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科创板扩容“成长层”
Huan Qiu Wang· 2025-07-17 03:11
【环球网财经综合报道】日前,上交所《科创板上市公司自律监管指引第5号——科创成长层》的正式 发布实施,科创板迎来重要扩容。32家存量未盈利企业直接纳入,新注册未盈利企业也将自此"落户"科 创成长层。消息一出,国金证券、国泰海通证券等多家券商迅速响应,火速在APP上线"科创板成长层 权限开通"功能,为投资者参与这一新赛道按下"快进键"。 国金证券透露,公司于7月13日晚即部署系统升级,并于次日完成服务功能更新。国泰海通证券也于7月 15日高效完成系统部署,正式开放权限开通。中信证券、兴业证券、国联民生等头部券商亦表示正加紧 部署中。投资者只需已开通科创板权限并签署《科创成长层风险揭示书》,即可申购、交易科创成长层 股票。 值得注意的是,个人投资者参与门槛并未提高,仍需满足"50万元资产+2年经验"的基本要求,仅需增加 签署一份专门的风险揭示书。这份揭示书旨在让投资者充分了解科创成长层企业特有的未盈利风险、科 技研发风险及股价波动等,体现了监管层在拓宽融资渠道的同时,对投资者保护的重视。 中国结算随后发布的"特急"文件,要求券商报送风险揭示书签署情况,并自9月22日起对投资者账户进 行分类标注(C类可投,K类不可 ...
裁员及关键疗法留市提振投资者信心!生物技术公司Sarepta(SRPT.US)盘后暴涨
Zhi Tong Cai Jing· 2025-07-17 00:52
Group 1 - Sarepta Therapeutics experienced a significant stock increase of over 35%, with a peak close to 60%, following the announcement of a workforce reduction of more than one-third and the continuation of its gene therapy for a fatal muscle disease under a warning for potential liver failure risks [1][2] - The company plans to implement a strategic restructuring and cost-saving measures, which include laying off 500 employees and pausing several drugs in its research pipeline, expected to save approximately $400 million annually [1] - The layoffs are intended to help maintain access to a $600 million revolving credit facility and generate cash flow to assist in repaying convertible bonds due in 2027 [1] Group 2 - In response to FDA requirements, Sarepta agreed to add a black box warning regarding liver failure risks to the label of its gene therapy Elevidys, which is the most severe safety warning for drugs [2] - Company executives indicated that the warning label appears to have addressed FDA concerns about using the therapy in ambulatory patients, while discussions continue regarding a new immunosuppressive regimen for non-ambulatory patients [2] - The CEO stated that Elevidys will remain on the market, and an analyst noted that the black box warning has avoided the worst-case scenario of the therapy being withdrawn [2]
Bragar Eagel & Squire, P.C. is Investigating Capricor Therapeutics, Inc. on Behalf of Capricor Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-16 23:55
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Capricor Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices affecting stockholders [1][3]. Company Developments - On May 5, 2025, Capricor announced a mid-cycle review meeting with the FDA regarding its Biologics License Application for deramiocel, leading to a stock price drop of $3.00 per share (29.13%) to $7.30 on May 6, 2025 [3]. - Following a report on June 20, 2025, that the FDA canceled the advisory committee meeting for deramiocel due to concerns over the drug's efficacy and safety, Capricor's stock fell by $3.68 per share (30.82%) to close at $8.26 [3]. Legal Context - The law firm is encouraging investors who suffered losses from Capricor's stock to reach out for discussions regarding their legal rights and options [1][4].
NKGen Biotech Announces New Funding to Regain Compliance with Reporting Obligations and Listing Standards
Globenewswire· 2025-07-16 21:45
Funding in the amount of $2.0M from Japanese strategic investor, in the form of common equity PIPE with warrants. New funding provides for necessary resources to regain compliance with reporting obligations and listing standards. Share trading will move to the OTC Expert Market temporarily, with potential to uplist to OTCQB as soon as SEC filings are current, with plan to return to Nasdaq or to NYSE American. SANTA ANA, Calif., July 16, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or t ...
