NEW YORK, May 21, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today that it will hold its annual general meeting on June 26, 2025 at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. The notice convening the annual general meeting stating the detailed agenda and modalities of participati ...

Accelerates product innovation, expands GMP manufacturing capacity, and deepens corporate-wide commitment to responsible growth Debuts enhanced greenhouse gas accounting across Scopes 1-3 and advances renewable energy initiatives Strengthens governance with appointment of independent Chairman of the Board and launches site level ethics liaison program SAN DIEGO, May 21, 2025 (GLOBE NEWSWIRE) -- This release corrects and replaces the version distributed earlier today at 16:05 ET. The original version inc ...

Accelerates product innovation, expands GMP manufacturing capacity, and deepens corporate-wide commitment to responsible growth Debuts enhanced greenhouse gas accounting across Scopes 1-3 and advances renewable energy initiatives Strengthens governance with appointment of independent Chairman of the Board and launches site level ethics liaison program SAN DIEGO, May 21, 2025 (GLOBE NEWSWIRE) -- Maravai LifeSciences Holdings, Inc. (NASDAQ: MRVI), a global provider of lifescience reagents and services to ...

TrialWire™ 是基于 Salesforce Health Cloud 构建的风险共担、按招募人数计费、人工智能和算法驱动的患者招募平台，并提供行业领先的患者数据和知识产权安全保障旧金山, May 22, 2025 (GLOBE NEWSWIRE) -- TrialWire 今日宣布荣获 Fierce Biotech 主办的 Fierce CRO 奖项杰出患者招募与留存类目提名，闯入决赛。 TrialWire 是基于 Salesforce Health Cloud 构建的人工智能和算法驱动的患者招募和入组特色平台，具备一流的数据和知识产权安全保障。 该平台是一家风险共担、按招募人数计费的平台，可加速多语言、多文化背景下的全球研究和单一国家或区域性研究，以及混合式去中心化临床试验的开展。 TrialWire 平台专门设计了其主打产品 RapidRescue™，用于挽救各个停滞不前的临床试验。 点击此处预先登记您的研究，以备不时之需希望从一开始就获得招募确定性的申办方和合同研究组织 (CRO)，也可以借助 TrialWire 精心策划的定制患者注册解决方案 GeoClinical™，以加快研究机构启动并提高 ...

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Summary of Nuvation Bio Conference Call Company Overview - **Company**: Nuvation Bio - **Focus**: Development of innovative therapies, particularly in oncology, with a strong emphasis on ROS1 inhibition for non-small cell lung cancer [1][2] Key Points and Arguments Drug Development and FDA Approval - Nuvation Bio is on the verge of receiving FDA approval for its first drug, **telotrectinib**, a ROS1 inhibitor targeting ROS1-driven non-small cell lung cancers [3][4] - The New Drug Application (NDA) was submitted last year and accepted with priority review, with a PDUFA date set for **June 23** [4][9] - Telotrectinib shows an **overall response rate of 89%** and a **progression-free survival (PFS) of 46 months**, significantly outperforming standard care options [5][10] Patient Outcomes - The drug has demonstrated long-term PFS, with some patients remaining progression-free for **up to nine years** [6][10] - The average age of patients with ROS1 lung cancer is around **50 years**, with a significant number developing brain metastases early in the disease [4][5] Competitive Landscape - Nuvation Bio is the only ROS1 agent in development with **breakthrough designation** in both first and second-line settings [8][36] - The company has a robust safety database with over **400 patients** and a follow-up time of up to **nine years** [37] Market Opportunity - The potential market for telotrectinib is estimated at nearly **$4 billion annually** based on current DNA testing, with expectations to exceed **$5 billion** once RNA testing becomes standard [24][25] - The company anticipates commanding a significant share of this market due to its favorable drug profile [25] Launch Preparations - The commercial team is fully prepared for an immediate launch upon FDA approval, leveraging prior experience from successful launches at Medivation [18][20] - The team is confident in the drug's value proposition and market opportunity, despite acknowledging that launches can be challenging [23] Regulatory Changes - Recent updates to NCCN guidelines now contraindicate the use of immunotherapy for patients with ROS1 mutations, which is expected to shift treatment dynamics significantly [14][15] Pipeline and Future Developments - Nuvation Bio is also developing **safacitinib**, a mutant IDH1 inhibitor, which has shown promising response rates in glioma [39][40] - The company is exploring the potential of safacitinib as a new generation oral immuno-oncology agent [42] - The drug-drug conjugate platform, including candidate **1511**, is currently in clinical trials for various difficult-to-treat cancers [45] Financial Position - Nuvation Bio has **$62 million** on its balance sheet and expects to access an additional **$250 million** in non-dilutive capital upon approval [47] - The company is actively seeking new opportunities to bolster its pipeline, with a focus on innovative deals [48] Additional Important Insights - The launch in China has been positively received, with endorsements from medical organizations, indicating strong potential for international markets [32][33] - The company is committed to increasing awareness and testing rates for ROS1 mutations, which could further enhance patient identification and treatment rates [28][29] This summary encapsulates the critical insights from the Nuvation Bio conference call, highlighting the company's strategic positioning, drug development progress, and market opportunities.

