FDA Calendar

Symbol Company Name and Treatment Status Catalyst Date Catalyst Description

KVD824

HAE attacks

Phase 2
10/04/2022
Provided Update

announced that it has terminated the KOMPLETE phase 2 clinical trial for KVD824 for the prevention of attacks in people with hereditary angioedema (HAE). This decision was based on the observation of liver enzyme (ALT/AST) elevations in multiple patients in all treatment groups of the trial.

TALAPRO-2

metastatic castration-resistant prostate cancer (mCRPC)

Phase 3
10/04/2022
Top-line results

announced positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations.

BT-001

Type 2 diabetes

Phase 3
10/04/2022
Positive Data

Announced the positive 90 day results from its pivotal trial for BT-001, a potentially first-of-its-kind digital therapeutic platform that is designed to use CBT to treat type 2 diabetes (T2D) in patients 18 years and older, have been published in the American Diabetes Association (ADA)-produced, peer reviewed journal Diabetes Care.

EB-101 (VITAL)

Recessive dystrophic epidermolysis bullosa (RDEB)

Phase 3
10/04/2022
Provided Update

Announced that the last patient has completed their 6-month follow-up visit in Abeona's pivotal Phase 3 VIITAL™ study of its investigational autologous, engineered cell therapy, EB-101, in patients with recessive dystrophic epidermolysis bullosa (RDEB).

INBRX-101

Alpha-1 antitrypsin deficiency (AATD)

Phase 1
10/04/2022
Provided Update

Announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is potential to pursue an accelerated approval in the U.S. for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, in patients with emphysema due to alpha-1 antitrypsin deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint.

AR-301

Staphylococcus aureus infected ventilator associated pneumonia (VAP)

Phase 3
10/04/2022
Enrollment Update

Announced that patient enrollment is closed in the AR-301 Phase 3 clinical study.

CUE-101 + Keytruda (pembrolizumab KEYNOTE-A78)

HPV+ Recurrent/Metastatic Head andNeck Cancer

Fast Track Designation
10/04/2022
Designation Grant

Announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CUE-101, its lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (KEYTRUDA®).

Lumasiran (ILLUMINATE-C)

Advanced renal disease

supplemental New Drug Application (sNDA)
10/06/2022
PDUFA Date

FDA Acceptance of Supplemental New Drug Application for OXLUMO® for the Treatment of Advanced Primary Hyperoxaluria Type 1, PDUFA Date Set for October 6, 2022

Sabizabulin (ARDS)

Acute Respiratory Distress Syndrome (ARDS)

Advisory Committee Meetings (AdCom)
10/06/2022
Regulatory Update

FDA Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

FUROSCIX

Decompensated heart failure

New Drug Application (NDA)
10/08/2022
PDUFA Date

FDA Acceptance of FUROSCIX® New Drug Application, PDUFA action date set for October 8, 2022

AMP-100

Ocular surface anesthesia and intraoperative pain management during ocular surgery

New Drug Application (NDA)
10/16/2022
PDUFA Date

FDA has accepted the New Drug Application (NDA) filing for AMP-100, sets target action date of October 16, 2022

DSUVIA

Same-day surgical procedure

FDA Approved
10/22/2022
Data Presentation

Abstract Acceptance for Podium Presentation at the ANESTHESIOLOGY® 2022 Annual Meeting

Omburtamab

CNS/Leptomeningeal Metastases from Neuroblastoma

Advisory Committee Meetings (AdCom)
10/28/2022
Adcom

The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration has been scheduled for October 28, 2022 to review the Biological License Application for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct

AT-GAA (cipaglucosidase alfa)

Pompe Disease

Biologics License Applications (BLA)
10/29/2022
PDUFA Date

FDA has extended the review period by 90 days for the Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, the two components of AT-GAA, new PDUFA date is October 29, 2022

Sabizabulin (ARDS)

Acute Respiratory Distress Syndrome (ARDS)

Advisory Committee Meetings (AdCom)
11/09/2022
Adcom

Veru Announces FDA has Updated the Meeting Date for the Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

LUPKYNIS (voclosporin)

Lupus Nephritis

Phase 3
11/10/2022
Data Presentation

Aurinia Pharmaceuticals Inc. announced that data from multiple studies of LUPKYNIS® (voclosporin), used to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), will be presented at American College of Rheumatology (ACR) Convergence 2022. ACR Convergence 2022 will take place November 10-14 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.

LX9211 (RELIEF-DPN 1)

Diabetic Peripheral Neuropathy

Phase 2
11/14/2022
Data Presentation

Lexicon Pharmaceuticals, Inc announced medical presentations describing the progression of its investigational drug LX9211 from discovery to translation in a clinical proof-of-concept study. An oral presentation will be given on November 14th at 3:35pm ET at Arrowhead's Annual Pain Therapeutics Summit in Washington, D.C.

tenapanor

control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis

New Drug Application (NDA)
11/16/2022
Adcom

FDA Advisory Committee Meeting to Review XPHOZAH® NDA Tentatively Scheduled for November 16, 2022

Sparsentan (PROTECT)

IgA nephropathy (IgAN) a rare kidney disorder that often progresses to end-stage kidney disease (ESKD)

New Drug Application (NDA) Priority Review
11/17/2022
PDUFA Date

FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy, with target action date of November 17, 2022

Teplizumab

type 1 diabetes (T1D)

Biologics License Applications (BLA)
11/17/2022
PDUFA Date

Extension of FDA User Fee Goal Date for Teplizumab to November 17, 2022

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