NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced the completion of the redomiciliation of the parent company of the AtaiBeckley group from a Netherlands company to a U.S. entity incorporated in Delaware. The redomiciliation was approved by approximately 99% of the votes cas ...

TORRANCE, Calif.--(BUSINESS WIRE)--Emmaus Life Sciences, Inc. (OTCQB: EMMA), a commercial- stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced that it has entered into a License and Exclusive Distribution Agreement with NeoImmuneTech, Inc. (KOSDAQ:950220), or NIT, pursuant to which Emmaus has granted NIT an exclusive license to all rights to market, sell and distribute Endari® (prescription grade L-glutamine oral powder) and any generic equivalents. ...

If approved, DTX401 will be the first therapy approved to treat the underlying cause of GSDIaNOVATO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), seeking approval for DTX401 AAV gene therapy (pariglasgene brecaparvovec) as a treatment for Glycogen Storage Disease Type Ia (GSDIa). "The completion of our rolling submi ...

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) ("Cybin†or the "Company†), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that it has launched an at-the-market equity program (the "ATM Program†) to allow Cybin to issue and sell up to US$100,000,000 of common shares in the capital of the Company (the "Shares†) from treasury to the pu. ...

财务数据和关键指标变化 - 无相关内容 各条业务线数据和关键指标变化 - 无相关内容 各个市场数据和关键指标变化 - 无相关内容 公司战略和发展方向和行业竞争 - 无相关内容 管理层对经营环境和未来前景的评论 - 无相关内容 其他重要信息 - 公司于2025年11月25日召开了2025年度股东大会，会议以虚拟形式进行 [1][3] - 出席会议的公司董事包括：Jay Kranzler（董事会主席）、Faith Charles、Neil Herskowitz、Alexandra MacLean（首席执行官）、Curtis Oltmans和Lindsay A. Rosenwald [1][4] - 毕马威会计师事务所（KPMG LLP）作为截至2024年12月31日财年的独立审计师出席会议 [2] - 会议法定人数已满足，即截至记录日（2025年11月25日）公司已发行投票权的多数已出席或由代理人代表出席 [3] - 股东大会投票表决了两项决议：选举上述六位提名人担任董事，任期至2026年年度股东大会；批准任命毕马威会计师事务所为公司2025财年的独立注册公共会计师事务所 [4][5][6] - 根据初步计票结果，所有董事提名人均已当选，任命毕马威为2025财年审计师的决议也已获得批准 [8] - 会议结束后，管理层和毕马威的代表将接受通过虚拟会议网站或指定邮箱提交的问题 [9] 总结问答环节所有的提问和回答 - 无相关内容

Fulcrum Therapeutics, Inc. (FULC) closed the last trading session at $11.99, gaining 21.5% 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 $19 indicates a 58.5% upside potential.The mean estimate comprises nine short-term price targets with a standard deviation of $6.89. While the lowest estimate of $7.00 indicates a 41.6% decline from the current price level, the most optimistic a ...

Key Takeaways KYTX stock jumped 41% in a month after miv-cel met endpoints in a pivotal phase II SPS study.KYTX reported a 46% median improvement in T25FW, showing sustained gains in mobility and stiffness.KYTX plans a BLA filing in H1 2026 for SPS.Kyverna Therapeutics’ (KYTX) lead CAR T-cell therapy candidate, mivocabtagene autoleucel (“miv-cel”, formerly KYV-101), is being developed in a pivotal phase II study for stiff person syndrome (SPS), a rare, debilitating and progressive autoimmune disease with no ...

PALI-2108 is the first and only PDE4 inhibitor in development targetingthe terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs Ongoing development of PALI-2108 across FSCD and UC, with Phase 2 IND submission planned for H1 2026 Carlsbad, CA, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, on ...

STOUGHTON, Mass., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), today announced the closing of its inaugural syndicated credit facility. The new aggregate $980 million credit facility will mature in 2030 and consists of a $580 million initial Term Loan, $300 million Delayed Draw Term Loan, and $100 million revolving credit facility (collectively the “Credit Facility”). The initial Term Loan was used to repay approximately $581 million of principal representing the entire r ...

核心观点 - Beyond Air公司任命拥有超过20年财务领导经验的Dan Moorhead为新任首席财务官 旨在加强财务管理 支持其核心产品LungFit PH的市场拓展及第二代产品的预期FDA批准与商业发布 [1][2][3] 公司管理层变动 - Dan Moorhead被任命为首席财务官 自2026年1月5日起生效 原临时承担CFO职责的公司控制人Duke Dewrell将恢复其原职 [1] - 新任CFO Dan Moorhead在上市公司和私营公司拥有超过20年财务领导经验 最近曾担任上市公司Zynex Inc的首席财务官近8年 负责实施预算和预测框架并支持公司多年商业扩张 此前还在Evolving Systems Inc担任了10年首席财务官等职务 他是注册会计师并拥有会计学学士学位 [3] - 作为任命的一部分 公司根据纳斯达克上市规则向Moorhead授予了激励性股票期权 该期权于2026年1月5日生效 可购买70,000股公司普通股 行权价等于2025年12月31日纳斯达克收盘价 期权期限十年 分四年归属 授予日一周年后归属25% 剩余部分在此后三年内每年等额归属 [4] 公司业务与产品管线 - Beyond Air是一家商业阶段的医疗器械和生物制药公司 致力于利用一氧化氮治疗呼吸系统疾病、神经系统疾病和实体瘤 [5] - 公司首个系统LungFit PH已获得FDA批准和CE标志 用于治疗足月和近足月新生儿的低氧性呼吸衰竭 [5] - 公司正在临床试验中推进其他革命性的LungFit系统 用于治疗病毒性社区获得性肺炎（包括COVID-19）和非结核分枝杆菌等严重肺部感染 [5] - 公司与耶路撒冷希伯来大学合作推进一项临床前项目 专注于治疗自闭症谱系障碍和其他神经系统疾病 [6] - 公司的关联公司Beyond Cancer Ltd 正在研究使用超高浓度一氧化氮及专有递送系统靶向临床前环境中的某些实体瘤 [6] 核心产品LungFit系统详情 - LungFit是一种无钢瓶、相位流量发生器和输送系统 被FDA指定为医疗器械 其呼吸机兼容版本可按需从环境空气中产生一氧化氮 输送至肺部的浓度范围为1 ppm至80 ppm [7] - 该系统的潜在优势包括可能取代大型高压一氧化氮钢瓶 显著减少医院库存和存储需求 通过消除二氧化氮净化步骤提高整体安全性 并提供其他操作便利 [7][8] - LungFit还可以输送浓度达到或超过80 ppm的一氧化氮 用于潜在治疗医院环境中的严重急性肺部感染以及家庭环境中的慢性难治性肺部感染 通过消除钢瓶 公司计划提供家庭环境的一氧化氮治疗 [9] - 需注意 LungFit PH已在美国、欧盟和全球许多国家获准商业使用 其他LungFit系统尚未获准商业使用 仅用于研究 [10]