| Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update |
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 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 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 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. |
globenewswire.com |
2025-05-09 10:00:00 |
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| Gyre Therapeutics Announces NMPA Approval for Clinical Trial Evaluating Pirfenidone Capsules in Oncology-Related Pulmonary Complications |
SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People's Republic of China (“PRC”) has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP). |
globenewswire.com |
2025-03-31 11:00:00 |
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| Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology |
SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). |
globenewswire.com |
2025-03-27 09:00:00 |
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| Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update |
Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025 Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025 Full year 2025 total revenue guidance of $118 to $128 million SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update. “2025 is shaping up to be a pivotal year for Gyre across both our commercial-stage and clinical-stage portfolios. |
globenewswire.com |
2025-03-17 18:15:00 |
Czytaj oryginał (ang.) |
| Gyre Therapeutics Reports Third Quarter 2024 and Year-To-Date Financial Results and Provides Business Update |
Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025 On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025 Commercial launch of avatrombopag maleate tablets expected by the first half of 2025 Commercial launch of nintedanib expected in 2025 Cash and cash equivalents totaled $15.9 million as of September 30, 2024 SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a business update. “Our team has made great progress over the last several months and recently achieved a significant milestone with the final patient completing 52 weeks of study in our pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis. |
globenewswire.com |
2024-11-13 08:00:00 |
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| Gyre Therapeutics Announces Last Patient Completed Pivotal Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis |
SAN DIEGO, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that the last patient in Gyre Pharmaceuticals' pivotal Phase 3 trial in the People's Republic of China (“PRC”) evaluating F351 (hydronidone) for Chronic Hepatitis B (“CHB”)-associated liver fibrosis has completed the 52-week study. Gyre Pharmaceuticals expects to report topline data from this trial by the first quarter of 2025. |
globenewswire.com |
2024-10-22 20:05:00 |
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| Gyre Therapeutics to Present at 8th Annual H.C. Wainwright MASH Investor Conference |
SAN DIEGO, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that Han Ying, PhD, Chief Executive Officer, will be presenting a company overview at the 8th Annual H.C. Wainwright MASH Investor Conference on Monday, October 7, 2024, at 2:30 PM ET (11:30 AM PT). |
globenewswire.com |
2024-10-01 20:05:00 |
Czytaj oryginał (ang.) |
| Gyre Therapeutics Reports Second Quarter 2024 and Year-To-Date Financial Results and Provides Business Update |
Received NMPA approval of avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia, expanding rare disease product lines Received IND approval from NMPA to evaluate F230 for the treatment of pulmonary arterial hypertension U.S. IND submission for F351 in MASH-associated liver fibrosis expected in late 2024 and data readout from Phase 3 trial in CHB-associated liver fibrosis in the PRC expected by early 2025 Cash and cash equivalents totaled $16.1 million as of June 30, 2024 SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced financial results for the second quarter ended June 30, 2024 and Year-To-Date 2024, and provided a business update. “We are extremely proud of our advancements expanding our commercial product offerings and therapeutic reach in the PRC,” said Han Ying, Ph.D. |
globenewswire.com |
2024-08-13 10:00:00 |
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| Gyre Therapeutics to Present at Sidoti Virtual Investor Conference |
SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that Han Ying, PhD, Chief Executive Officer, will be presenting a company overview at the Sidoti August Virtual Investor Conference on Thursday, August 15, 2024, at 10:45 a.m. ET (7:45 a.m. |
globenewswire.com |
2024-08-09 11:00:00 |
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| Gyre Therapeutics Announces China's NMPA Approval of Avatrombopag Maleate Tablets for the Treatment of CLD-Associated Thrombocytopenia |
SAN DIEGO, July 02, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that China's National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia (“TP”) associated with chronic liver disease (“CLD”) in adult patients undergoing elective diagnostics procedures or therapy. TP is the most common hematologic complication in patients with CLD and can be life threatening in severe cases. |
globenewswire.com |
2024-07-02 20:05:00 |
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| Gyre Therapeutics Announces Publication in Journal of Gastroenterology and Hepatology |
SAN DIEGO, June 18, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced the publication of the manuscript titled “Hydronidone induces apoptosis in activated hepatic stellate cells through endoplasmic reticulum stress-associated mitochondrial apoptotic pathway” in the Journal of Gastroenterology and Hepatology. This publication includes both in vivo and in vitro studies supporting the potential of hydronidone (F351), a novel derivate of pirfenidone, as a promising therapy for the treatment of liver fibrosis. |
