SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis. A total o ...

SAN DIEGO, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chro ...

Summary of Gyre Therapeutics FY Conference Call Company Overview - **Company Name**: Gyre Therapeutics (NasdaqCM: GYRE) - **Industry**: Pharmaceutical, specifically focused on fibrosis-first therapies - **Foundation Year**: 2002 - **Headquarters**: China with global ambitions - **Employee Count**: Approximately 600, with 400 in commercial activities [2][3] Core Business and Market Position - **Primary Focus**: Treatment of pulmonary fibrosis, particularly through the drug pirfenidone, branded as ETUARY® in China - **Market Share**: - 50% market share in the idiopathic pulmonary fibrosis (IPF) market - Over 90% market share in the pirfenidone space in China [3] - **Patient Reach**: Treated over 150,000 patients in the last decade, with coverage across 3,000 hospitals and pharmacies [4] Financial Performance - **EBITDA**: Positive since 2017, with a compounded annual growth rate of 32% [4] - **Revenue Trends**: Experienced a small dip in revenue last year due to economic conditions but anticipates continued growth [4] Product Pipeline and Development - **Lead Drug**: Hydronidone (F351), designed to tackle fibrosis with improved potency and safety profile compared to pirfenidone [5] - **Recent Clinical Results**: - Phase 3 results for chronic hepatitis B (CHB) showed statistically significant fibrosis regression with a treatment delta of approximately 23% [9] - Safety profile demonstrated a 4.88% rate of serious adverse events compared to 6.45% for placebo [10] - **Future Plans**: - Filing for Investigational New Drug (IND) status in the U.S. for advanced liver fibrosis (MASH) [10][12] - Expanding into additional indications such as radiation-induced lung injury (RALI), pneumoconiosis, and diabetic kidney disease (DKD) [6][7] Strategic Moves - **Acquisitions**: - Acquired generic rights for nintedanib, expanding treatment offerings [8] - Acquired rights to Contiva (Evotrauma PEG) to enter the hepatology space [8] - **Market Potential**: - Targeting a CHB market in China with approximately 5 million patients, including 2.6 million with unmet needs [11] - MASH market in the U.S. estimated at 650,000 patients, significantly larger than the CHB market [12] Competitive Advantages - **Integrated Platform**: - Two GMP-certified manufacturing facilities ready to scale production [5][16] - End-to-end control from discovery to commercialization, allowing for cost efficiency and rapid scaling [16] - **Market Strategy**: - Focus on China for faster patient enrollment and cost efficiency, with plans to expand globally [14] - Strong commercial execution in China to maintain market leadership [15] Conclusion - **Growth Narrative**: Gyre Therapeutics presents a story of sustainable growth with a diversified pipeline and strategic market positioning, offering potential upside for investors [17]

Preclinical data demonstrate ATYR0101's unique anti-fibrotic mechanism through interaction with LTBP-1. About ATYR0101 ATYR0101 to be showcased in oral presentation at the American Thoracic Society (ATS) 2025 Respiratory Innovation Summit. SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in- class medicines from its proprietary tRNA synthetase platform, today announ ...

Summary of Pliant Therapeutics (PLRX) FY Conference Call - January 10, 2023 Company Overview - **Company**: Pliant Therapeutics - **Focus**: Development of novel treatments for fibrotic diseases with an industry-leading fibrosis platform [2][3] Key Programs and Developments 1. **Bexotogast (formerly PLN74809)** - Currently in Phase 2A trials for Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC) [3][4] - Phase 2A data showed it was well tolerated with a clear anti-fibrotic effect, evidenced by an 80% reduction in FVC decline [23][24] - Expected interim data for 12-week treatment in early Q1 2023 and final data in Q2 2023 [7][31] 2. **PLN101095** - A potential first-in-class selective integrin small molecule inhibitor targeting immune checkpoint inhibitor resistance [4] - IND submitted late last year, with Phase I trials expected to start in Q2 2023 [4][39] 3. **PLN101325** - An allosteric activator aimed at muscle diseases and fibrosis, with an IND filing expected by the end of 2023 [5][6] 4. **PLN1474** - Focused on treating NASH-associated liver fibrosis, owned by Novartis, entering Phase II testing [6] Financial Position - **Cash Position**: $360 million at the end of Q3 2022, including $230 million from a follow-on financing [5] Market Landscape and Competitive Positioning - Current IPF market dominated by Asbriet and OFEV, generating over $3 billion in revenue in 2020 [9] - Asbriet went generic in 2022, and OFEV will lose exclusivity in 2025, creating a significant opportunity for new treatments [9] - Bexotogast offers advantages such as: - Direct anti-fibrotic effect through TGF beta inhibition [10] - Once-daily dosing compared to multiple daily doses for existing treatments [10] - Better tolerability with no GI side effects reported [10][28] Clinical Data Highlights - Bexotogast demonstrated a 15 mL decrease in FVC decline compared to placebo, with a notable improvement in the 80 mg dose group [24][25] - Safety profile showed no significant adverse events or discontinuations due to the drug [22][23] - The drug's mechanism involves blocking integrins selectively upregulated in fibrotic tissue, leading to reduced pro-fibrotic gene expression [13][14] Upcoming Milestones - Anticipated data releases for bexotogast in both IPF and PSC throughout 2023 [7][33] - Phase IIb study for bexotogast expected to start mid-2023, with a focus on both monotherapy and combination therapy [58][61] Regulatory Considerations - Ongoing discussions with the FDA regarding the design of the Phase IIb study, which will include a significant portion of patients not on standard care [58][61] - The potential for using validated biomarkers as co-primary endpoints in PSC trials, given the challenges of histological assessments [66][68] Conclusion - Pliant Therapeutics is well-positioned in the fibrotic disease market with promising clinical data and a strong financial foundation, aiming to address significant unmet needs in IPF and PSC treatments [2][5][9]