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Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
GlobeNewswire News Room· 2025-06-03 12:26
Core Insights - New data from clinical studies support the subcutaneous administration of Sarclisa via an on-body injector, demonstrating non-inferior efficacy and safety compared to intravenous infusion [1][5][6] Group 1: Clinical Study Findings - The IRAKLIA phase 3 study showed very good partial response (VGPR) rates of 46.4% for Sarclisa SC-Pd and 45.9% for Sarclisa IV-Pd, indicating non-inferiority [5] - The objective response rate (ORR) for Sarclisa SC-Pd was 71.1% compared to 70.5% for Sarclisa IV-Pd, establishing non-inferiority [7] - The overall safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower rate of systemic infusion reactions (1.5% vs. 25%) [12][8] Group 2: Patient Experience and Administration - The on-body injector (OBI) is expected to enhance patient experience by providing greater convenience and flexibility, leading to higher patient satisfaction scores [2][9] - 70% of patients treated with Sarclisa SC-Pd reported satisfaction with their injection, compared to 53.4% in the IV-Pd group [12] - The OBI allows for a hands-free administration process, potentially reducing the physical burden on healthcare providers [2][11] Group 3: Future Directions and Regulatory Submissions - Data from the IRAKLIA and IZALCO studies will form the basis for global regulatory submissions for Sarclisa SC administration [6][14] - Sanofi is also exploring Sarclisa SC administration in front-line treatment settings through additional studies [14] - The IRAKLIA study's abstract was selected for the 2025 Best of ASCO program, highlighting its significance in the field [14]
Entrada Therapeutics Appoints Maha Radhakrishnan, M.D., to its Board of Directors
GlobeNewswire News Room· 2025-06-03 11:00
Company Overview - Entrada Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a new class of medicines that target intracellular mechanisms previously deemed inaccessible [4] - The company utilizes its proprietary Endosomal Escape Vehicle (EEV™) technology to enhance the intracellular delivery of therapeutics, aiming to improve therapeutic indices across various diseases [4] Recent Developments - The company announced the appointment of Dr. Maha Radhakrishnan to its Board of Directors, which is expected to bolster its clinical momentum, particularly in the Duchenne muscular dystrophy franchise [1][2] - Dr. Radhakrishnan brings extensive experience in global drug development, having previously held senior roles at Biogen and Sanofi, which will be instrumental as Entrada advances its clinical-stage portfolio [3] Clinical Focus - Entrada is advancing multiple patient-focused clinical trials for its Duchenne muscular dystrophy programs throughout the year, with promising Phase 1 safety and target engagement data [2][3] - The company is developing lead oligonucleotide programs targeting exon 44, 45, 50, and 51 skipping for the treatment of Duchenne muscular dystrophy [4]
高盛:鲸吞Blueprint(BPMC.US)有望化解“专利悬崖”危机 维持赛诺菲(SNY.US)目标价67美元
Zhi Tong Cai Jing· 2025-06-03 08:13
Group 1 - Sanofi announced a plan to acquire Blueprint Medicines for $9.1 billion, aiming to integrate Blueprint's rare disease and immunology pipeline assets to fill the profit gap after the patent expiration of Dupixent in 2031/32 [1][2] - The acquisition will be conducted at a cash price of $129 per share, representing a 27% premium over the closing price on May 30, with potential additional payments based on the success of Blueprint's drug BLU-808 [1][2] - Goldman Sachs maintains a "neutral" rating on Sanofi with a target price of €117 (ADR $67) following the announcement of the acquisition [1] Group 2 - Key assets in the acquisition include the approved tyrosine kinase inhibitor Ayvakit and the investigational drug BLU-808, which targets non-mutant KIT for chronic urticaria and allergic asthma [2] - Ayvakit is projected to reach peak sales of €2.35 billion by 2033 with a gross margin of 95%, while BLU-808 is expected to achieve peak sales of $2.7 billion (€1.7 billion) by 2033 [2] - The acquisition is expected to strengthen Sanofi's position in the rare disease sector and support its immunology pipeline, serving as a long-term alternative to Dupixent [2]
潜在总金额95亿美元 赛诺菲收购罕见病疗法公司Blueprint
Jing Ji Guan Cha Bao· 2025-06-03 02:02
