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Rocket Pharmaceuticals (RCKT) FDA Events

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FDA Events for Rocket Pharmaceuticals (RCKT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Rocket Pharmaceuticals (RCKT). Over the past two years, Rocket Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KRESLADI, RP-A501, RP-A601, RP-A701, and RP-L102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Rocket Pharmaceuticals' Drugs in FDA Review

KRESLADI - FDA Regulatory Timeline and Events

KRESLADI is a drug developed by Rocket Pharmaceuticals for the following indication: For severe Leukocyte Adhesion Deficiency-I. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RP-A501 - FDA Regulatory Timeline and Events

RP-A501 is a drug developed by Rocket Pharmaceuticals for the following indication: Danon Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RP-A601 - FDA Regulatory Timeline and Events

RP-A601 is a drug developed by Rocket Pharmaceuticals for the following indication: RP-A601 decreased arrhythmias and increased survival in the PKP2 knockout mouse model. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RP-A701 - FDA Regulatory Timeline and Events

RP-A701 is a drug developed by Rocket Pharmaceuticals for the following indication: For the Treatment of BAG3-associated Dilated Cardiomyopathy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RP-L102 - FDA Regulatory Timeline and Events

RP-L102 is a drug developed by Rocket Pharmaceuticals for the following indication: Fanconi Anemia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Rocket Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Rocket Pharmaceuticals (RCKT) has reported FDA regulatory activity for the following drugs: RP-A501, RP-A601, RP-A701, KRESLADI and RP-L102.

The most recent FDA-related event for Rocket Pharmaceuticals occurred on June 30, 2025, involving RP-A701. The update was categorized as "FDA Clearance," with the company reporting: "Rocket Pharmaceuticals, Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Company's Investigational New Drug (IND) application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated Dilated Cardiomyopathy (BAG3-DCM), a severe form of heart failure characterized by progressive ventricular enlargement and impaired systolic function. "The FDA clearance of RP-A701, our third clinical-stage gen"

Current therapies from Rocket Pharmaceuticals in review with the FDA target conditions such as:

  • Danon Disease - RP-A501
  • RP-A601 decreased arrhythmias and increased survival in the PKP2 knockout mouse model - RP-A601
  • For the Treatment of BAG3-associated Dilated Cardiomyopathy - RP-A701
  • For severe Leukocyte Adhesion Deficiency-I - KRESLADI
  • Fanconi Anemia - RP-L102

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:RCKT) was last updated on 7/10/2025 by MarketBeat.com Staff
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