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Rhythm Pharmaceuticals (RYTM) FDA Events

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FDA Events for Rhythm Pharmaceuticals (RYTM)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Rhythm Pharmaceuticals (RYTM). Over the past two years, Rhythm Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as bivamelagon, IMCIVREE, LB54640, and Setmelanotide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Rhythm Pharmaceuticals' Drugs in FDA Review

bivamelagon - FDA Regulatory Timeline and Events

bivamelagon is a drug developed by Rhythm Pharmaceuticals for the following indication: In patients with acquired hypothalamic obesity. 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.

IMCIVREE (setmelanotide) - FDA Regulatory Timeline and Events

IMCIVREE (setmelanotide) is a drug developed by Rhythm Pharmaceuticals for the following indication: Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LB54640 - FDA Regulatory Timeline and Events

LB54640 is a drug developed by Rhythm Pharmaceuticals for the following indication: In hypothalamic obesity. 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.

Setmelanotide (HO) - FDA Regulatory Timeline and Events

Setmelanotide (HO) is a drug developed by Rhythm Pharmaceuticals for the following indication: Hypothalamic Obesity. 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.

Rhythm Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Rhythm Pharmaceuticals (RYTM) has received FDA approval for IMCIVREE (setmelanotide). This page tracks recent and historical FDA regulatory events related to Rhythm Pharmaceuticals' drug portfolio.

In the past two years, Rhythm Pharmaceuticals (RYTM) has reported FDA regulatory activity for the following drugs: Setmelanotide (HO), IMCIVREE (setmelanotide), bivamelagon and LB54640.

The most recent FDA-related event for Rhythm Pharmaceuticals occurred on July 9, 2025, involving bivamelagon. The update was categorized as "Top-line results," with the company reporting: "Rhythm Pharmaceuticals, Inc. announced positive topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity."

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

  • Hypothalamic Obesity - Setmelanotide (HO)
  • Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency - IMCIVREE (setmelanotide)
  • In patients with acquired hypothalamic obesity. - bivamelagon
  • In hypothalamic obesity. - LB54640

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:RYTM) was last updated on 7/10/2025 by MarketBeat.com Staff
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