FDA Events for ESSA Pharma (EPIX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by ESSA Pharma (EPIX).
Over the past two years, ESSA Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EPI-7386. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EPI-7386 + Enzalutamide - FDA Regulatory Timeline and Events
EPI-7386 + Enzalutamide is a drug developed by ESSA Pharma for the following indication: Metastatic Castration-Resistant Prostate 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.
- Drug:
- EPI-7386 + Enzalutamide
- Announced Date:
- September 13, 2024
- Indication:
- Metastatic Castration-Resistant Prostate Cancer
Announcement
ESSA Pharma Inc announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain..
AI Summary
ESSA Pharma Inc recently shared updated dose escalation data at the 2024 European Society for Medical Oncology Congress in Barcelona, Spain. The presentation focused on its Phase 1/2 study evaluating the novel agent masofaniten (formerly EPI-7386) combined with enzalutamide for patients with metastatic castration-resistant prostate cancer. After 15.2 months of follow-up, the combination therapy showed a well-tolerated safety profile and impressive, durable reductions in prostate-specific antigen (PSA) levels. In the study, 88% of patients achieved a PSA reduction of at least 90%, with many reaching these milestones in fewer than 90 days, while 63% attained PSA levels below 0.2 ng/mL. The recommended Phase 2 doses were identified as 600 mg masofaniten twice daily with enzalutamide 160 mg once daily. ESSA Pharma’s results support further expansion of the study and represent a promising new approach in prostate cancer treatment.
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ESSA Pharma FDA Events - Frequently Asked Questions
As of now, ESSA Pharma (EPIX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ESSA Pharma (EPIX) has reported FDA regulatory activity for EPI-7386 + Enzalutamide.
The most recent FDA-related event for ESSA Pharma occurred on September 13, 2024, involving EPI-7386 + Enzalutamide. The update was categorized as "Presentation," with the company reporting: "ESSA Pharma Inc announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain.."
Currently, ESSA Pharma has one therapy (EPI-7386 + Enzalutamide) targeting the following condition: Metastatic Castration-Resistant Prostate Cancer.
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:EPIX) was last updated on 7/11/2025 by MarketBeat.com Staff
