相关临床试验
4
2 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
2014
进行中（未招募）
2
50.0%
已完成
1
25.0%
终止
1
25.0%
- Sun Pharma will present updated long-term follow-up data for UNLOXCYT (cosibelimab-ipdl) in locally advanced cutaneous squamous cell carcinoma at ASCO 2026, representing the second largest prospective study of its kind. - The study demonstrated a 50% objective response rate with 27% complete responses in 64 patients, with median duration of response not yet reached after over 31 months of follow-up. - The treatment showed a manageable safety profile with only one patient experiencing Grade ≥3 immune-related adverse events, supporting its use in elderly patients with multiple comorbidities. - UNLOXCYT is indicated for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
- Fortress Biotech achieved a 20.5% increase in net revenue to $17.6 million in Q3 2025, driven by strong performance from its dermatology products portfolio. - The company completed strategic exits with Sun Pharma acquiring Checkpoint Therapeutics for ~$28 million upfront to Fortress, plus potential additional payments and royalties. - Dotinurad, a next-generation URAT1 inhibitor for gout treatment, advanced into two Phase 3 trials following Crystalys Therapeutics' $205 million Series A financing. - Journey Medical's rosacea treatment Emrosi demonstrated statistical superiority over existing therapies in pooled Phase 3 analysis, with expanded payer coverage reaching over 100 million lives.
- Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway. - Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT sales. - FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.
- Sun Pharmaceutical Industries will acquire Checkpoint Therapeutics for $355 million upfront, with stockholders receiving $4.10 per share plus a contingent value right worth up to $0.70 per share based on European approval milestones. - The acquisition adds UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma (cSCC), to Sun Pharma's global onco-dermatology portfolio. - Sun Pharma plans to leverage its global presence to accelerate patient access to UNLOXCYT in the United States, Europe, and other markets worldwide, addressing a significant unmet need in the second most common skin cancer.
• The FDA has rejected Checkpoint Therapeutics' application for cosibelimab in advanced cutaneous squamous cell carcinoma, citing manufacturing facility issues rather than safety or efficacy concerns. • Clinical trials demonstrated promising results with a 55% overall response rate in locally advanced cSCC and 50% in metastatic disease, positioning cosibelimab as a potential low-cost alternative to existing treatments. • Checkpoint Therapeutics plans to address the manufacturing concerns and resubmit their application, aiming for potential approval in 2024, though the news triggered a 45% drop in company stock.
- The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden. - Checkpoint Therapeutics received FDA approval for Unloxcyt to treat advanced cutaneous squamous cell carcinoma, targeting a $1 billion market opportunity. - Galderma's Nemluvio gains FDA approval for moderate-to-severe atopic dermatitis in patients 12 and older, with projected peak annual sales exceeding $2 billion.
- The FDA has approved Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults who cannot undergo surgery or radiation. - Approval was based on Study CK-301-101, showing a 47% objective response rate in metastatic cSCC and 48% in locally advanced cSCC patients. - Unloxcyt is administered intravenously every three weeks and is the first PD-L1 blocking antibody approved for this specific indication. - Common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea and hypothyroidism, with serious immune-mediated reactions possible.
- The FDA has granted approval to Checkpoint Therapeutics' Unloxcyt (cosibelimab-ipdl) for the treatment of advanced cutaneous squamous cell carcinoma (cSCC). - Unloxcyt, a PD-L1 antibody, represents Checkpoint Therapeutics' first FDA-approved drug, marking a significant milestone for the company. - The approval allows Unloxcyt to compete in the U.S. market for cSCC, estimated to exceed $1 billion annually, offering a new treatment option. - Checkpoint Therapeutics is now developing a commercial launch plan for Unloxcyt, aiming to provide a differentiated treatment by targeting PD-L1.
• The FDA is set to decide on Ionis Pharmaceuticals' olezarsen for familial chylomicronemia syndrome (FCS), a rare genetic disease, by December 19, following positive Phase III results. • Lexicon Pharmaceuticals awaits the FDA's decision on sotagliflozin as an adjunct therapy for type 1 diabetes by December 20, despite concerns raised by an advisory committee. • AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC is under FDA review, with a decision expected by December 20, based on Phase III data showing progression-free survival benefits. • Neurocrine Biosciences anticipates FDA decisions on crinecerfont for congenital adrenal hyperplasia (CAH) by December 29 and 30, potentially marking the first new treatment in 70 years.
- Fortress Biotech announced FDA approval for Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults, marking their first FDA approval. - The PDUFA goal date for cosibelimab, an anti-PD-L1 antibody, is set for December 28, 2024, targeting metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). - Clinical data presented at the Fall Clinical Dermatology Conference showed Emrosi has higher dermal concentration than oral doxycycline for rosacea treatment. - Longer-term data from the pivotal trial of cosibelimab in cSCC demonstrated deepening responses over time, with higher objective and complete response rates.
