GYRE

U.S. Stock Market Overview: U.S. stocks declined, with the Dow Jones index dropping over 100 points, while several companies like Cognyte Software and AngioDynamics saw significant gains after reporting better-than-expected financial results.

Notable Stock Performances: Cognyte Software's shares surged 22.1% following a strong earnings report, and other companies such as Rocket Companies and Cytokinetics also experienced notable increases in their stock prices.

Apparel Stores Performance: Apparel store shares have increased by approximately 2.6%, with Duluth Holdings rising by about 9.6% and Children's Place up by around 8% on Wednesday.

Market Commentary: The views expressed in the article represent the author's opinions and do not necessarily reflect those of Nasdaq, Inc.

Regulatory Approval: Gyre Therapeutics has received approval from China's National Medical Products Administration for a clinical trial to evaluate pirfenidone in treating radiation-induced lung injury and immune-related pneumonitis in cancer patients.

Clinical Trial Plans: The company plans to initiate an adaptive Phase 2/3 clinical trial in the second half of 2025, aiming to explore dosages and confirm efficacy of pirfenidone as a new treatment option in oncology supportive care.

U.S. Stock Market Performance: U.S. stocks experienced a decline, with the S&P 500 dropping approximately 1%, while notable companies like IHS Holding reported better-than-expected earnings, and Aditxt, Inc. saw a significant share increase after announcing new funding opportunities.

Global Market Trends: European and Asian markets closed higher, with increases in major indices, while U.S. economic indicators showed a surge in housing starts and an increase in industrial production, despite a slight decline in building permits.

Q4 Revenue and Future Plans: Gyre Therapeutics reported Q4 revenue of $27.87 million, exceeding the consensus estimate of $23.5 million, and plans to expand its product offerings in 2025 with nintedanib and avatrombopag while sharing pivotal trial data for F351 in liver fibrosis.

Market Positioning: The company is confident in its ability to successfully launch new products in the PRC, supported by a strong sales and marketing platform, as it prepares for significant developments in both commercial and clinical stages.

Insider Trading Activity: Songjiang Ma, President of $GYRE, sold 1,878 shares for approximately $21,634, marking a total of 35 insider sales without any purchases in the last six months.

Institutional Investor Movements: In the latest quarter, 21 institutional investors increased their holdings in $GYRE, while 13 reduced their positions.

Board Changes at Gyre Therapeutics: Gyre Therapeutics appointed Ping Zhang as the lead independent director and member of the Nominating and Corporate Governance Committee, while Ying Luo resigned as Chairman to focus on other responsibilities. Songjiang Ma has been named the new Chairman of Gyre Pharmaceuticals.

Company Focus and Developments: Gyre Therapeutics is advancing its clinical programs for chronic organ diseases, particularly F351 for MASH-associated fibrosis, and Gyre Pharmaceuticals continues to develop innovative drugs for organ fibrosis, with ETUARY® being a key product in the PRC market.

Company Overview and Financial Performance: Gyre Therapeutics Inc. reported a decrease in Q3 revenues to $25.5 million, attributed to lower sales of anti-fibrosis drugs, while maintaining a cash position of $15.9 million to support future operations.

Future Prospects and Developments: The company completed a pivotal Phase 3 trial for F351 and plans to launch several products in 2025, aiming for growth in the biotech sector with new therapies and clinical trials on the horizon.

Clinical Trials and Product Launches: Gyre Therapeutics has completed a pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis, with topline data expected in Q1 2025. The company plans to launch avatrombopag maleate tablets and nintedanib in the PRC by mid-2025 and is set to initiate a U.S. Phase 2 trial for F351 in MASH-associated liver fibrosis.

Financial Performance: As of September 30, 2024, Gyre reported cash and equivalents of $15.9 million, with revenues of $25.5 million for Q3 2024, down from $32 million in the same period last year, primarily due to decreased sales of anti-fibrosis drugs. Despite this, the company anticipates future revenue growth from upcoming product launches.

Stock Performance Overview: GYRE's stock has a 52-week range with a low of $5.88 and a high of $30.40, currently trading at $14.55.

Market Analysis Note: The article includes a link to information about other stocks that have recently crossed above their 200-day moving average.

