• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

    3/17/25 4:15:00 PM ET
    $GYRE
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $GYRE alert in real time by email

    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. We plan to expand and enhance our commercial product offerings through the additions of nintedanib for IPF, SSc-ILD and PF-ILD, as well as avatrombopag for CLD-associated thrombocytopenia and chronic idiopathic thrombocytopenia ("ITP"). Given our proven track record and extensive sales and marketing platform, we are confident in our ability to successfully launch and expand these two products in the PRC," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "In parallel, we expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025, which will help inform our U.S. Phase 2 proof-of-concept trial of F351 in MASH-associated liver fibrosis."

    Full Year 2024 Business Highlights and Upcoming Milestones

    Commercial-Stage Updates

    • ETUARY (Pirfenidone) sales update: For the year ended December 31, 2024, Gyre Pharmaceuticals generated $105.0 million primarily in sales of ETUARY.
    • Nintedanib: In May 2024, Gyre Pharmaceuticals executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to obtain the drug registration certificate for and became the marketing authorization holder of nintedanib, the other product approved for the treatment of treatment of idiopathic pulmonary fibrosis ("IPF"). In addition, it has also been approved for the treatment of SSc-ILD and PF-ILD. Gyre Pharmaceuticals plans to initiate commercialization of the nintedanib product in the PRC in 2025.
    • Avatrombopag: In June 2024, Gyre Pharmaceuticals received approval from China's National Medical Products Administration ("NMPA") for avatrombopag maleate tablets for the treatment of thrombocytopenia associated with chronic liver disease ("CLD") and chronic idiopathic thrombocytopenia ("ITP") in adult patients undergoing elective diagnostics procedures or therapy. Gyre Pharmaceuticals plans to begin commercialization of avatrombopag in 2025.

    Pipeline Development Updates

    F351 (Hydronidone):

    • All patients completed 52-week pivotal Phase 3 trial in chronic hepatitis B ("CHB")-associated liver fibrosis in the PRC. In October 2024, Gyre Pharmaceuticals announced the last patient completed the 52-week pivotal Phase 3 trial. The trial is evaluating 248 patients with CHB-associated liver fibrosis in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after taking F351 in combination with entecavir. Gyre expects to report topline data in the second quarter of 2025.
    • Plans to initiate a Phase 2 clinical trial in metabolic dysfunction-associated steatohepatitis ("MASH")-associated liver fibrosis in 2025. Pending the results from the pivotal Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept trial in the U.S. to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025.

    F573:

    • F573 is a caspase inhibitor and a potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure ("ALF/ACLF"). Completion of the Phase 2 clinical trial of F573 as a treatment for ALF/ACLF is expected by the end of 2026.

    F230:

    • F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension ("PAH"), is expected to begin a Phase 1 trial in 2025.

    F528:

    • F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease ("COPD"), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.

    Corporate Updates

    • In January 2025, appointed Ping Zhang to the Company's Board of Directors as the lead independent director and member of the Nominating Committee. In addition, Ying Luo, Ph.D., resigned as Chairman and member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre's majority indirectly owned subsidiary in the People's Republic of China ("PRC"), to focus on other responsibilities at GNI Group Ltd. Songjiang Ma has been appointed Chairman of the Board of Directors of Gyre Pharmaceuticals.



    Financial Results

    Cash Position

    As of December 31, 2024, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $51.2 million.

