Latest news with #GyreTherapeutics
Yahoo
6 hours ago
- Business
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Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China
SAN DIEGO, June 10, 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 the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ('ETA') receptor antagonist, for the treatment of pulmonary arterial hypertension ('PAH').This milestone marks Gyre's entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China's National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China's PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre's fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.F230 joins Gyre's pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application ('NDA') submission to China's National Medical Products Administration ('NMPA') is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis ('MASH') Gyre TherapeuticsGyre 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 U.S. 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 StatementsThis press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning the expectations regarding Gyre's research and development efforts and timing of expected clinical trials, including an NDA submission to the NMPA for F351, the expected clinical benefits of F230 and expectations regarding interactions with regulators. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'plan' or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre's ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre's capital resources and its ability to raise additional capital. Additional risks and factors are identified under 'Risk Factors' in Gyre's Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by Contact:David ZhangGyre in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
31-05-2025
- Business
- Yahoo
Gyre Therapeutics, Inc. (GYRE) Raises $23M in Public Stock Offering to Fund Liver Fibrosis Trials
Gyre Therapeutics, Inc. (NASDAQ:GYRE), a biopharmaceutical company developing innovative fibrosis-focused therapies, has successfully closed a public offering, raising approximately $23 million in gross proceeds. The offering included 2,555,555 shares of common stock at $9.00 per share, with Jefferies serving as lead book-running manager and H.C. Wainwright & Co. as co-manager. A research scientist in an idiopathic pulmonary fibrosis laboratory, carrying out clinical trials. The capital infusion, which follows the full exercise of underwriters' options, will support Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s ongoing Phase 2 clinical trial of F351, a promising treatment targeting liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the United States. The funds will also bolster research and development, manufacturing scale-up, and general corporate operations. The shares were offered under a shelf registration statement previously approved by the SEC. Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s latest fundraising effort underscores its commitment to advancing therapies for chronic diseases marked by fibrosis, aiming to address significant unmet medical needs. While we acknowledge the potential of GYRE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GYRE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
30-05-2025
- Business
- Yahoo
Gyre Therapeutics, Inc. (GYRE) Raises $23M in Public Stock Offering to Fund Liver Fibrosis Trials
Gyre Therapeutics, Inc. (NASDAQ:GYRE), a biopharmaceutical company developing innovative fibrosis-focused therapies, has successfully closed a public offering, raising approximately $23 million in gross proceeds. The offering included 2,555,555 shares of common stock at $9.00 per share, with Jefferies serving as lead book-running manager and H.C. Wainwright & Co. as co-manager. A research scientist in an idiopathic pulmonary fibrosis laboratory, carrying out clinical trials. The capital infusion, which follows the full exercise of underwriters' options, will support Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s ongoing Phase 2 clinical trial of F351, a promising treatment targeting liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the United States. The funds will also bolster research and development, manufacturing scale-up, and general corporate operations. The shares were offered under a shelf registration statement previously approved by the SEC. Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s latest fundraising effort underscores its commitment to advancing therapies for chronic diseases marked by fibrosis, aiming to address significant unmet medical needs. While we acknowledge the potential of GYRE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GYRE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
29-05-2025
- Business
- Yahoo
Gyre Therapeutics Announces Closing of its Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares
SAN DIEGO, May 29, 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 closed its previously announced underwritten public offering of 2,555,555 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 333,333 shares, at a public offering price of $9.00 per share, less the underwriting discount. The gross proceeds of the offering to Gyre, before deducting underwriting discounts and commissions and other offering expenses payable by Gyre, were approximately $23.0 million. Jefferies acted as lead book-running manager for the offering and H.C. Wainwright & Co. acted as co-manager for the offering. Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis ('MASH')-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes. The shares of common stock described above were offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission ('SEC') that was declared effective by the SEC on November 22, 2024. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC's website, located at and may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@ This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 U.S. 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. Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning Gyre's expectations regarding expected use of net proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'plan' or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre's ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre's capital resources and its ability to raise additional capital. Additional risks and factors are identified under 'Risk Factors' in Gyre's Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact:David Zhang Gyre
Yahoo
23-05-2025
- Business
- Yahoo
Gyre Therapeutics Announces Pricing of $20.0 Million Public Offering of Common Stock
SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ('Gyre') (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds of the offering to Gyre, before deducting the underwriting discounts and commissions and other offering expenses payable by Gyre, are expected to be approximately $20.0 million. The offering is expected to close on or about May 27, 2025, subject to the satisfaction of customary closing conditions. Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering. Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis ('MASH')-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes. The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission ('SEC') that was declared effective by the SEC on November 22, 2024. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website, located at Electronic copies of the final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website at and may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@ This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 U.S. 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. Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: Gyre's expectations regarding the consummation of the offering and the satisfaction of customary closing conditions with respect to the offering; and the expected use of net proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'plan' or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; Gyre's ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre's capital resources and its ability to raise additional capital. Additional risks and factors are identified under 'Risk Factors' in Gyre's Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact:David Zhang Gyre
