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Lucid Diagnostics to Join Russell 2000® and Russell 3000® Indexes
Prnewswire· 2025-05-27 11:31
Core Points - Lucid Diagnostics Inc. will be added to the small-cap Russell 2000® Index and the broad-market Russell 3000® Index effective after the close of U.S. equity markets on June 27, 2025, as part of the 2025 annual reconstitution [1][2] - This inclusion is expected to enhance Lucid's visibility and access to a broader range of institutional investors, reflecting the company's progress in enhancing shareholder value over the past year [2] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [4] - The company's EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device are the first and only commercially available tools aimed at preventing cancer through early detection of esophageal precancer in at-risk patients [4] Market Context - The Russell 3000 Index includes the largest 3,000 U.S. public companies by market capitalization, while the Russell 2000 Index is a subset focused on small-cap companies [2] - Approximately $10.6 trillion in assets are benchmarked against the Russell U.S. Indexes, indicating the significance of these indices for institutional investors and investment managers [2]
Adagene to Present at Jefferies Global Healthcare Conference 2025
Globenewswire· 2025-05-27 11:30
Core Insights - Adagene Inc. is participating in the Jefferies Global Healthcare Conference 2025, highlighting its commitment to investor engagement and communication [1][2]. Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3]. - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology, which is at the forefront of scientific innovation [3]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to improve the safety and tolerability of antibody therapeutics [4]. - The SAFEbody technology specifically addresses safety challenges by masking the binding domain of biologic therapies, allowing for targeted action in the tumor microenvironment while reducing toxicity to healthy tissues [4]. Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies in combination with anti-PD-1 therapy for Metastatic Microsatellite-stable Colorectal Cancer [5]. - The SAFEbody platform is versatile and can be applied to various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5].
Tokio Marine HCC and Susan G. Komen® Team Up Once Again with Golf Champion Nelly Korda to Help End Breast Cancer
GlobeNewswire News Room· 2025-05-25 16:00
Core Insights - The partnership between Susan G. Komen, Tokio Marine HCC (TMHCC), and Nelly Korda aims to raise awareness and funds for breast cancer research and support [1][5][6] Group 1: Partnership and Contributions - TMHCC will donate $5,000 for every birdie and $10,000 for every eagle scored by Nelly Korda during the tournament, with a guaranteed minimum donation of $50,000 [3] - Additional donations from TMHCC include $25,000 for a hole in one, $100,000 for a three-stroke win, $500,000 for a four-stroke win, and $1 million for a five or more stroke win [4] Group 2: Breast Cancer Statistics - An estimated 316,950 women in the U.S. will be diagnosed with invasive breast cancer for the first time in 2025, with 42,170 expected to succumb to the disease [2] Group 3: Organizational Background - TMHCC is part of the Tokio Marine Group, which has a market capitalization of $74 billion as of March 31, 2025, and holds strong financial ratings from S&P Global Ratings, AM Best, and Fitch Ratings [8] - Susan G. Komen is the leading nonprofit organization focused on breast cancer, providing comprehensive support and advocacy for patients while driving research for breakthroughs [10]
Medicus Pharma begins UAE cancer trial expansion – ICYMI
Proactiveinvestors NA· 2025-05-25 13:32
Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer
Globenewswire· 2025-05-23 13:00
Core Viewpoint - Roche's Itovebi™ (inavolisib) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for use in combination with palbociclib and fulvestrant for treating specific breast cancer patients, potentially transforming first-line treatment standards [1][2][3]. Group 1: Treatment Efficacy - The CHMP's positive opinion is based on phase III INAVO120 study results, which demonstrated a 57% reduction in the risk of disease worsening or death (progression-free survival) with the Itovebi-based regimen compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, p<0.001) [3][8]. - The final overall survival analysis showed a statistically significant benefit with the Itovebi-based regimen, with a stratified HR of 0.64 (95% CI: 0.43-0.97, p=0.0338) [4][8]. Group 2: Patient Population and Mutation Significance - The presence of a PIK3CA mutation, found in approximately 40% of hormone receptor-positive breast cancers, is associated with more aggressive disease and poorer survival outcomes, highlighting the need for testing prior to treatment [2][3]. - The Itovebi-based regimen is specifically designed for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer [5][7]. Group 3: Ongoing Research and Development - Beyond the INAVO120 study, Itovebi is being investigated in three additional phase III studies (INAVO121, INAVO122, INAVO123) for various combinations in PIK3CA-mutated breast cancer [6][11]. - Roche aims to explore additional studies in breast cancer and other tumor types to expand the benefits of this targeted therapy [6][11].