Clinical Trial Completion: Gyre Therapeutics announced the completion of its pivotal Phase 3 trial in China for F351 (hydronidone) targeting Chronic Hepatitis B-associated liver fibrosis, with topline data expected by Q1 2025.

Future Development Plans: The company plans to initiate a Phase 2 clinical trial in the U.S. for F351 focusing on Metabolic Dysfunction-Associated Steatohepatitis-related fibrosis in 2025, following promising results from the ongoing trials.

Stock Market Performance: U.S. stocks showed mixed results with the Dow Jones index declining by approximately 0.2%, while several companies, including Applied Therapeutics and Intuitive Machines, saw significant gains in their stock prices due to positive news and contract awards.

Notable Stock Movements: Applied Therapeutics shares surged by 72% after FDA updates, Intuitive Machines rose 52% following a NASA contract announcement, and other companies like PowerFleet and Braskem also experienced notable increases in their stock values due to analyst upgrades and strategic acquisitions.

U.S. Stock Market Performance: U.S. stocks saw a mostly positive trend, with the Dow Jones gaining approximately 150 points on Monday, driven by significant gains in various companies' shares.

Notable Stock Movements: Galapagos NV's shares surged 10% after Ecor1 Capital acquired a 9.9% stake, while other notable gainers included COMPASS Pathways (up 14.3%) and MoneyLion Inc (up 9.4%) following their share repurchase announcement.

Gyre Therapeutics Q2 2024 Results: Gyre Therapeutics reported earnings per share of 1 cent and revenue of $25.23 million for the second quarter of 2024.

InvestorPlace Earnings Automation: InvestorPlace Earnings utilizes TradeSmith data to automate coverage of quarterly earnings reports, providing quick insights on key financial figures without human intervention.

• ReShape Lifesciences Inc. received a patent, leading to an 82.8% jump in its shares.
• Innovative Eyewear, Inc. saw a 56.1% increase after launching a new eyewear collection.
• Brand Engagement Network, Inc. climbed 41% following a private placement announcement.
• Siyata Mobile Inc. gained 40% due to an order from the City of Lancaster Public Utilities Department.
• AST SpaceMobile, Inc. rose 29% after partnering with Verizon for a new service.

• Faraday Future Intelligent Electric Inc. fell 38.8% due to disappointing annual financial results.
• AERWINS Technologies Inc. dropped 37% after a significant increase in EPS results the day before.
• SOBR Safe, Inc. shares declined 32% following a previous 84% surge.
• Cue Health Inc. fell 29.1% after filing for Chapter 7 bankruptcy.
• Sharps Technology, Inc. decreased by 26.4% after entering agreements with Nephron SC.

• Fangdd Network Group Ltd. fell 23.8%.
• Genetic Technologies Limited declined 18.4% despite launching a new geneType test.
• Predictive Oncology Inc. dropped 17.6% after announcing study results.
• Maravai LifeSciences Holdings, Inc. decreased by 15.3%.
• American Airlines Group Inc. shares declined 15.3% due to executive changes and revised guidance.

• Bank OZK fell 15% following a downgrade by Citigroup.
• Crown ElectroKinetics Corp. dipped 15%.
• Onfolio Holdings, Inc. shares fell 14.3% after posting a quarterly loss.
• Veru Inc. dropped 13.1%.
• Telephone and Data Systems, Inc. fell 9.3% after a price target adjustment by JP Morgan.

• AST SpaceMobile, Inc. shares surged by 29% after announcing a partnership with Verizon.
• Ooma, Inc. saw a 22.3% increase following positive first-quarter financial results.
• Several other companies like SOPHiA GENETICS SA, Surmodics, Abercrombie & Fitch Co., and DICK’S Sporting Goods, Inc. recorded significant gains.

• Semler Scientific adopted bitcoin as its primary treasury reserve asset, leading to a 14.8% surge in its stock.
• Gyre Therapeutics, Inc. rose by 12.3% after the announcement of its expected addition to the Russell 2000® and Russell 3000® Indexes.

• Various companies such as Immunovant, Hello Group Inc., Marathon Oil Corporation, Box, Inc., N-able, Inc., Titan Machinery Inc., Daqo New Energy Corp., and JinkoSolar Holding Co., Ltd. experienced notable increases in their stock prices.