GYRE

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers First patient enrolled in Phase 2/3 trial evaluating ETUARY™ for radiation-induced lung injury, including immune-related pneumonitis SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial stage biopharmaceutical company with operations in the United States and China, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “Building on our successful pre-NDA meeting with China’s CDE at the beginning of the year, we are particularly encouraged by the NMPA’s priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis,” said Ying Luo, Chief Executive Officer of Gyre Therapeutics. “In parallel, our acquisition of Cullgen expands our capabilities into targeted protein degradation, positioning Gyre to drive long-term innovation beyond fibrosis. We believe these achievements strengthen our foundation as a fully integrated, multi-national biopharmaceutical company as we advance our mission to deliver transformative therapies to patients worldwide.” First Quarter Business Highlights and Upcoming Milestones Commercial Products: ETUARY™ (pirfenidone), the Company's primary product, generated $21.0 million in sales for the quarter ended March 31, 2026, compared to $21.7 million for the same period in 2025. Etorel™ (nintedanib ethanesulfonate soft capsules), which was launched in June 2025, generated $0.7 million in sales for the quarter ended March 31, 2026. Contiva™ (avatrombopag maleate tablets), launched in March 2025, generated $0.8 million in sales for the quarter ended March 31, 2026, compared to $0.3 million for the same period in 2025. Pipeline Development Updates Hydronidone (F351): In March 2026, Gyre announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted priority review designation to F351 for the treatment...

Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China’s Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients across 18 sites) Hydronidone U.S. Investigational New Drug (IND) application for MASH-associated liver fibrosis anticipated in 2026 SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update. “2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China’s CDE,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. “Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States.”...

Gyre Therapeutics, Inc. (GYRE) came out with quarterly earnings of $0.04 per share, missing the Zacks Consensus Estimate of $0.08 per share. This compares to earnings of $0.01 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -50.00%. A quarter ago, it was expected that this company would post earnings of $0.05 per share when it actually produced earnings of $0.06, delivering a surprise of +20%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Gyre Therapeutics, Inc., which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $37.2 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 2.17%. This compares to year-ago revenues of $27.87 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Gyre Therapeutics, Inc. shares have added about 18% since the beginning of the year versus the S&P 500's decline of 1%. While Gyre Therapeutics, Inc. has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Gyre Therapeutics, Inc. was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future....

Unsurprisingly, Gyre Therapeutics, Inc.'s (NASDAQ:GYRE) stock price was strong on the back of its healthy earnings report. However, we think that shareholders may be missing some concerning details in the numbers. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. One essential aspect of assessing earnings quality is to look at how much a company is diluting shareholders. In fact, Gyre Therapeutics increased the number of shares on issue by 5.9% over the last twelve months by issuing new shares. That means its earnings are split among a greater number of shares. Per share metrics like EPS help us understand how much actual shareholders are benefitting from the company's profits, while the net income level gives us a better view of the company's absolute size. Check out Gyre Therapeutics' historical EPS growth by clicking on this link. As it happens, we don't know how much the company made or lost three years ago, because we don't have the data. Zooming in to the last year, we still can't talk about growth rates coherently, since it made a loss last year. But mathematics aside, it is always good to see when a formerly unprofitable business come good (though we accept profit would have been higher if dilution had not been required). So you can see that the dilution has had a bit of an impact on shareholders. If Gyre Therapeutics' EPS can grow over time then that drastically improves the chances of the share price moving in the same direction. But on the other hand, we'd be far less excited to learn profit (but not EPS) was improving. For the ordinary retail shareholder, EPS is a great measure to check your hypothetical "share" of the company's profit. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Gyre Therapeutics issued shares during the year, and that means its EPS performance lags its net income growth. Therefore, it seems possible to us that Gyre Therapeutics' true underlying earnings power is actually less than its statutory profit. On the bright side, the company showed enough improvement to book a profit this year, after losing money last year. At the end of the day, it's essential to consider more than just the factors above, i...

Gyre Therapeutics, Inc. (GYRE) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.05 per share. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +20.00%. A quarter ago, it was expected that this company would post earnings of $0.03 per share when it actually produced earnings of $0.02, delivering a surprise of -33.33%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Gyre Therapeutics, Inc., which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $30.56 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 8.89%. This compares to year-ago revenues of $25.49 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Gyre Therapeutics, Inc. shares have lost about 39.3% since the beginning of the year versus the S&P 500's gain of 14.3%. While Gyre Therapeutics, Inc. has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Gyre Therapeutics, Inc. was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near futur...

Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively Full-year revenue guidance revised to $115-118 million (from $118 - $128 million previously) due to delayed Etorel® (Nintedanib) rollout and government procurement-related uncertainty Q3 2025 vs Q3 2024 Highlights Quarterly revenue of $30.6 million, up 20% year-over-year, driven by ETUARY® growth and contributions from sales of Etorel® and Contiva®. GAAP net income doubled to $5.9 million and adjusted net income rose to $8.8 million, reflecting commercial execution and disciplined cost control. Operating income increased 64% to $6.9 million, as operating expenses grew at a slower pace than revenue. Basic EPS improved to $0.04, compared to $0.01 year-over-year. Nine-Month 2025 Highlights Revenue of $79.4 million, moderately above the prior-year period, supported by steady Q3 growth of Etorel® and Contiva®, after earlier supply chain and distribution delays related to new product launches. Basic EPS down from $0.14 to $0.08, reflecting higher operating expenses related to the dual product launches in the first half of 2025, partially offset by the strong Q3 profit recovery. $80.3 million in cash, cash equivalents, and short and long-term deposits, up 57% year-to-date, as of Sept 30, 2025. Business Update Hydronidone New Drug Application (NDA) progressing in China, with Priority Review discussions ongoing and targeted submission following completion of regulatory interactions. Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients, 18 sites). Plan to initiate an adaptive Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications (RILI/immune-related pneumonitis) in Q4 2025. U.S. MASH IND anticipated timeline adjusted to 2026 to allow for (i) the incorporation of the complete Phase 2 and 3 CHB-associated liver fibrosis clinical data from China; and (ii) planning and expected initiation of a hepatic impairment study under the existing U.S. IND to further inform safety, dose optimization, and regulatory discussions. SAN DIEGO, Nov. 07, 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 financial results...

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 chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® 2025 is being held November 7-10, 2025, in Washington D.C. This abstract has been selected as a Poster of Distinction, and the details are below: Title: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B Presenting Author: Prof. Lungen Lu, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Session: Hepatitis B (“1187-1367”) Date/Time: Friday, November 7, 2025, 8:00 a.m. – 5:00 p.m. Eastern Time Publication Number: 1121 About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230. For Investors: David Zhang Gyre Therapeutics [email protected]

Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectively GAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectively Pivotal Phase 3 trial of Hydronidone (F351) in CHB-associated liver fibrosis demonstrated statistically significant fibrosis regression after 52 weeks of treatment; Phase 2 trial in the United States evaluating Hydronidone for the treatment of MASH-associated liver fibrosis expected to initiate in 2H 2025, pending regulatory approval Successfully launched Etorel (nintedanib ethanesulfonate soft capsules) in the PRC for the treatment of SSc-ILD and PF-ILD Announced NMPA approval for clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications with Phase 2/3 trial anticipated in 2H 2025 First volunteer dosed in Phase 1 clinical trial of F230 for treatment of PAH SAN DIEGO, Aug. 11, 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 financial results for the second quarter ended June 30, 2025 and provided a business and leadership update. Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre’s fibrosis focused pipeline. Ping Zhang, Executive Chairman, has been appointed Interim Chief Executive Officer, and will lead the company’s day-to-day operations and strategic global expansion. “I want to thank Dr. Ying for his contributions and dedication during his tenure as CEO. His deep background in research and discovery will be invaluable to advance our science and continued innovation,” said Mr. Zhang. “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.” “Looking ahead, we are thrilled with the rapid progres...

