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Schrodinger (SDGR) FDA Events

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FDA Events for Schrodinger (SDGR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Schrodinger (SDGR). Over the past two years, Schrodinger has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SGR-1505, SGR-3515, and SGR-4174. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Schrodinger's Drugs in FDA Review

SGR-1505 - FDA Regulatory Timeline and Events

SGR-1505 is a drug developed by Schrodinger for the following indication: Relapsed or refractory B-cell lymphoma. 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.

SGR-3515 - FDA Regulatory Timeline and Events

SGR-3515 is a drug developed by Schrodinger for the following indication: For patients with advanced solid tumors. 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.

SGR-4174 - FDA Regulatory Timeline and Events

SGR-4174 is a drug developed by Schrodinger for the following indication: SOS1 inhibitor. 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.

Schrodinger FDA Events - Frequently Asked Questions

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

In the past two years, Schrodinger (SDGR) has reported FDA regulatory activity for the following drugs: SGR-1505, SGR-3515 and SGR-4174.

The most recent FDA-related event for Schrodinger occurred on June 27, 2025, involving SGR-1505. The update was categorized as "Provided Update," with the company reporting: "Schrödinger, Inc. announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor."

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

  • Relapsed or refractory B-cell lymphoma - SGR-1505
  • For patients with advanced solid tumors - SGR-3515
  • SOS1 inhibitor - SGR-4174

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