Clinical Trials
26
18 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2005
Active, not recruiting
17
65.4%
Completed
5
19.2%
Not yet recruiting
1
3.9%
Terminated
3
11.5%
No approval data available
- Flare Therapeutics closed an $85 million insider-led Series C financing led by Third Rock Ventures and Nextech Invest, with participation from Pfizer Ventures, Eli Lilly, Novartis, and others. - Proceeds will fund advancement of FX-111, a first-in-class degrader targeting ARON, through proof-of-concept clinical studies, with Phase 1A initiation expected in Q3 2026 following FDA IND clearance. - Veteran biotech executive Anna Protopapas, former CEO of Mersana Therapeutics and President of Millennium/Takeda Oncology, has been appointed CEO to guide the company's prostate cancer-focused strategy. - The company will seek an external partner for FX-909, its Phase 1B-stage oral PPARG inhibitor for urothelial cancer, while concentrating internal resources on the ARON franchise.
- Day One Biopharmaceuticals reported preliminary 2025 OJEMDA net product revenue of $155.4 million, representing 172% year-over-year growth driven by increasing patient demand. - The company projects 2026 OJEMDA U.S. net product revenue between $225-250 million, representing 53% growth at the midpoint. - Day One completed the strategic acquisition of Mersana Therapeutics, adding Emi-Le (emiltatug ledadotin), a B7-H4-targeted ADC for adenoid cystic carcinoma. - The company plans to complete enrollment in the pivotal Phase 3 FIREFLY-2 trial for first-line pediatric low-grade glioma in the first half of 2026.
- Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics for $129 million upfront, with potential additional payments of $156 million tied to development milestones. - The deal centers on Mersana's B7-H4-targeting ADC emiltatug ledadotin, which Day One plans to develop for adenoid cystic carcinoma type 1, a rare and aggressive cancer. - Mersana shareholders will receive $25 per share upfront, representing a 180% premium to Wednesday's closing price, though the company's stock had declined 75% year-to-date. - The acquisition provides Day One with Mersana's Dolasynthen ADC technology platform and $77 million in cash, expanding beyond its single approved drug Ojemda.
- Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics for up to $285 million to gain access to emiltatug ledadotin (Emi-Le), a novel antibody-drug conjugate targeting B7-H4. - Emi-Le has demonstrated early anti-tumor activity in an ongoing Phase 1 study for adenoid cystic carcinoma type-1 (ACC-1), an aggressive cancer with high unmet medical need and no approved therapies. - The acquisition positions Day One to leverage its existing capabilities to develop this potential first-in-class monotherapy through a clear registration pathway for a well-defined patient population. - The deal structure includes $25 per share upfront plus contingent value rights worth up to $30.25 per share based on clinical, regulatory, and commercial milestones.
- Day One Biopharmaceuticals announced a definitive merger agreement to acquire Mersana Therapeutics for $25 per share in cash, representing a 182% premium over the previous closing price. - The transaction includes potential milestone payments up to $30.25 per share through contingent value rights tied to Mersana's B7-H4-directed antibody-drug conjugate Emi-Le, bringing total potential value to $55.25 per share. - Mersana's stock surged over 200% in premarket trading following the announcement, with the deal valued at approximately $129 million at closing and up to $285 million including milestones. - The acquisition is expected to close by the end of January 2026, with Day One financing the transaction entirely through existing cash resources.
- Orum Therapeutics has appointed Dr. Dorin Toader as Head of Platform Technology to advance its degrader-antibody conjugate (DAC) platforms and expand therapeutic applications. - Dr. Toader brings over 27 years of drug discovery experience, including 15+ years in antibody-drug conjugates, having previously advanced multiple first-in-class ADC candidates into clinical development. - The appointment strengthens Orum's proprietary Dual-Precision Targeted Protein Degradation (TPD²) approach, which combines targeted protein degraders with antibody delivery mechanisms for cancer treatment. - Dr. Toader will lead innovation in payload design, conjugation technologies, and computational modeling to develop next-generation targeted degrader-antibody conjugates for various cancers and serious diseases.
• The FDA has granted Fast Track designation to Mersana's Emiltatug Ledadotin (XMT-1660) for advanced or metastatic HER2-low or HER2-negative breast cancer, including triple-negative breast cancer. • This designation applies to patients who have previously received a topoisomerase-1 inhibitor ADC and, if hormone-receptor positive, have received or are ineligible for endocrine therapy. • Phase 1 trial data shows Emiltatug Ledadotin demonstrates promising efficacy and a favorable safety profile, particularly in heavily pre-treated triple-negative breast cancer patients. • The WHO has approved emiltatug ledadotin (Emi-Le) as the international nonproprietary name (INN) for XMT-1660, marking a significant step in its global recognition.
- Mersana Therapeutics' Emiltatug Ledadotin (XMT-1660) demonstrates a favorable safety profile in a Phase 1 trial with no Grade 4 or 5 treatment-related adverse events. - The Phase 1 trial of Emi-Le shows a 23% confirmed objective response rate in B7-H4 high tumors at intermediate doses, particularly in heavily pre-treated TNBC patients. - The FDA grants Fast Track designation to Emiltatug Ledadotin for advanced or metastatic HER2-low or HER2-negative breast cancer, including triple-negative breast cancer. - Mersana Therapeutics plans to continue enrollment in expansion cohorts and present additional Phase 1 data for Emi-Le in 2025, focusing on TNBC patients.
- Merus' petosemtamab demonstrates a 36% overall response rate in recurrent/metastatic head and neck squamous cell carcinoma, with median overall survival of 11.4 months. - Mersana Therapeutics' Emi-Le receives Fast Track designation for HER2-negative breast cancer, showing promising monotherapy activity in multiple tumors. - Petosemtamab's clinical trials are ongoing, including phase 3 studies in HNSCC and expanded evaluation in metastatic colorectal cancer, with data updates planned for 2025.
