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The U.S. Food and Drug Administration Completes Review of Cibus' Altered Lignin Alfalfa Developed in Partnership with S&W Seed Company for use in Livestock Feed
Globenewswire· 2025-06-24 11:00
SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- Cibus, Inc. (Nasdaq: CBUS) (the "Company"), a leading agricultural technology company that develops and licenses plant traits to seed companies, announced today that it has completed the U.S. Food and Drug Administration's (FDA) Plant Biotechnology Consultation Program for its altered lignin alfalfa trait with the FDA notifying Cibus that it has no further questions concerning the use of altered lignin alfalfa in food or feed. This press release contains "forward ...
Jennifer Doudna on the Future of AI and Gene Editing
Bloomberg Originals· 2025-06-23 14:48
Welcome to the Bloomberg Tech Conference. This is our annual event where we bring together a powerhouse lineup of big tech voices. Oh, we're going to be doing a live taping of the circuit today.So, Dylan, our director of photography, is here up from LA. Look at his little shirt. Says the circuit on it.Say hi for the socials. Hi for the socials. 1 2 3 4 5 6 7 8 9 10.So excited. Please welcome to the stage Jennifer Dana, Nobel Laurate in chemistry and founder of the innovative genomics institute for a convers ...
2 Biotech Stocks to Buy Before They Soar 84% and 240%, According to Certain Wall Street Analysts
The Motley Fool· 2025-06-21 22:10
Core Insights - Biotech stocks present significant growth opportunities due to ongoing research and potential breakthroughs in treatments [1] - Wall Street identifies two biotech candidates with projected gains exceeding 80% and 200% in the next 12 months [2] Company Summaries Viking Therapeutics - Viking Therapeutics (VKTX) experienced a surge in stock price following positive phase 2 trial results for its weight loss drug VK2735, but has since returned to pre-announcement levels [4] - The company is advancing VK2735 in both injectable and pill forms, with high demand for weight loss drugs, indicating potential for future growth [5] - Viking is set to begin phase 3 trials for the injectable version in Q2 and expects phase 2 data for the pill version in the second half of the year, with the weight loss drug market projected to reach $100 billion [6] - Wall Street forecasts a 240% increase in Viking's stock price, contingent on trial outcomes [7] CRISPR Therapeutics - CRISPR Therapeutics (CRSP) saw its stock rise leading up to the approval of its first product, Casgevy, but has since declined as investors locked in gains [8] - The company is positioned for potential growth as Casgevy requires a longer rollout process, with expectations for significant increases in new patient initiations this year [10] - Positive phase 1 data for a gene-editing candidate targeting high cholesterol has been reported, with further updates expected on candidates for lipoprotein(a), oncology, and autoimmune diseases [11][12] - Wall Street anticipates an 84% gain for CRISPR Therapeutics, making it a potential buying opportunity for growth investors [12]
Biotech Stock Surging on Billion-Dollar Buyout
Schaeffers Investment Research· 2025-06-17 13:53
Biotech stock Verve Therapeutics Inc (NASDAQ:VERV) is up 75.3% to trade at $10.99 at last check amid news that peer Eli Lilly (LLY) will buy the company for $10.50 per share, or roughly $1.3 billion. The pair have already been partnering on several drugs, with the move allowing Eli Lilly to push further into gene editing. VERV is now trading at its highest level since April 2024, and sports an 11.2% year-to-date lead. The shares have been using the $6 region and 100-day moving average as support in recent w ...
