Pliant Therapeutics, Inc. Stock Price, News & Analysis

Pliant Therapeutics (Nasdaq: PLRX) announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will feature a fireside chat with Keith Cummings, M.D., Chief Financial Officer, and Éric Lefebvre, M.D., Chief Medical Officer. The chat is scheduled for Wednesday, August 14, 2024, at 1:00 p.m. Eastern Time at the Intercontinental Hotel in Boston, Massachusetts.

Interested parties can access a live webcast of the fireside chat through Pliant's website Investor Relations' Events & Presentation page. A replay of the webcast will be available on the company's website for 30 days after the event concludes.

Pliant Therapeutics (Nasdaq: PLRX) announced positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a Phase 2a trial of bexotegrast in primary sclerosing cholangitis (PSC) patients. Key findings include:

1. Safety: Bexotegrast was well-tolerated up to 40 weeks with no treatment-related severe or serious adverse events.

2. Efficacy: Improvement in liver stiffness at Week 24 compared to placebo, statistically significant improvement in alkaline phosphatase (ALP) levels, and continued improvement in hepatocyte function and bile flow.

3. FDA Guidance: The FDA supports a 52-week, dose-ranging Phase 2b trial using non-invasive endpoints for the next steps in PSC development.

These results suggest bexotegrast's potential for disease stabilization in PSC, a rare liver disease with no FDA or EMA-approved therapies.

Pliant Therapeutics (Nasdaq: PLRX) has appointed Steve Krognes to its Board of Directors as announced on June 13, 2024. Krognes brings over 30 years of financial and corporate strategy experience in the biopharmaceutical industry. His prior roles include Chief Financial Officer at Denali Therapeutics and Genentech, and Global Head of Mergers and Acquisitions at Roche. Krognes' financial expertise and strategic leadership are expected to complement Pliant’s existing board, aiding in the company's evolution as a late-stage clinical entity. Currently, Krognes serves on several other boards, including Denali Therapeutics, Guardant Health, argenx, and ClavystBio. He holds an MBA from Harvard Business School and a B.S. in Economics from Wharton School, University of Pennsylvania.

Pliant Therapeutics (Nasdaq: PLRX) announced an inducement grant under Nasdaq Listing Rule 5635(c)(4) on June 12, 2024. The company granted stock options for 120,000 shares to Dr. Chohee Yun, the newly appointed Senior VP of Clinical Development. These options have an exercise price of $11.51 per share, aligned with the closing price on June 10, 2024. The options will vest over four years: 25% on the first anniversary and the remainder monthly over the next three years. The options have a 10-year term and are governed by the 2022 Inducement Plan.

Pliant Therapeutics presented promising data on their drug bexotegrast at the EASL International Liver Congress. Key findings included positive interim results from the Phase 2a INTEGRIS-PSC trial, showing that bexotegrast was well tolerated and effective in reducing markers of liver fibrosis over 12 weeks. Additionally, bexotegrast demonstrated a unique mechanism of action in targeting fibrogenic cells and inhibiting TGF-β signaling. These results further validate bexotegrast's potential as a treatment for fibrotic liver disease.

Pliant Therapeutics presented key data on their drug bexotegrast at the American Thoracic Society 2024 International Conference. The data includes clinical safety, imaging, and preclinical results supporting late-stage development of the drug for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). Dr. Gregory P. Cosgrove highlighted that bexotegrast has been well tolerated in over 700 participants across 15 trials with mostly mild to moderate adverse events. Dr. Mahru C. An shared that bexotegrast effectively targets TGF-beta signaling in fibrogenic cells. Dr. Martin L. Decaris reviewed a post-hoc analysis showing significant modulation of plasma biomarkers in IPF patients over 12 weeks. Lastly, Dr. Jonathan G. Goldin reported a reduction in lung fibrosis progression and no increase in alveolar inflammation in bexotegrast-treated patients over 24 weeks.

Pliant Therapeutics announced positive topline data from a 12-week Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The study showed that bexotegrast 160 mg led to a reduction in total lung collagen compared to an increase in the placebo group, suggesting potential reversal of fibrosis. Improvements in forced vital capacity (FVC) and reduced cough severity were observed in bexotegrast-treated patients at all timepoints. The drug was well tolerated with no serious adverse events or discontinuations. The trial involved 10 patients, with 7 receiving bexotegrast and 3 on placebo. PET imaging was used to measure changes in lung collagen levels. The primary endpoint was the change in standardized uptake value (SUV) of a PET ligand that binds to type 1 collagen. Bexotegrast-treated patients showed a reduction in SUV, indicating a decrease in lung collagen. Additionally, improvements in fibrosis biomarkers, FVCpp, and patient-reported cough severity were noted.

Pliant Therapeutics, Inc. (PLRX) announces two poster presentations at the EASL International Liver Congress in Milan, Italy. The presentations focus on the updated safety and efficacy analysis of the INTEGRIS-PSC Phase 2a trial and the TGF-beta inhibition in human liver explant tissue with biliary fibrosis. The company continues to lead in the discovery of novel therapeutics for fibrotic diseases.

Pliant Therapeutics, a leader in fibrotic disease therapeutics, reported positive safety and efficacy data from Phase 2a trials. They accelerated the BEACON-IPF Phase 2b trial and received regulatory clearance for the PLN-101325 muscular dystrophy program. Financially, they reported a net loss of $47.0 million, with $483.9 million in cash and investments as of March 31, 2024.