Summary of Atyre Pharma Conference Call Company Overview - Atyre Pharma is positioned as a leading company in the interstitial lung disease sector, focusing on the development of therapies for conditions such as pulmonary sarcoidosis with its lead program, esofitimod [4][5] Key Points and Arguments Upcoming Phase Three Catalyst - Atyre Pharma is anticipating a major phase three trial readout for esofitimod in pulmonary sarcoidosis, which could be the first new therapy for this condition in 70 years [4][5] - The company has transitioned esofitimod through various stages of development, culminating in a highly derisked asset ready for pivotal trials [5] Data-Driven Approach - Atyre emphasizes a data-driven methodology, showcasing significant preclinical and phase two data that supports the efficacy of esofitimod in modulating immune responses without the heavy immunosuppressive effects typical of existing treatments [6][7][9] - The company has published extensively, including in high-impact journals, to validate its findings and maintain transparency with investors [12][14][15] FDA Interaction and Endpoint Adjustments - Recent discussions with the FDA have led to a refined approach to analyzing steroid reduction as a primary endpoint, which is now expected to yield more favorable statistical outcomes [18][19][22] - The FDA's guidance has allowed Atyre to adjust its statistical model positively, potentially lowering the threshold for demonstrating statistical significance [19][22] Market Potential and Demographics - Atyre's updated epidemiological work indicates that the steroid-dependent population for sarcoidosis is larger than previously estimated, now believed to be around 75% of the 200,000 patients in the U.S. [44][45] - The potential market opportunity for esofitimod is now projected to be between $5 billion to $6 billion, significantly higher than earlier estimates [46] Clinical Trial Insights - The trial involves a diverse patient population across 90 centers in nine countries, with baseline demographics aligning closely with previous studies [30][31][34] - The company has taken steps to ensure data integrity and quality, which is crucial for the pivotal submission [39] Future Indications and Pipeline - Atyre is exploring additional indications for esofitimod, including scleroderma ILD, although the readouts from this trial are not expected to directly influence the sarcoidosis data [50][53] - The company has introduced a new IND program targeting myofibroblast apoptosis, which could have significant implications for treating idiopathic pulmonary fibrosis (IPF) [58][60] Other Important Content - The company has received positive feedback from the medical community regarding its innovative approach to treating sarcoidosis, with many expressing gratitude for the efforts to reduce steroid dependency [10][26] - Atyre's commitment to rigorous clinical trial design and data publication is highlighted as a key differentiator in the biotech space [12][15] This summary encapsulates the critical insights and developments discussed during the conference call, reflecting Atyre Pharma's strategic direction and market positioning.

Core Insights - Amgen Inc. has reported a strong start to 2025, with first-quarter revenues increasing by 9% and non-GAAP earnings per share rising by 24% year-over-year, driven by 14 products that delivered double-digit growth across various therapeutic areas [3]. Company Performance - The company experienced broad-based strength in its portfolio, particularly in general medicine, rare disease, inflammation, and oncology [3]. - The macro and policy environment remains fluid, especially concerning taxes and pricing, but Amgen emphasizes the need for more innovation in healthcare [4]. Product Highlights - Specific product highlights were anticipated to be discussed by the Senior Vice President of Global Marketing & Access, indicating a focus on key growth drivers within the portfolio [5].

Silence Therapeutics PLC Sponsored ADR (SLN) closed the last trading session at $5.14, gaining 68.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $35.50 indicates a 590.7% upside potential.The average comprises six short-term price targets ranging from a low of $3 to a high of $75, with a standard deviation of $23.86. While the lowest estimate indicates a decline of 41.6% from t ...

Both companies have earned a year-long opportunity for access to a distinguished life-science incubator in San Francisco along with the invaluable expertise provided by Astellas to advance their research endeavors Award helps biotech startups accelerate early research effortsNORTHBROOK, Ill., May 21, 2025 /PRNewswire/ -- Astellas Pharma U.S. Inc. (Head of Commercial: Mike Petroutsas, "Astellas"), and MBC BioLabs, a premier launchpad for early-stage life-science companies, today announced DeepSeq.AI, Inc. & ...