Apellis Awaits A European Rejection

If the CHMP recommends against Syfovre Apellis intends to appeal, but the chances are this will be in vain.  

close up of an eye

Apellis Pharmaceuticals, Inc. has admitted that Syfovre was unlikely to get past EU regulators and onto the market. Analysts had predicted that Europe would account for 40% of peak worldwide sales of the geographic atrophy therapy; with these now out of reach, ramping up sales in the US becomes vital.

Key Takeaways
  • The geographic atrophy therapy Syfovre is likely to get a negative vote from the CHMP, Apellis believes

The company said it expects the Committee for Medicinal Products for Human Use (CHMP) to give a negative opinion on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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

More from Business

Nektar Bounces Back As Eczema Drug Rezpeg Heads For Phase III

 
• By 

Lilly-rejected candidate impresses in Phase IIb atopic dermatitis trial.

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By 

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

Positive Fabry Data Should Smooth Way For Sangamo’s Partnering Efforts

 

The biotech announced results from the pivotal trial of isaralgagene civoparvovec and plans to file for approval in 2026 as it looks for a commercialization partner.

More from Scrip

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By 

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

Positive Fabry Data Should Smooth Way For Sangamo’s Partnering Efforts

 

The biotech announced results from the pivotal trial of isaralgagene civoparvovec and plans to file for approval in 2026 as it looks for a commercialization partner.

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.