Lilly to acquire Verve Therapeutics to advance one-time treatments for people with high cardiovascular risk
Prnewswire· 2025-06-17 10:45
Core Viewpoint - Eli Lilly and Company has announced a definitive agreement to acquire Verve Therapeutics, a clinical-stage company focused on genetic medicines for cardiovascular disease, with the aim of transforming treatment from chronic care to a single-dose solution [1][2][3] Company Overview - Verve Therapeutics is developing gene editing medicines targeting atherosclerotic cardiovascular disease (ASCVD), with its lead program VERVE-102 focusing on the PCSK9 gene, which is linked to cholesterol levels [2][7] - VERVE-102 is currently in a Phase 1b clinical trial and has received Fast Track designation from the U.S. FDA, indicating its potential significance in treating conditions like heterozygous familial hypercholesterolemia [2][3] Acquisition Details - Under the acquisition agreement, Lilly will offer $10.50 per share in cash for Verve's outstanding shares, totaling approximately $1.0 billion, with potential additional contingent value rights (CVR) bringing the total to up to $13.50 per share, or approximately $1.3 billion [3][4] - The purchase price represents a premium of about 113% over Verve's 30-day volume-weighted average trading price as of June 16, 2025 [4] - The transaction is expected to close in the third quarter of 2025, subject to customary closing conditions [3][4] Strategic Rationale - Lilly's acquisition of Verve is seen as a strategic move to enhance its capabilities in cardiometabolic disease and genetic medicines, aligning with Verve's vision to provide lifelong cardiovascular risk reduction through innovative treatments [1][3] - The collaboration is anticipated to accelerate the development of Verve's gene editing programs, addressing significant unmet medical needs in cardiovascular care [3][7] Shareholder Support - Verve's board of directors unanimously recommends that shareholders tender their shares in the tender offer, and key stakeholders representing approximately 17.8% of Verve's outstanding common stock have signed support agreements [5][4]
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
Globenewswire· 2025-06-15 14:45
Core Insights - Intellia Therapeutics announced promising three-year follow-up data from the Phase 1 portion of its ongoing Phase 1/2 study for lonvoguran ziclumeran (lonvo-z) in patients with hereditary angioedema (HAE) [1][2] - All 10 patients in the Phase 1 study were attack-free and treatment-free for a median of nearly two years, demonstrating the potential of lonvo-z as a one-time therapy [2][6] - The global Phase 3 HAELO trial has completed screening ahead of schedule, with over half of the patients screened in the United States [4][6] Clinical Results - A single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% compared to pre-treatment baseline [2][6] - Patients showed deep, dose-dependent, and durable reductions in plasma kallikrein protein levels throughout the study [2][6] - The treatment was well tolerated, with the most frequent adverse events being infusion-related reactions, which were mostly Grade 1 and resolved without complications [3][6] Development Plans - The ongoing Phase 3 HAELO trial is randomized, double-blind, and placebo-controlled, assessing the safety and efficacy of lonvo-z at the 50 mg dosage [4][5] - Intellia plans to submit a biologics license application (BLA) in 2026, aiming for a U.S. launch in 2027 [4][8] - New data from the Phase 2 portion of the ongoing Phase 1/2 study is expected to be presented in the second half of 2025 [4][10] About Lonvo-z - Lonvo-z is based on CRISPR/Cas9 technology and aims to prevent HAE attacks by inactivating the kallikrein B1 (KLKB1) gene [8] - The therapy has received multiple regulatory designations, including Orphan Drug and RMAT Designation from the FDA [8][9] - Intellia is focused on leveraging gene editing technology to develop novel therapies that address unmet medical needs [9]
Beam Therapeutics (BEAM) 2025 Conference Transcript
2025-06-13 21:02
Summary of Beam Therapeutics Conference Call Company Overview - **Company**: Beam Therapeutics (BEAM) - **Industry**: Gene Editing and Gene Therapy, specifically targeting sickle cell disease Key Points and Arguments 1. **Vision and Mission**: Beam aims to provide lifelong cures for patients with serious diseases through one-time curative therapies, particularly for sickle cell disease [5][12][46] 2. **Clinical Trial Update**: The BEACON trial for BEAM-101 in sickle cell disease has shown promising results, with the potential to be a best-in-class option for patients [5][10][12] 3. **Patient Story**: A patient named Brandon, who suffered from severe sickle cell disease, received BEAM-101 and has since experienced significant improvements in health and quality of