NewAmsterdam Pharma (NASDAQ:NAMS) Chief Financial Officer Ian Somaiya said the company remains encouraged by early observations from its PREVAIL cardiovascular outcomes trial and reiterated plans to provide a mid-year update on study timelines during remarks at Guggenheim’s 2026 Emerging Outlook Biotech Summit.
PREVAIL timelines and event-rate observations
Somaiya pointed back to comments the company made in January, saying that on a blinded basis the event rate in PREVAIL at 12 months was tracking in line with BROADWAY, a separate study the company designed as a “mini outcome study.” He said this comparison is meaningful because PREVAIL and BROADWAY are “nearly identical in design,” conducted at the same time and at the same sites, which he characterized as an ideal setup for a like-for-like comparison.
When asked about powering assumptions, Somaiya said the company has not commented on PREVAIL’s powering and indicated the firm intends to provide those details when it publishes a design paper. He said the company would “ideally” share the design paper sometime this year.
Compliance focus and patient retention
Somaiya emphasized that compliance and retention are priorities given the long duration typical of outcomes trials. He said that after the company completed most of its LDL-focused studies in 2024, it increased focus on PREVAIL with more site visits by both its CRO and NewAmsterdam, and by sharing results from completed LDL studies with sites and patients to encourage continued participation.
He described “clinical trial fatigue” as a challenge in lengthy studies and said the company believes having data from BROADWAY, BROOKLYN, and TANDEM helps support retention conversations, particularly when patients consider leaving due to adverse events. Somaiya said results from completed LDL studies showed adverse events occurred at a lower rate on drug versus placebo, adding that while the company does not claim the drug is safer than placebo, it uses those findings to communicate that a concerning adverse event is “highly unlikely” to be drug-related and encourage patients to remain in the study while issues are evaluated.
What the company says differentiates obicetrapib
Somaiya said NewAmsterdam has conducted market research among cardiologists and primary care physicians and believes multiple aspects of obicetrapib’s profile are resonating. He highlighted the company’s data suggesting that, either as monotherapy or in a fixed-dose combination with ezetimibe, obicetrapib can get 70%–80% of patients to their risk-based LDL goals. He also emphasized convenience (a 10-mg oral, once-daily pill) and the importance of tolerability in an asymptomatic disease state.
Beyond LDL-C lowering, Somaiya listed several additional effects the company has discussed publicly, including Lp(a) reduction and effects on small LDL particles. He said the company has shown reductions in Lp(a) “by upwards of 50%” in a target patient population and described obicetrapib as the first drug to be able to “virtually eliminate small particles.” He also said the company has shown a reduction in the rate of incidence of diabetes, and referenced more recent data the company has shared regarding a potential role for obicetrapib in prevention or treatment of Alzheimer’s disease.
Somaiya framed the commercial opportunity as broad, citing that at least 30 million patients in the U.S. are not at their risk-based lipid goals despite diagnosis and treatment.
BROADWAY MACE benefit, revascularization, and mechanistic questions
In discussing BROADWAY, Somaiya reiterated that the company observed a 21% MACE benefit and addressed questions about why the effect appeared larger than what might be predicted by LDL-C lowering alone. He said the company previously shared an analysis suggesting there was likely roughly equal contribution from Lp(a) and LDL particle effects, around 5%–6% each, while noting that validation will require ongoing studies and that there is no historical regression framework for LDL particle reductions comparable to what exists for LDL-C.
Somaiya also addressed questions about the composition of events in BROADWAY, where he said nearly half of events in the one-year trial were revascularizations. He said the company reviewed reasons for revascularization and concluded that without the procedure, patients likely would have had another event such as myocardial infarction or stroke. He pointed to results from Amgen’s VESALIUS-CV as supportive context, describing early separation driven by revascularization and later separation on a three-point MACE definition that excludes revascularization. Somaiya added that BROADWAY also showed fewer deaths and fewer myocardial infarctions on treatment, in addition to fewer revascularizations.
Regulatory strategy and launch planning
Somaiya said NewAmsterdam expects approval in Europe this year and that the company will provide U.S. regulatory timelines in the middle of this year. He contrasted U.S. and European strategy, explaining that the company’s U.S. filing is predicated on having outcomes data “in the public domain” at the time of launch and confirming that LDL-C reduction via CETP inhibition translates to outcomes benefit. In Europe, he said, the earlier filing reflects pricing dynamics that include an additional roughly 12-month clock.
He also discussed the evolving competitive landscape, including oral PCSK9 data, saying he views it as confirmation of PCSK9 efficacy in lowering LDL rather than “confusion,” and argued the market is large enough for multiple therapies. Somaiya said he expected Merck to launch first in the U.S. and characterized Merck’s non-branded efforts as helpful in keeping hyperlipidemia screening and treatment front of mind, particularly around the message that oral options can be preferable for patients. He said NewAmsterdam expects to differentiate by communicating benefits beyond LDL-C.
On launch capability, Somaiya said the company has commercial leadership in place with relevant experience, citing Biohaven’s Nurtec launch as an example of competing successfully in a large, competitive market. He said the company is confident it can launch obicetrapib and is “excited” to do so.
In closing, Somaiya said the upcoming HORIZON Lp(a) outcomes readout is now less critical for NewAmsterdam as a directional “read-through” because the company has already reported an observed MACE benefit in BROADWAY, but he said HORIZON could still inform attribution—specifically, the contribution of Lp(a) lowering to BROADWAY’s observed benefit and what that could imply for PREVAIL.
About NewAmsterdam Pharma (NASDAQ:NAMS)
NewAmsterdam Pharma, Inc is a clinical?stage biopharmaceutical company focused on discovering and developing novel small?molecule therapies for cardiometabolic diseases. The company’s research efforts are aimed at addressing key unmet needs in metabolic syndrome, obesity and type 2 diabetes by modulating pathways involved in glucose regulation, energy homeostasis and lipid metabolism.
The company’s development pipeline features multiple small?molecule candidates at various stages of preclinical and clinical evaluation.
