Clinical Trials
37
21 active
Approvals
1
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
21
56.8%
Approved For Marketing
1
2.7%
Completed
12
32.4%
Recruiting
3
8.1%
- BRC Therapeutics has appointed Ron Eastman, a pharmaceutical executive with over 40 years of drug development and investment experience, to its Board of Directors. - Mr. Eastman previously served as CEO of Geron Corporation and Rinat Neuroscience, and most recently as Senior Advisor at EW Healthcare Partners. - His appointment comes as BRC advances multiple assets through clinical development, including the recent FDA clearance of an IND for BRC-002 in Complex Regional Pain Syndrome. - BRC is developing multimodal cannabinoid-based therapeutics targeting neurological and inflammatory conditions, with two candidates currently in clinical trials.
- Geron Corporation forecasts RYTELO net product revenue of $220-240 million for 2026, reflecting expected growth in the telomerase inhibitor's commercial performance. - The company implemented a strategic restructuring plan reducing workforce by approximately one-third to streamline operations and lower 2026 operating expenses to $230-240 million. - Management expects stronger RYTELO performance in the second half of 2026 driven by more focused healthcare provider and patient targeting strategies.
- A decade-long multicenter trial of 247 patients demonstrated that five-day azacitidine significantly improved event-free survival and overall survival compared to three-day azacitidine or decitabine regimens in lower-risk myelodysplastic syndrome. - The five-day azacitidine regimen achieved overall response rates of 48% in transfusion-dependent patients and 70% in transfusion-independent patients while maintaining a favorable safety profile without increased toxicity. - These findings establish five-day azacitidine as the optimal shorter-duration hypomethylating agent regimen for lower-risk MDS, offering improved outcomes with reduced side effects compared to traditional seven-day protocols.
- DelveInsight's comprehensive analysis reveals over 50 companies actively developing more than 55 JAK inhibitor therapies, demonstrating significant industry investment in this therapeutic class. - Recent FDA approvals include Leqselvi for alopecia areata in July 2024, Litfulo for severe alopecia areata in June 2023, and Ojjaara for myelofibrosis in September 2023. - Leading pipeline candidates include Povorcitinib by Incyte Corporation in Phase III trials, CPL409116 by Celon Pharma targeting dual JAK/ROCK inhibition, and ATI-2138 by Aclaris Therapeutics as an oral ITK/JAK3 inhibitor. - The pipeline spans multiple development stages from discovery to Phase III, with therapies targeting diverse conditions including autoimmune diseases, cancer, and dermatological disorders.
- Geron Corporation has appointed Harout Semerjian as President and CEO effective August 7, 2025, bringing over 30 years of hematology and oncology experience from leadership roles at Novartis, Ipsen, and GlycoMimetics. - The appointment comes as Geron focuses on expanding awareness and access to RYTELO, its first-in-class telomerase inhibitor approved for treating lower-risk myelodysplastic syndromes with transfusion-dependent anemia. - Under new leadership, the company aims to advance its late-stage pipeline including completion of the pivotal Phase 3 IMpactMF trial for relapsed/refractory myelofibrosis. - Wall Street analysts maintain an "Outperform" consensus with an average price target of $3.39, representing potential upside of 182.41%.
- Imetelstat, a first-in-class telomerase inhibitor, is advancing to phase 3 trials after demonstrating promising survival benefits in patients with myelofibrosis resistant to JAK inhibitor therapy. - The phase 2 IMbark trial showed a median overall survival of 29.9 months, with 32% of patients achieving significant symptom reduction and evidence of disease-modifying activity. - The ongoing IMpactMF phase 3 trial is enrolling approximately 320 patients globally, with 75% enrollment completed as of December 2024 and interim results expected in early 2026.
• Vivo Capital has closed the third cycle of its Opportunity Fund with over $740 million in commitments, focusing on preclinical and clinical-stage life sciences companies developing novel therapies. • The fund has previously backed companies that achieved significant milestones, including FDA approvals for treatments targeting COPD, myelodysplastic syndrome, narcolepsy, and Prader-Willi Syndrome. • Several Vivo-backed companies have been acquired by pharmaceutical giants in billion-dollar deals, including RayzeBio (Bristol-Myers Squibb, $4.1B), Chinook Therapeutics (Novartis, $3.2B), and Sierra Oncology (GSK, $1.9B).
- New analyses from IMerge Phase 3 trial demonstrate imetelstat's efficacy in lower-risk MDS patients, showing consistent clinical activity regardless of prior treatment history. - Phase 1 IMproveMF study results indicate favorable tolerability profile for imetelstat when combined with ruxolitinib as first-line therapy in myelofibrosis patients. - Geron Corporation's latest data presentation at ASH 2024 strengthens imetelstat's potential as a versatile treatment option across different myeloid disorders.
- Geron Corporation achieved $47.5 million in RYTELO (imetelstat) net product revenue in Q4 2024 and $76.5 million since its commercial launch in June 2024, following FDA approval for lower-risk myelodysplastic syndromes. - The company expects to reach profitability without additional financing based on current sales trajectory and operating expense projections of $270-285 million for fiscal year 2025. - Geron's Phase 3 IMpactMF trial evaluating imetelstat in relapsed/refractory myelofibrosis has reached approximately 80% enrollment, with interim analysis expected in second half of 2026.
- The FDA approved Madrigal's Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), addressing a significant unmet need in liver disease. - X4 Pharmaceuticals' Xolremdi gained approval as the first targeted therapy for WHIM syndrome, a rare immunodeficiency, marking a milestone for the company. - Day One Biopharmaceuticals' Ojemda secured approval for BRAF-altered pediatric low-grade glioma, offering a new treatment option for this common childhood brain tumor. - Geron Corporation's Rytelo, a telomerase inhibitor, received FDA approval for lower- to intermediate-risk myelodysplastic syndromes (MDS), after 34 years in business. - ImmunityBio's Anktiva, a novel IL-15 superagonist, was approved for non-muscle invasive bladder cancer, providing a new therapeutic approach for BCG-unresponsive patients.
