相关临床试验
9
0 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
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已完成
8
88.9%
撤回
1
11.1%
- The U.S. FDA has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for endogenous Cushing's syndrome. - Asedebart is a humanized antibody that blocks ACTH binding to the melanocortin 2 receptor, reducing adrenal secretion of glucocorticoids, mineralocorticoids and androgens. - Proof-of-concept trials are ongoing in Cushing's disease and classic congenital adrenal hyperplasia, with orphan designations already secured in the EU, U.S. and Japan. - The designation offers development incentives including tax credits, FDA fee exemptions and, if approved, seven years of market exclusivity for the indication.
- McKesson Corporation signed a definitive agreement to acquire Precision Medicine Group, a global provider of clinical research and biopharma commercialization services, for approximately $2.25 billion. - Following completion, Precision Medicine Group will report within McKesson's Oncology & Multispecialty segment, enhancing clinical trial execution and broadening clinical service offerings. - The acquisition strengthens McKesson's oncology and multispecialty strategy by adding biomarker intelligence, lab services, a global CRO, and market access consulting capabilities. - The deal reflects broader industry consolidation, complementing a separate Lundbeck–Eversana partnership focused on AI-powered commercialization.
- Lundbeck's total revenue grew +16% CER (+11% DKK) to DKK 13,588 million in H1 2026, with double-digit growth in the U.S. and Europe. - Vyepti led strategic brand momentum with +46% CER growth, while Rexulti grew +17% CER, together driving 77% of total revenue from strategic brands. - The pipeline advanced with completion of enrollment in the phase III DEEp OCEAN trial of bexicaserin and FDA Fast Track designation for Lu AH69593. - Adjusted EBITDA rose +19% CER to DKK 4,765 million, reflecting strong commercial execution partially offset by higher R&D investment.
- FDA's OPDP sent an untitled letter to Sanofi over promotional emails for Beyfortus that misleadingly suggested the monoclonal antibody prevents all RSV disease, rather than only lower respiratory tract disease. - Viatris received an untitled letter for a DTC TV ad for TOBI Podhaler that implied the cystic fibrosis treatment can be administered anywhere, contradicting FDA-approved instructions requiring adequate lighting and stable conditions. - Both companies must respond within 15 working days and take immediate corrective action, including pulling the violative promotional materials. - This marks Sanofi's second untitled letter since the FDA's advertising enforcement crackdown began in September 2025.
- Vedana Therapeutics emerged from stealth with $46 million in Series A financing co-led by Westlake BioPartners and Canaan Partners to advance next-generation migraine prevention therapies. - The company is developing antibody drugs targeting PACAP, a nervous system protein that drives migraines in a similar but distinct way from CGRP, aiming to fill a treatment gap where over half of patients don't respond to existing CGRP-blocking therapies. - Vedana's leadership team includes veterans who discovered and developed multiple approved migraine therapies, including CGRP antibodies and the emerging PACAP drug class at Alder BioPharmaceuticals and Labrys Biologics. - The company's two lead programs — an anti-PACAP antibody and a bispecific antibody targeting both PACAP and CGRP — are on track to enter human trials next year.
- The developmental and epileptic encephalopathies (DEE) market reached USD 2.2 billion across the 7MM in 2025, with the United States accounting for approximately 59% of the total market share. - The diagnosed prevalent population of DEE in the 7MM is projected to rise from approximately 288,000 in 2025 to 326,000 by 2036, reflecting improved genetic testing and diagnostic awareness. - A robust pipeline featuring antisense oligonucleotides, gene therapies, and precision medicines—including zorevunersen, bexicaserin, and relutrigine—is expected to reshape the treatment landscape for genetically defined DEE subtypes. - Praxis Precision Medicines' relutrigine received FDA Priority Review acceptance in March 2026 with a PDUFA target action date of September 27, 2026, for SCN2A and SCN8A DEEs.
- Mentari Therapeutics plans to go public through a reverse merger with InMed Pharmaceuticals, creating a combined company valued at $421 million focused on antibody drugs for migraine prevention. - The deal includes a $290 million private placement led by Fairmount and other major investors, providing funding through 2028 to support clinical development of two lead programs targeting the PACAP protein. - Mentari's approach targets PACAP, a nervous system protein that regulates stress and triggers migraine symptoms, offering potential relief for patients inadequately controlled by current CGRP-blocking therapies. - The company's lead programs MT-001 and MT-002 are expected to deliver Phase 2 proof-of-concept data by 2028 and Phase 1 data by 2027, respectively.
- Lundbeck received orphan drug designation in Japan for asedebart, a first-in-class anti-ACTH monoclonal antibody targeting congenital adrenal hyperplasia and Cushing's disease. - The investigational therapy addresses a shared underlying mechanism of elevated ACTH levels in both rare endocrine disorders, which affect thousands of patients globally. - Asedebart has previously received orphan drug designations in the EU and US, with proof-of-concept clinical trials currently evaluating its efficacy and safety profile.
- Lundbeck's Phase 1b trial of Lu AF28996, a novel dopamine D1/D2 receptor agonist, demonstrated good tolerability and early signals consistent with its mechanism of action in advanced Parkinson's disease patients. - The oral investigational therapy aims to address motor fluctuations and "OFF" time periods that persist despite current treatments in advanced Parkinson's disease. - Based on positive Phase 1 results, Lundbeck is initiating a Phase 2 study in 2026 to further evaluate Lu AF28996's potential in advanced Parkinson's disease patients. - The company also presented advances in multiple system atrophy research, including progress on its amlenetug pivotal program for this fatal neurodegenerative disease with no approved treatments.
- Lundbeck announced ahead-of-schedule completion of patient randomization in the global Phase 3 MASCOT trial evaluating amlenetug for multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder with no approved treatments. - Amlenetug is a novel monoclonal antibody targeting α-synuclein protein that showed promising results in Phase 2 trials and could become the first-in-class therapy for MSA. - The early enrollment completion reflects strong engagement from the global MSA community and underscores the urgent unmet medical need for this devastating disease. - Headline results are anticipated in Q3 2027 with expected market launch in Q1 2029, offering hope for patients with this rapidly progressing condition.
