相关临床试验
79
21 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
21
26.6%
已完成
46
58.2%
No Longer Available
1
1.3%
招募中
3
3.8%
终止
8
10.1%
- The biotech M&A market is heating up as pharmaceutical companies face a patent cliff that will eliminate $200-250 billion in branded medicine sales by 2032, driving acquisition activity. - Research projects both the number of acquisitions and total dollars spent on deals will increase 15% in 2026, with approximately 520 transactions totaling $230 billion expected across the sector. - Big Pharma is targeting companies with drugs in advanced clinical trials, with 80% of expected 2026 deals focused on acquiring treatments already proven effective in patients. - Key therapeutic areas drawing acquisition interest include diabetes, kidney disease, obesity, radiopharmacy, RNA-based therapies, and cardiovascular diseases.
- MannKind Corporation announced FDA acceptance of its supplemental New Drug Application for the FUROSCIX ReadyFlow Autoinjector, targeting adults with edema from chronic heart failure or chronic kidney disease. - The ReadyFlow device delivers subcutaneous furosemide in under 10 seconds, representing a significant improvement over the current five-hour FUROSCIX on-body infusor for at-home diuretic therapy. - Bioequivalence data demonstrates comparable diuretic effects to intravenous furosemide, with a PDUFA target action date set for July 26, 2026. - The potential market includes an estimated 670,000 to 1.34 million U.S. heart failure patients, with MannKind reporting strong Q3 2025 results including $82.13 million in revenue and $7.99 million net income.
- MannKind Corporation has discontinued its Phase 3 ICoN-1 trial of nebulized clofazimine (MNKD-101) for refractory nontuberculous mycobacterial lung disease after no sputum culture conversions were observed in the first 46 participants. - The independent Data Safety Monitoring Board agreed with the futility determination on November 8, 2025, though no safety concerns were identified during the study. - The company remains committed to developing MNKD-102, a dry powder inhalation formulation of clofazimine, which continues toward Phase 1 development. - NTM lung disease affects over 100,000 patients in the U.S. with approximately 15-20% being refractory to current treatments, representing a significant unmet medical need.
- MannKind Corporation has appointed Dr. Ajay Ahuja as Chief Medical Officer, bringing over two decades of biopharmaceutical leadership experience to advance the company's inhaled therapeutics pipeline. - Dr. Ahuja's expertise in cardiometabolic diseases and clinical development will support MannKind's mission to address endocrine and orphan lung diseases through innovative dry-powder formulations and inhalation devices. - The appointment strengthens MannKind's executive leadership as the company focuses on developing treatments for diabetes, nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension.
- United Therapeutics has exercised its option to develop a second dry powder inhalation therapy using MannKind's Technosphere platform, expanding their successful 2018 collaboration. - The partnership builds on the success of Tyvaso DPI, which became the first FDA-approved dry powder inhalation treatment for pulmonary hypertension in May 2022. - MannKind will receive $5 million upfront and is eligible for up to $35 million in development milestones plus 10% royalties on net sales. - Formulation and development activities for the new investigational molecule will begin immediately, targeting patients with pulmonary hypertension.
- MannKind Corporation announced the acquisition of scPharmaceuticals for up to $360 million, marking its strategic expansion into cardiorenal medicine with FUROSCIX as the key asset. - The deal includes an upfront payment of $5.35 per share plus contingent value rights worth up to $1.00 per share, representing a 36% premium to scPharmaceuticals' 90-day trading average. - FUROSCIX demonstrated strong commercial momentum with net sales of $27.8 million for the first half of 2025, representing 96% year-over-year growth. - The acquisition is expected to diversify MannKind's revenue base and accelerate double-digit growth goals, with the combined company targeting an annualized run rate exceeding $370 million.
- MannKind Corporation has secured up to $500 million in non-dilutive financing from Blackstone, with $75 million available immediately at closing. - The funding will support commercial team expansion for the anticipated pediatric Afrezza launch, pipeline advancement, and potential business development opportunities. - The senior secured credit facility includes a variable interest rate of SOFR plus 4.75% and matures in August 2030 without scheduled amortization payments. - MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases including diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension.
- MannKind Corporation will showcase results from its Phase 3 INHALE-1 clinical trial of Afrezza inhaled insulin in children and adolescents aged 4-17 at the American Diabetes Association's 85th Scientific Sessions in Chicago. - Dr. Michael J. Haller from the University of Florida will present breakthrough pediatric Type 1 diabetes care data during a "Future Ready" symposium on June 22, 2025. - The company expects to release topline results from the full pediatric dataset in Q2 2025 and plans to submit a Supplemental Biologics License Application for pediatric indication by mid-2025. - Additional presentations will cover patient-reported outcomes and Phase III trial results comparing Afrezza with placebo in adult Type 2 diabetes patients from an Indian clinical trial.
- INHALE-3 trial data reveals that 74% of adults with type 1 diabetes increased their technosphere insulin (Afrezza) dose by more than 4 units over 30 weeks, with total daily doses rising from 36 to 52 units. - Technosphere insulin demonstrated significant HbA1c reductions at 30 weeks, with the percentage of patients achieving HbA1c below 7% increasing from 21% at baseline to 42% at study completion. - Proper administration timing is critical for maximizing benefits, with researchers emphasizing that inhaled insulin should be taken at the start of meals rather than waiting as with traditional rapid-acting analogs.
- MannKind Corporation has started its Phase 3 ICoN-1 trial to assess Clofazimine Inhalation Suspension for treating nontuberculous mycobacterial (NTM) lung disease. - The ICoN-1 study, a global, randomized, double-blind, placebo-controlled trial, aims to enroll approximately 230 participants across more than 100 sites. - Regulatory bodies in Australia, the U.S., Japan, and South Korea have cleared the trial, with Taiwan anticipated to follow by the end of the year. - The primary endpoint is sputum culture conversion after six months, with a co-primary endpoint in the U.S. focusing on changes in quality of life.
