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Granada Gold Announces Appointment of New CFO
Thenewswire· 2025-09-09 20:40
Company Overview - Granada Gold Mine Inc. has appointed Heidi Gutte as the new Chief Financial Officer, effective immediately, replacing Remantra Sheopaul [1] - Heidi Gutte brings nearly 15 years of experience in corporate finance, IFRS financial reporting, audit preparation, tax optimization, and corporate compliance within the mineral exploration and junior mining sector [2] - The company expresses gratitude to Mr. Sheopaul for his contributions and wishes him well in future endeavors [3] Mining Operations - Granada Gold Mine Inc. is actively developing and exploring its 100% owned Granada Gold Property located near Rouyn-Noranda, Quebec, which is adjacent to the Cadillac Break [5] - The company owns 14.73 square kilometers of land, consisting of mining leases and claims, and is currently conducting a large drill program with 20,000 meters completed out of a planned 120,000 meters [5] - Drilling operations are currently paused to allow the technical team to evaluate existing data and await improved market conditions [5] Historical Production - The Granada Shear Zone and the South Shear Zone contain up to twenty-two mineralized structures trending east-west over five and a half kilometers, with historical underground grades ranging from 8 to 10 grams per tonne gold [6] - The former Granada Gold underground mine produced over 50,000 ounces of gold at a grade of 10 grams per tonne in the 1930s before a fire destroyed surface buildings [7] - In the 1990s, Granada Resources extracted a bulk sample of 87,311 tonnes grading 5.17 grams per tonne gold from Pit 1 and 22,095 tonnes grading 3.46 grams per tonne gold from Pit 2 [7]
北京初一女生HPV疫苗免费接种全面启动;赛诺菲创新药在华获批
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-08 00:42
Group 1: Pharmaceutical Companies and Products - 63 pharmaceutical companies have been exposed for serious credit violations, with 63 companies rated as "particularly serious" or "serious" by the National Medical Insurance Administration [1] - Junshi Biosciences announced positive results from a Phase III clinical trial of JS005 for moderate to severe plaque psoriasis, planning to submit a marketing application soon [1] - Sanofi's teplizumab injection has been approved in China for delaying the progression of type 1 diabetes in patients aged 8 and above [2] Group 2: Corporate Actions - Yingke Medical adjusted its share repurchase price limit from RMB 26.51 to RMB 41.88 per share, effective from September 8, 2025, with a total repurchase fund of RMB 80 million to 120 million [3] - Qidi Pharmaceutical plans to change its name to "Guhan Health Industry Group Co., Ltd." and will revise its articles of association accordingly [4] - Jiuan Medical intends to cancel 9.77 million shares, which is 2.06% of its total share capital, as part of a strategy to enhance shareholder returns [5] Group 3: Market Movements and Regulations - Xiangrikui is planning to acquire controlling stakes in Xi Pu Materials and 40% of Beid Pharmaceutical, leading to a temporary suspension of its stock [6] - Beijing has launched a free HPV vaccination program for new first-year junior high school girls, aiming to increase vaccination rates [7][8] - Two studies on iza-bren (EGFR×HER3 dual antibody ADC) have been selected for the official news release program at the 2025 WCLC, highlighting its clinical significance [9] Group 4: Shareholder Actions - Chengda Pharmaceutical announced that a shareholder plans to reduce their stake by up to 7.27% within three months [10] - Kangchen Pharmaceutical's controlling shareholder plans to reduce their stake by up to 3% between September 29 and December 28, 2025, due to personal funding needs [11]
湿疹药物试验数据令人失望 赛诺菲股价暴跌9%
Zheng Quan Shi Bao Wang· 2025-09-05 00:26
Core Viewpoint - Sanofi's stock price dropped by 9% due to unsatisfactory late-stage trial data for its eczema treatment drug, amlitelimab, which failed to meet analyst expectations [1] Group 1: Drug Performance - Sanofi claims that amlitelimab achieved its primary goals, showing better skin clearance rates and disease severity compared to placebo [1] - Analysts believe the results are weaker than earlier trials and less effective compared to competitors' biologics [1] - JPMorgan noted that amlitelimab's efficacy is inferior to Sanofi's existing blockbuster drug, Dupixent, which treats the same skin condition and is set to lose patent protection in 2031 [1] Group 2: Analyst Expectations - TD Cowen analysts previously expected amlitelimab to achieve an EASI-75 rate of 45% to 50% within 24 weeks, while actual data showed an EASI-75 rate of 35.9% to 46.0% [1] Group 3: Future Potential - Sanofi executives stated that amlitelimab has the potential for administration only four times a year and could make significant advancements in treating atopic dermatitis [1] - The drug is anticipated to complement or replace Dupixent before its patent expiration, with peak sales projected to exceed $5 billion [1]
赛诺菲(SNY.US)全球首创OX40L单抗III期研究成功
Zhi Tong Cai Jing· 2025-09-04 23:38
Core Viewpoint - Sanofi announced that the Phase III COAST 1 study of Amlitelimab for the treatment of atopic dermatitis has met all primary and secondary endpoints [1] Group 1: Drug Information - Amlitelimab is a fully human non-T cell depleting monoclonal antibody targeting OX40L, developed by Sanofi [1] - The drug works by blocking the interaction between the key immune regulatory factor OX40L and its receptor OX40, maintaining the balance between pro-inflammatory T cells and regulatory T cells [1] - Amlitelimab is currently the only OX40L antibody in Phase III development [1] Group 2: Therapeutic Applications - The drug is intended for the treatment of a range of immune and inflammatory diseases, including atopic dermatitis, asthma, and hidradenitis suppurativa [1]
Why Is Sanofi Stock Falling Thursday?