中国生物技术2025年美国临床肿瘤学会(ASCO)摘要解读
Morgan Stanley· 2025-05-23 10:50
Investment Rating - The industry investment rating is Attractive [7] Core Insights - The report highlights several promising clinical trial results for various biotech companies, indicating potential best-in-class therapies in oncology and other therapeutic areas [2][3][4][5][6] - The report emphasizes the competitive landscape in the biotech sector, particularly in the context of EGFRm+ NSCLC, where DB-1310 faces significant competition [3] - The report provides a detailed analysis of multiple abstracts presented at ASCO, showcasing the efficacy and safety of various drug candidates [6][10] Summary by Relevant Sections Clinical Trial Results - DB-1311 in 3L CRPC shows a median rPFS of 8.3 months, indicating best-in-class potential [2] - DB-1310 in pre-treated EGFRm+ NSCLC demonstrates a uORR of 35.7% and mPFS of 7.0 months, competitive against peer HER3-ADCs [3] - Surufatinib + KN046 in 1L PDAC shows better response and safety, with mPFS competitive against SoC [4] - IBI363 in MSS/pMMR CRC shows consistent ORR and potential best-in-class mDoR of 7.5 months [4] Abstract Reactions - The report includes reactions to select abstracts from ASCO, indicating meaningful upside for DB-1311 and modest upside for DB-1310 [6][10] - IBI363 shows consistent results in immunotherapy-treated acral/mucosal melanoma with a DoR of 14 months [5] - ZL-1310 in r/r ES-SCLC shows an ORR of 68%, demonstrating best-in-class potential [5] Company Ratings - The report provides ratings for various companies in the healthcare sector, with notable mentions including: - 3SBio rated as ++ - Adicon Holdings rated as Overweight - Alibaba Health rated as Overweight [61]
Rigel Announces Poster Presentations at the 2025 ASCO Annual Meeting and EHA2025 Congress
Prnewswire· 2025-05-22 21:20
Core Insights - Rigel Pharmaceuticals is set to present seven posters at the 2025 ASCO Annual Meeting and EHA Congress, focusing on their hematology and oncology product portfolio, particularly GAVRETO® and REZLIDHIA® [1][2][3] Group 1: GAVRETO® (pralsetinib) - GAVRETO is being highlighted for its treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC), with final data from the Phase 1/2 ARROW study demonstrating a 70.3% overall response rate (ORR) and a median duration of response (DOR) of 19.1 months [6][8] - The study also reported a median overall survival (OS) of 44.3 months and a median progression-free survival (PFS) of 13.1 months, with notable differences in PFS across regions: 25.9 months in the U.S. compared to 12.6 months in Asia and 12.9 months in Europe [6][8] - Additional data from the ARROW study indicated promising anti-tumor activity in various RET fusion-positive solid tumors, suggesting GAVRETO's potential to address unmet medical needs [3][6] Group 2: REZLIDHIA® (olutasidenib) - REZLIDHIA is being presented for its efficacy in relapsed or refractory acute myeloid leukemia (AML), with data supporting its use in earlier lines of treatment, particularly for patients with mutated isocitrate dehydrogenase-1 (mIDH1) [3][5] - In a pivotal cohort of R/R AML patients, REZLIDHIA showed a 50% ORR and a 30% complete response (CR) rate, with a median duration of CR of 17.6 months [12] - The drug demonstrated clinically meaningful activity and a durable response in patients with primary refractory AML, indicating its potential as an effective therapeutic option for this challenging patient population [12][19] Group 3: Clinical Data and Comparisons - A matching-adjusted indirect comparison (MAIC) analysis of olutasidenib versus ivosidenib in mIDH1 R/R AML showed comparable response rates, with olutasidenib favoring longer durations of CR [11] - Final results from the Phase 2 portion of the ARROW study in RET fusion-positive solid tumors other than NSCLC indicated an ORR of 46.4%, including a 100% ORR in pancreatic cancer [11] - The data validate RET fusions as a tissue-agnostic target, supporting the promising potential of pralsetinib to address unmet medical needs across various tumor types [11][12]
Atossa Therapeutics (ATOS) Update / Briefing Transcript
2025-05-22 21:15
