FDA Events for MyMD Pharmaceuticals (MYMD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MyMD Pharmaceuticals (MYMD).
Over the past two years, MyMD Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MYMD-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MYMD-1 - FDA Regulatory Timeline and Events
MYMD-1 is a drug developed by MyMD Pharmaceuticals for the following indication: Aging and post- COVID-19 complications.
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:
- MYMD-1
- Announced Date:
- December 9, 2024
- Indication:
- Aging and post- COVID-19 complications
Announcement
TNF Pharmaceuticals, Inc announced that significant positive topline results from a Phase 2a study of its lead drug candidate MYMD-1® (isomyosamine) was presented at a prestigious international congress of global experts in sarcopenia and related disorders held December 6–8, 2024 in Washington, D.C.
AI Summary
TNF Pharmaceuticals, Inc. recently shared significant topline results from its Phase 2a study of MYMD-1® (isomyosamine) during a prestigious international congress held in Washington, D.C. from December 6–8, 2024. The study involved elderly patients with sarcopenia and related disorders, where once-daily oral doses of MYMD-1® showed notable decreases in key inflammation biomarkers such as TNF-α, IL-6, and sTNFR1 over a 28-day treatment period. These promising results support the potential of MYMD-1® as an effective treatment for sarcopenia, especially given the lack of FDA-approved options that target the disease itself. Building on the success of this Phase 2a study, TNF Pharmaceuticals is preparing to launch a Phase 2b trial in early 2025, aiming to further evaluate the benefits of MYMD-1® in a broader patient population.
Read Announcement
MyMD Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, MyMD Pharmaceuticals (MYMD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MyMD Pharmaceuticals (MYMD) has reported FDA regulatory activity for MYMD-1.
The most recent FDA-related event for MyMD Pharmaceuticals occurred on December 9, 2024, involving MYMD-1. The update was categorized as "Top-line results," with the company reporting: "TNF Pharmaceuticals, Inc announced that significant positive topline results from a Phase 2a study of its lead drug candidate MYMD-1® (isomyosamine) was presented at a prestigious international congress of global experts in sarcopenia and related disorders held December 6–8, 2024 in Washington, D.C."
Currently, MyMD Pharmaceuticals has one therapy (MYMD-1) targeting the following condition: Aging and post- COVID-19 complications.
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:MYMD) was last updated on 7/12/2025 by MarketBeat.com Staff
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