Savara’s Persistence May Pay Off In Rare Lung Disease

Five years after a Phase III failure, Savara reports pivotal data supporting approval of molgramostim as the first drug for autoimmune pulmonary alveolar proteinosis.

Alveoli
Savara is trying to bring a first approved drug for a rare alveoli disorder • Source: Shutterstock

Despite an earlier Phase III failure, Savara Inc. has stuck with its goal to bring recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) to approval in autoimmune pulmonary alveolar proteinosis (aPAP), and on 26 June reported positive Phase III results for molgramostim that it said support global filings in the rare lung disease in early 2025.

More from Clinical Trials

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
• By 

With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By 

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Hengrui Renews Global Phase III Push As China Players Plan Pivotal Multinational Trials

 

After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.

More from R&D

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
• By 

After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.

Baxdrostat, AstraZeneca’s Next Big CVRM Bet

 
• By 

The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.

Merck’s Winrevair Slashes Morbidity-Mortality Risk For PAH Patients

 

The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.