    Financial Results for the Three Months Ended December 31, 2024

    • Revenues: Revenues for the three months ended December 31, 2024 were $27.9 million, compared to $27.1 million for the same period in 2023. The $0.8 million increase was primarily driven by a $1.0 million increase in ETUARY's revenue and a $0.2 million decrease in generic drug revenue. The growth in ETUARY sales was attributed to the active expansion of the IPF treatment market, increased market penetration, and a stronger focus on ETUARY sales. To support future revenue growth, Gyre Pharmaceuticals plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by its extensive sales and marketing platform in the PRC.
    • Cost of Revenues: For the three months ended December 31, 2024, cost of revenues was $1.2 million, compared to $1.3 million for the same period in 2023. The $0.1 million decrease was primarily driven by a $0.2 million decrease in generic drug cost due to the decrease in sales and a $0.1 million decrease in factory stoppage loss due to factory renovation in 2023, offset by a $0.2 million increase due to the increase of ETUARY's cost due to the increase in sales.
    • Selling and Marketing Expense: For the three months ended December 31, 2024, selling and marketing expense was $16.9 million, compared to $16.5 million for the same period in 2023. The increase was primarily driven by a $2.1 million increase in promotion expense and conference expenses, offset by a $1.1 million decrease in selling and marketing payroll costs, a $0.3 million decrease in stock-based compensation expense and a $0.3 million decrease in travel and miscellaneous expenses.
    • Research and Development Expense: For the three months ended December 31, 2024, research and development expense was $3.7 million, compared to $4.6 million for the same period in 2023. The decrease was primarily driven by a $0.5 million decrease in pre-clinical and clinical research expenses and a $0.5 million decrease in stock-based compensation expense, offset by a $0.1 million increase in miscellaneous expense.
    • General and Administrative Expense: For the three months ended December 31, 2024, general and administrative expense was $5.5 million, compared to $10.1 million for the same period in 2023. The decrease was primarily driven by a $5.8 million decrease in stock-based compensation cost, offset by a $0.8 million increase in the functional and administrative department's personnel cost and a $0.4 million increase in professional expense, including legal and consulting fees.
    • Income (Loss) from Operations: For the three months ended December 31, 2024, income from operations was $0.7 million, compared to $91.1 million loss from operation for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in the fourth quarter of 2023 and there was no such expense in the same period in 2024.
    • Net Income (Loss): For the three months ended December 31, 2024, net income was $0.6 million, compared to $101.0 million net loss for the same period in 2023.
    • Non-GAAP Adjusted Net Income: For the three months ended December 31, 2024, non-GAAP adjusted net income was $1.1 million, compared to $2.1 million for the same period in 2023. The decrease was primarily driven by the costs of being a public company for three months in 2024, as compared to two months in 2023.

    Financial Results for the Full Year Ended December 31, 2024

    • Revenues: Revenues for the full year ended December 31, 2024 were $ 105.8 million, compared to $113.5 million for the same period in 2023. The $7.7 million decrease was primarily driven by a $7.1 million decrease in ETUARY's revenue and a $0.6 million decrease in generic drug revenue as a result of decreased sales volumes. The decrease in ETUARY and generic drug sales volumes was due to fluctuations in the Chinese economy that significantly affected demand for anti-fibrosis drugs and decreasing healthcare spending generally. To support future revenue growth, Gyre plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by Gyre Pharmaceuticals' extensive sales and marketing platform across the PRC.
    • Cost of Revenues: For the full year ended December 31, 2024, cost of revenues was $3.9 million, compared to $4.6 million for the same period in 2023. The $0.7 million decrease was primarily driven by a $0.5 million factory stoppage loss due to factory renovation in 2023, which did not occur in 2024, and a $0.2 million decrease due to decreased sales volumes.
    • Selling and Marketing Expense: For the full year ended December 31, 2024, selling and marketing expense was $57.5 million, compared to $61.2 million for the same period in 2023. The decrease was primarily driven by a $2.4 million decrease in conference costs and promotion expense due to decreased sales activities, a $0.9 million decrease in selling and marketing payroll costs due to the decrease of sales of ETUARY in 2024, a $0.3 million decrease in share base compensation expense, and a $0.1 million decrease in miscellaneous expenses.
    • Research and Development Expense: For the full year ended December 31, 2024, research and development expense was $12.0 million, compared to $13.8 million for the same period in 2023. The decrease was primarily from Gyre Pharmaceuticals, and was driven by a $0.3 million decrease in materials and utilities, a $1.3 million decrease in pre-clinical research expense due to several research and development projects advancing to the clinical trials stage or reaching the application phase in 2024, and a $0.4 million decrease in staff cost due to reduced headcount, and a $0.5 million decrease in stock-based compensation, related to options being fully vested in 2023, which did not occur in 2024, This overall decrease was partially offset by a 0.7 million increase in general research and development expense from Gyre Therapeutics due to increased consulting fees.
    • General and Administrative Expense: For the full year ended December 31, 2024, general and administrative expense was $16.1 million, compared to $14.7 million for the same period in 2023. The increase was primarily driven by costs associated with being a public company, including a $1.9 million increase in professional expense, a $2.1 million increase in miscellaneous expenses and a $3.0 million increase in the functional and administrative department's personnel cost, offset by a $5.6 million decrease in stock-based compensation cost.
    • Income (loss) from Operations: For the full year ended December 31, 2024, income from operations was $16.2 million, compared to $67.2 million loss for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in 2023 and there was no such expense in the same period in 2024.
    • Net Income (loss): For the full year ended December 31, 2024, net income was $17.9 million, compared to $85.5 million net loss for the same period in 2023.
    • Non-GAAP Adjusted Net Income: For the full year ended December 31, 2024, non-GAAP adjusted net income was $16.9 million, compared to $25.4 million for the same period in 2023. The decrease was primarily driven by a $7.7 million decline in revenue and a $1.1 million increase in operating expenses. Despite these changes, the gross profit margin remained consistent.

