FDA Calendar

Symbol Company Name and Treatment Status Catalyst Date Catalyst Description

Biosimilar insulin glargine

Diabetes

Phase 1
02/01/2023
Top-line results

Lannett Company, Inc. announced that the pivotal trial results for its biosimilar insulin glargine continues, though it now anticipates top-line data to be available by the end of February 2023.

Renuvion APR Handpiece

Improves Appearance of Lax (Loose) Skin

FDA 501(k) marketing clearance
02/01/2023
Regulatory Update

Apyx Medical Corporation announced it has submitted a 510(k) premarket notification ("510(k) submission") for the Renuvion APR Handpiece to the U.S. Food and Drug Administration ("FDA"), supported by a clinical study and real-world evidence.

NERLYNX (neratinib)

HER2-Positive Early Stage and Metastatic Breast Cancer

02/01/2023
Provided Update

Puma Biotechnology, Inc. announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer were updated to include an addition involving neratinib

TNX-1500

Humanized monoclonal antibody

Pre-Clinical Stage
02/01/2023
Provided Update

Tonix Pharmaceuticals Holding Corp announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-15001, an Fc-modified humanized monoclonal antibody directed against CD40-ligand.

Olutasidenib (FT-2102)

Acute myeloid leukemia

New Drug Application (NDA)
02/15/2023
PDUFA Date

FDA has accepted New Drug Application (NDA) for olutasidenib and sets target action date of February 15, 2023

B-VEC

Dystrophic Epidermolysis Bullosa (DEB)

Biologics License Applications (BLA) Priority Review
02/17/2023
PDUFA Date

FDA has accepted for filing the Biologics License Application (BLA) for B-VEC for the treatment of patients with dystrophic epidermolysis bullosa (DEB) and granted Priority Review with target action date of February 17, 2023

Iomab-B

Active Relapsed or Refractory Acute Myeloid Leukemia

Phase 3
02/18/2023
Data Presentation

Actinium Pharmaceuticals, Inc. announced that data from its pivotal Phase 3 SIERRA trial of Iomab-B have been accepted as a late-breaker presentation at the Transplantation & Cellular Therapy (TCT) Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). TCT, the largest bone marrow transplant (BMT) focused medical conference globally, is being held February 15 – 19, 2023 at the World Center Marriott in Orlando, Florida.

FUROSCIX

Decompensated heart failure

Complete Response Letter (CRL)
02/20/2023
Provided Update

scPharmaceuticals Inc. announced that the company is targeting February 20, 2023 as the date for commercial availability of FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for outpatient treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

pegcetacoplan

paroxysmal nocturnal hemoglobinuria (PNH)

New Drug Application (NDA)
02/26/2023
PDUFA Date

The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023. The FDA also restated that they do not plan to hold an advisory committee meeting to discuss the application.

Omecamtiv Mecarbil (METEORIC-HF)

Heart Failure with reduced Ejection Fraction (HFrEF)

New Drug Application (NDA)
02/28/2023
PDUFA Date

After an initial review of the company's submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission

EYLEA (aflibercept) DR

Diabetic Retinopathy (DR)

supplemental Biologics License Applications (sBLA)
02/28/2023
PDUFA Date

EYLEA (aflibercept) Injection sBLA for Every 16-week Dosing Regimen in Patients with Diabetic Retinopathy Accepted for FDA Review, target action date is February 28, 2023

Omaveloxolone

Friedreich's ataxia

New Drug Application (NDA)
02/28/2023
PDUFA Date

FDA has extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich's ataxia by three months, new target action date is February 28, 2023

Efruxifermin (HARMONY)

Non-alcoholic steatohepatitis (NASH)

Meeting With FDA
03/01/2023
FDA Meeting

Akero Therapeutics, Inc announced that the Following designation of EFX as a Breakthrough Therapy, a meeting has been scheduled for March 2023 with FDA to review results of the Phase 2b HARMONY

IMC-1

Fibromyalgia

Phase 2
03/01/2023
FDA Meeting

Virios Therapeutics, Inc. announced that its end-of-Phase 2 meeting request with the U.S. Food and Drug Administration ("FDA") to discuss advancing IMC-1 into Phase 3 development as a treatment for FM has been scheduled for mid-March 2023.

Trofinetide

Rett Syndrome

New Drug Application (NDA)
03/12/2023
PDUFA Date

Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA, action date set for March 12, 2023

Rezafungin

Invasive Fungal Disease

New Drug Application (NDA) Priority Review
03/22/2023
PDUFA Date

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023 enabled by rezafungin's designation as a Qualified Infectious Disease Product (QIDP).

Rezafungin

Invasive Fungal Disease

Phase 3
03/22/2023
PDUFA Date

Cidara Therapeutics, Inc announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin's designation as a Qualified Infectious Disease Product (QIDP).

Rezafungin

Invasive Fungal Disease

Phase 3
03/22/2023
PDUFA Date

Cidara Therapeutics, Inc. and Melinta Therapeutics, LLC announced that FDA decision expected by PDUFA target action date of March 22, 2023

QD ruxolitinib (XR) LIMBER

Myelofibrosis polycythemia vera and GVHD

New Drug Application (NDA)
03/23/2023
PDUFA Date

FDA acceptance of the NDA for once-daily (QD) ruxolitinib, and the progression of multiple ongoing and planned combination trials with ruxolitinib, sets target action date of March 23, 2023.

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