BioMarin Prepares To Launch Roctavian For Hemophilia In An Uncertain Environment

The company lowered revenue guidance due to COVID-19, but announced a new brand name, Roctavian, for its hemophilia A gene therapy, which it said remains on track for FDA approval later this year.

Selected focus on nurse hand preparing a saline tube for infuse patient arm in the hospital. Patient is on drip receiving saline solution.
Infused medicines are facing some challenges because of COVID-19 • Source: Shutterstock

BioMarin Pharmaceutical Inc. is still on track to launch the first gene therapy for hemophilia A in the US later this year, but acknowledged during its first quarter sales and earnings call on 29 April that the commercial dynamics are uncertain because of the COVID-19 outbreak.

Management unveiled a new brand name for valoctocogene roxaparvovec, which will be marketed as Roctavian. BioMarin is anticipating FDA action on the biologics licensing application for the gene therapy by...

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 Earnings

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

 
• By 

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 

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

 

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.

Stock Watch: Q1 Sales Trends And Forex Muddle Pharma Outlook

 
• By 

Pharma firms tended to downplay first-quarter trends in full-year guidance. However, raised guidance seems fragile amid ongoing foreign exchange effects and Medicare Part D redesign pressures.

More from Business

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

 
• By 

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 

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.

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.