REDWOOD CITY, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will be presenting data from its DCCR clinical development program for the treatment of Prader-Willi syndrome (PWS) at the 62nd Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2024, being held November 16-18, 2024 in Liverpool, UK. Details of the ora ...

Exhibit 99.1 Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results REDWOOD CITY, Calif., November 6, 2024 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the third quarter ended September 30, 2024. Third Quarter 2024 and Recent Corporate Highlights • New Drug Application (NDA) for DCCR ...

新药研发和商业化 - 公司正在开发和商业化用于治疗罕见疾病的新型治疗药物[63] - 公司的主要候选药物DCCR(Diazoxide Choline)延释片已获得美国FDA的快速通道和突破性疗法认定,以及美国和欧盟的孤儿药认定[63] - DCCR在一项为期3个月的III期随机双盲安慰剂对照研究(DESTINY PWS)中完成了入组,尽管未达到主要终点,但在两个关键次要终点上观察到了显著改善[64] - FDA建议在新药申请中包括更多对照数据,公司随后启动了C602研究的随机双盲安慰剂对照期,并于2023年9月宣布取得了积极的统计学显著性结果[65] - 2024年4月,DCCR获得FDA突破性疗法认定,这是首个针对普拉德-威利综合征获得此认定的药物,2024年6月公司向FDA提交了新药申请[66] - 2024年8月,FDA授予DCCR优先审评,并设定了2024年12月27日的PDUFA目标日期[66] 费用和财务状况 - 研发费用大幅增加,主要由于人员成本上升、新药申请提交相关成本增加以及为商业化做准备的供应链投入[71,77] - 管理费用大幅增加,主要由于人员成本上升、商业化准备相关的专业服务费用和其他项目成本增加[72,78] - 公司有义务根据与Essentialis的并购协议支付最高2.12亿美元的或有对价,相关负债公允价值估计有所增加[73,79] - 利息收入大幅增加,主要由于现金、有价证券和长期有价证券余额增加所致[74,80] - 公司在2024年9月30日拥有4,840万美元的现金及现金等价物、2.084亿美元的有价证券、2,790万美元的长期有价证券和2.432亿美元的营运资金[81] - 公司在2024年9月30日的累计亏损为3.963亿美元[81] - 公司在2024年5月完成了1.587亿美元的公开发行股票融资[81] - 公司在2024年7月与Jefferies LLC签订了最高1.5亿美元的股票发行协议[81] - 公司在2023年10月完成了1.29亿美元的公开发行股票和私募融资[81] - 公司在2022年12月完成了6,000万美元的认股权证融资,截至2024年9月30日已收到1,000万美元[81] - 公司在2024年9月30日的9个月内使用了4,510万美元的经营活动现金[84] - 公司在2024年9月30日的9个月内使用了2.321亿美元的投资活动现金[85] - 公司在2024年9月30日的9个月内获得了1.56亿美元的融资活动现金[86,87]

Soleno Therapeutics, Inc. (NASDAQ: SLNO ) focuses on rare diseases, particularly PWS hyperphagia. This condition creates insatiable hunger in patients, severely affecting their quality of life. Unfortunately, there are no approved treatments for this condition. However, SLNO's leading drug candidate, DCCR, has effectively reduced hunger My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. deg ...

Shares of Soleno Therapeutics (SLNO) jumped 9.1% on Tuesday and continued to gain another 4.1% during the after-market hours following a positive regulatory update on its new drug application (NDA) seeking approval for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS). Per SLNO, the Review Division of the FDA has stated that there is no need for an advisory committee meeting for the DCCR NDA at present. However, the regulatory body will continue to consider the potential ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. Inv ...

Soleno Therapeutics (SLNO, Financial) experienced a notable stock price increase of 9.11% following positive developments in its regulatory process. This performance far exceeded that of the S&P 500 index, which saw gains of less than 1%. The catalyst behind this surge is the announcement that the FDA will not require an advisory committee meeting for its New Drug Application (NDA) for diazoxide choline (DCCR) tablets, which are designed to treat Prader-Willi Syndrome. This move suggests a potentially smoot ...

The company's Prader-Willi treatment inched closer to FDA approval. Soleno Therapeutics (SLNO 9.11%) had some good news to report on the regulatory front on Tuesday. Investors were cheered by this as evidenced by their sending the biotech's stock more than 9% higher in price on the day. This performance was much better than that of the closely watched S&P 500 index, which closed up by less than 1%. Skipping ahead in the review process? Before market open that day, Soleno reported that the U.S. Food and Drug ...

文章核心观点 - 美国FDA受理了Soleno Therapeutics公司的新药申请,申请批准其主要候选药物DCCR(diazoxide choline)用于治疗普拉德-威利综合征(PWS)患者的暴食症状[1][2][3] - DCCR是一种新型的口服、每日一次的缓释剂型,含有diazoxide choline,这是diazoxide的结晶盐,尽管diazoxide尚未获批用于治疗PWS,但已获批用于治疗一些罕见疾病[3] - Soleno公司已为DCCR在PWS患者中的治疗用途建立了广泛的专利保护,并获得了FDA的突破性疗法、快速通道和孤儿药品指定,以及欧盟的孤儿药品指定[4] 行业概况 - 根据PWS协会的数据,每15,000名新生儿中就有1例患有这种罕见的遗传性疾病,最常见的症状是暴食,严重影响患者的生活质量,长期可能导致糖尿病、肥胖和心血管疾病等并发症[5] - 目前还没有获批用于治疗PWS患者暴食症状、代谢、认知功能或行为方面的治疗方法,这代表了一个重大的未满足的医疗需求[6] 竞争格局 - 去年,Acadia Pharmaceuticals公司也将一种新的候选药物carbetocin鼻喷雾剂(ACP-101)加入到其罕见疾病产品组合中,用于治疗PWS相关的暴食症状,该公司通过收购Levo Therapeutics获得了该药物的全球开发和商业化权利[7][8][9] - 在Levo之前进行的一项晚期临床试验中,carbetocin在统计学上显示可以显著减少PWS患者的暴食相关行为,因此Acadia公司于2023年第四季度启动了一项III期关键性COMPASS PWS试验,评估该候选药物的疗效和安全性[8][9]

PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in indi ...