Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

Stada To Commercialize In EU

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.  

Tarpeyo Now Has Two Major Regulatory Thumbs Ups • Source: Shutterstock

STADA Arzneimittel AG is getting ready to commercialize Calliditas Therapeutics AB’ nephrology product, Tarpeyo, now that it has received a positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP) for it after an initial pushback from the body.

The CHMP issued a positive opinion on the EU approval of Tarpeyo (delayed-release budesonide) in immunoglobulin A nephropathy (IgAN) patients...

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 New Products

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

Bayer Bags First Global Okay For Hot Flashes Therapy

 
• By 

Lynkuet will compete with Astellas's Veozah/Veoza

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By 

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

More from Scrip

China’s Biotechs Were The Small-Cap Rising Stars In H1 2025

 

The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By 

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.