Regulatory Developments - Atossa Therapeutics, Inc. (ATOS) received Orphan Drug Designation from the U.S. FDA for (Z)-endoxifen to treat Duchenne muscular dystrophy, leading to a 12.98% increase in stock price to $0.69 [1] - ImmunityBio, Inc. (IBRX) reported that enrollment in its QUILT-2.005 trial for bladder cancer exceeded expectations, with over 85% enrollment, anticipating full enrollment by Q2 2026 and FDA submission by year-end 2026, resulting in a 9.43% stock price increase to $6.04 [2] Financing Updates - Foghorn Therapeutics Inc. (FHTX) closed a $50 million registered direct financing at a 30% premium, contributing to a 4.02% increase in stock price to $6.26 [4] - Femasys Inc. (FEMY) received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement, allowing until July 13, 2026, for compliance, leading to a 10.68% increase in stock price to $0.72 [3] Investor Sentiment - Theravance Biopharma, Inc. (TBPH) saw a 5.00% increase in stock price to $21.01 despite no new announcements [5] - Daré Bioscience, Inc. (DARE) experienced a modest gain of 1.04% to $1.95 without any new news [4]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

Financial Performance - Multi Ways Holdings Ltd reported net revenue of $26.44 million for the first half of 2025, representing an increase of 87.65% from $14.09 million in the same period last year [1] - The company's shares rose 59.6% to $0.40 in pre-market trading following the financial results announcement [1] Stock Movements - Indaptus Therapeutics Inc saw a surge of 62.1% to $3.21 after disclosing a significant investment by David E. Lazar [4] - X3 Holdings Co Ltd increased by 43.5% to $0.24 after previously dipping 90% [4] - Northann Corp rose 38.8% to $0.24 after engaging advisory services for business development [4] - Dynavax Technologies Corp gained 37.7% to $15.33 following Sanofi's agreement to acquire the company at $15.50 per share, valuing it at $2.2 billion [4] - Starfighters Space Inc shares jumped 18.2% to $15.30 amid post-IPO volatility [4] - Sidus Space Inc rose 17% to $1.93 after announcing a $25 million offering [4] - UiPath Inc increased by 8.7% to $17.35 after being announced as a member of the S&P Midcap 400 [4] Declines in Stock Prices - Picocela Inc fell 26.1% to $0.27 after a significant increase the previous day [4] - Can Fite Biopharma declined 25% to $0.18 following a reverse share split announcement [4] - Femasys Inc dropped 11.8% to $0.71 after filing a prospectus for a $9.8 million common stock offering [4] - SeaStar Medical Holding Corp fell 9.5% to $0.21 after announcing a reverse split [4] - EUDA Health Holdings Ltd dipped 8.3% to $1.75 after a previous jump of 41% [4]

Core Insights - Biotech stocks experienced significant gains in after-hours trading, with Inhibrx Biosciences leading the surge due to positive trial results [1][2] Company Summaries - **Inhibrx Biosciences (INBX)**: Shares surged over 81% to $51.52 following positive topline results from the ChonDRAgon study, which evaluated ozekibart as a monotherapy for advanced chondrosarcoma. The company also reported progress on expansion cohorts for colorectal cancer and Ewing sarcoma [2] - **Femasys Inc. (FEMY)**: Stock increased by more than 18% to $0.7227 after launching a post-market surveillance clinical study for its FemBloc Permanent Birth Control, complying with EU Medical Device Regulation [3] - **Cingulate Inc. (CING)**: Shares rose over 6% to $3.80 after announcing that data from its ADHD candidate CTx-1301 was selected for presentation at the AACAP Annual Meeting, highlighting its potential in ADHD treatment [4] - **Community Health Systems, Inc. (CYH)**: Stock increased over 4% to $3.41 following positive Q3 results [5] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed over 10% to $0.6295 in after-hours trading [6] - **Ascendis Pharma A/S (ASND)**: Stock gained more than 4%, reaching $210.68 post-market [6] - **ADC Therapeutics SA (ADCT)**: Shares rose over 5% to $4.2887 in after-hours trading [6] - **Zura Bio Limited (ZURA)**: Stock increased more than 5% to $3.55 post-market [6] - **Foghorn Therapeutics Inc. (FHTX)**: Shares gained more than 5%, closing at $4.11 after hours [6]

