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Investing.com — Novo Nordisk (CSE:NOVOb) shares jumped over 9% on Monday, regardless of the corporate’s disappointing outcomes for its experimental weight problems therapy, CagriSema.
This adopted the discharge of information from the REDEFINE-1 section 3 trial on Friday, which evaluated CagriSema—a mixture of cagrilintide, an amylin agonist, and semaglutide, a GLP-1 receptor agonist—for its efficacy in selling weight reduction.
As per analysts at Bernstein, the trial demonstrated a weight lack of 22.7% after 68 weeks of therapy, with a placebo-adjusted results of 20.3%.
Whereas this final result was a step up from the person elements alone, it fell in need of each expectations and the corporate’s personal projections.
Novo Nordisk (NYSE:NVO) had modeled a 25% weight reduction from the trial, making this consequence a substantial disappointment for buyers, particularly given the anticipation surrounding the drug as a possible contender for the title of the highest-efficacy weight problems therapy available on the market.
Regardless of CagriSema’s superior efficiency in comparison with the person elements—cagrilintide and semaglutide, which achieved weight reduction reductions of 11.8% and 16.1%, respectively—the 22.7% weight reduction seen within the trial was nonetheless underwhelming.
The trial additionally highlighted some sensible challenges, with many members remaining on decrease doses all through the research; solely 57% of sufferers had escalated to the high-dose model of the drug by the trial’s finish.
Moreover, Novo Nordisk indicated that the hostile occasions associated to CagriSema have been primarily gastrointestinal and have been delicate to reasonable in nature, which did little to dampen the general sense of letdown surrounding the trial’s outcomes.
Jefferies analysts weighed in, noting that CagriSema’s 20.4% weight reduction at 68 weeks intently mirrored the 20.9% seen in Lilly’s Tirzepatide (15mg) at 72 weeks within the SURMOUNT-1 trial.
Nevertheless, whereas CagriSema’s outcomes have been much like Tirzepatide, it fell in need of expectations, significantly given the flexibleness of dosing in REDEFINE-1, which may have probably allowed for less-than-optimal dosing.
Analysts speculated that one motive for the subpar efficiency was the comparatively low proportion of sufferers who reached the best dose of CagriSema (57.3%) in comparison with different therapies, akin to Tirzepatide (84.9% in SURMOUNT-1).
The versatile dosing design in REDEFINE-1 could have led to decrease efficacy, regardless of the research’s efforts to enhance gastrointestinal tolerability.
Jefferies additional indicated that whereas Novo Nordisk plans to run one other trial in 2025 with much less versatile dosing, the tolerability points surrounding CagriSema won’t enhance, elevating considerations about its future efficiency.
This casts a shadow over the prospects for CagriSema, significantly as the main focus within the weight problems house shifts to better-tolerated and simpler medication.
In mild of those outcomes, Jefferies analysts concluded that Lilly stays in a robust aggressive place. Lilly’s Tirzepatide continues to guide the weight problems market, and with its next-generation injectable therapies—akin to Orforglipron (oral) and Retatrutide (next-gen efficacy)—Lilly seems poised to take care of dominance.
The analysts see CagriSema’s outcomes as a constructive improvement for Lilly, noting that the corporate’s skill to mix totally different mechanisms (e.g., GLP-1, GIP, and amylin) positions it nicely to supply each greater and more healthy weight reduction outcomes.
Additionally they pointed to Lilly’s deal with improvements akin to a one-chamber auto-injector, which may additional distinguish it from rivals.
Jefferies additionally underscored the potential of Orforglipron, which may emerge as a first-in-class and best-in-class oral therapy.
With sturdy efficacy, good tolerability, and scalability, Orforglipron has the potential to rival injectable therapies like Wegovy, additional cementing Lilly’s management within the subject.
For Novo Nordisk, this trial final result represents a big setback, because it struggles to distinguish CagriSema from present therapies in a quickly advancing weight problems therapy market.
The corporate has indicated that it is going to be taking a second shot at optimizing weight reduction by way of a brand new section 3 trial, however as analysts at Bernstein and Jefferies agree, this will delay CagriSema’s anticipated 2026 submitting and launch, leaving the door vast open for Lilly to solidify its place as the worldwide chief in weight problems remedies.
The disappointing outcomes are additional compounded by Lilly’s increasing pipeline, with the following wave of oral and injectable therapies set to drive future progress.