X @Bloomberg
Bloomberg· 2025-07-16 20:10
Sarepta is cutting more than one-third of its workforce and will add a black box warning label to its gene therapy for a fatal muscle disorder after two patient deaths raised doubts about the future of the company https://t.co/FHYwnWd7ml ...
Kessler Topaz Meltzer & Check, LLP Notifies Sarepta Therapeutics, Inc. Investors of Upcoming Deadline in Securities Fraud Class Action Lawsuit
GlobeNewswire News Room· 2025-07-16 20:07
RADNOR, Pa., July 16, 2025 (GLOBE NEWSWIRE) -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York against Sarepta Therapeutics, Inc. (“Sarepta”) (NASDAQ: SRPT) on behalf of those who purchased or otherwise acquired Sarepta securities between June 22, 2023, and June 24, 2025, inclusive (the “Class Period”). The lead plaintiff deadline is August 25, 2 ...
BriaCell Therapeutics Announces Closing of $15 million Public Offering
Globenewswire· 2025-07-16 20:05
PHILADELPHIA and VANCOUVER, British Columbia, July 16, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announced the closing of its best-efforts public offering of 12,000,000 units. Each unit consists of one common share (or one pre-funded warrant (“Pre-Funded Warrant”) in lieu thereof) and one warrant (the “Warrants”). Each un ...
Adverum Biotechnologies (ADVM) Conference Transcript
2025-07-16 17:35
Summary of Adverum Biotechnologies Conference Call Company Overview - **Company**: Adverum Biotechnologies (Ticker: ADVM) - **Industry**: Ocular Gene Therapy - **Focus**: Developing gene therapy to preserve sight in prevalent ocular diseases, particularly wet age-related macular degeneration (wet AMD) [1][3] Key Points and Arguments Market Potential - **Epidemiology**: Approximately 20 million patients worldwide suffer from wet AMD, with a projected market size of $13.5 billion by 2035 [4] - **Incidence**: Over 200,000 new diagnoses in the U.S. annually, with a 42% chance of bilateral disease within 2-3 years for affected patients [5] - **Current Treatment Costs**: Current anti-VEGF treatments account for 12% of Medicare Part B budget, with additional costs related to vision loss and fractures exceeding $80 billion in the U.S. [7][8] Product Development - **Ixabec**: A gene therapy utilizing aflibercept, designed to provide sustained anti-VEGF expression in the retina, potentially allowing for a "one and done" treatment approach [8][14] - **Delivery Method**: Administered via intravitreal injection, aligning with current treatment practices, thus minimizing procedural risks and complications [26][30] Clinical Data - **Phase 1 and 2 Studies**: - Nearly 50% of patients remained injection-free for four years in the OPTIC study [34] - Injection-free rates increased over time, indicating a potential disease-modifying effect [35] - Over 80% reduction in annualized anti-VEGF treatments [36] - Favorable safety profile with 100% of patients inflammation-free at year one through four [36] Patient Preference - High patient satisfaction with Ixabec, with 93% preferring it over previous treatments and 96% willing to recommend it to family and friends [39][40] Economic Impact - **Integration into Practice**: Ixabec is expected to enhance revenue and profitability for healthcare providers by front-loading treatment costs and reducing patient drop-off rates [31][32] - **Cost-Effectiveness**: Potential to lower overall healthcare costs by reducing treatment frequency and associated complications [33] Future Milestones - Upcoming long-term data presentation from the LUNA study in Q4 of this year [51] - Initiation of the AQUARIUS phase three study in the second half of the year [51] - Strong cash runway projected into the second half of the year, with confidence in funding ongoing clinical programs [53][54] Additional Important Content - **Challenges with Current Treatments**: Current anti-VEGF therapies require frequent injections, leading to patient burden and potential vision loss due to treatment gaps [10][18] - **Innovative Approach**: Ixabec aims to eliminate the oscillation of fluid in the retina, providing stable and durable visual outcomes [22][21] - **Regulatory and Commercial Success**: The ARTEMIS study is designed to maximize the probability of success in clinical and regulatory pathways [42] This summary encapsulates the critical insights from the Adverum Biotechnologies conference call, highlighting the company's innovative approach to treating wet AMD and the significant market opportunity it represents.