Pliant Therapeutics Initiates FORTIFY Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 30 2026
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Should l Buy PLRX?
Pliant Therapeutics announced the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor -refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins alphavbeta8 and alphavbeta1.
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Analyst Views on PLRX
Wall Street analysts forecast PLRX stock price to rise
4 Analyst Rating
0 Buy
3 Hold
1 Sell
Hold
Current: 1.165
Low
2.00
Averages
3.00
High
4.00
Current: 1.165
Low
2.00
Averages
3.00
High
4.00
About PLRX
Pliant Therapeutics, Inc. is a late-stage biotechnology company, which is focused on discovering and developing novel therapies for the treatment of fibrosis and related diseases. The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of avb6 and avb1 integrins that is in development in the lead indication for the treatment of idiopathic pulmonary fibrosis, or idiopathic pulmonary fibrosis (IPF). The Company’s second clinical program, PLN-101095, is a small molecule, dual selective inhibitor of integrins avb8 and avb1 for the treatment of solid tumors that are resistant to immune checkpoint inhibitors. Its Phase 1-ready program PLN-101325, is in development for treatment of muscular dystrophies, including Duchenne muscular dystrophy. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin a7b1.
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.
Atisama Advances RB042 Clinical Trial Progress
- Clinical Trial Progress: Atisama Therapeutics' RB042 has advanced to the multiple ascending dose phase in its Phase 1 trial involving healthy volunteers, demonstrating good safety and tolerability, with three single ascending dose cohorts completed and the first multiple ascending dose cohort initiated, with higher-dose results expected in H2 2026.
- Board Appointment: Atisama has appointed Dr. Bernard Coulie as Chair of the Board, bringing over 25 years of international biopharma leadership in pulmonary disease, which is expected to provide strategic depth and governance experience as the company progresses through critical clinical development phases.
- Market Demand Opportunity: COPD affects approximately 400 million people globally and is the third leading cause of death; RB042 aims to address the significant unmet need for targeted therapies in this area by modulating inflammation-related gene expression, presenting substantial market potential.
- Scientific Innovation Platform: Atisama's SSO platform uniquely down-regulates disease-driving isoforms while up-regulating protective counterparts, with RB042 as its lead asset currently in clinical development, poised to potentially deliver breakthrough advancements in respiratory medicine.
See More
Pliant Therapeutics Initiates PLN-101095 Clinical Trial for Solid Tumors
- Clinical Trial Launch: Pliant Therapeutics has announced the dosing of the first participant in the FORTIFY Phase 1b clinical trial for PLN-101095, marking a significant advancement in the treatment of immune checkpoint inhibitor-resistant tumors, which is expected to open new avenues for future therapies.
- Mechanism Exploration: PLN-101095, an oral small molecule dual-selective inhibitor targeting integrins αvβ8 and αvβ1, aims to improve the tumor microenvironment by blocking TGF-β activation, potentially enhancing immune cell infiltration and significantly improving treatment outcomes.
- Patient Recruitment Progress: The trial is currently enrolling three cohorts of patients, including those with non-small cell lung cancer and tumors with high mutational burden, with interim data expected in 2027, which will provide preliminary evidence of the drug's clinical efficacy.
- Strategic Development Focus: As a leader in integrin drug development, Pliant Therapeutics is committed to expanding its market share in oncology through the development of PLN-101095, further solidifying its position in the biopharmaceutical industry.
See More
Pliant Therapeutics Presents Updated Clinical Data for PLN-101095
- Significant Tumor Reduction: In heavily pretreated immune checkpoint inhibitor (ICI)-refractory patients, the combination of PLN-101095 and pembrolizumab demonstrated an average tumor reduction of 89%, with a median treatment duration of 19 months for three confirmed responders, indicating the potential efficacy of this therapy in hard-to-treat tumors.
- Biomarker Exploration: All responders exhibited a significant increase in plasma interferon gamma (IFN-γ) levels, ranging from 4 to 13-fold after a 14-day monotherapy, and maintained over a 2-fold increase at Week 10, suggesting that PLN-101095 may serve as a biomarker for TGF-β inhibition and an early indicator of its anti-tumor activity.
- Trial Expansion: Pliant has initiated a Phase 1b trial enrolling patients with NSCLC and high tumor mutational burden, where they will receive PLN-101095 monotherapy followed by pembrolizumab, with interim data expected in 2027 to further validate the clinical value of this combination therapy.
- Good Safety Profile: PLN-101095 was generally well tolerated across all doses, with only two discontinuations due to adverse events, and most treatment-related adverse events were Grade 1 or 2 rashes, demonstrating the safety and feasibility of this drug in clinical applications.
