- Trial Phase
- Phase 3
- Time to Market
- Phase 3 topline data expected early 2027 (primary completion January 21, 2027). If successful, NDA submission would follow in 2027-2028, with potential FDA approval in 2028-2030 based on analyst estimates.
- Why 7/10
- The next hard catalyst is the Phase 3 MARITIME-1/2 topline readout, expected shortly after the estimated primary completion date of January 21, 2027 (about 2.5 months from today). MariTide is Amgen's lead pipeline growth asset and its only remaining obesity program after discontinuing AMG 513, but Amgen is a large diversified biotech with $10.4B in quarterly revenue and many approved drugs, so the impact is capped at 7.
The next hard catalyst is the Phase 3 MARITIME-1/2 topline readout, expected shortly after the estimated primary completion date of January 21, 2027. Positive data (confirming ~20% weight loss with monthly dosing and good tolerability) could drive significant upside as it validates Amgen's differentiated GIP-antagonist approach and monthly dosing advantage. Negative data (efficacy below competitors or tolerability issues) would be a major setback since Amgen has narrowed its obesity pipeline to MariTide alone. The stock already trades near 52-week highs with elevated options implied volatility (IV rank 76), suggesting the market is pricing in this binary event.
Price Chart
Executive Summary
MariTide (maridebart cafraglutide, formerly AMG 133) is Amgen's investigational once-monthly injectable obesity drug that combines GLP-1 receptor activation with GIP receptor blockade, a novel mechanism distinct from approved weekly GLP-1 drugs. Phase 2 data published in the New England Journal of Medicine showed up to ~20% average weight loss at 52 weeks with monthly dosing and no plateau. The drug is now in Phase 3 (MARITIME program) with two pivotal trials (MARITIME-1 in obesity, MARITIME-2 in obesity with type 2 diabetes) fully enrolled and estimated primary completion on January 21, 2027. Amgen has narrowed its obesity pipeline to MariTide alone after discontinuing AMG 513. The stock trades near 52-week highs ($478.48) with a consensus Hold rating and mean analyst target of $404 (implying -15.5% downside), suggesting much of the MariTide optimism may already be priced in for this diversified biotech giant.
How It Works
MariTide is a once-monthly injectable drug that works through two mechanisms to promote weight loss. It activates the GLP-1 receptor (the same target as Ozempic/Wegovy, which slows digestion and signals fullness) while blocking the GIP receptor (a related metabolic target that most other obesity drugs activate rather than block). This unique combination of stimulating one pathway and blocking another is delivered as a single antibody-peptide conjugate molecule designed to last in the body for weeks, enabling monthly dosing.
Trial Status
The Phase 3 MARITIME program includes two pivotal 72-week placebo-controlled trials: MARITIME-1 (obesity without type 2 diabetes, 3,853 participants) and MARITIME-2 (obesity with type 2 diabetes, 1,105 participants). Both are fully enrolled, active but not recruiting as of September 2026, with estimated primary completion on January 21, 2027. Additional studies include MARITIME-CV (cardiovascular outcomes), MARITIME-HF (heart failure), sleep apnea, and switch studies. Phase 2 results were published in NEJM in June 2025 showing up to ~20% weight loss at 52 weeks.
The Two-Sided Case
Upcoming Catalysts
- Phase 3 MARITIME-1/2 topline data readout expected early 2027 (primary completion estimated January 21, 2027)
- Autoinjector formulation study (primary completion June 2027)
- Potential NDA submission in 2027-2028 if Phase 3 successful
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report