Core Viewpoint - Sanofi has agreed to acquire Blueprint Medicines Corporation for approximately $9.1 billion, with a total equity value of about $9.5 billion including potential milestone payments [1][2]. Group 1: Acquisition Details - Sanofi will pay $129.00 per share in cash at closing, representing an equity value of approximately $9.1 billion [1]. - Blueprint shareholders will receive a non-tradable contingent value right (CVR) that entitles them to potential milestone payments of $2 and $4 for the future development and regulatory milestones of BLU-808 [1]. - The total equity value of the transaction, including potential CVR payments, is approximately $9.5 billion on a fully diluted basis [1]. Group 2: Product and Revenue Insights - Ayvakit/Ayvakyt, a drug for systemic mastocytosis, has achieved net revenues of $479 million in 2024 and nearly $150 million in the first quarter of 2025, representing over 60% year-over-year growth compared to the first quarter of 2024 [2]. - Ayvakit/Ayvakyt is a potent and selective inhibitor of activated KIT and PDGFRA mutations, which are associated with certain diseases where these protein kinases become increasingly active [2].
Sanofi Signs a $9.5B Agreement to Acquire Blueprint Medicines
ZACKS· 2025-06-02 17:00
Core Insights - Sanofi has entered into a definitive agreement to acquire Blueprint Medicines for a total deal value of up to $9.5 billion, with BPMC shares rising 26% following the announcement [1][6] - The acquisition is expected to be completed in the third quarter of 2025, subject to customary closing conditions [1] - The deal will enhance Sanofi's immunology portfolio by adding Blueprint Medicines' marketed product Ayvakit and its innovative pipeline candidates [2][5] Financial Details - Sanofi will pay $129 per share in cash, representing a 27% premium over BPMC's closing price, resulting in an equity value of approximately $9.1 billion [9] - Blueprint Medicines shareholders will also receive contingent value rights (CVRs) tied to future milestones for BLU-808, potentially increasing the total equity value to $9.5 billion [10] - Ayvakit generated $149.4 million in sales in Q1 2025, reflecting a 61% year-over-year increase, with projections of reaching $2 billion by 2030 [7][6] Strategic Intent - The acquisition aims to reduce Sanofi's reliance on Dupixent by expanding its immunology portfolio, which includes 12 potential blockbuster assets in phase III development [12][14] - Sanofi's first-quarter 2025 sales from Dupixent reached €3.48 billion, accounting for about a third of the company's total revenues, indicating the importance of diversifying its product offerings [14]
Sanofi Exercises License Extension Option to Nurix's STAT6 Program
GlobeNewswire News Room· 2025-06-02 11:00
Core Insights - Nurix Therapeutics has announced that Sanofi has exercised its option to exclusively license Nurix's STAT6 program, which includes the drug candidate NX-3911, a selective STAT6 degrader targeting type 2 inflammation-related diseases such as atopic dermatitis and asthma [2][3] Financial Summary - Nurix will receive a $15 million license extension fee from Sanofi, increasing the total amount received under their collaboration to $127 million [1][3] - Nurix is eligible for an additional $465 million in development, regulatory, and commercial milestones associated with the STAT6 program, along with potential future royalties [1][3] Product Development - NX-3911 is described as a potent, selective, orally administered STAT6 degrader that has shown robust efficacy in preclinical models for atopic dermatitis and asthma, demonstrating anti-inflammatory effects comparable to a STAT6 gene knockout [3][4] - The collaboration leverages Nurix's DEL-AI drug discovery platform to identify novel agents that induce degradation of specified drug targets, with Sanofi having the option to license drug candidates resulting from this work [3][4] Strategic Collaboration - This marks the second license extension of a Nurix autoimmune disease program by Sanofi within 90 days, indicating the effectiveness of Nurix's drug discovery platform [3] - Nurix retains the option to co-develop and co-promote up to two future products in the U.S., with profits and losses split evenly for those programs [3][4]
Recludix Pharma Announces Development Candidate Nomination of First-in-Class Oral STAT6 Inhibitor for Inflammatory Diseases and Achievement of Significant Milestone Under Collaboration with Sanofi
GlobeNewswire News Room· 2025-06-02 11:00
--Completion of GLP toxicology studies associated with a $50 million payment to Recludix under the collaboration with Sanofi -- REX-8756 is a potent and selective oral STAT6 inhibitor that demonstrates complete pathway inhibition and is well tolerated in preclinical studies --Investigational New Drug (IND)-enabling activities ongoing to support IND submission later this year SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for infla ...
