MIMEDX Group Inc. MDXG
MIMEDX Group Inc. (Nasdaq: MDXG) is a drug developer. Its lead program is marketed.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Recent results and decisions
- Oct 28, 2026positive EPIEFFECT interim RCT results demonstrate clinical benefit compared to standard of care in diabetic foot ulcers.
Interim RCT Results Demonstrate Clinical Benefit Associated with Use of EPIEFFECT Compared to Standard of Care
Filing - Oct 28, 2026positive Federal court vacated FDA's regulatory classification of AXIOFILL and remanded to FDA for reconsideration.
The Court vacated FDA's determination that AXIOFILL is not a Section 361 HCT/P because it is more than minimally manipulated and FDA's determination that AXIOFILL should be classified as a biological product rather than a medical device.
Filing - Oct 28, 2026submitted Company's first two 510(k) submissions for antimicrobial xenograft and ECM particulate are in FDA review.
The 510(k) designation is an important step to unlock new markets, applications, coverage and claims that we expect will grow our presence in the operating room.
Filing
17 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.