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

SER-109

Recurrent Clostridioides Difficile Infection

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

Acelarin (NUC-1031)

Biliary tract cancer.

Phase 3
2022-H1
Interim Data Due

Enrollment of 418 Evaluable Patients Expected to Enable First Interim Analysis in the First Half of 2022

SYNB1934 (Synthetic Biotic)

Phenylketonuria (PKU)

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

SYNB8802

Dietary Hyperoxaluria

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

ANEB-001

Cannabinoid overdose

Phase 2
2022-H1
Top-line Data Due

Expects topline results to be available in the first half of 2022

SB206 (B-SIMPLE4)

Molluscum Contagiosum (Molluscum)

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

AGTC-501

X-linked retinitis pigmentosa (XLRP)

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

ALT-801

Non-alcoholic steatohepatitis (NASH)

Phase 2
2022-H1
Study Initiation

Intends to begin a 52-week Phase 2 biopsy-driven NASH trial in H1 2022

SY-2101

Acute Promyelocytic Leukemia

Phase 1
2022-H1
Initial Data Due

Confirmatory Dose and PK Data Expected in First Half of 2022

Imatinib

Pulmonary Arterial Hypertension (PAH)

Phase 3
2022-Q2
Study Initiation

On Track to Initiate a Single Phase 3 in PAH in 2Q 2022

RGLS8429

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Phase 1
2022-Q2
IND Filing

Anticipates initiating a phase 1 study in the second quarter of 2022

FPI-2059

Solit Tumors

Pre-Clinical Stage
2022-H1
IND Filing

Expects to submit an IND for FPI-2059 in the first half of 2022

MET642 (IBD)

Inflammatory bowel disease (IBD)

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

ATH-1017 (ACT-AD)

Mild-to-moderate Alzheimer's disease

Phase 2
2022-H1
Top-line Data Due

Expects to report topline results from the trial in the first half of 2022

CTP-543 (THRIVE-AA1)

Alopecia areata

Phase 3
2022-Q2
Top-line Data Due

Topline data from THRIVE-AA1 is expected in the second quarter of 2022

lanifibranor + Empagliflozin

NASH and type 2 diabetes

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

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