See More
Pliant Therapeutics Reports Q4 EPS In-Line with Expectations
- Earnings Performance: Pliant Therapeutics reported a Q4 GAAP EPS of -$0.38, aligning with market expectations, which indicates the company's financial stability amidst ongoing challenges.
- Cash Reserves: As of December 31, 2025, the company holds $192.4 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the second half of 2028, thereby enhancing investor confidence in its operational sustainability.
- Market Opportunity: The expiration of the poison pill plan has created a reverse arbitrage opportunity for Pliant Therapeutics, potentially offering investors new strategic avenues and reflecting market interest in the company's future prospects.
- Industry Engagement: The company presented at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, further elevating its visibility and influence within the industry.
See More
Pliant Therapeutics Shifts Focus to Oncology, Showcases Early PLN-101095 Data
- Strategic Shift: Pliant Therapeutics has pivoted from fibrosis to oncology, focusing on its integrin small-molecule platform while evaluating external assets for potential in-licensing or acquisition, indicating a proactive approach in a new therapeutic area.
- Clinical Data Highlights: Early Phase I data for oral PLN-101095 showed activity at doses of ≥1,000 mg BID with four clinical responders and an average tumor reduction of approximately 71%, suggesting significant potential efficacy across multiple tumor types and laying the groundwork for future studies.
- Strong Financial Position: Pliant reported approximately $211 million in cash, expected to sustain operations into at least the second half of 2028, demonstrating the company's financial stability while advancing its oncology initiatives.
- Future Plans: The company plans to initiate a Phase Ib expansion study of PLN-101095 in combination with pembrolizumab in Q2, focusing on specific indications like non-small cell lung cancer, which is anticipated to yield more data and development opportunities in oncology.
See More
Combination of Pliant Cancer Drug and Merck's Keytruda Enhances Treatment Responses in Challenging Tumors
Pliant Therapeutics' Trial Results: Pliant Therapeutics released promising interim data from its Phase 1 trial of PLN-101095, showing antitumor activity in combination with Merck's Keytruda in patients with advanced solid tumors that are refractory to immune checkpoint inhibitors.
Clinical Responses Observed: Among the heavily pretreated patient population, there were four responders, including one complete response and three partial responses, with clinical responses noted in various cancer types such as cholangiocarcinoma and melanoma.
IFN-γ Levels and Tolerability: Responding patients exhibited significant increases in plasma interferon gamma levels, while PLN-101095 was generally well tolerated, demonstrating a dose-dependent pharmacokinetic profile.
Stock Performance and Future Plans: Despite the positive trial results, Pliant's stock fell by over 20%, trading near its 52-week low, while the company plans to initiate a Phase 1b trial in 2026 to further explore PLN-101095's efficacy in non-small cell lung cancer and other tumor types.
See More
Atisama Advances RB042 Clinical Trial Progress
- Clinical Trial Progress: Atisama Therapeutics' RB042 has advanced to the multiple ascending dose phase in its Phase 1 trial involving healthy volunteers, demonstrating good safety and tolerability, with three single ascending dose cohorts completed and the first multiple ascending dose cohort initiated, with higher-dose results expected in H2 2026.
- Board Appointment: Atisama has appointed Dr. Bernard Coulie as Chair of the Board, bringing over 25 years of international biopharma leadership in pulmonary disease, which is expected to provide strategic depth and governance experience as the company progresses through critical clinical development phases.
- Market Demand Opportunity: COPD affects approximately 400 million people globally and is the third leading cause of death; RB042 aims to address the significant unmet need for targeted therapies in this area by modulating inflammation-related gene expression, presenting substantial market potential.
- Scientific Innovation Platform: Atisama's SSO platform uniquely down-regulates disease-driving isoforms while up-regulating protective counterparts, with RB042 as its lead asset currently in clinical development, poised to potentially deliver breakthrough advancements in respiratory medicine.
See More
Pliant Therapeutics Initiates PLN-101095 Clinical Trial for Solid Tumors
- Clinical Trial Launch: Pliant Therapeutics has announced the dosing of the first participant in the FORTIFY Phase 1b clinical trial for PLN-101095, marking a significant advancement in the treatment of immune checkpoint inhibitor-resistant tumors, which is expected to open new avenues for future therapies.
- Mechanism Exploration: PLN-101095, an oral small molecule dual-selective inhibitor targeting integrins αvβ8 and αvβ1, aims to improve the tumor microenvironment by blocking TGF-β activation, potentially enhancing immune cell infiltration and significantly improving treatment outcomes.