    Full Year 2025 Financial Guidance

    For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of nintedanib and avatrombopag and sales of ETUARY.

     Guidance Range
      
    Total Revenue$118 to $128 million
      

    Please note the following regarding the total revenue guidance:

    • Guidance assumes a constant foreign currency exchange rate.
    • Guidance assumes no significant economic disruption or downturn.

    Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

    Gyre reports financial results in accordance with accounting principles generally accepted in the United States ("GAAP"). This release presents the financial measure "adjusted net income," which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is "net income." Adjusted net income presents Gyre's results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre's financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre's performance and valuation. See the reconciliation of adjusted net income to net income in the section titled "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

    About Hydronidone (F351)

    F351 is a structural analogue of the approved anti-fibrotic (IPF) drug Pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells ("HSCs"), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).

    About Gyre Pharmaceuticals

    Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

    About Gyre Therapeutics

    Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre's development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, 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: the expectations regarding Gyre's research and development efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals' Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, initiation of Gyre's Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, timing of completion of Gyre's Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib and avatrombopag maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre's financial position and cash resources. 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, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission.

    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.

    For Investors:

    Stephen Jasper

    [email protected]

    Gyre Therapeutics, Inc.
    Consolidated Statements of Operations
    (In thousands, except share and per share amounts)
     
     Three Months Ended 

    December 31, 

    (Unaudited)
      Year Ended December 31, 
     2024  2023  2024  2023 
    Revenues$27,872  $27,148  $105,757  $113,450 
    Operating expenses:           
    Cost of revenues 1,177   1,250   3,884   4,636 
    Selling and marketing 16,856   16,464   57,511   61,159 
    Research and development 3,712   4,568   12,024   13,780 
    General and administrative 5,464   10,055   16,109   14,662 
    Acquired in-process research and development —   83,104   —   83,104 
    Divestiture losses —   2,711   —   2,711 
    Loss on disposal of property and equipment (2)  102   66   628 
    Total operating expenses 27,207   118,254   89,594   180,680 
    Income (loss) from operations 665   (91,106)  16,163   (67,230)
    Other income (expense), net:           
    Interest income, net 346   326   1,547   1,044 
    Other expense, net (433)  (237)  (1,659)  (1,518)
    Change in fair value of warrant liability 194   (9,261)  7,167   (9,261)
    Income (loss) before income taxes 772   (100,278)  23,218   (76,965)
    Provision for income taxes (203)  (699)  (5,320)  (8,515)
    Net income (loss) 569   (100,977)  17,898   (85,480)
    Net income attributable to noncontrolling interest 668   29   5,813   7,453 
    Net income (loss) attributable to common stockholders$(99) $(101,006) $12,085  $(92,933)
    Net income (loss) per share attributable to common stockholders:           
    Basic$(0.00) $(1.39) $0.14  $(1.41)
    Diluted$(0.00) $(1.39) $0.05  $(1.41)
    Weighted average shares used in calculating net income (loss) per share attributable to common stockholders:           
    Basic 85,952,413   72,489,183   85,094,948   65,831,675 
    Diluted 85,952,413   72,489,183   102,293,526   65,831,675 
                    



