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Ultragenyx (RARE), Mereo Ink Deal for Bone Disease Candidate

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Ultragenyx Pharmaceutical Inc.(RARE - Free Report) and Mereo BioPharma Group plc (MREO - Free Report) recently announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). OIis a group of genetic disorders that mainly affect the bones, resulting in bones that break easily. 

Shares of the company have soared 285.3% year to date compared with the industry’s growth of 10.9%.

Per the terms of the collaboration, Ultragenyx will lead the future global development of setrusumab in both pediatric and adult patients. Ultragenyx has been granted an exclusive license to develop and commercialize setrusumab in the United States and rest of the world, excluding Europe, where Mereo retains commercial rights.

Ultragenyx will make an upfront payment of $50 million to Mereo and fund the global development of the program until it is approved. When the clinical, regulatory, and commercial milestones are met, Ultragenyx will also pay a total of up to $254 million. Ultragenyx will pay tiered double-digit percentage royalties to Mereo on net sales outside of Europe, while Mereo will pay a fixed double-digit percentage royalty to Ultragenyx on net sales in Europe.  Mereo will also pay a percentage of proceeds to Novartis (NVS - Free Report) , subject to certain deductions, with the former receiving a substantial majority of the payments from Ultragenyx.

Mereo has completed the phase IIb ASTEROID study of setrusumab across three dose groups monthly for 12 months in 90 adults with OI types I, III, and IV. Results from the study demonstrated a dose-dependent increase in bone formation, density, and strength in adults with OI.

Setrusumab has received orphan drug designation from FDA and European Medicines Agency (EMA), rare pediatric disease designation from the FDA, and was accepted into the EMA’s Priority Medicines program (PRIME).

Setrusumab complements Ultragenyx’s product portfolio, and enables the company to leverage the broad expertise and infrastructure it has established in metabolic bone diseases with Crysvita.

 

Zacks Rank & Stocks to Consider

Ultragenyx currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the healthcare sector includes Aerpio Pharmaceuticals Ltd. , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimate has narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.

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Novartis AG (NVS) - free report >>

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MEREO BIOPHARMA (MREO) - free report >>

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