Altamira Therapeutics Receives FDA Acceptance for Bentrio 510 Application

Altamira Therapeutics获得FDA批准Bentrio 510申请

2021-10-15 06:30:04 BioSpace

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HAMILTON, BERMUDA / ACCESSWIRE / October 14, 2021 / Altamira Therapeutics Ltd. , a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced that its 510 application for premarket clearance filed with the U.S. Food and Drug Administration for its Bentrio™ nasal spray for protection against airborne allergens has cleared the Agency's acceptance review. The application now moves to a substantive review by the FDA. "This 510(k) submission is a major step towards gaining entry to the U.S. market for Bentrio and we look forward to working closely with the FDA as it proceeds through its review," said Thomas Meyer, Altamira's founder, Chairman and CEO. About Altamira Therapeutics Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or for the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®; Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO". Forward-looking Statements This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2020, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. Investor contact: Stephen Kilmer 646.274.3580 sjk@altamiratherapeutics.com SOURCE: Altamira Therapeutics Ltd. View source version on accesswire.com: https://www.accesswire.com/668070/Altamira-Therapeutics-Receives-FDA-Acceptance-for-Bentrio-510k-Application
百慕大HAMILTON/ACCESSWIRE/2021年10月14日/阿尔塔米拉治疗有限公司(Altamira Therapeutics Ltd.)是一家致力于通过RNA治疗、过敏和病毒感染保护以及内耳治疗来解决未满足的医疗需求的公司,该公司今天宣布,其向美国食品药品监督管理局提交的510份上市前许可申请已经通过了该机构的受理审查。该申请现在进入美国食品和药物管理局的实质性审查。 Altamira的创始人、董事长兼首席执行官托马斯·迈耶(Thomas Meyer)表示:“此次提交的510(k)是宾利欧进入美国市场的重要一步,我们期待着在FDA进行审查时与它密切合作。” 关于Altamira疗法 Altamira治疗学致力于开发治疗学,以解决重要的未满足的医疗需求。该公司目前活跃在三个领域:开发用于肝外治疗靶点的RNA疗法(寡聚体™/信号量™平台;临床前)、用于防止空气传播病毒和过敏原的鼻喷剂(™Bentrio;商业)或用于治疗眩晕(AM-125;第2阶段),以及开发用于耳鸣或听力损失的鼓室内治疗疗法(®Keyzilen和®Sonsuvi;第3阶段)。该公司成立于2003年,总部位于百慕大汉密尔顿,主要业务在瑞士巴塞尔。Altamira Therapeutics Ltd.的股票在纳斯达克资本市场交易,代码为“CYTO”。 前瞻性陈述 本新闻稿可能包含构成1933年《证券法》第27A条和1934年《证券交易法》第21E条含义内的“前瞻性陈述”的陈述。前瞻性陈述是历史事实以外的陈述,可能包括涉及未来经营、财务或业务表现或Altamira Therapeutics的战略或预期的陈述。在某些情况下,你可以通过前瞻性的词汇来识别这些陈述,如“可能”、“可能”、“将”、“应该”、“预期”、“计划”、“预期”、“相信”、“估计”、“预测”、“项目”、“潜在”、“展望”或“继续”,或者这些术语的负面或其他可比术语。前瞻性陈述基于管理层目前的预期和信念,涉及重大风险和不确定性,可能导致实际结果、发展和业务决策与这些陈述预期的结果、发展和业务决策大不相同。这些风险和不确定性包括但不限于AM-301商业化的批准和时间、Altamira Therapeutics是否需要和有能力筹集大量额外资金以继续开发其候选产品、Altamira Therapeutics候选产品的临床试验的时间和进行、Altamira Therapeutics候选产品的临床效用、监管备案和批准的时间或可能性、Altamira Therapeutics的知识产权状况和Altamira Therapeutics的财务状况,包括任何未来收购、处置、合作关系、许可证交易或Altamira Therapeutics资本结构变化的影响,包括未来证券发行。这些风险和不确定性还包括但不限于Altamira Therapeutics截至2020年12月31日止年度的20-F表年度报告中“风险因素”标题下描述的风险和不确定性,以及Altamira Therapeutics向SEC提交的其他文件中描述的风险和不确定性,这些文件可在证券交易委员会的网站www.SEC.gov免费获得。如果这些风险或不确定性中的一个或多个成为现实,或者基础假设被证明是不正确的,实际结果可能与所示结果相差很大。Altamira Therapeutics或代表Altamira Therapeutics的人员的所有前瞻性陈述及随后的所有书面和口头前瞻性陈述均通过提及这些风险和不确定性而明确限定其全部内容。你不应该过分依赖前瞻性陈述。前瞻性陈述仅限于发表之日,Altamira Therapeutics不承担任何义务根据新信息、未来发展或其他情况对其进行更新,除非适用法律可能有要求。 投资者联系方式: 斯蒂芬·基尔默 646.274.3580 sjk@altamiraTherapeutics.com 资料来源:Altamira Therapeutics Ltd. 在AccessWire.com上查看源版本: https://www.accesswire.com/668070/altamira-therapeutics-receives-fda-acceptance-for-bentrio-510k-application

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