Benzinga· 2025-09-04 18:36
Core Viewpoint - Sanofi SA's stock declined after the late-stage trial results for amlitelimab, a potential successor to Dupixent, did not meet investor expectations, raising concerns about the company's dermatology franchise sustainability post-patent expiration [1] Group 1: Trial Results - The global COAST 1 phase 3 study indicated that amlitelimab met all primary and key secondary endpoints, showing statistically significant skin clearance and disease severity improvement compared to placebo at Week 24 for patients aged 12 years and older with moderate-to-severe atopic dermatitis [2] - However, the efficacy of amlitelimab and Amgen's rocatinlimab in Phase 3 studies did not reach the benchmark set by Dupixent, which demonstrated a 36% improvement on EASI-75 over placebo [3] Group 2: Comparison with Competitors - Analyst observations noted that both rocatinlimab and amlitelimab offer a more favorable dosing schedule compared to Dupixent, with potential for monthly or quarterly dosing, respectively [4] - The results suggest that OX40/OX40L therapies, including amlitelimab, may provide slower and less robust responses than IL-13/4 drugs, likely confining their use to second-line treatments for patients who do not respond to IL-13/4 options [4] Group 3: Market Dynamics - Advanced therapies account for less than 20% of the atopic dermatitis market, with only three approved mechanisms (IL-13/4, IL-31, JAK), indicating a potential market opportunity for OX40 drugs, albeit smaller than for therapies that match or exceed IL-13/4 efficacy [5] - Ongoing discussions focus on the differences between amlitelimab and rocatinlimab, particularly regarding side effects like pyrexia and chills [5] Group 4: Side Effects and Dosing - Amgen's rocatinlimab is associated with immune-related side effects, including pyrexia (10%) and chills (6%), which may have limited dosing in Phase 3 trials to 300 mg, below the 600 mg tested in Phase 2, potentially affecting its efficacy [6] - In contrast, amlitelimab exhibited lower rates of pyrexia (1.1% vs. 0.7% placebo) and chills (0.4% vs. 0.0% placebo), while achieving comparable efficacy to rocatinlimab at higher dose levels [6] Group 5: Stock Performance - Following the trial results, Sanofi's stock price fell by 8.59% to $45.61 [7]
SNY Down Despite Eczema Candidate Meeting Goal in Phase III Study
ZACKS· 2025-09-04 15:51
Core Insights - Sanofi announced positive results from the phase III COAST 1 study for amlitelimab, an anti-OX40L monoclonal antibody, aimed at treating moderate-to-severe atopic dermatitis in patients aged 12 and above [1][7] - The study achieved all primary and key secondary endpoints, demonstrating significant skin clearance and improvement in disease severity compared to placebo [2][7] Study Results - Amlitelimab, administered every four weeks or every 12 weeks, showed statistically significant and clinically meaningful efficacy in skin clearance and disease severity at week 24 [2] - The treatment was generally safe and well-tolerated, with no new safety concerns reported [2] Market Reaction - Despite the positive data, Sanofi's shares fell by 8.8% in pre-market trading on September 4, as the results did not meet investor expectations [3] - Analysts expressed concerns that amlitelimab may be less effective than Sanofi's existing drug Dupixent, which is a leading treatment for various inflammatory diseases [3] Dupixent Performance - In the first half of 2025, Dupixent generated sales of €7.31 billion, marking a 20.7% year-over-year increase [4] - Dupixent holds the top new-to-brand prescription market share across all its approved indications in the U.S., with ongoing efforts to expand its label [4] Stock Performance - Year-to-date, Sanofi's shares have increased by 3.5%, contrasting with a 0.1% decline in the industry [5] Future Developments - Amlitelimab is part of the OCEANA clinical development program, which includes four other phase III studies, with data expected through 2026 [9][10] - Positive results from these studies could support global regulatory filings for amlitelimab for atopic dermatitis [9] Additional Indications - Besides atopic dermatitis, Sanofi is also exploring amlitelimab for celiac disease, alopecia areata, asthma, and systemic sclerosis in mid-stage studies [10]
