Novo Nordisk (NVO) Meets Semaglutide Higher Dosage Study Goal
Novo Nordisk A/S NVO announced positive top-line results from its phase IIIb PIONEER PLUS study. The study evaluates the safety and efficacy of its once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as an add-on to a stable dose of 1–3 oral antidiabetic medicines in people with type II diabetes in need of treatment intensification.
The primary endpoint of the study, showing a superior reduction in HbA1c at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide, was met with statistical significance. Currently, oral semaglutide 3 mg, 7 mg and 14 mg are approved under the brand name, Rybelsus, for the treatment of type II diabetes.
In the past year, the shares of Novo Nordisk have shot up 41.6% compared with the industry’s 2.5% increase.
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In the study,when evaluating the effects of treatment as intended and taking a mean baseline HbA1c of 9.0%, it was observed that the people treated with 25 mg and 50 mg oral semaglutide achieved a statistically significant higher HbA1c reduction of 1.9 percentage points and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
The mean baseline body weight of patients in the study was 96.4 kg. A statistically significant higher weight loss of 7.0 kg and 9.2 kg was witnessed in people treated with oral semaglutide 25 mg and 50 mg, while oral semaglutide 14 mg only resulted in a 4.5 kg reduction.
In the context of the treatment policy estimand, people treated with 25 mg and 50 mg oral semaglutide achieved a superior HbA1c reduction of 1.8 percentage points and 2.0 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg. Treatment policy estimand here represents the purpose of the study. People treated with oral semaglutide 25 mg and 50 mg experienced a superior weight loss of 6.7 kg and 8.0 kg, respectively, compared with a 4.4 kg reduction with oral semaglutide 14 mg.
All doses of oral semaglutide were reported to be safe and well-tolerated by the patients. Mild to moderate common adverse gastrointestinal events were observed which diminished over time and were consistent with the GLP-1 receptor agonist class.
Per management, the favorable efficacy reports upon treatment with 25 mg and 50 mg doses of semaglutide offer the option to progress to higher doses if additional glycemic control or weight loss is needed. Novo Nordisk anticipates completing regulatory filings for approval in the United States and European Union in 2023. However, the launch of the 25 mg and 50 mg doses will depend on the portfolio prioritizations and manufacturing capacity of the company.
Novo Nordisk A/S Price and Consensus
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Zacks Rank and Other Stocks to Consider
Novo Nordisk currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A few other stocks from the overall healthcare sector worth mentioning are Avalo Therapeutics AVTX, Avita Medical RCEL and EQRx EQRX, each carrying a Zacks Rank #2 (Buy) at present.
In the last 90 days, Avalo’s loss estimates for the year 2023 have narrowed from $3.62 to $1.56 per share. In the past year, shares of Avalo have plunged 76.2%.
AVTX beat estimates in two of the last three reported quarters, missing the mark on one occasion, delivering an average earnings surprise of 37.83%.
In the last 90 days, Avita’s loss estimates for the year 2023 have narrowed from $1.26 to 99 cents per share. In the past year, shares of Avita have shot up 63.3%.
RCEL beat estimates in three of the last four reported quarters, missing the mark on one occasion, delivering an average earnings surprise of 22.16%.
In the last 90 days, EQRx’s loss estimates for the year 2023 have narrowed from 71 cents to 58 cents per share. In the past year, shares of EQRx have fallen 55%.
EQRX beat earnings estimates in all the last four reported quarters clocking an average earnings surprise of 34.99%.
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