Group 1 - Advanced Micro Devices, Inc. (AMD) shares increased significantly by 34.2% to $221.10 in pre-market trading following a major agreement with OpenAI to deploy up to 6 gigawatts of AMD Instinct GPU power for AI infrastructure [1][2] - The initial phase of the agreement includes a rollout of 1 gigawatt of AMD Instinct MI450 GPUs scheduled for the second half of 2026, with plans for further expansions across multiple generations of AMD's data center chips [1]

Group 1 - The core point of the article is that Femasys (FEMY.US) experienced a significant stock price drop of 37%, reaching a new low for the year at $0.32 [1] - The company announced a public offering to raise $8 million, which will be used to support its business expansion and product development plans [1]

Company Performance - Precision BioSciences reported a quarterly loss of $2.13 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.09, representing an earnings surprise of -2,266.67% [1] - The company posted revenues of $0.02 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 99.87%, compared to revenues of $49.9 million a year ago [2] - Over the last four quarters, Precision BioSciences has not surpassed consensus EPS or revenue estimates [2] Stock Movement and Outlook - Precision BioSciences shares have increased by approximately 26.3% since the beginning of the year, outperforming the S&P 500's gain of 7.9% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.38 on $11 million in revenues for the coming quarter and -$2.77 on $35.7 million in revenues for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Precision BioSciences belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Precision BioSciences may be influenced by the overall industry outlook, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

BioMarin Pharmaceutical (BMRN) came out with quarterly earnings of $1.13 per share, beating the Zacks Consensus Estimate of $0.94 per share. This compares to earnings of $0.71 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 20.21%. A quarter ago, it was expected that this rare disease biopharmaceutical would post earnings of $0.73 per share when it actually produced earnings of $0.92, delivering a surprise of 26.03%.Over the l ...

Company Performance - Femasys Inc. reported a quarterly loss of $0.23 per share, which was better than the Zacks Consensus Estimate of a loss of $0.25, but worse than the loss of $0.19 per share from the previous year, indicating an earnings surprise of 8% [1] - The company posted revenues of $0.58 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 41.80%, compared to revenues of $0.21 million a year ago [2] - Over the last four quarters, Femasys has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Outlook - Femasys shares have increased by approximately 38.2% since the beginning of the year, contrasting with the S&P 500's decline of -2.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.23 on revenues of $1.9 million, and for the current fiscal year, it is -$0.59 on revenues of $11 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Femasys belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Femasys's stock performance [5]

2025年2月4日，美国生物医学公司Femasys Inc.（纳斯达克：FEMY）（2024年前三季度收入约为132万美元）宣布，其不孕症治疗产品 FemaSeed® 及两款诊断设备 FemVue® （输卵管评估）和 FemCerv® （宫颈癌检测）获得以色列卫生部医疗器械分部（AMAR）批准。这是继美国FDA（2023年9月）和欧盟CE（2024年6月） 后，Femasys全球化布局的又一关键进展。 # 产品介绍 1. FemaSeed® ：输卵管内定向人工授精系统 ● 操作流程： 超声定位优势卵泡位置； ○ 安全性：非侵入性，无麻醉需求； ○ 适用人群：男性少精症（精子数<500万/毫升）、不明原因不孕夫妇。 2. FemVue® ：输卵管超声评估系统 已获得以色列监管机构批准。 3. FemCerv® ：无痛宫颈组织取样器 ○ 无痛操作：减少患者不适，门诊即可完成。 ● 临床价值： 用于异常宫颈涂片后的阴道镜活检，降低漏诊率。 2024年第三季度在美国和欧洲(西班牙)开始商业化；2025年2月获得以色列监管机构批准。 ● 技术原理： 通过导管将精子直接注入输卵管（自然受孕部位），提升受精率。 ○ 导管定 ...