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华东医药董秘陈波:完成体重管理适应症临床III期研究首例受试者入组
Quan Jing Wang· 2025-06-04 04:39
Group 1 - The 2025 Zhejiang Listed Companies Investor Online Reception Day and 2024 Annual Performance Briefing was held on May 13, 2025 [1] - East China Pharmaceutical's board secretary Chen Bo announced that the oral small molecule GLP-1 receptor agonist HDM1002 (conveglipron) completed the first subject enrollment for weight management indication in the Phase III clinical study in April 2025, with plans to complete all subject enrollments by the end of June 2025 [1] - The Phase II clinical study for diabetes indication is progressing smoothly, with topline results expected in Q3 2025 and entry into Phase III clinical research planned for the second half of 2025 [1] Group 2 - The GLP-1R/GIPR dual-target long-acting peptide agonist HDM1005 (poterepatide) is currently undergoing Phase II clinical trials for weight management indication, with all subjects enrolled by April 2025 and expected to enter Phase III clinical research in Q4 2025 [1] - The Phase II clinical trial for diabetes indication also completed the first subject enrollment in April 2025, and new indication IND applications for HDM1005 have been approved by NMPA for the treatment of obstructive sleep apnea (OSA) with obesity or overweight, and heart failure with preserved ejection fraction (HFpEF) with obesity or overweight [1] Group 3 - The FGF21R/GCGR/GLP-1R tri-target agonist DR10624 injection is currently conducting Phase II clinical research in China for the treatment of metabolic-associated fatty liver disease with high-risk liver fibrosis and metabolic-associated alcoholic fatty liver disease, with the first subject enrolled in April 2025 [2] - Another Phase II clinical study for DR10624 targeting severe hypertriglyceridemia in China has completed all patient enrollments, with topline results expected in Q3 2025 [2] - DR10624 has also received approval for clinical trial applications in China for type 2 diabetes and weight indications, and key research data for DR10624 in treating obesity with hypertriglyceridemia was presented at the EASL Congress 2025 in Amsterdam [2]
Trevi Therapeutics Showcases Drug That Cuts Cough Frequency In Lung Disease Patients
Benzinga· 2025-06-02 17:42
Core Insights - Trevi Therapeutics, Inc. reported positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), achieving the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six [1][2]. Group 1: Trial Results - The 108 mg BID, 54 mg BID, and 27 mg BID dose groups achieved reductions from baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction of 16.9% [2]. - A rapid reduction in 24-hour cough frequency was observed at week two, with 65% of patients on 108 mg BID, 63% on 54 mg BID, and 60% on 27 mg BID experiencing a 50% reduction at week six, compared to 19% of placebo patients [5]. - Statistically significant improvements were noted in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including a mean reduction of 3.0 points for 108 mg BID and 3.2 points for 54 mg BID on the cough-severity numerical rating scale, compared to a 1.5-point reduction for placebo [5]. Group 2: Safety and Discontinuation - Discontinuation rates due to adverse events were similar between the Haduvio (5.6%) and placebo groups (5%) [4]. Group 3: Stock Performance - Following the announcement, Trevi Therapeutics' stock declined by 10.45%, trading at $5.83 [4].
These Analysts Revise Their Forecasts On Karyopharm Therapeutics After Q1 Results
Benzinga· 2025-05-13 17:39
Financial Performance - Karyopharm Therapeutics reported quarterly losses of $2.77 per share, which was better than the analyst consensus estimate of losses of $4.16 per share [1] - The company reported quarterly sales of $30.02 million, missing the analyst consensus estimate of $35.24 million [1] Clinical Trial Update - The Phase 3 SENTRY trial in patients with JAKi-naïve myelofibrosis has passed its pre-specified futility analysis and continues as planned without modifications [2] - New data in hard-to-treat myelofibrosis patients showed spleen volume reduction, symptom improvement, hemoglobin stabilization, and evidence of disease modification with selinexor monotherapy [2] Sales Guidance and Market Reaction - Karyopharm affirmed FY2025 sales guidance of $140.00 million to $155.00 million, compared to market estimates of $149.32 million [3] - Following the earnings announcement, Karyopharm shares fell 15.6% to trade at $5.17 [3] Analyst Ratings and Price Targets - Baird analyst Michael Ulz maintained an Outperform rating and lowered the price target from $54 to $42 [8] - Barclays analyst Peter Lawson maintained an Overweight rating and raised the price target from $5 to $10 [8] - RBC Capital analyst Brian Abrahams maintained an Outperform rating and lowered the price target from $34 to $33 [8]
Karyopharm Therapeutics(KPTI) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:32
Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $30 million, down from $33.1 million in Q1 2024 [46] - U.S. XPOVIO net product revenue decreased to $21.1 million from $26 million year-over-year, attributed to a $5 million increase in product return reserves [47] - Gross to net provisions for XPOVIO were 45% in Q1 2025 compared to 29.3% in the same period in 2024 [47] - Cash, cash equivalents, and investments at the end of Q1 2025 were $70.3 million, down from $109.1 million at the end of 2024 [48] Business Line Data and Key Metrics Changes - Demand growth for Q1 was 5% year-over-year, with net product revenue impacted by atypical returns of expired products [40] - Royalty revenue increased by 57% to $1.7 million in Q1 2025 compared to Q1 2024, reflecting growing global demand for XPOVIO [42] Market Data and Key Metrics Changes - The multiple myeloma market remains highly competitive, with expectations of additional new entrants this year [41] - The company anticipates a peak revenue potential of approximately $1 billion in the U.S. for selinexor in myelofibrosis if approved [10] Company Strategy and Development Direction - The company is focused on completing enrollment in the Phase III SENTRY trial for myelofibrosis and advancing the Phase III trial in endometrial cancer [7][38] - The strategy includes leveraging a profitable commercial organization in multiple myeloma to drive rapid commercialization in new disease areas [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of selinexor to redefine the standard of care in myelofibrosis, with encouraging clinical data supporting its efficacy [8][10] - The company is exploring various opportunities to extend its cash runway while focusing on advancing clinical trials and commercial performance [51][53] Other Important Information - The Phase III SENTRY trial successfully passed its pre-specified futility analysis, allowing the study to continue as planned [35] - The company expects to complete enrollment in the SENTRY trial by June-July 2025 [35][67] Q&A Session Summary Question: Can you talk about the futility analysis and its basis? - The futility analysis was based on efficacy and safety data from the first 61 patients, with thresholds for no worsening compared to ruxolitinib alone [55][56] Question: What are the assumptions for achieving full enrollment in June and July? - The company is currently 80% enrolled and expects to complete enrollment in the June-July timeframe, with a press release to follow [67] Question: What is driving utilization in multiple myeloma? - The company reported 5% growth in demand, with utilization driven by its flexible combination therapy positioning in both community and academic settings [82] Question: What is the normal run rate of return product? - The atypical returns of $5 million were related to high-dose products, and the company does not expect this to continue into future quarters [89] Question: How confident is the company in reaching its revenue guidance? - The company believes it can deliver at the lower end of its revenue guidance due to strong demand growth and global partner revenue [97]