VIKING THERAPEUT.DL -,005 WKN: A12GD6 ISIN: US92686J1060 Kürzel: VKTX Forum: Aktien Thema: Hauptdiskussion
We had the opportunity to host an investor event with VKTX management and a KOL investor event at ObesityWeek. VKTX mgmt is weighing a potentially streamlined Phase 3 path for oral VK2735, possibly discussing with FDA a smaller (~500-patient) Ph3 study that leverages data from the sc program to satisfy FDA, and could be a nice upside surprise. Feedback from the planned EOP2 meeting in 4025 will provide next steps. Mgmt also discussed key takes from the LLY amylin agonist and potential differences to their program which will move into Phase 1 clinical trials in 2026. We also discussed strategy given LLY/NVO GLP1 MFN pricing and believe sc margins are intact. Is There A Possibility for ~500-Patient Study to Satisfy Phase 3 Requirement for Oral VK2735? We hosted VKTX for a cocktail reception on Thursday evening following ObesityWeek and came away with several interesting takea-ways. Notably, mgmt highlighted the potential for a smaller (~500 patient) Phase 3 study for oral VK2735, contingent on FDA agreement to leverage data from the subcutaneous program, which shares the same active molecule. For context, the FDA guidance for weight loss therapies typically calls for ≥3000 patients on active drug and ≥1500 on placebo with at least 1 year of exposure at the target dose - an undertaking that costs an estimated ~$300M. While there is precedent for the FDA accepting partial data crossover (e.g., oral sema), we'll need to wait for the update to understand the agency's thinking in this case. Any endorsement of a smaller Phase 3 program would offer meaningful upside to current investor expectations, both in terms of timelines and overall trial costs. Based on the rapid enrollment pace of VANQUISH-1 (began enrolling on 6/25/25; n=4500 expected fully enrolled by YE25), a 500-patient trial could theoretically complete enrollment in ~3 months. Feedback from the planned EOP2 meeting in 4025 will be key to • VKTX Comments on Evolving Pricing and Strategic Dynamic As It Moves to Completing SC VK2735 Phase 3 Enrollment in 4Q'25/1Q'26. VKTX mgmt believes sc VK2735 margins are attractive given the current evolving pricing with current GLP1s. Expects good margins with oral VK2735 at lower doses but believes API prices for peptides should come down over next few years. Per mgmt, best position for oral VK2735 is in maintenance setting; which they are evaluating in Phase 2 with data in 3Q'26. The autoinjector will be introduced into the current sc VK2735 Phase 3 trials in 1Q'26. On amylin IND in 1Q'26, states could either be sc or oral that's evaluated in SAD/Phase 1 patient study in 2026. On strategic interest (given all the Metsera news), mgmt believes there's broad interest, including from companies that are not household names and from pharma that publicly express no interest in obesity. Hier mal etwas, damit nicht jeder von euch du99 bleibt
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