Clinical Trials
83
37 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1993
Active, not recruiting
37
44.6%
Completed
31
37.4%
Recruiting
1
1.2%
Suspended
1
1.2%
Terminated
10
12.1%
Unknown
2
2.4%
Withdrawn
1
1.2%
No approval data available
- FibroGen has rebranded to Kyntra Bio, reflecting its strategic focus on oncology and rare disease therapeutics with a strengthened financial position extending cash runway into 2028. - The company is advancing FG-3246, a first-in-class CD46-targeting antibody-drug conjugate in Phase 2 trials for metastatic castration-resistant prostate cancer, with topline combination results expected at ASCO GU 2026. - Roxadustat received FDA Orphan Drug Designation for myelodysplastic syndromes, with a pivotal Phase 3 trial protocol submitted for treating anemia in lower-risk MDS patients. - Kyntra Bio will begin trading on Nasdaq under the new symbol "KYNB" effective January 8, 2026, marking the completion of its corporate transformation.
- FibroGen announced that the FDA's Office of Orphan Products Development has granted roxadustat Orphan Drug Designation for treating myelodysplastic syndromes (MDS). - Post-hoc analysis from the Phase 3 MATTERHORN trial showed roxadustat improved transfusion-independence in patients with high transfusion burden compared to placebo. - The company plans to finalize and submit a Phase 3 protocol for this patient population to the FDA in the fourth quarter of 2025. - The designation addresses a significant treatment gap, as current first-line treatments achieve transfusion independence in less than 50% of MDS patients.
- The Duchenne Muscular Dystrophy market reached approximately $2.15 billion in 2023 and is expected to grow significantly due to increased drug uptake and anticipated gene therapy launches. - Over 75 companies are actively developing pipeline therapies for DMD, with recent FDA designations including Atossa Therapeutics' (Z)-Endoxifen receiving Rare Pediatric Disease designation. - Capricor Therapeutics announced positive Phase 3 HOPE-3 trial results for Deramiocel, while the FDA accepted their BLA for review with Priority Review designation. - Current approved treatments include EMFLAZA, VYONDYS 53, EXONDYS 51, AMONDYS 45, VILTEPSO, and gene therapy ELEVIDYS in the US, with AGAMREE launched in Germany in 2024.
- FibroGen has reached agreement with the FDA on key design elements for a pivotal Phase 3 trial of roxadustat in lower-risk myelodysplastic syndrome patients with high transfusion burden. - The oral HIF-PH inhibitor demonstrated promising efficacy in a post-hoc analysis, with 36% of high transfusion burden patients achieving transfusion independence compared to 7% on placebo. - The randomized, placebo-controlled trial will enroll approximately 200 patients and evaluate 8-week or 16-week transfusion independence as the primary endpoint. - FibroGen plans to submit the Phase 3 protocol to the FDA in the fourth quarter of 2025, addressing a significant unmet medical need in this patient population.
- FG-3246, a first-in-class antibody-drug conjugate targeting CD46, demonstrated an 80% disease control rate and 20% objective response rate in heavily pre-treated metastatic castration-resistant prostate cancer patients. - The phase 1 trial established 2.7 mg/kg as the maximum tolerated dose, with manageable safety profile including neutropenia as the most common adverse event, while showing a median radiographic progression-free survival of 8.7 months. - FibroGen plans to advance FG-3246 with a phase 2 monotherapy study by mid-2025 and will disclose results from a combination trial with enzalutamide in the second half of 2025.
- FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings. - The strategic sale will extend FibroGen's cash runway into 2027 and enable continued development of its oncology pipeline, including the Phase 2 trial of FG-3246 for metastatic prostate cancer. - Upon closing in mid-2025, AstraZeneca will acquire all rights to roxadustat in China, where it leads the market for chronic kidney disease anemia treatment.
• Over 75 drugs are in development for Duchenne Muscular Dystrophy (DMD), targeting various mechanisms and routes of administration. • REGENXBIO initiated a Phase I/II trial of RGX-202 in young boys with DMD to assess safety and efficacy. • Emerging therapies focus on gene modulation, dystrophin replacement, and anti-inflammatory approaches to combat DMD. • Key companies like Sarepta Therapeutics, Italfarmaco, and FibroGen are advancing DMD therapeutics through clinical trials.
• FibroGen's lead drug pamrevlumab fails to demonstrate survival benefits in two pivotal pancreatic cancer trials, leading to complete termination of the program. • The company announces plans to reduce its workforce by 75% following the drug's failure, marking a significant setback after previous unsuccessful trials in Duchenne muscular dystrophy. • Despite setbacks, FibroGen maintains a $215 million cash reserve and continues development of other pipeline candidates, including promising ADC therapy FG-3246 for prostate cancer.
- FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need. - Roxadustat sales in China increased by 24% year-over-year, driven by a 39% volume increase, with potential for further growth pending approval for chemotherapy-induced anemia. - FG-3246, a first-in-class ADC, shows promising Phase 1 results in metastatic castration-resistant prostate cancer, with plans for a Phase 2/3 study in late 2024. - FibroGen's strong cash position of $214.7 million is expected to fund operations into 2026, supporting the advancement of its clinical programs.
- Sarepta Therapeutics' Elevidys (delandistrogene moxeparvovec) gains accelerated FDA approval for treating ambulatory pediatric Duchenne muscular dystrophy (DMD) patients aged 4-5. - Bristol Myers Squibb's Camzyos (mavacamten) is approved in the EU for symptomatic obstructive hypertrophic cardiomyopathy (HCM) based on positive Phase III trial results. - FibroGen's pamrevlumab fails in a Phase III trial for idiopathic pulmonary fibrosis (IPF), leading to discontinuation of further studies. - Intercept Pharmaceuticals receives a Complete Response Letter from the FDA for obeticholic acid (OCA) in treating pre-cirrhotic fibrosis due to NASH, prompting restructuring.
