1. Scrip
  2. >>Business
  3. >>Earnings

US FDA AdComm For Vertex’s Sickle Cell Gene Therapy ‘Not A Concern’

 
• By Ayisha Sharma

The US biotech revealed the US Food and Drug Administration would be holding an advisory committee meeting for exa-cel during its second quarter earnings, but analysts are unfazed by the news amid robust revenues and raised guidance.  

3d graphic of sickled blood cell
Sickle Cell Disease Affects Around 100,000 People In The US • Source: Shutterstock
Key Takeaways:

  • Sales of cystic fibrosis drug Trikafta rose due to uptake in the younger pediatric population.

Vertex Pharmaceuticals Incorporated/CRISPR Therapeutics AG’s gene therapy candidate for inherited blood disorders, exagamglogene autotemcel (exa-cel), will be subject to a US advisory committee meeting, but analysts remained unconcerned amid decent Q2 revenues and other upcoming milestones.

The firm’s second-quarter revenues increased by 14% to $2.49bn, driven by the strong uptake of its cystic fibrosis treatment Trikafta/Kaftrio...

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
Start Free Trial

Already a subscriber?

More from Earnings

Stock Watch: On Q1 Vaccine Sales And Measles Outbreaks

 
• By Andy Smith

A recent study suggested that measles could become endemic in the US due to low vaccination rates. However, first-quarter vaccine sales offered a more nuanced picture.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

More from Business

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 
• By Jessica Merrill

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
• By Kevin Grogan

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.