    Gyre Therapeutics, Inc.
    Consolidated Balance Sheets
    (In thousands, except share and per share amounts)
     
     December 31,

    2024
      December 31,

    2023
     
    Assets     
    Current assets:     
    Cash and cash equivalents$11,813  $33,509 
    Short-term bank deposits 14,858   — 
    Notes receivable 4,373   389 
    Accounts receivable, net 19,589   15,163 
    Other receivables from GNI 230   1,287 
    Inventories, net 6,337   4,281 
    Prepaid assets 1,189   1,547 
    Receivable from GCBP 4,961   — 
    Other current assets 1,436   1,045 
    Total current assets: 64,786   57,221 
    Property and equipment, net 23,880   23,288 
    Long-term receivable from GCBP —   4,722 
    Intangible assets, net 273   205 
    Right-of-use assets 1,818   489 
    Land use rights, net 1,432   1,493 
    Deferred tax assets 5,619   4,695 
    Long-term certificates of deposit 24,568   23,431 
    Other assets, noncurrent 3,030   995 
    Total assets$125,406  $116,539 
    Liabilities, convertible preferred stock, and equity     
    Current liabilities:     
    Accounts payable$108  $355 
    Contract liabilities 61   39 
    Due to related parties 227   1,369 
    CVR excess closing cash payable —   1,085 
    Accrued expenses and other current liabilities 10,615   11,935 
    Income tax payable 2,831   5,054 
    Operating lease liabilities, current 713   210 
    CVR derivative liability 4,961   — 
    Total current liabilities: 19,516   20,047 
    Operating lease liabilities, noncurrent 885   199 
    Deferred government grants 928   213 
    CVR derivative liability, noncurrent —   4,722 
    Warrant liability, noncurrent 5,668   12,835 
    Other noncurrent liabilities 7   49 
    Total liabilities$27,004  $38,065 
    Commitments and Contingencies     
    Convertible Preferred Stock, $0.001 par value, 5,000,000 shares authorized; nil shares and 13,151 shares issued and outstanding at December 31, 2024 and 2023, respectively —   64,525 
    Equity:     
    Common stock, $0.001 par value, 400,000,000 shares authorized; 86,307,544 shares and 76,595,616 shares issued and outstanding at December 31, 2024 and 2023, respectively 86   77 
    Additional paid-in capital 136,185   68,179 
    Statutory reserve 3,098   3,098 
    Accumulated deficit (73,453)  (85,538)
    Accumulated other comprehensive loss (2,597)  (1,644)
    Total Gyre stockholders' equity (deficit) 63,319   (15,828)
    Noncontrolling interest 35,083   29,777 
    Total equity 98,402   13,949 
    Total liabilities, convertible preferred stock, and equity$125,406  $116,539 
            



    Gyre Therapeutics, Inc.
    Reconciliation of GAAP to Non-GAAP Financial Measures
    (in thousands)
    (unaudited)
     
     Three Months Ended 

    December 31,
      Years Ended

    December 31,
     
     2024  2023  2024  2023 
    Net income (loss)$569  $(100,977) $17,898  $(85,480)
    Acquired in-process research and development (1) —   83,104   —   83,104 
    (Gain) loss from change in fair value of warrants (2) (194)  9,261   (7,167)  9,261 
    Stock-based compensation 567   7,281   831   7,281 
    Divestiture losses (3) —   2,711   —   2,711 
    Provision for income taxes 203   699   5,320   8,515 
    Non-GAAP adjusted net income$1,145  $2,079  $16,882  $25,392 
                    

    (1)   Reflects adjustments for a reverse asset acquisition with CPI as the accounting acquirer and Catalyst as the legal acquirer.

    (2)   Reflects adjustments for fair value of warrants based on the Black-Sholes option pricing model.

    (3)   Reflects adjustments loss from the divestiture of all assets other than 56.0% indirect ownership interest in Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals).





