Novo Nordisk Seeks US and EU Approval for Sickle Cell Pill While Berenberg Stays on Hold
Published on 11/13/2026 at 17:21 | Editorial boerse-global.de
Novo Nordisk has filed for regulatory approval of Etavopivat in both the United States and the European Union, seeking a green light for sickle cell disease patients aged 12 and older. The submissions to the FDA and the EMA rest on the Phase 3 HIBISCUS trial, and decisions are anticipated in 2027. For investors, the candidate represents an additional shot at growth at a time when the company's core franchise is drawing cautious commentary from the analyst community.
The HIBISCUS data showed a 27% lower rate of vaso-occlusive crises compared with placebo, according to Novo Nordisk, with patients on the drug going roughly four months longer before their first such episode. Etavopivat is taken once daily as a tablet and could serve as a disease-modifying therapy if cleared. Full trial results are slated for presentation at a future medical conference.
Enrollment in HIBISCUS totaled about 440 participants. A follow-on study, HIBISCUS 2, is set to involve 510 patients, while the open-label extension trial FLORAL is gathering long-term safety data — a reminder that efficacy alone will not settle the regulatory question.
The compound carries Fast Track, Rare Pediatric Disease and Orphan Drug designations in the US, and Orphan Drug status in the EU. Approval, launch and reimbursement terms all remain outstanding. Novo Nordisk puts the sickle cell population at approximately 100,000 in the US and 110,000 in Europe, with around 8 million affected worldwide. That scale describes the medical need; the commercial prize will depend on the approved label and payer coverage. Etavopivat entered the portfolio through the 2022 acquisition of Forma.
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A pipeline story set against a muted growth debate
The filing lands as analysts take a measured view of Novo Nordisk's growth prospects, citing substantial long-term uncertainty on pricing and competition. Berenberg reiterated its "Hold" rating and a price target of 305 DKK. Analyst Kerry Holford called the third quarter of 2026 solid: Wegovy tablets surprised positively once again, while injectable products remained rather weak. In her assessment, Eli Lilly is capturing the largest share of market growth — making Etavopivat a route to an additional perspective outside that contest, provided the review succeeds and a commercial launch follows.
Berenberg's stance precedes the planned introduction of CagriSema, and it comes despite an improved operating picture. Novo Nordisk has now raised its annual guidance for the third time. BMO Capital Markets likewise pairs better expectations with a neutral rating, pointing to the strength of the Wegovy tablet, whose US sales ran 17% above consensus in the firm's view. At both houses, a more positive view of the equity would require further progress.
The tablet is doing the heavy lifting
In the third quarter of 2026, Novo Nordisk posted adjusted revenue of DKK 79.2 billion, beating analyst expectations. The Wegovy tablet generated quarterly sales of DKK 5.39 billion, up 53% from the prior quarter — concrete evidence of operating momentum as the company prepares to bring CagriSema to market.
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That performance underpins the upgraded outlook. For 2026, management now expects revenue and operating profit to land anywhere between a 2% decline and 2% growth. The tablet launched in the US in January, and Novo plans to offer it in more than 20 countries by mid-2027, subject to sufficient manufacturing capacity and the necessary approvals. International rollout could open additional sales opportunities if the regulatory and industrial prerequisites are met.
Further out, the growth story faces mounting pressure: core products will confront staggered patent expirations from 2031, with Lilly among the competitors. The central question for shareholders is whether Novo can extend the tablet's strong run beyond its current market. The raised guidance offers operating support; a broader growth base will only emerge if the planned launches deliver.
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