FDA Events for SOPHiA GENETICS (SOPH)
This section highlights FDA-related milestones and regulatory updates for drugs developed by SOPHiA GENETICS (SOPH).
Over the past two years, SOPHiA GENETICS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BBI-355. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BBI-355 - FDA Regulatory Timeline and Events
BBI-355 is a drug developed by SOPHiA GENETICS for the following indication: FOR ecDNA amplified 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.
- Drug:
- BBI-355
- Announced Date:
- September 5, 2024
- Indication:
- FOR ecDNA amplified tumors
Announcement
SOPHiA GENETICS announced an update from the Company's work with biopharma company Boundless Bio.
AI Summary
SOPHiA GENETICS announced an update about its collaboration with biopharma company Boundless Bio. Together, they have successfully developed an innovative test called the ecDNA Solution (ECS) algorithm. This assay detects extrachromosomal DNA (ecDNA) from routine next-generation sequencing data, which is important because ecDNA plays a key role in oncogene amplification in certain cancers. The ECS algorithm is designed according to FDA guidelines as an Investigational Use Only Clinical Trial Assay.
This new test is being used in Boundless Bio’s POTENTIATE Phase 1/2 clinical trial, which targets patients with ecDNA amplified tumors for their investigational cancer therapy, BBI-355. SOPHiA GENETICS supports the program using its cloud-based DDM™ Platform, while Precision for Medicine has helped validate the diagnostic workflow, ensuring accurate patient selection. This partnership aims to speed up clinical trial enrollment and bring promising therapies to patients more efficiently.
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SOPHiA GENETICS FDA Events - Frequently Asked Questions
As of now, SOPHiA GENETICS (SOPH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, SOPHiA GENETICS (SOPH) has reported FDA regulatory activity for BBI-355.
The most recent FDA-related event for SOPHiA GENETICS occurred on September 5, 2024, involving BBI-355. The update was categorized as "Provided Update," with the company reporting: "SOPHiA GENETICS announced an update from the Company's work with biopharma company Boundless Bio."
Currently, SOPHiA GENETICS has one therapy (BBI-355) targeting the following condition: FOR ecDNA amplified tumors.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:SOPH) was last updated on 7/13/2025 by MarketBeat.com Staff
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