IRVINE, Calif., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer, will participate in a fireside chat at the upcoming Cantor Global Healthcare Conference on Friday, September 5, 2025, at 9:10 a.m. ET (6:10 a.m. PT). To register in advance for the fireside chat webcast, sign up here. A webcast replay will be accessible following the live session on the Company’s website under Events. About Eled ...

PRINCETON, N.J., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in September. Cantor Global Healthcare Conference 2025 in New York, NY, on Wednesday, September 3, 2025, at 10:20 a.m. ETMorgan Stanley 23rd Annual Global Healthcare Conference 2025 in New York, NY on Tuesday, September 9, 2025, at 3:20 p.m. ET A live audio webcast of each presentation can also be accessed via t ...

Core Viewpoint - Karolinska Development AB emphasizes its clear strategy and stable scientific foundation for its investment portfolio, focusing on patient benefits amidst challenging market conditions [1]. Significant Events - Organon plans to discontinue the clinical development of drug candidate OG-6219, following Phase 2 study results [3]. - Umecrine Cognition presented preclinical data on golexanolone's effects on Parkinsonian symptoms at the AD/PD 2025 conference [4]. - Umecrine Cognition received a USD 420,000 research grant from The Michael J. Fox Foundation for golexanolone studies [4]. - OssDsign achieved a milestone of treating 10,000 patients with its bone graft product in the US market [4]. - Karolinska Development divested its remaining shares in OssDsign, resulting in a capital injection of approximately SEK 34.5 million [4]. Financial Update - The net profit/loss for Q2 2025 was SEK -73.3 million, compared to SEK -16.0 million in Q2 2024 [5]. - The total fair value of the portfolio decreased to SEK 1,384.9 million at the end of June 2025, down from SEK 1,434.2 million [5]. - Net asset value at the end of June 2025 was SEK 1,148.6 million, or SEK 4.3 per share, compared to SEK 1,238.2 million, or SEK 4.6 per share, at the end of June 2024 [5]. - Cash and cash equivalents increased by SEK 20.0 million, totaling SEK 71.1 million on June 30, 2025 [5].

Core Viewpoint - PCI Biotech has decided to discontinue the development of its PCL technology due to insufficient progress towards its 2025 goals, which has raised project risks and extended timelines [2][3]. Operations - The decision to halt PCL development was made on August 18, 2025, primarily due to a lack of convincing results in demonstrating improved net yield at mini benchtop bioreactor scale [2][3]. - Additional initiatives aimed at showcasing PCL's capability to enhance net AAV yield did not yield satisfactory outcomes, leading to increased resource requirements and overall project risk [3]. Corporate - As of June 30, 2025, PCI Biotech's cash position was NOK 13.6 million, which is projected to sustain operations into Q4 2025 [4]. - The company is currently evaluating its future, considering options such as a potential sale, merger, or complete wind-down of operations [4]. - CEO Ronny Skuggedal emphasized that the evaluation process is in its early stages, and no assurances can be provided regarding the outcome [5].

平行论坛三，聚焦海洋生物医药。海洋生物医药是海洋强国和健康中国两大战略的承接，是海洋新兴产 业中最具发展潜力的领域之一。平行论坛三以"向海问药—生物医药创新的蓝色机遇"为主题，邀请到中 国医药创新促进会执行会长宋瑞霖，中国工程院院士薛长湖等院士专家发布一系列重量级主题报告，推 动更多生物医药企业拓展海洋业务，共创蓝色发展机遇。同时，围绕创新药、海洋生物制品、医美美妆 生物技术等重点领域，邀请华熙生物、修正药业等龙头企业与本地高校院所、重点企业进行对话，推动 建立以企业为主体、市场为导向、产学研深度融合的协同创新体系。 平行论坛四，聚焦海洋青年人才。主要探讨海洋领域青年人才合作及科技创新，促进海洋人才交流合 作。 平行论坛一，聚焦海洋人工智能。推动"海洋+AI"深度融合，是顺应时代发展潮流、服务国家重大战略 的必然选择。平行论坛一以"智绘蔚蓝—模塑'海洋+AI'融合发展新未来"为主题，组织举办海洋人工智 能大模型产业联盟成立仪式、大模型赋能海洋产业实践秀、擘画"海洋+AI"新蓝图主题报告等活动，拟 邀请来自清华大学、中国科学院海洋研究所、中国信通院等高校院所，以及华为、百度等领军企业的 150余位院士、专家、企 ...

Hualan released its 1H25 results on Aug 27, 2025. Both its revenue (Rmb1,798mn, +9% yoy) and net profit (Rmb516mn, +17% yoy) were largely in-line with GSe (Rmb1,905mn/519mn). By product breakdown, revenue from albumin/IVIG/other plasma products/vaccines reached Rmb696mn/453mn/588mn/57mn, with +8% /-1%/+15%/+93% yoy respectively. The company noted that unit prices for its two key plasma products, albumin and IVIG, both declined by c.5%, though management emphasized that this performance is relatively favorab ...