Revenue: US$22.1m (down 19% from 1Q 2024). Revenue: US$22.1m (down 19% from 1Q 2024). Net income: US$2.70m (down 64% from 1Q 2024). Net income: US$2.70m (down 64% from 1Q 2024). Profit margin: 12% (down from 28% in 1Q 2024). The decrease in margin was driven by lower revenue. Profit margin: 12% (down from 28% in 1Q 2024). The decrease in margin was driven by lower revenue. EPS: US$0.031 (down from US$0.09 in 1Q 2024). EPS: US$0.031 (down from US$0.09 in 1Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Gyre Therapeutics shares are up 2.9% from a week ago. You should always think about risks. Case in point, we've spotted 1 warning sign for Gyre Therapeutics you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Net Income of $3.7 million; reaffirms Full-Year Revenue Guidance of $118–$128 million Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03 Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03 Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (“CHB”)-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025 Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (“CHB”)-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025 Received IND approval from China’s National Medical Products Administration (“NMPA”) for a new indication of pirfenidone to treat radiation-induced lung injury (“RILI”), with or without immune-related pneumonitis (“CIP”), marking Gyre’s first entry into oncology supportive care space Received IND approval from China’s National Medical Products Administration (“NMPA”) for a new indication of pirfenidone to treat radiation-induced lung injury (“RILI”), with or without immune-related pneumonitis (“CIP”), marking Gyre’s first entry into oncology supportive care space Initiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialists Initiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialists Nintedanib remains on track for commercialization in May 2025, expanding IPF treatment options across our physician network Nintedanib remains on track for commercialization in May 2025, expanding IPF treatment options across our physician network $51.3 million in cash, cash equivalents, and short and long-term deposits as of March 31, 2025 $51.3 million in cash, cash equivalents, and short and long-term deposits as of March 31, 2025 SAN DIEGO, May 09, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced financial results for the first quarter ended March 31, 2025 and provided a business update. “This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “The successful launch of avatromb...

The stock price didn't jump after Gyre Therapeutics, Inc. (NASDAQ:GYRE) posted decent earnings last week. We did some digging and believe investors may be worried about some underlying factors in the report. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. One key financial ratio used to measure how well a company converts its profit to free cash flow (FCF) is the accrual ratio. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. This ratio tells us how much of a company's profit is not backed by free cashflow. Therefore, it's actually considered a good thing when a company has a negative accrual ratio, but a bad thing if its accrual ratio is positive. While having an accrual ratio above zero is of little concern, we do think it's worth noting when a company has a relatively high accrual ratio. To quote a 2014 paper by Lewellen and Resutek, "firms with higher accruals tend to be less profitable in the future". For the year to December 2024, Gyre Therapeutics had an accrual ratio of 0.32. We can therefore deduce that its free cash flow fell well short of covering its statutory profit, suggesting we might want to think twice before putting a lot of weight on the latter. Even though it reported a profit of US$12.1m, a look at free cash flow indicates it actually burnt through US$6.8m in the last year. We saw that FCF was US$17m a year ago though, so Gyre Therapeutics has at least been able to generate positive FCF in the past. Unfortunately for shareholders, the company has also been issuing new shares, diluting their share of future earnings. The good news for shareholders is that Gyre Therapeutics' accrual ratio was much better last year, so this year's poor reading might simply be a case of a short term mismatch between profit and FCF. Shareholders should look for improved cashflow relative to profit in the current year, if that is indeed the case. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. To understand the value of a company's earnings growth, it is imperative to consider any dilution of shareholders' interests. In fact, Gyre Therapeuti...

Revenue: US$105.8m (down 6.8% from FY 2023). Revenue: US$105.8m (down 6.8% from FY 2023). Net income: US$12.1m (up from US$92.9m loss in FY 2023). Net income: US$12.1m (up from US$92.9m loss in FY 2023). Profit margin: 11% (up from net loss in FY 2023). The move to profitability was driven by lower expenses. Profit margin: 11% (up from net loss in FY 2023). The move to profitability was driven by lower expenses. EPS: US$0.14 (up from US$1.41 loss in FY 2023). EPS: US$0.14 (up from US$1.41 loss in FY 2023). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Phase I: 2. Phase I: 2. Phase II: 1. Phase II: 1. Phase III: 2. Phase III: 2. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) missed analyst estimates by 71%. In the last 12 months, the only revenue segment was Gyre Pharmaceuticals contributing US$105.8m. The largest operating expense was Sales & Marketing costs, amounting to US$57.5m (64% of total expenses). Explore how GYRE's revenue and expenses shape its earnings. Looking ahead, revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 24% from a week ago. We should say that we've discovered 2 warning signs for Gyre Therapeutics (1 shouldn't be ignored!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.