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Genentech's Giredestrant Becomes the First Oral SERD to Show Superior Invasive Disease-Free Survival in Early Breast Cancer
Businesswire· 2025-11-18 06:10
Core Insights - Genentech, a member of the Roche Group, announced positive Phase III results from the lidERA Breast Cancer study for giredestrant as an adjuvant endocrine treatment for ER-positive, HER2-negative early-stage breast cancer [1] Group 1 - The study met its primary endpoint at a pre-planned interim analysis [1] - The results showed a statistically significant outcome [1]
[Ad hoc announcement pursuant to Art. 53 LR] Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer
Globenewswire· 2025-11-18 06:00
Core Insights - Roche announced positive phase III results from the lidERA Breast Cancer study, demonstrating that giredestrant significantly improves invasive disease-free survival compared to standard endocrine therapy for early-stage ER-positive, HER2-negative breast cancer [1][2][8] - Giredestrant is positioned as a potential new standard of care in the adjuvant setting, particularly as ER-positive breast cancer accounts for approximately 70% of cases diagnosed [2][3][4] Study Details - The lidERA study is a phase III, randomized, open-label trial involving over 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative breast cancer [6][8] - The primary endpoint was invasive disease-free survival (iDFS), with key secondary endpoints including overall survival and safety [7][8] Clinical Implications - Giredestrant was well tolerated, with adverse events aligning with its known safety profile, indicating a favorable treatment option for patients who often face recurrence or treatment interruptions [2][3][4] - The results from lidERA, along with previous studies like evERA, support the efficacy of giredestrant across various treatment settings for ER-positive breast cancer [4][8] Market Context - The need for more effective and better-tolerated treatment options is underscored by the fact that up to a third of patients experience recurrence after adjuvant endocrine therapy [3][12] - Roche's commitment to advancing breast cancer research is evident through its extensive clinical development program for giredestrant, which spans multiple treatment settings [5][10][13]
[Ad hoc announcement pursuant to Art. 53 LR] Roche's giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer
Globenewswire· 2025-11-18 06:00
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapyThese unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage settingData to be presented at an upcoming medical meeting and shared with health authorities around the world lidERA is the second positive phase III readout for giredestrant following evERA presented at ESMO 20251 Basel, 18 November 2025 - Roc ...
X @Bloomberg
Bloomberg· 2025-11-18 05:08
A US congressional commission is ringing alarm bells about China’s growing dominance over America’s drug supply, saying it is putting the country’s health in the hands of an adversarial nation https://t.co/wCLmtSxjU3 ...
深圳市AI+药械研发公共服务平台正式启动
Nan Fang Du Shi Bao· 2025-11-18 04:25
Core Insights - The 27th China International High-tech Achievements Fair concluded with a focus on the development of innovative pharmaceuticals in Shenzhen, emphasizing the theme "AI Empowerment, Moving Forward" [1][3] Group 1: Event Overview - The forum was guided by the Shenzhen Development and Reform Commission and the Shenzhen Science and Technology Innovation Bureau, hosted by Shenzhen Polytechnic University, featuring top academicians and industry leaders [3] - Key activities included policy interpretation, platform launches, achievement announcements, project signings, and high-level dialogues [3] Group 2: Policy and Infrastructure Development - Shenzhen is actively promoting high-quality development in the biopharmaceutical industry, establishing a city-level medical device office, implementing supportive policies, and creating a new medical academy mechanism [3] - The city has set up over 10 billion yuan industry funds and is focusing on AI drug development among other new tracks [3] Group 3: AI and Pharmaceutical Research Initiatives - The Shenzhen AI + Pharmaceutical Research Public Service Platform was officially launched, integrating multiple AI-driven research platforms to enhance drug development [5] - The forum also introduced the "AI for Science Innovation Application Competition" to foster innovation teams in the biopharmaceutical sector [5] Group 4: Research Collaborations and Project Signings - Shenzhen Polytechnic University signed eight major projects with various enterprises and institutions to enhance research collaboration and talent cultivation [6] - These initiatives aim to strengthen the foundation for high-quality development in the biopharmaceutical industry [6] Group 5: Industry Achievements and Future Goals - The forum highlighted 10 innovative pharmaceutical achievements expected by 2025, covering areas such as AI drug development, cell therapy, and targeted cancer drugs [5] - From 2015 to 2024, China has developed a total of 3,575 innovative drugs, surpassing the United States, with Shenzhen positioned as a key base in the biopharmaceutical industry aiming for an annual output value of 200 billion yuan [8]
Pfizer's CEO Sends a Warning to Eli Lilly. Is the Stock a Buy?
