Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program
Apimeds Pharmaceuticals US, Inc. (APUS)
Company Research
Source: Business Wire
MATAWAN, N.J.--(BUSINESS WIRE)--Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company’s lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry”, can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:“The FDA’s draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency’s call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulato
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APUS
Sec Filings
- 12/2/25 - Form 425
- 12/2/25 - Form 8-K
- 11/21/25 - Form 4/A
- APUS's page on the SEC website