Summary of Atosa Therapeutics Webinar Company Overview - **Company**: Atosa Therapeutics - **Ticker**: ATOS (NASDAQ) - **Market Focus**: Estrogen receptor positive breast cancer, addressing a multibillion dollar market opportunity [5][39] Key Points and Arguments Product Development - **Drug**: Z endoxifen, a prodrug of tamoxifen, is being developed for various stages of breast cancer treatment including prevention, neoadjuvant, adjuvant, and metastatic settings [5][11][39] - **Market Potential**: The market for estrogen receptor positive breast cancer is projected to reach $42 billion by 2030 [25] - **Clinical Utility**: Z endoxifen shows broad clinical utility and aims to address significant unmet needs in breast cancer treatment, particularly in improving efficacy and reducing resistance to therapy [8][9][39] Clinical Insights - **Efficacy**: Approximately 50% of patients discontinue adjuvant endocrine therapy due to side effects, and nearly 60% do not respond to second-line therapies [8][9] - **Unique Mechanism**: Z endoxifen not only blocks estrogen receptor binding but also induces apoptosis, which is a critical mechanism lacking in current therapies [10][15] - **Resistance**: Z endoxifen remains effective even in cases of estrogen receptor mutations, which occur in over 50% of long-term endocrine therapy patients [16][17] Safety and Tolerability - **Adverse Events**: Z endoxifen has a low adverse event profile, enhancing patient adherence to treatment [18][32] - **Combination Therapy**: The drug is positioned as a promising backbone for combination therapies, showing compatibility with existing treatments [19][30] Regulatory Strategy - **FDA Approval Pathway**: The company is prioritizing the metastatic setting for FDA approval, which is expected to provide the fastest path to market [24][36] - **Ongoing Discussions**: Atosa is actively engaging with the FDA to align on registrational endpoints and accelerated approval pathways [47] Financial Position - **Cash Reserves**: Atosa has approximately $65 million in cash with nearly two years of runway and zero debt [37][39] - **Market Capitalization**: As of May, the company's market cap was $140 million, with a stock price of $1.06 [39] Additional Important Information - **Intellectual Property**: Atosa has a robust and growing IP portfolio providing protection in the US and globally [6][39] - **Leadership Team**: The company boasts an experienced leadership team with a history of successful drug development [6][40] - **Clinical Trials**: Ongoing trials include the EVANGELINE trial for grade one and two estrogen receptor breast cancers in the neoadjuvant setting [32][34] Conclusion Atosa Therapeutics is positioned to make significant advancements in the treatment of estrogen receptor positive breast cancer with its lead product Z endoxifen, backed by a strong financial position and a clear regulatory strategy aimed at addressing a substantial market need.
Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-05-22 21:05
CTLA-4 inhibitor ADG126 can be dosed at 20 mg/kg Q6W in combination with pembrolizumab with <20% Grade 3 adverse events In combination with pembrolizumab, ADG126 showed a 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months and only 1 out of 41 patients was ...
Lilly announces details of presentations at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Prnewswire· 2025-05-22 21:05
Core Insights - Eli Lilly and Company is set to present data on several investigational drugs at the 2025 ASCO Annual Meeting, including imlunestrant, olomorasib, LY4170156, and Verzenio [1] Group 1: Imlunestrant (Investigational Oral SERD) - The company will present patient-reported outcomes from the Phase 3 EMBER-3 trial for patients with ER+, HER2- advanced breast cancer [2] - Expanded safety analyses from the EMBER-3 trial will also be featured in a poster presentation [2] Group 2: Olomorasib (Investigational KRAS G12C Inhibitor) - Updated results from a Phase 1/2 study of olomorasib will be reported, showing preliminary evidence of CNS activity in combination with pembrolizumab for KRAS G12C-mutant advanced NSCLC and with cetuximab for KRAS G12C-mutant colorectal cancer [3] - The presentations will utilize data cut-off dates of January 15, 2025, and November 13, 2024 [3] Group 3: LY4170156 (Investigational ADC Targeting FRα) - Initial results from a Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer will be presented [4] - The study involves a humanized monoclonal antibody linked to a topoisomerase I inhibitor [4] Group 4: Verzenio (Abemaciclib) - The impact of body mass index (BMI) on the efficacy and safety of Verzenio in breast cancer patients will be discussed [8] - Verzenio is an approved treatment for certain HR+, HER2- breast cancers and is available in multiple strengths [12][13]