Free Trial

Alkermes (ALKS) FDA Events

Alkermes logo
$29.98 +0.60 (+2.04%)
Closing price 04:00 PM Eastern
Extended Trading
$29.84 -0.15 (-0.48%)
As of 04:23 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Alkermes (ALKS)

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

Alkermes' Drugs in FDA Review

ALKS 2680 - FDA Regulatory Timeline and Events

ALKS 2680 is a drug developed by Alkermes for the following indication: For the treatment of narcolepsy. 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.

LYBALVI (olanzapine and samidorphan) - FDA Regulatory Timeline and Events

LYBALVI (olanzapine and samidorphan) is a drug developed by Alkermes for the following indication: Early in Illness. 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.

Alkermes FDA Events - Frequently Asked Questions

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

In the past two years, Alkermes (ALKS) has reported FDA regulatory activity for the following drugs: ALKS 2680 and LYBALVI (olanzapine and samidorphan).

The most recent FDA-related event for Alkermes occurred on April 1, 2025, involving ALKS 2680. The update was categorized as "Study Initiation," with the company reporting: "Alkermes plc announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH)."

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

  • For the treatment of narcolepsy - ALKS 2680
  • Early in Illness - LYBALVI (olanzapine and samidorphan)

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:ALKS) was last updated on 7/9/2025 by MarketBeat.com Staff
From Our Partners