1. In Vivo
  2. >>Leadership

Stryker Misses the Goal with OP-1

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

Analysts watching the progress of Stryker Corp. 's OP-1, the first orthobiologic product to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Only 100 patients were enrolled, the label indication—for the treatment of tibial nonunion fractures—was narrow, and both the treatment and control arms of the study used nails to fix the fractures, making it more difficult to ascribe any clinical benefit directly to OP-1.

Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended OP-1(osteogenic protein-1, also known as bone morphogenetic protein-7...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Leadership

Podcast: Poolbeg CEO On The Biotech’s Big Bet On Small Molecules

 
• By Jo Shorthouse

In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company’s ambitious pipeline and strategic direction.

Infographic: How Big Pharma Is Scaling Beyond Pilot AI Projects

 
• By David Wild

Pharma leaders are shifting from AI pilots to enterprise-scale deployment, favoring external partnerships for efficiency gains while maintaining tight control over sensitive clinical data.

Podcast: Inside MoonLake’s Fast-Track Vision And $500m Deal

 
• By Jo Shorthouse

MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. In this episode, its CEO and CFO discuss the company’s rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.

Rising leaders 2025: Aneesh Karatt-Vellatt On Maxion Therapeutics’ Antibody Revolution

 
• By Jo Shorthouse

Aneesh Karatt-Vellatt is leading the charge to redefine how ion channels and G protein-coupled receptors (GPCRs) are targeted with antibody therapies, one of the most notoriously challenging classes of drug targets.

More from In Vivo

video
Sponsored by:

Meeting the demands of the global biologics market

Lonza is addressing the growing global demand for biologics by utilizing its expert teams and the advanced capabilities of its newly acquired large-scale manufacturing site in Vacaville, California. Joanna McCafferty, Director of Commercial Development, shares more in this brief video. Ask ChatG

Mapping The Power And Potential Of Europe’s Market Access Collaborations

 
• By Leela Barham

Understand who’s influencing access decisions and how pharma can engage strategically across the continent.

Infographic: How Big Pharma Is Scaling Beyond Pilot AI Projects

 
• By David Wild

Pharma leaders are shifting from AI pilots to enterprise-scale deployment, favoring external partnerships for efficiency gains while maintaining tight control over sensitive clinical data.