Sanofi Hit With Shock As Flagship Drug Successor Disappoints Investors
Benzinga· 2025-09-04 13:21
Core Viewpoint - Sanofi's stock experienced a significant decline following the disappointing late-stage trial results for amlitelimab, which raised concerns about the company's ability to maintain its dermatology portfolio after the expiration of patent protections for Dupixent [1][5]. Group 1: Trial Results - The global COAST 1 phase 3 study demonstrated that amlitelimab met all primary and key secondary endpoints, showing statistically significant and clinically meaningful improvements in skin clearance and disease severity compared to placebo at Week 24 for patients aged 12 years and older with moderate-to-severe atopic dermatitis [2]. - Amlitelimab was well-tolerated, with no new safety concerns identified during the study [2]. - The EASI-75 results indicated that 35.9% and 46% of patients achieved a 75% or greater improvement in the eczema area and severity index total score at Q4W, compared to 19.1% on placebo, and 39.1% and 50.3% at Q12W versus 27.6% [3]. Group 2: Comparative Analysis - The validated investigator global assessment scale for atopic dermatitis (vIGA-AD) showed results of 21.1% and 22.5% for amlitelimab compared to 9.2% and 26.5% for placebo, depending on patient inclusion [4]. - Analysts noted that the Phase 3 results were weaker than those of Sanofi's existing drug Dupixent and rival biologic drugs, although the safety profile and convenient 12-week dosing of amlitelimab could still support its use [6]. Group 3: Market Reaction - Following the trial results, Sanofi's stock price fell by 8.52%, trading at $45.64 during the premarket session [6]. - Investors had previously viewed amlitelimab as a key pipeline asset and potential successor to Dupixent, which is set to lose patent protection in 2031 [5].
赛诺菲创新药特瑞可 在华获批 用于延缓1型糖尿病进展
Jing Ji Guan Cha Wang· 2025-09-04 09:36
Core Viewpoint - Sanofi's Tzield (teplizumab) has received approval from the National Medical Products Administration (NMPA) in China for use in children aged 8 and above and adults with stage 2 type 1 diabetes, aiming to delay progression to stage 3 diabetes [1] Group 1 - Teplizumab is a CD3-targeting monoclonal antibody that protects endogenous pancreatic function, allowing patients to delay the progression from stage 2 to stage 3 type 1 diabetes by nearly 3 years [1] - This approval marks a significant milestone for the product, following its status as the first prescription approved in Asia earlier in June [1] - The approval represents a breakthrough in the treatment of type 1 diabetes in China, shifting the approach from "passive treatment" to "active intervention" [1]
赛诺菲(SNY.US)盘前跌近9% 特应性皮炎药物后期试验疗效不及预期
Zhi Tong Cai Jing· 2025-09-04 09:23
Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are crucial for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Prospects and Comparisons - Sanofi is seeking alternatives to Dupixent, which is projected to generate over €21 billion annually at peak sales [3]. - Amlitelimab is expected to generate approximately €1.5 billion (around $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration only once every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Other Drug Developments - The efficacy results of itepekimab have been mixed in recent late-stage trials, as it is being tested for chronic obstructive pulmonary disease in former smokers [4].
美股异动 | 赛诺菲(SNY.US)盘前跌近9% 特应性皮炎药物后期试验疗效不及预期
智通财经网· 2025-09-04 09:23
Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo after 24 weeks of treatment, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are critical for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Projections and Comparisons - Dupixent is projected to generate over €21 billion (approximately $25 billion) annually at its peak, and Sanofi is actively seeking alternatives to replace it [3]. - Amlitelimab is expected to generate around €1.5 billion (approximately $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Additional Drug Development - The efficacy results of itepekimab, developed in collaboration with Regeneron, have shown contrasting outcomes in late-stage trials [4].