Clinical Trials
7
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2022
Active, not recruiting
1
14.3%
Completed
2
28.6%
Recruiting
4
57.1%
No approval data available
- Rapport Therapeutics is advancing RAP-219, a first-in-class AMPA receptor modulator targeting TARPγ8, into Phase 3 trials for focal epilepsy. - Phase 2 results showed a 78% reduction from baseline in clinical seizure frequency, corroborated by objective electrographic biomarkers from implantable neurostimulation devices. - CEO Abraham Ceesay stated the company is "fully prepared" to commercialize RAP-219 independently, citing neuroscience as a field where emerging biotechs have successfully launched products. - The company is pursuing a strategic partnership to include China in its global Phase 3 development program while maintaining control over commercialization in other markets.
- MBX Biosciences shares jumped 33% after-hours ahead of Phase 2 topline results for Canvuparatide, a once-weekly therapy for chronic hypoparathyroidism, scheduled for release on Monday. - Structure Therapeutics gained 11.37% in extended trading as attention builds around its obesity drug aleniglipron, with Phase 2b trial results expected by end of 2025. - Multiple biotech companies including Cartesian Therapeutics, Rapport Therapeutics, and Rezolute saw significant after-hours gains driven by upcoming clinical milestones and positive trial developments. - The rally reflects strong investor appetite for clinical-stage biotechnology companies with near-term data catalysts and promising pipeline assets.
- Inductive Bio has raised $25M in Series A funding led by Obvious Ventures to accelerate its AI-driven approach to small molecule drug discovery, focusing on predicting ADMET properties before synthesis. - The company's Compass platform has already supported dozens of drug programs with medicinal chemists exploring over 1 million molecule designs, demonstrating real-world impact on drug development efficiency. - Inductive's pre-competitive data consortium allows multiple companies to contribute anonymized data in a secure environment, creating a foundational dataset that powers AI models trained on thousands of real-world drug discovery programs.
- Rapport Therapeutics' RAP-219 achieved target receptor occupancy within five days, supporting its potential for treating CNS disorders. - The Phase 1 trials demonstrated a favorable tolerability profile for RAP-219, with no serious adverse events reported in healthy volunteers. - RAP-219 selectively targets TARPγ8-associated AMPA receptors, potentially enhancing the therapeutic index for AMPA receptor modulation. - A Phase 2a trial of RAP-219 in focal epilepsy is ongoing, with topline data expected in mid-2025, according to Rapport Therapeutics.
- Rapport Therapeutics presents data linking reductions in long episode (LE) frequency to clinical seizure reduction in focal epilepsy. - A 30% reduction in LEs correlates with a 50% or greater reduction in clinical seizures, establishing a benchmark for RAP-219. - RAP-219, a selective TARPγ8 NAM, demonstrates potential for improved tolerability and efficacy in treating refractory focal epilepsy. - Phase 2a trial topline data for RAP-219 in focal epilepsy is expected in mid-2025, marking a key milestone for the program.
• The FDA has placed a clinical hold on Rapport Therapeutics' RAP-219 IND application for diabetic peripheral neuropathic pain (DPNP) due to protocol design concerns. • A phase 2 trial (cAPPricorn-1) will evaluate Alnylam's mivelsiran, an RNAi therapeutic targeting APP, for cerebral amyloid angiopathy (CAA) in a 200-patient global study. • The FDA has accepted PTC Therapeutics' resubmitted NDA for ataluren to treat nonsense mutation Duchenne muscular dystrophy (nmDMD), with no PDUFA date set.
- Rapport Therapeutics is advancing RAP-219, a precision medicine for CNS disorders, with Phase 2a trial in focal epilepsy on track for mid-2025 data. - A clinical hold was placed on the RAP-219 trial for diabetic peripheral neuropathic pain (DPNP) by the FDA, pending protocol amendments. - The company's MAD-2 and PET trials of RAP-219 are ongoing, with topline data expected in Q1 2025, informing bipolar disorder treatment. - Rapport Therapeutics ended Q3 2024 with $320.7 million in cash, expected to fund operations through 2026, and appointed new board members.
- The FDA has placed a clinical hold on Rapport Therapeutics' IND application for RAP-219, an investigational therapy for diabetic peripheral neuropathic pain (DPNP). - The agency is requesting additional information on the trial's protocol design, which Rapport Therapeutics believes it can address promptly. - This hold does not affect Rapport's other RAP-219 studies, including the ongoing Phase 2a trial for focal epilepsy and planned trial for bipolar disorder. - Rapport Therapeutics anticipates providing an update on the Phase 2a trial initiation timeline once the FDA's requests are resolved.
- Rapport Therapeutics is advancing RAP-219 in Phase 2a trials for focal epilepsy, with topline data expected in mid-2025, showing commitment to CNS disorder treatments. - The FDA placed a clinical hold on Rapport's RAP-219 trial for diabetic peripheral neuropathic pain, prompting the company to address protocol feedback. - The company appointed biotech leaders to its Board of Directors and reported $320.7 million in cash, expected to fund operations through 2026. - Rapport is set to release topline data from the RAP-219 MAD-2 and PET trials in Q1 2025, informing the bipolar disorder trial and target receptor occupancy.
- Rapport Therapeutics is progressing with Phase 2a trial of RAP-219 in focal epilepsy, with topline data expected in mid-2025. - Multiple Ascending Dose (MAD-2) and PET trials of RAP-219 are ongoing, with topline results anticipated in Q1 2025. - The FDA placed a clinical hold on the IND for RAP-219 in diabetic peripheral neuropathic pain, pending protocol amendments. - New biotech industry leaders have been appointed to Rapport's Board of Directors, bringing expertise in drug discovery and clinical development.