globenewswire.com |
2024-06-18 20:05:00 |
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| Gyre Pharmaceuticals Receives IND Approval from China's NMPA to Evaluate F230 for the Treatment of Pulmonary Arterial Hypertension |
SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that the Center for Drug Evaluation (“CDE”) of China's National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) Investigational New Drug (“IND”) application for F230 tablets, a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”). F230 was originally licensed from Eisai through Gyre's indirect majority stockholder, GNI Group Ltd. |
globenewswire.com |
2024-05-30 20:05:00 |
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| Gyre Therapeutics Announces Expected Addition to the Russell 2000® and Russell 3000® Indexes |
SAN DIEGO, May 28, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that it expects to be added to the small-cap Russell 2000® and all-cap Russell 3000® Indexes at the conclusion of the 2024 Russell Indexes annual reconstitution, effective after U.S. market close on June 28, 2024, according to a preliminary list of additions posted on May 24, 2024. “Gyre's addition to the widely-tracked Russell Indexes represents another important milestone for our company,” said Han Ying, Ph.D. |
globenewswire.com |
2024-05-28 20:05:00 |
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| Gyre Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update |
Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025 U.S. IND submission to evaluate F351 for the treatment of NASH-associated liver fibrosis expected in late 2024; Phase 2a trial expected to initiate in 2025 Acquired the rights to complementary assets relating to nintedanib through Gyre Pharmaceuticals to improve competitiveness in the PRC Cash and cash equivalents totaled $29.8 million as of March 31, 2024 SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. “Supported by sales of our market-leading IPF drug, ETUARY, Gyre is well-positioned to advance multiple pipeline programs addressing organ fibrosis, including our Phase 3 clinical trial of F351 in CHB-associated liver fibrosis in the PRC that is on track to report data by early 2025,” said Han Ying, Ph.D. |
globenewswire.com |
2024-05-09 20:10:00 |
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| The Cream Of The Crop: 5 Biotechs That Outrank Most Stocks |
The top five biotech stocks today have several commonalities. Among them are strong ratings. |
investors.com |
2024-04-01 12:00:38 |
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| Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update |
Data readout from Phase 3 clinical trial in the People's Republic of China (“PRC”) evaluating F351 for the treatment of CHB-associated liver fibrosis expected by early 2025 U.S. Phase 2a clinical trial evaluating F351 for the treatment of NASH-associated liver fibrosis planned for 2025 Appointed Dr. Han Ying as Chief Executive Officer Acquired indirect controlling interest in Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd) as part of business combination agreement with GNI Cash and cash equivalents totaled $33.5 million as of December 31, 2023 SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”) (Nasdaq: GYRE), a clinical-stage biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced financial results for the full year ended December 31, 2023 and provided a business update. |
globenewswire.com |
2024-03-26 08:00:00 |
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| Gyre Therapeutics Expands Board of Directors with Appointment of Rodney L. Nussbaum |
SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced the appointment of Rodney L. Nussbaum to the Company's Board of Directors and as a member of its Audit Committee. |
globenewswire.com |
2024-03-21 09:00:00 |
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| INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / February 12, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-02-13 01:45:00 |
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| Is It Time to Buy the Nasdaq's 5 Worst-Performing Stocks in February 2024? |
Sigma Lithium, despite its vast reserves, faces challenges as lithium prices plummet, making its stock's steep drop a cautionary tale. Hut 8 and Cipher Mining may be promising bets on a Bitcoin turnaround in the long run, but they may not survive the trip. |
fool.com |
2024-02-07 16:17:00 |
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| IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / February 7, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-02-07 05:00:00 |
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| IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / February 3, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-02-03 10:00:00 |
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| INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / February 2, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-02-02 09:00:00 |
Czytaj oryginał (ang.) |
| IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / February 1, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-02-01 09:00:00 |
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| SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Gyre Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm |
LOS ANGELES, CA / ACCESSWIRE / January 31, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Gyre Therapeutics, Inc. ("Gyre" or "the Company") (NASDAQ:GYRE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. |
accesswire.com |
2024-01-31 10:00:00 |
Czytaj oryginał (ang.) |