Pliant Therapeutics, Inc. Stock Price, News & Analysis

Pliant Therapeutics (NASDAQ: PLRX) has announced that its lead drug candidate, PLN-74809, received Fast Track designation from the FDA for treating primary sclerosing cholangitis (PSC). This designation aims to expedite the drug's development due to the disease’s severity and lack of FDA-approved therapies. PLN-74809 is currently in the Phase 2a INTEGRIS-PSC trial, with topline data expected in the first half of 2023. PSC affects over 30,000 patients in the U.S. alone, highlighting a significant unmet medical need.

Pliant Therapeutics, a clinical-stage biotechnology company, has successfully completed an upsized underwritten public offering of 12,432,432 shares at $18.50 each, generating approximately $230 million in gross proceeds. The offering included the full exercise of the underwriters' option for additional shares. Pliant intends to utilize the net proceeds to advance ongoing and future clinical programs, including PLN-74809, as well as to support working capital and general corporate purposes. J.P. Morgan and Cowen acted as lead book-running managers for this offering.

Pliant Therapeutics (PLRX) announced the pricing of an upsized underwritten public offering of 10,810,811 shares at $18.50 each, aiming to raise approximately $200 million. The offering is set to close around July 15, 2022. The proceeds will support ongoing and future clinical programs, working capital, operating expenses, and capital expenditures. Underwriters have an option for an additional 1,621,621 shares. The offering is conducted under a previously effective SEC registration statement.

Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced a public offering of $150 million in common stock, with an optional $22.5 million for underwriters. The funds will support ongoing and future clinical programs, including PLN-74809, operational expenses, and development of their integrin targeting platform. The offering is subject to market conditions and regulatory approvals. J.P. Morgan and Cowen are leading the offering, with RBC Capital Markets acting as a book-running manager.

Pliant Therapeutics announced positive results from the INTEGRIS-IPF Phase 2a trial of PLN-74809 for idiopathic pulmonary fibrosis (IPF). The trial met its primary and secondary endpoints over 12 weeks, demonstrating a favorable safety profile with no drug-related serious adverse events. Notably, PLN-74809 showed a dose-dependent treatment effect, achieving an 80% reduction in forced vital capacity (FVC) decline compared to placebo. 97% of patients completed the trial without discontinuations due to adverse effects. The company plans to share results with regulatory authorities and anticipates interim data from an additional cohort in early 2023.

Pliant Therapeutics (PLRX) presented significant findings on its antifibrotic candidate, PLN-74809, at the International Liver Congress 2022. The posters highlighted the oral dual integrin inhibitor's favorable tolerability in the INTEGRIS-PSC study and its preclinical efficacy in reducing fibrosis markers in biliary fibrosis models. Results indicated dose-dependent reductions in liver fibrosis and TGF-β signaling, positioning PLN-74809 as a promising treatment for primary sclerosing cholangitis (PSC) and idiopathic pulmonary fibrosis (IPF). The ongoing Phase 2a trials aim to further evaluate the drug's impact.

Pliant Therapeutics, Inc. (Nasdaq: PLRX) has presented promising preclinical data for PLN-101325, an allosteric antibody targeting the α₇β₁ integrin, at the New Directions in Biology and Disease of Skeletal Muscle Conference. The data indicates improved muscle function in dystrophic conditions, particularly in diaphragm strength, which could lead to better treatments for muscular dystrophies like Duchenne Muscular Dystrophy (DMD). An IND submission for PLN-101325 is expected by the end of 2022, with clinical trials anticipated to commence in early 2023.

Pliant Therapeutics (Nasdaq: PLRX) has announced the advancement of a fibrosis-directed integrin target into development, following a successful validation from its 2019 collaboration with Novartis. The company will receive a $4 million milestone payment alongside research funding to support the initiation of development activities. This milestone showcases Pliant's commitment to advancing therapies for fibrotic diseases, highlighting the productivity of its antifibrotic drug development platform.

Pliant Therapeutics (Nasdaq: PLRX) announced the presentation of two scientific posters at the International Liver Congress™ 2022 in London from June 22-26, 2022. The posters will focus on the dual inhibition of integrins α_vß₆ and α_vß₁ by PLN-74809 in treating primary sclerosing cholangitis (PSC).

The first poster highlights findings from preclinical studies, while the second investigates portal pressure and liver fibrosis in rats with biliary cirrhosis. The presentations will be available on-demand at Pliant's website.