If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...

今日，麦科奥特正式宣布与云顶新耀达成战略合作，授予后者其全球首创的CaSR/OGP双靶点多肽新药MT1013在中国及亚太区（日本除外）的独家商业 化权利。根据协议，麦科奥特将获得2亿元人民币首付款及最高可达10.4亿元人民币的里程碑付款，标志着公司在创新药价值实现与全球化布局中迈出关 键一步。 破解SHPT治疗困境，双机制开启主动调控时代 继发性甲状旁腺功能亢进（SHPT）是慢性肾脏病（CKD）患者常见的严重并发症，可导致骨矿物质代谢紊乱、血管钙化及心血管事件风险显著增加，传 统疗法在综合管理钙、磷及甲状旁腺激素方面存在局限。 MT1013是麦科奥特自主研发的全球首创（First-in-Class）多肽药物，通过同时靶向钙敏感受体（CaSR）与成骨生长肽（OGP）通路，实现了从"被动抑制 骨吸收"到"主动促进骨生成"的治疗理念革新。其设计旨在从源头综合调控PTH分泌、纠正钙磷代谢，并直接促进骨骼健康。 Ⅱ期数据彰显超越潜力，头对头研究取得综合优势 MT1013的关键Ⅱ期临床研究数据表现出显著疗效与治疗潜力： 目前，MT1013针对接受维持性血液透析的SHPT患者的III期注册临床研究已全面展开。此次与云顶新耀 ...

Group 1 - Intellia Therapeutics, Inc. (NTLA) is ranked seventh in a list of the 20 Best Biotech Stocks Under $20 to Buy Now [1] - Baird raised its price target on NTLA to $7 from $4 while maintaining a Neutral rating, following the FDA's lifting of the clinical hold on the Nex-z hATTR-PN trial [1][2] - H.C. Wainwright analyst increased the price target on NTLA to $25 from $15 and maintained a Buy rating, noting that the FDA's decision indicates manageable risks for Nex-Z and raised the probability of approval for Nex-Z to 35% from 25% [2] Group 2 - Intellia Therapeutics is a clinical-stage biotechnology company focused on CRISPR-based gene editing therapies for serious genetic diseases, utilizing proprietary in vivo and ex vivo platforms [3] - The company is advancing multiple programs aimed at providing durable, curative solutions and expanding the potential of gene editing [3]

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Key Takeaways FDA lifts clinical hold on NTLA's MAGNITUDE-2 phase III IND for nex-z in ATTRv-PN, enabling study resumption.NTLA aligned with the FDA on study changes and liver monitoring. It plans to resume enrollment and dosing.Nex-z is Intellia's lead program, in partnership with Regeneron, which shares 25% of R&D costs and profits.Intellia Therapeutics (NTLA) announced that the FDA lifted the clinical hold on the investigational new drug application (IND) for the phase III study, MAGNITUDE-2, evaluating ...

Core Viewpoint - Intellia Therapeutics, Inc. (NTLA) shares experienced a 6.3% increase, closing at $14.83, driven by notable trading volume and a 52.6% gain over the past four weeks [1][2]. Group 1: Company Developments - The recent price surge is attributed to increased investor confidence following the FDA's lifting of the clinical hold on the MAGNITUDE-2 study for nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) [2]. - Intellia has aligned with the FDA on study modifications and risk-mitigation measures, including enhanced liver safety monitoring, and plans to resume patient enrollment and dosing promptly [2]. Group 2: Financial Expectations - The company is expected to report a quarterly loss of $0.99 per share, reflecting a year-over-year change of +20.2%, with revenues projected at $11.85 million, down 7.9% from the previous year [3]. - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4]. Group 3: Industry Context - Intellia Therapeutics holds a Zacks Rank of 3 (Hold) within the Zacks Medical - Biomedical and Genetics industry, while Vanda Pharmaceuticals (VNDA), another stock in the same industry, finished 3.1% higher at $8.02 and has returned 8.1% over the past month [5]. - Vanda's consensus EPS estimate has changed +7.7% over the past month to -$2.18, representing a significant year-over-year change of -2625%, and it currently holds a Zacks Rank of 2 (Buy) [6].

The U.S. Food and Drug Administration (FDA) on Tuesday said it removed the clinical hold on Intellia Therapeutics Inc.‘s (NASDAQ:NTLA) Investigational New Drug application (IND) for the MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran (nex-z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).ATTRv-PN is a rare, fatal, autosomal dominant progressive disease where misfolded transthyretin proteins form amyloid deposits in peripheral nerves, causing sensory and motor dysfunction.The compa ...

Group 1: HCA Healthcare Inc - HCA Healthcare reported fourth-quarter adjusted EPS of $8.01, exceeding the analyst consensus estimate of $7.43 [1] - Following the earnings report, HCA Healthcare shares increased by 9.5% to $517.00 [1] - The company raised its FY25 guidance above estimates, indicating positive future expectations [1] Group 2: Other Notable Stock Movements - SuperX AI Technology Ltd shares surged by 27.1% to $16.79 [3] - Redwire Corp gained 21.4% to $13.29 after securing a contract worth up to $151 billion for missile defense [3] - HUYA Inc saw a 14.9% increase to $4.12 [3] - Cloudflare Inc shares rose by 14.5% to $216.99 [3] - Regencell Bioscience Holdings Ltd gained 13.5% to $33.13 [3] - Gold.com Inc surged 13.5% to $50.00 [3] - Corning Inc increased by 12.4% to $106.78 following a $6 billion agreement with Meta [3] - General Motors Co reported better-than-expected quarterly adjusted EPS results and raised its dividend, leading to a 6.8% increase to $84.84 [3]

Intellia Therapeutics said on Tuesday that the U.S. Food and Drug Administration has lifted a clinical hold on one of its gene therapy late-stage trial, allowing the company to resume testing its expe... ...

Plan to resume MAGNITUDE-2 patient enrollment and dosing FDA engagement ongoing regarding clinical hold on MAGNITUDE Phase 3 clinical trial in ATTR-CM CAMBRIDGE, Mass., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MA ...