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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]
Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
Globenewswire· 2025-06-03 12:26
Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]
古根海姆:将赛诺菲目标价从108欧元上调至110欧元。
news flash· 2025-06-03 10:21
古根海姆:将赛诺菲目标价从108欧元上调至110欧元。 ...
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]
Johnson Fistel Investigates Fairness of Proposed Sale of Blueprint Medicines
GlobeNewswire News Room· 2025-06-02 16:48
Core Viewpoint - Johnson Fistel, PLLP has initiated an investigation into potential breaches of fiduciary duties by the board members of Blueprint Medicines Corporation in relation to its proposed sale to Sanofi [1] Group 1: Acquisition Details - Blueprint Medicines has entered into a definitive agreement with Sanofi to sell all outstanding shares for $129.00 per share in cash, along with a non-tradeable contingent value right that could yield two milestone payments of $2 and $4 for future development and regulatory achievements related to BLU-808 [2] - The transaction agreement includes a provision that restricts Blueprint's ability to solicit or accept superior proposals, imposing a significant termination fee if the board pursues a competing bid [3] Group 2: Market Analysis - A Wall Street analyst has set a price target of $167 per share for Blueprint's common stock, which is significantly higher than the agreed transaction price of $129.00 [3]
深夜,美钢铁股暴涨!特朗普宣布加税!
Zheng Quan Shi Bao· 2025-06-02 15:17
Market Overview - US stock indices opened lower on Monday, with the Dow Jones down 0.43%, Nasdaq down 0.25%, and S&P 500 down 0.30%. The Dow Jones index fell below 42,000 points, closing at 41,964.54, down 0.72% for the day [1] Manufacturing Sector - US factory activity has contracted for the fourth consecutive month in May, with the ISM manufacturing index decreasing by 0.2 percentage points to 48.5. The import index dropped to its lowest level in 16 years, down 7.2 points to 39.9, marking one of the largest monthly declines on record [3] - The export index reached a five-year low, potentially reflecting retaliatory tariffs imposed by other countries on US producers. The supplier delivery index rose to its highest level since June 2022, indicating extended delivery times [3] - The report highlighted the impact of increased tariffs on demand, with new orders shrinking for the fourth consecutive month and backlogs decreasing at the slowest pace since September 2022 [3] Steel Industry - Steel stocks saw significant gains, with Cleveland-Cliffs up 23.3%, Steel Dynamics up 12.5%, and Nucor up 13.5%. This surge followed President Trump's announcement to raise the import tariff on steel from 25% to 50% [3] Biopharmaceutical Sector - BioNTech shares rose by 12.3% following a $11.1 billion collaboration agreement with Bristol-Myers Squibb. Blueprint Medicines experienced a 26.3% increase after agreeing to be acquired by Sanofi for approximately $9.5 billion [4]
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
Core Insights - Recludix Pharma has nominated REX-8756 as a lead development candidate, an oral, selective, and reversible small molecule inhibitor of STAT6, completing GLP toxicology studies associated with a $50 million payment to Recludix from Sanofi [1][4] - REX-8756 demonstrates complete pathway inhibition and is well tolerated in preclinical studies, showing potential for fewer side effects compared to JAK inhibitors [1][2] - The company is advancing REX-8756 towards Investigational New Drug (IND) submission later this year, with ongoing IND-enabling activities [1][2] Company Overview - Recludix Pharma specializes in discovering inhibitors for challenging targets related to inflammatory diseases, with a focus on developing best-in-class drug candidates [2][6] - The company has developed a unique drug discovery platform that integrates custom DNA-encoded libraries and proprietary screening tools, particularly targeting SH2 domain inhibitors [6] - Recludix has a strategic collaboration with Sanofi for the development and commercialization of STAT6 inhibitors, with potential for significant financial milestones exceeding $1.2 billion [4][6] Product Development - REX-8756 has shown robust efficacy in preclinical models of asthma, acute lung inflammation, and dermatitis, disrupting IL-4/13 stimulated inflammatory biomarkers [2][3] - The compound inhibits STAT6 through its SH2 domain, which is crucial for mediating protein-protein interactions and was previously considered undruggable [2][3] - The company aims to provide oral medicines with biologic-like activity and favorable safety profiles as alternatives to current therapies like JAK inhibitors [2][3] Collaboration with Sanofi - Under the collaboration, Sanofi will take over worldwide clinical development and commercialization responsibilities after the start of Phase 2 clinical trials [4] - Recludix has received $125 million in near-term payments and has the option to participate in U.S. profit/loss sharing, including co-promotion activities [4]