The Motley Fool· 2025-11-18 02:10
Core Insights - Pfizer is making significant moves in the weight management market, which is expected to grow rapidly in the next decade, potentially rewarding leading companies handsomely [1][2] - The acquisition of Metsera for $7 billion, with potential milestone payments bringing the total to $10 billion, positions Pfizer as a strong contender in the weight management space [3][4] - Pfizer's CEO, Albert Bourla, expressed confidence in the company's ability to succeed in the obesity market, drawing parallels to past successes with drugs like Lipitor and COVID products [7] Company Developments - Pfizer's acquisition of Metsera indicates its commitment to entering the weight management market, especially after competing with Novo Nordisk for the deal [3][4] - Metsera's leading candidate, MET-097i, has shown promising results in clinical trials, indicating potential for substantial weight loss and good tolerability [6] - Pfizer plans to launch its first anti-obesity drug by the end of 2028, although Eli Lilly currently holds a significant lead with existing products on the market [8] Competitive Landscape - Eli Lilly is currently the leader in the weight management market with its product Zepbound, which has seen exceptional sales growth [8][11] - Eli Lilly has several promising candidates in its pipeline, including orforglipron and retatrutide, which are expected to enhance its competitive position [9][10][11] - Despite Pfizer's efforts, Eli Lilly's established presence and upcoming product launches may allow it to maintain its leadership in the anti-obesity market for the foreseeable future [11] Financial Outlook - Pfizer's recent financial performance has been underwhelming, with concerns about the impending patent cliff for its top growth driver, Eliquis [13] - However, the acquisition of Metsera and the potential success in the weight management sector could help Pfizer rebound [14] - The company also has a strong dividend program, which may attract investors despite current challenges [15]
机构积极看多创新药,慢牛行情或呈现
Xin Lang Cai Jing· 2025-11-18 01:48
方正证券表示,当下时点更应积极看多,新一轮行情有别于今年第一轮估值修复的轰轰烈烈行情,未来 创新药将呈现核心龙头震荡上行,新机会继续涌现的慢牛行情。 恒生医药ETF(159892)聚焦创新+药品主线,涵盖创新药、CXO、互联网药店等细分领域,具备较强 的创新特征,契合创新、出海等主线方向。 百济神州的三季报相当于给创新药行情注入了稳定剂,提示中国原研新药可以在国际市场获得丰厚的回 报和利润,打开创新药行情空间。 方正证券表示,本轮创新药从8月中下旬进行调整状态,部分个股尤其是港股调整剧烈,市场对创新药 的核心逻辑出现怀疑,部分市场资金在国际博弈扰动下有减仓,但实质上创新药BD的逻辑从未改变。 从后续一二级层出不穷的BD可以印证,部分个股调整剧烈是预期过高、过于超前导致,不是行情逻辑 的证伪或终结,这点从龙头稳健的走势上可见一斑。 ...
Global Markets Face Headwinds as RBA Holds Rates, J&J Expands Oncology, and Japan Warns on Yen Volatility
Stock Market News· 2025-11-18 01:08
Key TakeawaysThe Reserve Bank of Australia (RBA) maintained its cash rate, signaling a cautious stance on inflation and the economic outlook, while acknowledging potential for future policy adjustments.Global equity markets experienced a downturn, with Seoul shares declining due to tech losses and Australian shares hitting a four-month low amidst significant losses in the banking and mining sectors.Johnson & Johnson (JNJ) is set to bolster its oncology portfolio with the acquisition of Halda Therapeutics fo ...
Global Markets Navigate Japan’s FX Concerns, Major M&A, and Geopolitical Shifts
Stock Market News· 2025-11-18 00:38
Corporate Moves: Acquisitions, Succession, and IPOs - Johnson & Johnson (JNJ) announced a definitive agreement to acquire Halda Therapeutics for $3.05 billion in cash, aiming to expand its oncology portfolio, particularly in treatments for solid tumors and prostate cancer [5] - Apple (AAPL) is reportedly intensifying preparations for CEO Tim Cook's succession, with John Ternus, Senior Vice President of Hardware Engineering, considered the likely successor [6] - The Pinkfong Company (403850.KQ), creator of "Baby Shark," saw its shares surge 55% above its IPO price on debut, pricing its IPO at 38,000 won per share and raising 76 billion won ($53 million) [7] Geopolitical and Economic Policy Developments - The UK has raised its bank deposit guarantee to £120,000 from £85,000, effective December 1, to keep pace with inflation and maintain public confidence in the banking system [8] - U.S. sanctions on Russian oil majors Rosneft and Lukoil are effectively reducing Russian oil revenues, pushing crude prices to multi-year lows and expected to negatively impact Russian oil export volumes [10]
Artisan Therapeutics and Tulex Pharmaceuticals Announce Positive Phase 2a Results for ART-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder
Globenewswire· 2025-11-17 22:30
SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Artisan Therapeutics, Inc. (“Artisan”) and Tulex Pharmaceuticals (“Tulex”) today announced encouraging Phase 2a clinical results highlighting the potential of ART-501 for the treatment of autism spectrum disorder (“ASD”)-related conditions. In this pilot, proof-of-concept study, four out of six participants demonstrated meaningful signs of clinical benefit. ART-501 was generally well-tolerated, with adverse events reported as mostly mild and transient, and with n ...