赛诺菲斥资超90亿美元收购罕见病疗法公司,创欧洲药企今年收购规模之最
Di Yi Cai Jing· 2025-06-02 09:54
Core Viewpoint - Sanofi has announced a $9.5 billion acquisition of Blueprint Medicines, marking the largest healthcare acquisition by a European pharmaceutical company this year, aimed at expanding its portfolio in rare immune diseases with the drug avapritinib [1][2]. Group 1: Acquisition Details - The acquisition includes avapritinib, the only approved drug globally for advanced systemic mastocytosis, which is a rare immune disease characterized by abnormal mast cell accumulation [1]. - Blueprint's stock surged over 26% following the announcement, while its Chinese partner, Basilea Pharmaceutica, saw a nearly 5% increase in share price [1]. - The deal is expected to enhance Sanofi's research pipeline in rare immune diseases [1]. Group 2: Financial Performance - Avapritinib generated $479 million in net revenue for Sanofi in 2024, with nearly $150 million in revenue in Q1 2025, reflecting a year-over-year growth of over 60% [2]. - In China, avapritinib has been approved and recommended as a first-line treatment in the first "Systemic Mastocytosis Diagnosis and Treatment Guidelines" [2]. Group 3: Future Prospects - The acquisition will also provide Sanofi with the next-generation systemic mastocytosis drug elenestinib and the highly selective oral wild-type KIT inhibitor BLU-808, which has potential applications in various immune diseases [2]. - Sanofi's CEO Paul Hudson indicated that this acquisition complements recent purchases of early-stage drugs and that the company retains significant capacity for further acquisitions [2].
【美股盘前】三大期指齐跌,钢铁和铝业股普涨;FDA批准新型新冠疫苗,莫德纳涨超4%;谷歌表示将对在线搜索反垄断裁决提出上诉;Blueprint Medicines涨逾27%,赛诺菲将以91亿美元发起收购;特斯拉5月在瑞典销量同比下降53.7%
Mei Ri Jing Ji Xin Wen· 2025-06-02 09:39
Group 1 - U.S. stock index futures are down, with Dow futures down 0.43%, S&P 500 futures down 0.50%, and Nasdaq futures down 0.67% [1] - U.S. steel and aluminum stocks are rising ahead of market opening, following Trump's announcement to increase import tariffs on steel from 25% to 50%. Cleveland-Cliffs Inc. is up 25.56%, Nucor Corporation is up 8.69%, and Steel Dynamics Inc. is up 9.69% [1] - Moderna's new low-dose COVID-19 vaccine has been approved by the FDA, leading to a 4.74% increase in its stock price [1] Group 2 - Google plans to appeal a recent antitrust ruling that found it guilty of illegal monopoly in the advertising technology sector, resulting in a 0.9% drop in its stock [2] - Novartis reports strong results from clinical trials of its cancer drug Pluvicto for advanced prostate cancer patients [2] - Sanofi is set to acquire Blueprint Medicines for $9.1 billion, with Blueprint's stock rising 27.08% following the announcement [2] Group 3 - Apple has appealed against the EU's Digital Markets Act, which requires it to share user data with third-party developers, causing its stock to drop 0.76% [3] - Tesla's new car sales in Sweden fell by 53.7% year-over-year in May, with only 503 vehicles sold, leading to a 2.17% decline in its stock [3]