non-small cell lung cancer, tumors with high tumor mutational burden, or clear cell renal cell

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

Tue, 18 Aug 2026 08:30:00 -0400

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

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

Tue, 18 Aug 2026 08:30:00 -0400

“While immune checkpoint inhibitors have fundamentally changed the oncology treatment landscape, primary

Form SCHEDULE 13G PLIANT THERAPEUTICS, Filed by: ADAR1 Capital Management, LLC

Fri, 14 Aug 2026 21:31:00 -0400

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Form SCHEDULE 13G PLIANT THERAPEUTICS, Filed by: ADAR1 Capital Management, LLC

Fri, 14 Aug 2026 21:31:00 -0400

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Form SCHEDULE 13G/A PLIANT THERAPEUTICS, Filed by: CITADEL ADVISORS LLC

Fri, 14 Aug 2026 16:11:00 -0400

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Form SCHEDULE 13G/A PLIANT THERAPEUTICS, Filed by: CITADEL ADVISORS LLC

Fri, 14 Aug 2026 16:11:00 -0400

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Pliant Therapeutics, Inc. (PLRX) Misses Q2 EPS by 2c

Tue, 11 Aug 2026 17:10:06 -0400

Pliant Therapeutics, Inc. (NASDAQ: PLRX) reported Q2 EPS of ($0.36), $0.02 worse than the analyst estimate of ($0.34).

For earnings history and earnings-related data on Pliant Therapeutics, Inc. (PLRX) click here.

Form 8-K PLIANT THERAPEUTICS, For: Aug 11

Tue, 11 Aug 2026 16:11:00 -0400

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Form 8-K PLIANT THERAPEUTICS, For: Aug 11

Tue, 11 Aug 2026 16:11:00 -0400

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Form 10-Q PLIANT THERAPEUTICS, For: Jun 30

Tue, 11 Aug 2026 16:09:00 -0400

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Form 10-Q PLIANT THERAPEUTICS, For: Jun 30

Tue, 11 Aug 2026 16:09:00 -0400

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Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results

Tue, 11 Aug 2026 16:05:00 -0400

FORTIFY, a Phase 1b indication expansion trial of PLN-101095,
experiencing strong enrollment

Appointed seasoned oncology drug development leaders
Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to Board of Directors

SOUTH SAN FRANCISCO, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported second quarter 2026 financial results.

“In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY,” said Bernard Coulie, M.D.,

Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results

Tue, 11 Aug 2026 16:05:00 -0400

FORTIFY, a Phase 1b indication expansion trial of PLN-101095,
experiencing strong enrollment

Appointed seasoned oncology drug development leaders
Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to Board of Directors

“In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY,” said Bernard Coulie, M.D.,

Form 3 PLIANT THERAPEUTICS, For: Jul 09 Filed by: Iannone Robert

Mon, 13 Jul 2026 16:33:00 -0400

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Form 3 PLIANT THERAPEUTICS, For: Jul 09 Filed by: Iannone Robert

Mon, 13 Jul 2026 16:33:00 -0400

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Form 4 PLIANT THERAPEUTICS, For: Jul 09 Filed by: Borellini Flavia