FDA Calendar
| Symbol | Company | Name and Treatment | Status | Catalyst Date | Catalyst | Description |
|---|---|---|---|---|---|---|
| Validive (clonidine HCl MBT)Severe oral mucositis in head and neck cancer | Phase 2/3 | 2022-H1 | Interim Data Due | Anticipates reaching the interim of the Phase 2b/3 VOICE trial in the first half of 2022 | |
| Phase 3 | 2022-H1 | BLA Filing | Intends to seek agreement with the FDA to begin a rolling submission of the BLA for SER-109 in the first half of 2022 | ||
| Phase 3 | 2022-H1 | Interim Data Due | Enrollment of 418 Evaluable Patients Expected to Enable First Interim Analysis in the First Half of 2022 | ||
| Phase 1 | 2022-H1 | Top-line Data Due | Intends to complete the SynPheny-1 study with a cohort of patients receiving SYNB1934 and anticipates final SynPheny-1 results in the first half of 2022 | ||
| Phase 1 | 2022-H1 | Study Data Due | Continuous to enroll Part B of the Phase 1 study of SYNB8802 and due to ongoing challenges presented by the COVID-19 pandemic, anticipates study data will be available in the first half of 2022 | ||
| Rubraca (rucaparib - TRITON3)Castration Resistant Prostate Cancer | Phase 2 | 2022-Q2 | Study Data Due | Expects to report clinical data from TRITON3 monotherapy in second-line metastatic castration-resistant prostate cancer in Q2 2022 | |
| Allocetra (Covid)COVID-19 with acute respiratory distress syndrome (ARDS) | Phase 2b | 2022-Q2 | Top-line Data Due | Top-line data from the randomized, multi-center trial are expected in Q2-2022 | |
| Phase 2 | 2022-H1 | Top-line Data Due | Expects topline results to be available in the first half of 2022 | ||
| Pre-NDA Meeting | 2022-H1 | FDA Meeting | Pre-NDA meeting with the FDA, as well as conduct of customary stability testing, targeted for 1H 2022 | ||
| Phase 1/2 | 2022-H1 | Interim Data Due | AGTC is amending its guidance on the three-month Skyline interim data release to the first half of 2022, but maintaining the six-month Vista interim data release for 4Q 2022 | ||
| Phase 2 | 2022-H1 | Study Initiation | Intends to begin a 52-week Phase 2 biopsy-driven NASH trial in H1 2022 | ||
| Phase 1 | 2022-H1 | Initial Data Due | Confirmatory Dose and PK Data Expected in First Half of 2022 | ||
| Phase 3 | 2022-Q2 | Study Initiation | On Track to Initiate a Single Phase 3 in PAH in 2Q 2022 | ||
| Phase 1 | 2022-Q2 | IND Filing | Anticipates initiating a phase 1 study in the second quarter of 2022 | ||
| Pre-Clinical Stage | 2022-H1 | IND Filing | Expects to submit an IND for FPI-2059 in the first half of 2022 | ||
| Phase 2 | 2022-H1 | Study Initiation | Prioritizing clinical development effort and resources to advance MET642 into a Phase 2 trial in inflammatory bowel disease (IBD) in the first half of 2022 | ||
| Phase 2 | 2022-H1 | Top-line Data Due | Expects to report topline results from the trial in the first half of 2022 | ||
| Phase 3 | 2022-Q2 | Top-line Data Due | Topline data from THRIVE-AA1 is expected in the second quarter of 2022 | ||
| Phase 2a | 2022-H1 | Study Initiation | The initiation of the trial is planned for H1 2022 and the publication of topline results is expected for H2 2023 |