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OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
Newsfile· 2025-09-30 11:40
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory UpdateSeptember 30, 2025 7:40 AM EDT | Source: OS TherapiesCompany updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRAIn principle, UK MHRA accepts use of historical control arm to support conditional MAAUK MHRA conditional MAA and US FDA Biologics Licensing ...
New Binance Coin and Aethir Treasuries Raise Over $400M To Launch
Yahoo Finance· 2025-09-30 11:32
The DAT era is here. | Credit: Credit: Raymond Boyd/Getty Images.. Key Takeaways Digital Asset Treasuries are publicly traded firms dedicated to accumulating crypto. Aethir is a DePIN project offering GPU-as-a-service solutions for AI, gaming, and cloud. Binance Coin treasuries currently comprise over $500 million worth of BNB. Two new Digital Asset Treasuries (DATs) from two separate biotech firms are set to launch after raising a combined $402 million in private placements to acquire huge sums o ...
Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI™ (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung Cancer
Businesswire· 2025-09-30 11:30
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZIâ"¢ (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC). "While surgi. ...
Precision BioSciences Announces Late-Breaking Poster Presentation at the 30th Annual International Congress of the World Muscle Society
Businesswire· 2025-09-30 11:01
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society (WMS) being held October 7-12, 2025, in Vienna, Austria. "We look forward to sharing the latest preclinical data for PBGENE-DMD at the upcoming. ...
BioMarin: Valuation, Growth, And The Pipeline May Outweigh TransCon Competition And Regulatory Risks
Seeking Alpha· 2025-09-30 11:01
Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in BMRN over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...
CollPlant Biotechnologies Announces Positive Results from non-clinical Studies of its Photocurable Regenerative Dermal and Soft Tissue Filler
Prnewswire· 2025-09-30 11:00
Accessibility StatementSkip Navigation CollPlant is now moving towards clinical trials and scaling and optimizing its manufacturing to ensure readiness for the upcoming clinical trials REHOVOT, Israel, Sept. 30, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing disruptive technologies and products based on its proprietary non-animal recombinant human collagen (rhCollagen), today announced positive results from its non-clinical program eva ...
NLS Pharmaceutics Shareholders Approve Merger with Kadimastem and Related Proposals at Extraordinary General Meeting
Prnewswire· 2025-09-30 11:00
Ronen Twito, Kadimastem's Executive Chairman and CEO and Alexander C. Zwyer NLS's CEO & Executive Board Member stated: ""We are grateful to our shareholders for their strong support of the merger. Today's outcome marks a pivotal step in creating NewCelX, a transatlantic biopharma leader†The merger will create: Nasdaq-listed company: Under the symbol "NCEL": Governance and capital structure approvals completed Diversified pipeline: Unites Kadimastem's advanced cell therapy programs (including a Phase 2a AL ...
aTyr Pharma Presents Additional Findings from Phase 3 EFZO-FIT™ Study in Late-Breaking Oral Abstract at the European Respiratory Society (ERS) Congress 2025
Globenewswire· 2025-09-30 09:30
Clinical benefit for efzofitimod across multiple disease-related health outcomes reported. Improvement in Fatigue Assessment Scale Total Score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0226). Improvement in King’s Sarcoidosis Questionnaire-General Health score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0197). SAN DIEGO, Sept. 30, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage b ...
粤港澳大湾区创业大赛闭幕,深圳奖项数居各城市榜首
南方都市报· 2025-09-30 08:49
大赛概况与深圳表现 - 粤港澳大湾区创业大赛总决赛于9月27日在佛山举办,共有150个优秀创业项目参与最终角逐 [1] - 大赛设立人工智能与机器人、集成电路与低空经济、医药健康与生物制造、食品科技与现代农业、现代服务与文化创意五大核心赛道,自5月启动以来共吸引海内外超7000个创业项目报名 [3] - 深圳共有47个项目入围决赛,最终取得2个特等奖、8个金奖、12个银奖和10个铜奖,成为获奖数最多的城市 [1] - 在所有报名项目中,来自深圳市的项目有1134个,占比达15.9%;在晋级决赛的150个项目中,47个来自深圳,占比超过30% [3] - 深圳在人工智能与机器人赛道表现抢眼,取得2金4银4铜的成绩 [3] 重点赛道与获奖项目 - 由深圳承办的集成电路与低空经济赛道共有1053个项目报名,经过评审最终有30个项目晋级总决赛 [4] - “下一代心腔超声成像系统”与“新型二氧化碳捕集与转化应用技术”两个项目分获医药健康与生物制造赛道、现代服务与文化创意赛道特等奖,各将50万元大奖收入囊中 [3] - 集成电路与低空经济赛道复赛阶段,“单涵道尾座式垂直起降固定翼无人机”等30个项目晋级总决赛 [4] 创业支持体系与生态构建 - 深圳着力打造“选、赛、引、落、扶”全链条创业支撑服务体系 [4] - 在资金支持方面,深圳创业担保贷款个人最高额度60万元,小微企业最高500万元,并给予最长3年贴息,2023年以来累计发放贷款52.54亿元 [6] - 2025年上半年联合中国银行深圳分行发放稳岗扩岗贷278亿元,并研究设立青年创新创业专项基金 [6] - 深圳组建了近400人的创业导师队伍,可免费为创业者提供一对一服务 [6] - 目前深圳经市、区两级人社部门认定的创业孵化基地有122家,累计入孵创业实体32038个 [7] - 入驻基地企业可获得每月800至1560元不等的创业场租补贴,2023年以来11家市级基地推动141个入孵初创实体获得591个市场订单,涉及金额4954万元 [7] 资源对接与平台建设 - 大赛复赛现场设置对接洽谈区,邀请深创投、深天使等近30家创投机构和20余家创业孵化载体与项目互动 [4] - 联合前海管理局举办3场专项资源对接会,针对优秀项目开展政策宣介及资源对接 [4] - 与市场化投融资机构合作为复赛项目开展创业能力提升培训班 [4] - 组织创业项目参与高交会、文博会、日内瓦国际发明展等专业展会,提升项目知名度并拓展市场机会 [6]
Wall Street Has a Mixed Opinion on Apellis Pharmaceuticals (APLS)
Yahoo Finance· 2025-09-30 08:13
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) is one of the Oversold Growth Stocks to Buy According to Analysts. Wall Street has a mixed opinion on Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) since the company released its fiscal second quarter 2025 results. The company posted $178.49 million in revenue, down 10.61% year-over-year and below expectations by $10.15 million. On the bright side, the EPS of negative $0.33 topped estimates by $0.15. Management noted that they are proud of the FDA approval of EMPA ...