Lakewood-Amedex Biotherapeutics (LABT) has upcoming FDA regulatory milestones for Nu-3. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Lakewood-Amedex Biotherapeutics (LABT).
Over the past two years, Lakewood-Amedex Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bisphosphocin and Nu-3. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Bisphosphocin FDA Regulatory Events
Bisphosphocin is a drug developed by Lakewood-Amedex Biotherapeutics for the following indication: in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin® compounds.
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:
- Bisphosphocin
- Announced Date:
- October 7, 2026
- Indication:
- in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin® compounds.
Announcement
Lakewood-Amedex Biotherapeutics announced positive preclinical data in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin® compounds.
Read Announcement
Nu-3 FDA Regulatory Timeline and Events
Nu-3 is a drug developed by Lakewood-Amedex Biotherapeutics for the following indication: for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
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:
- Nu-3
- Announced Date:
- September 28, 2026
- Target Action Date:
- Q1 2027
- Estimated Target Date Range:
- January 1, 2027 - March 31, 2027
- Indication:
- for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
Announcement
Lakewood-Amedex Biotherapeutics Inc. announced that it is currently being investigated in a Phase 2a clinical trial as a topical treatment of mildly infected diabetic foot ulcers (iDFU) with topline data expected in the first quarter of 2027.
Read Announcement- Drug:
- Nu-3
- Announced Date:
- September 28, 2026
- Indication:
- for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
Announcement
Lakewood-Amedex Biotherapeutics Inc announced positive Minimum Inhibitory Concentration (MIC) data from recent clinical isolates for its lead clinical candidate, Nu-3.
Read Announcement- Drug:
- Nu-3
- Announced Date:
- September 24, 2026
- Indication:
- for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
Announcement
- Lakewood-Amedex Biotherapeutics Inc. announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
Read Announcement
