Apellis Aims New Pegcetacoplan Data At Market, Not Regulators

The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.

Apellis said it was submitting new, longer-term follow-up data to the FDA for its geographic atrophy drug • Source: Shutterstock

Apellis Pharmaceuticals, Inc. is looking at a three-month extension of the US Food and Drug Administration action date for its pegcetacoplan in geographic atrophy (GA), but that’s because it is choosing to submit additional data to the agency. The firm opted for the short delay in order to have a more compelling dataset to take to the market.

Apellis said 3 November that it would submit 24-month Phase III data from the 637-patient DERBY and 621-patient OAKS clinical...

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 Sensory

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By 

Series B cash will be used to advance its Stargardt disease gene therapy.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By 

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

Lilly To Diversify Pain Pipeline With SiteOne Acquisition

 
• By 

Deal snapshot: With several internal non-opioid pain candidates in Phase II or earlier, Lilly looks to add R&D potential in pain with $1bn buyout of SiteOne.

More from Therapy Areas

Sanofi Revels In More Positive Rilzabrutinib Data

 
• By 

The oral BTK inhibitor impresses in a Phase II trial for IgG4-related disease.

BioNTech To Buy mRNA Rivals CureVac

 

The $1.25bn buyout is a simple deal for BioNTech, bringing new mRNA R&D and manufacturing capacity while also ending a bothersome patent dispute.

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By 

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?