- Patient Recruitment Progress: The trial is currently enrolling three cohorts of patients, including those with non-small cell lung cancer and tumors with high mutational burden, with interim data expected in 2027, which will provide preliminary evidence of the drug's clinical efficacy.
- Strategic Development Focus: As a leader in integrin drug development, Pliant Therapeutics is committed to expanding its market share in oncology through the development of PLN-101095, further solidifying its position in the biopharmaceutical industry.
See More
Pliant Therapeutics Presents Updated Clinical Data for PLN-101095
- Significant Tumor Reduction: In heavily pretreated immune checkpoint inhibitor (ICI)-refractory patients, the combination of PLN-101095 and pembrolizumab demonstrated an average tumor reduction of 89%, with a median treatment duration of 19 months for three confirmed responders, indicating the potential efficacy of this therapy in hard-to-treat tumors.
- Biomarker Exploration: All responders exhibited a significant increase in plasma interferon gamma (IFN-γ) levels, ranging from 4 to 13-fold after a 14-day monotherapy, and maintained over a 2-fold increase at Week 10, suggesting that PLN-101095 may serve as a biomarker for TGF-β inhibition and an early indicator of its anti-tumor activity.
- Trial Expansion: Pliant has initiated a Phase 1b trial enrolling patients with NSCLC and high tumor mutational burden, where they will receive PLN-101095 monotherapy followed by pembrolizumab, with interim data expected in 2027 to further validate the clinical value of this combination therapy.
- Good Safety Profile: PLN-101095 was generally well tolerated across all doses, with only two discontinuations due to adverse events, and most treatment-related adverse events were Grade 1 or 2 rashes, demonstrating the safety and feasibility of this drug in clinical applications.
See More
Pliant Therapeutics Reports Q4 EPS In-Line with Expectations
- Earnings Performance: Pliant Therapeutics reported a Q4 GAAP EPS of -$0.38, aligning with market expectations, which indicates the company's financial stability amidst ongoing challenges.
- Cash Reserves: As of December 31, 2025, the company holds $192.4 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the second half of 2028, thereby enhancing investor confidence in its operational sustainability.
- Market Opportunity: The expiration of the poison pill plan has created a reverse arbitrage opportunity for Pliant Therapeutics, potentially offering investors new strategic avenues and reflecting market interest in the company's future prospects.
- Industry Engagement: The company presented at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, further elevating its visibility and influence within the industry.
See More
Pliant Therapeutics Shifts Focus to Oncology, Showcases Early PLN-101095 Data
- Strategic Shift: Pliant Therapeutics has pivoted from fibrosis to oncology, focusing on its integrin small-molecule platform while evaluating external assets for potential in-licensing or acquisition, indicating a proactive approach in a new therapeutic area.
- Clinical Data Highlights: Early Phase I data for oral PLN-101095 showed activity at doses of ≥1,000 mg BID with four clinical responders and an average tumor reduction of approximately 71%, suggesting significant potential efficacy across multiple tumor types and laying the groundwork for future studies.
- Strong Financial Position: Pliant reported approximately $211 million in cash, expected to sustain operations into at least the second half of 2028, demonstrating the company's financial stability while advancing its oncology initiatives.
- Future Plans: The company plans to initiate a Phase Ib expansion study of PLN-101095 in combination with pembrolizumab in Q2, focusing on specific indications like non-small cell lung cancer, which is anticipated to yield more data and development opportunities in oncology.
See More
Combination of Pliant Cancer Drug and Merck's Keytruda Enhances Treatment Responses in Challenging Tumors
Pliant Therapeutics' Trial Results: Pliant Therapeutics released promising interim data from its Phase 1 trial of PLN-101095, showing antitumor activity in combination with Merck's Keytruda in patients with advanced solid tumors that are refractory to immune checkpoint inhibitors.
Clinical Responses Observed: Among the heavily pretreated patient population, there were four responders, including one complete response and three partial responses, with clinical responses noted in various cancer types such as cholangiocarcinoma and melanoma.
IFN-γ Levels and Tolerability: Responding patients exhibited significant increases in plasma interferon gamma levels, while PLN-101095 was generally well tolerated, demonstrating a dose-dependent pharmacokinetic profile.
Stock Performance and Future Plans: Despite the positive trial results, Pliant's stock fell by over 20%, trading near its 52-week low, while the company plans to initiate a Phase 1b trial in 2026 to further explore PLN-101095's efficacy in non-small cell lung cancer and other tumor types.
See More
