FDA Events for Siga Technologies (SIGA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Siga Technologies (SIGA).
Over the past two years, Siga Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PALM. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PALM 007 - FDA Regulatory Timeline and Events
PALM 007 is a drug developed by Siga Technologies for the following indication: In Treatment of Mpox Released.
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:
- PALM 007
- Announced Date:
- August 15, 2024
- Indication:
- In Treatment of Mpox Released
Announcement
The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial (NCT05559099).
AI Summary
The National Institute of Allergy and Infectious Diseases (NIAID) shared topline results from the preliminary analysis of the PALM 007 clinical trial, which evaluated tecovirimat for treating monkeypox virus infection. Although the trial did not show a statistically significant benefit of tecovirimat over placebo for overall lesion resolution within 28 days, the data revealed potential clinical benefits in specific groups. Patients who began treatment within seven days of symptom onset and those with severe disease, defined by having 100 or more lesions, experienced meaningful improvement. Additionally, tecovirimat maintained a safety profile similar to placebo, supporting past studies that have confirmed its safety over the years. Researchers believe these results justify further clinical trials to better understand the benefits of early treatment and its use in patients with more severe manifestations of monkeypox.
Read Announcement
Siga Technologies FDA Events - Frequently Asked Questions
As of now, Siga Technologies (SIGA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Siga Technologies (SIGA) has reported FDA regulatory activity for PALM 007.
The most recent FDA-related event for Siga Technologies occurred on August 15, 2024, involving PALM 007. The update was categorized as "Top-line results," with the company reporting: "The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial (NCT05559099)."
Currently, Siga Technologies has one therapy (PALM 007) targeting the following condition: In Treatment of Mpox Released.
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:SIGA) was last updated on 7/12/2025 by MarketBeat.com Staff
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