    Primary Logo

    Get the next $GYRE alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $GYRE

    DatePrice TargetRatingAnalyst
    3/11/2025Outperform
    Noble Capital Markets
    More analyst ratings

    $GYRE
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • 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 of

      5/22/25 8:57:29 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Gyre Therapeutics Announces Proposed Underwritten 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 that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the

      5/22/25 4:02:00 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Gyre Therapeutics' Hydronidone Met the Primary Endpoint and Demonstrated Statistically Significant Fibrosis Regression in Pivotal Phase 3 Trial for the Treatment of CHB-associated Liver Fibrosis in China

      Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.Breakthrough Therapy Designation granted by China's National Medical Products Administration ("NMPA") in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis ("CHB fibrosis").Gyre intends to seek accelerated approval for Hydronidone in CHB fibrosis, with a New Drug Application ("NDA") submission to the NMPA expected in Q3 2025. U.S. Phase 2 trial in MASH-associated liver fibrosis expected to begin in

      5/22/25 4:01:00 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $GYRE
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Noble Capital Markets initiated coverage on Gyre Therapeutics

      Noble Capital Markets initiated coverage of Gyre Therapeutics with a rating of Outperform

      3/11/25 10:02:24 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $GYRE
    Financials

    Live finance-specific insights

    See more
    • Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

      Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03Completed 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 2025Received 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 spaceInitiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialistsNin

      5/9/25 6:00:00 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • 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

      3/17/25 4:15:00 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • 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 f

      11/13/24 6:00:00 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $GYRE
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • President Ma Songjiang sold $44,160 worth of shares (4,000 units at $11.04) (SEC Form 4)

      4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

      5/22/25 4:01:08 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • President Ma Songjiang sold $44,840 worth of shares (4,000 units at $11.21) (SEC Form 4)

      4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

      5/20/25 4:01:17 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • President Ma Songjiang sold $21,586 worth of shares (2,020 units at $10.69) (SEC Form 4)

      4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

      5/16/25 4:01:12 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $GYRE
    SEC Filings

    See more
    • Gyre Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits

      8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

      5/23/25 4:46:36 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 424B5 filed by Gyre Therapeutics Inc.

      424B5 - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

      5/23/25 4:37:26 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 424B5 filed by Gyre Therapeutics Inc.

      424B5 - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

      5/22/25 5:27:39 PM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $GYRE
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more

    $GYRE
    Leadership Updates

    Live Leadership Updates

    See more
    • SEC Form SC 13D filed by Gyre Therapeutics Inc.

      SC 13D - GYRE THERAPEUTICS, INC. (0001124105) (Subject)

      9/6/24 8:31:07 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13D filed by Gyre Therapeutics Inc.

      SC 13D - GYRE THERAPEUTICS, INC. (0001124105) (Subject)

      9/6/24 8:15:45 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Gyre Therapeutics Announces the Appointment of Ping Zhang to Board of Directors

      SAN DIEGO, Jan. 06, 2025 (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 the appointment of Ping Zhang to its Board of Directors (the "Board") as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee of the Board. In addition, Ying Luo, Ph.D. resigned as Chairman and a member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre's majority indirectly owned subsidiary in the People's Republic of China ("PRC"), to focus on other responsibilities at GNI Grou

      1/6/25 7:00:00 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Gyre Therapeutics Announces Appointment of David M. Epstein, Ph.D., to Board of Directors

      SAN DIEGO, Aug. 08, 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 the appointment of David M. Epstein, Ph.D., to Gyre's Board of Directors (the "Board"), effective August 6, 2024. Dr. Epstein will serve as a member of the Audit Committee of the Board and as member of the Compensation Committee of the Board. "We are thrilled to welcome David to the Gyre Board," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "His extensive global experience in biotech companies across the U.S. and Asia will be

      8/8/24 4:05:00 PM ET
      $BDTX
      $GYRE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
      Biotechnology: Pharmaceutical Preparations
    • 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. "Rodney has an extensive background in finance, accounting, and financial reporting with nearly four decades of experience working at global auditing and consulting firms," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "He joins our Board at a pivotal time as we advance our diversified pipeline of anti-fibrotic therapies. We look forwa

      3/21/24 7:00:00 AM ET
      $GYRE
      Biotechnology: Pharmaceutical Preparations
      Health Care