Financial Data and Key Metrics Changes - Revenue from cell therapy products increased to $17.2 million, up 191% from the prior year, driven by the successful launch of Ryoncil [12][15] - Net operating cash spend for the year was $50 million, consistent with the prior year, despite investments in commercial team build-out and product launch activities [13][15] - Cash on hand as of June 30 was $162 million [13] Business Line Data and Key Metrics Changes - Ryoncil generated $13.2 million in gross sales and $11.3 million in net sales after a 14.6% gross to net adjustment [12] - Cost of revenues related to product sales was $1.2 million, representing 10% of net product sales, resulting in a gross margin of 90% [15] - Selling, general, and administrative expenses rose to $39.3 million, an increase of $14.3 million from FY 2024, primarily due to the commercial team build-out and product launch [15] Market Data and Key Metrics Changes - The addressable market for Ryoncil in pediatric acute graft versus host disease (GVHD) is approximately $1 billion, with potential label extensions in adults and inflammatory bowel disease exceeding $5 billion [8] - The addressable market for chronic low back pain and heart failure with reduced ejection fraction is each over $10 billion [8] Company Strategy and Development Direction - The company aims to expand Ryoncil's label to include adult patients with GVHD and other inflammatory conditions, leveraging existing pediatric treatment centers [24][25] - Plans to initiate pivotal studies for Ryoncil in inflammatory bowel disease and chronic low back pain, targeting significant unmet medical needs [40][41] - The company is transitioning from an R&D-focused organization to a commercial biotech entity, emphasizing the importance of building a robust commercial infrastructure [87] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the successful launch of Ryoncil and the potential for continued revenue growth as more treatment centers are onboarded [76] - The company is focused on addressing the opioid crisis by providing alternatives for chronic pain management through its RexLemistroCell product [32] - Management highlighted the importance of FDA alignment for accelerated approval pathways and ongoing discussions regarding trial designs for heart failure and inflammatory bowel disease [77] Other Important Information - Ryoncil became commercially available on March 28, 2025, shortly after receiving FDA approval in December 2024 [10] - The company has onboarded 32 transplant centers in the U.S. and aims to reach 45 centers that account for 80% of pediatric bone marrow transplants [10][11] - Medicaid coverage for Ryoncil was mandated on July 1, expanding access to over 250 million lives in the U.S. [11][82] Q&A Session Summary Question: Timeline for adult GVHD label extension - Management expects to commence an adult acute GVHD trial this quarter, aiming to add Ryoncil on top of existing second-line agents [45][46] Question: Update on Phase III chronic lower back pain trial - Enrollment is progressing well with almost 40 sites, and management is optimistic about outcomes similar to previous trials [48][50] Question: Monthly treatment kits administered and inventory dynamics - Treatment kits are stocked based on weight bands, and inventory is replenished as children are treated [55][56] Question: Gross to net dynamics and adult GVHD trial design - Management expects gross to net adjustments to remain flat and will target patients on Jakafi for the adult trial [59][60] Question: Details on adult study and trial design - The trial will focus on patients with severe disease on Jakafi, aiming to increase responder rates significantly [64][65] Question: Timeline for inflammatory bowel disease trials - A KOL group is designing the trial, with updates expected this quarter [68] Question: Distribution of initial sales and revenue trajectory - It is too early to project future sales, but management expects continued strengthening of sales as infrastructure is built [73][76] Question: Market access progress - The company has engaged with over 97 payers, achieving coverage for over 250 million lives, with Medicaid coverage in place across all states [81][82]

mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Results and Operational Update for the Full Year Ended June 30, 2025 August 2025 ASX: MSB; Nasdaq: MESO For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activit ...

Financial Performance - Total revenue for Q2 2025 was $27,997, a significant decrease from $620,437 in Q2 2024, primarily due to the sale of the animal health business [9] - Gross loss for Q2 2025 was $(45,526), compared to a gross profit of $360,490 in Q2 2024 [9] - Total operating expenses for Q2 2025 were $229,930, down from $1,463,397 in Q2 2024, attributed to staff reductions and other cost-saving measures [9] - Net loss for Q2 2025 was $(348,541), an improvement from a net loss of $(1,215,996) in Q2 2024 [9] Corporate Governance - Three new directors were elected at the Annual and Special Meeting of Shareholders on June 25, 2025, alongside the reelection of three existing directors [2] - Mr. Shameze Rampertab was appointed as Chair of the Audit and Compensation Committee, and Ms. Anne Greven as Chair of the Governance & Nomination Committee [3] Product Development and Clinical Engagement - Kane Biotech presented novel preclinical data and clinical observations at two major North American wound care conferences in 2025 [4] - The company is engaging with key wound care specialists in the U.S. and is completing a clinical case series program to generate additional clinical data [5] Distribution and Financial Obligations - The company terminated its exclusive distribution agreement with ProgenaCare due to material breaches and is in discussions with potential new distributors [6] - Kane Biotech received a notice of default from Prairies Economic Development Canada regarding approximately $1.4 million outstanding from a $2.5 million Contribution Agreement [8] Strategic Outlook - The company aims to enhance its distributor networks in the U.S. and is focused on generating compelling clinical evidence to support the commercialization of its revyve portfolio [10] - The addition of three qualified directors is expected to strengthen the company's strategic capabilities during a pivotal growth stage [10]

SAN DIEGO, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that company management will participate in the three upcoming investor conferences in September 2025. Details of the events can be found below. Wells Fargo 20th Annual Healthcare Conference Format: 1x1 Meetings Date: 09/05/2025Location: Encore Boston Harbor, Everett, MA Morgan Stanley 23rd ...