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Novo Nordisk's (NVO) Haemophilia A Study Meets Safety Endpoint

Novo Nordisk A/S NVO announced positive data from the phase I & II FRONTIER1 dose-escalation study, which evaluated its next-generation Factor VIIIa (FVIIIa) mimetic, Mim8, for the treatment of patients with haemophilia A. The study met its primary safety endpoint.

Data from the study showed that treatment with once-weekly and once-monthly under-the-skin administration of Mim8 was tolerated at all doses, regardless of inhibitor status in people with haemophilia A.

No serious adverse side effects or thromboembolic events (blood clots in the veins) were reported in the FRONTIER1 study.

Per the company, the above result is likely to support the development of Mim8 in phase III studies for treating people living with haemophilia A.

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The company plans to begin dosing in the phase III study in the fourth quarter of 2022.

Shares of Novo Nordisk have lost 2.2% so far this year against the industry’s increase of 5.2%.

Zacks Investment Research
Zacks Investment Research


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The above-mentioned phase I & II FRONTIER1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of Mim8 in 48 healthy participants (phase I) and 42 participants with severe haemophilia A, independent of FVIII inhibitor status(phase II).

Novo Nordisk is also evaluating concizumab in phase III study for treating people with haemophilia A or B with inhibitors.

Hemophilia A is a genetic disorder caused by missing or defective factor VIII. Despite being prescribed the current standard-of-care medicines, severe hemophilia A patients persistently experience painful bleeds, which creates significant need for medicines that can improve patients' quality of life. Several companies are developing their respective pipeline candidates to treat severe hemophilia A.

BioMarin Pharmaceutical BMRN is developing its gene therapy candidate, valoctocogene roxaparvovec, to treat adults with severe hemophilia A.

In June 2022, the Committee for Medicinal Products for Human Use (“CHMP”), rendered a positive opinion, recommending a conditional marketing authorization (CMA) for valoctocogene roxaparvovec, to treat adults with severe hemophilia A.

BMRN will market valoctocogene roxaparvovec under the trade name Roctavian. BioMarin plans to re-file the BLA for Roctavian with the FDA by September end.

Big pharma companies like Pfizer and Roche are also developing their respective gene therapy candidates to treat hemophilia A.

Zacks Rank & Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. LPTX and Precision BioSciences, Inc. DTIL, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.

Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.

Precision BioSciences’ loss per share estimates narrowed 18.1% for 2022 and 29.5% for 2023 in the past 60 days.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.


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