MAX-001 / MAXONA Pharmaceuticals - LARVOL DELTA

MAXONA Pharmaceuticals has taken a key step toward advancing its flagship pain therapy, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for MAX-001, a novel oral treatment for acute pain. (MSN News) - "President and CEO Shawn Fatholahi credited the team’s efforts over the past six months, noting the company is ready to launch a Phase 2 trial pending FDA clearance."

IND • New P2 trial • Pain

MAXONA PHARMACEUTICALS SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR MAX-001 (PRNewswire) - "MAXONA Pharmaceuticals today announced that the company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for the company's lead compound, MAX-001, for the treatment of acute pain. MAX-001 is being developed as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain....'Our IND submission reflects our extensive formulation optimization work, comprehensive IND-enabling pre-clinical studies, and the results of the MAX-001 Phase 1 clinical program that was completed in Q1 2025 and will be published later this year.'"

IND • P1 data • Pain

Maxion Therapeutics Raises $72 million (£58 million) in an Oversubscribed Series A Financing to Advance its KnotBody Pipeline and Platform (GlobeNewswire) - "Proceeds will be used to transform Maxion into a clinical-stage biotech company, taking the lead KnotBody programme MAX001 to clinical proof-of-concept and advancing additional programmes towards the clinic...Maxion’s lead KnotBody programme, MAX001, is currently in preclinical development to target a broad spectrum of inflammatory diseases such as atopic dermatitis and inflammatory bowel disease. Other early-stage programmes include KnotBody molecules for the treatment of pain and cardiovascular disease."

Commercial • Atopic Dermatitis • Cardiovascular • Inflammatory Bowel Disease • Pain

MAXONA PHARMACEUTICALS ANNOUNCES MAX-001 PHASE 1 CLINICAL PROGRAM RESULTS (PRNewswire) - P=1| N=NA | "MAXONA Pharmaceuticals today announced the preliminary results of the Phase 1 clinical program for MAX-001, which is in development as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. The results show that MAX-001 was well tolerated with no serious adverse events or treatment related discontinuations."

P1 data • Pain

MAXONA PHARMACEUTICALS GRANTED FIFTH PATENT FOR FIRST TO MARKET PRODUCT MAX-001 (PRNewswire) - "MAXONA Pharmaceuticals...announced the United States Patents and Trademark Office (USPTO) has issued Patent No. 12,226,421 for MAX-001, the company's first to market product which is a non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. With the issuance of this patent, Maxona Pharmaceuticals now holds a total of five Method of Use and Composition of Matter patents that cover research and uses of nefopam, the active ingredient in MAX-001....The compound will enter Phase 2 clinical trials later this year."

New P2 trial • Patent • Pain

MAXONA PHARMACEUTICALS EMERGES FROM STEALTH AS IT ACHIEVES MILESTONE IN DEVELOPMENT OF FIRST-TO-MARKET CANDIDATE MAX-001 (PRNewswire) - "MAXONA Pharmaceuticals today announced that it has emerged from stealth with the completion of the U.S. Phase 1 clinical development program for the company's first to market product, MAX-001, as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain."

Trial completion • Pain