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Sonnet BioTherapeutics (SONN) FDA Events

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FDA Events for Sonnet BioTherapeutics (SONN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Sonnet BioTherapeutics (SONN). Over the past two years, Sonnet BioTherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SON-080, SON-1010, SON-1210, SON-1400, and SON-1411. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Sonnet BioTherapeutics' Drugs in FDA Review

SON-080 - FDA Regulatory Timeline and Events

SON-080 is a drug developed by Sonnet BioTherapeutics for the following indication: In Chemotherapy-Induced Peripheral Neuropathy (CIPN). 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.

SON-1010 - FDA Regulatory Timeline and Events

SON-1010 is a drug developed by Sonnet BioTherapeutics for the following indication: 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.

SON-1210 - FDA Regulatory Timeline and Events

SON-1210 is a drug developed by Sonnet BioTherapeutics for the following indication: For the Treatment of Pancreatic Cancer. 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.

SON-1400 - FDA Regulatory Timeline and Events

SON-1400 is a drug developed by Sonnet BioTherapeutics for the following indication: for the treatment of cancers. 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.

SON-1411 - FDA Regulatory Timeline and Events

SON-1411 is a drug developed by Sonnet BioTherapeutics for the following indication: for the treatment of cancers. 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.

Sonnet BioTherapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Sonnet BioTherapeutics (SONN) has reported FDA regulatory activity for the following drugs: SON-1010, SON-080, SON-1210, SON-1400 and SON-1411.

The most recent FDA-related event for Sonnet BioTherapeutics occurred on April 4, 2025, involving SON-1010. The update was categorized as "Results," with the company reporting: "Sonnet BioTherapeutics announced positive safety results of SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the SB221 study)."

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

  • Advanced Solid Tumors - SON-1010
  • In Chemotherapy-Induced Peripheral Neuropathy (CIPN) - SON-080
  • For the Treatment of Pancreatic Cancer - SON-1210
  • for the treatment of cancers. - SON-1400
  • for the treatment of cancers. - SON-1411

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