Core Viewpoint - Adial Pharmaceuticals has executed agreements with Cambrex and Thermo Fisher to support the production of its lead investigational drug AD04, aimed at treating Alcohol Use Disorder (AUD) in the U.S. [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a genetically targeted serotonin-3 receptor antagonist [4]. - The company recently conducted the ONWARD™ pivotal Phase 3 clinical trial for AD04, which showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [4]. Agreements and Collaborations - The collaboration with Thermo Fisher as the Contract Development and Manufacturing Organization (CDMO) and Cambrex as the drug substance supplier has commenced, focusing on the completion of demonstration batches necessary for clinical trials [2][3]. - The agreements encompass all manufacturing phases for clinical supplies and the Chemistry, Manufacturing, and Controls (CMC) documentation required for the NDA submission to the FDA [2]. Strategic Importance - The selection of CDMOs with proven track records in both drug substance development and manufacturing was crucial for the agreements [2]. - The partnerships are expected to be vital for meeting timelines for the upcoming Phase 3 clinical trials and addressing commercial demands for AD04, especially considering recent tariff implications [3]. Future Potential - AD04 is not only targeted for AUD but is also believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4].

Alto Neuroscience (ANRO) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Okay, we're gonna get started with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies and it's my pleasure to have Amit Ekken by my side. Welcome. Speaker1 Thank you. Speaker0 I forgot to mention from Alto Neuroscience. So maybe give us spend two minutes, three minutes talking about the Alto story, what you're trying to achieve and what milestones we can expect over the next six to twelve months. You've got a lot ...

Alto Neuroscience (ANRO) Update / Briefing June 03, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Alto Neuroscience Investor Conference Call to discuss the company's acquisition of a novel dopamine agonist combination product candidate. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Amit Edkin, Founder ...