life [6][7] 4. **Financial Position**: Beam has a strong balance sheet with $1.2 billion in cash and equivalents, expected to support operations until 2028 [7] 5. **Clinical Proof of Concept**: Beam has established clinical proof of concept for its base editing technology and delivery methods, with strong evidence of efficacy and safety [8][9] 6. **Regulatory Progress**: Beam has received IND clearance and orphan drug designations from the FDA for its lead programs, including BEAM-302 for alpha-one antitrypsin deficiency [10][45] 7. **Market Potential**: The peak annual revenue potential for the sickle cell market is estimated to be between $3 billion to $4 billion, with a strong reimbursement landscape [14][15] 8. **Patient Demand**: There is significant demand for BEAM-101, with many patients on waiting lists for treatment, indicating that demand is outpacing supply [16][17][92] 9. **Manufacturing Efficiency**: Beam's internal GMP manufacturing allows for high yields and rapid processing, contributing to a more efficient treatment process [20][42][44] 10. **Safety and Efficacy**: The BEACON trial has shown rapid engraftment of edited cells, with median times of 16.5 days for neutrophil engraftment and 19.5 days for platelet engraftment [27][42] 11. **Clinical Outcomes**: All patients treated with BEAM-101 have achieved hemoglobin F levels above 60% and hemoglobin S levels below 40%, indicating a successful treatment response [19][30][39] 12. **Quality of Life Improvements**: Patients have reported significant improvements in quality of life, including the ability to engage in activities previously restricted due to their condition [78][79] Additional Important Content - **Wave Strategy**: Beam's approach includes multiple waves of treatment, with Wave 1 focusing on BEAM-101, Wave 2 incorporating non-genotoxic conditioning, and Wave 3 exploring in vivo delivery methods [13][14] - **Patient Experience Metrics**: Metrics such as mobilization, hospital stay, safety, and efficacy will influence provider capacity and therapy choice [15] - **Regulatory Environment**: The reimbursement landscape is evolving, with improvements expected as more standardized plans are adopted [56][58] - **Future Outlook**: Beam is optimistic about the commercial outlook for its therapies and plans to advance its next-generation innovations in hematology [45][46] This summary encapsulates the key points discussed during the conference call, highlighting Beam Therapeutics' advancements in gene therapy for sickle cell disease and the promising data from their clinical trials.
ElevateBio CEO Ger Brophy on AWS partnership for AI technology
CNBC Television· 2025-06-12 17:00
So what most people realize is, you know, there's amazing cell and gene therapies coming through in the market at the moment and they're done and actuated in different ways. Uh crisper gene editing is a way in which you can make very precise edits to a patient's DNA. And what that allows you to do is identify new targets, but also to correct some diseases, more importantly expand the number of treatable diseases.And we're working with our partners. We've built the world's most powerful crisper gene editing ...
CNBC Disruptor 50: ElevateBio CEO Ger Brophy on AI and CRISPR for rare disease treatments
CNBC Television· 2025-06-12 11:47
Crispr Technology & Applications - Crispr 基因编辑技术能够对患者的 DNA 进行精确编辑,从而识别新的治疗靶点并纠正某些疾病,扩大可治疗疾病的范围 [2] - Crispr 技术与 AI 结合,加速识别靶点和疗法,从而加快新疗法上市的速度 [3] - 癌症,尤其是无法以其他方式治疗的儿童疾病和罕见癌症,可能是 Crispr 技术首先产生影响的领域 [5] Regulatory Landscape - FDA 对新的治疗方法和技术平台持支持态度,并倾向于快速批准 [5] - 美国卫生与公众服务部 (HHS) 部长承诺支持细胞和基因治疗领域,这对行业来说是一个巨大的推动力 [7] - 众议院拨款委员会也表达了对细胞和基因治疗领域的支持,释放了积极信号 [7] Manufacturing & Supply Chain - 该公司主要在美国本土进行生产,对进口尤其是来自中国的依赖程度不高 [9] - 公司在马萨诸塞州进行生产,并在匹兹堡进行扩张 [9] - 匹兹堡的团队致力于支持当地学校的 STEM (科学、技术、工程和数学) 项目 [9]
Cibus, Inc. Announces Closing of $27.5 Million Public Offering
Globenewswire· 2025-06-10 00:22
Core Insights - Cibus, Inc. has successfully closed a public offering of 15,714,285 shares of Class A Common Stock at a price of $1.75 per share, raising gross proceeds of $27.5 million [1][2] Company Overview - Cibus is a leading agricultural biotechnology company focused on developing plant traits through proprietary gene editing technologies, addressing productivity and sustainability challenges for farmers [6] - The company is not a seed company but a technology company that licenses developed crop traits to seed companies in exchange for royalties on seed sales [6] Use of Proceeds - The net proceeds from the offering will be utilized for the development of weed management productivity traits in rice, as well as for working capital and general corporate purposes [2] Offering Details - The offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission, with A.G.P./Alliance Global Partners acting as the sole placement agent [3][4]