1. Scrip
  2. >>New Products

Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy

 
• By Joseph Haas

Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.

FDA Complete response stamp holder
Mesoblast is planning new trial after second FDA complete response • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

For a second time, the US Food and Drug Administration has told Mesoblast Limited that a biologic licensing application for its cell therapy candidate for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) lacks necessary data. On a 4 August analyst call, Mesoblast said it now plans to conduct a small study in high-risk adult GVHD patients that it hopes will meet the agency’s requirements for approval.

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 New Products

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 
• By Alaric DeArment and Andrew McConaghie

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 
• By Alexandra Shimmings

It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.

More from Scrip

Verve Moves Toward Lilly Opt-In For PCSK9 Program With Phase Ib Results

 
• By Alaric DeArment

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.

Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.