Savara Inc. (NASDAQ: SVRA) shares more than doubled on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its autoimmune pulmonary alveolar proteinosis (aPAP) treatment Molgradex.
Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor for the treatment of aPAP. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on clinically significant endpoints.
In particular, the Molgradex Breakthrough Therapy designation is based on data from the Impala Phase 3 clinical study. Data from the study was recently presented at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain.
Rob Neville, CEO of Savara, commented:
We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options. We believe this designation reflects the significance of Molgradex as an investigational product that, based on the IMPALA study, has been demonstrated to improve patient outcomes. Breakthrough designation is designed to provide increased collaboration and more frequent dialogue with the FDA and is an important milestone as we work to determine the best path forward for this product.
Shares of Savara were last seen up about 115%, at $3.73 in a 52-week range of $0.69 to $11.96. The consensus analyst target is $5.44.
24/7 Wall St.In 20 Years, I Haven’t Seen A Cash Back Card This Good
After two decades of reviewing financial products I haven’t seen anything like this. Credit card companies are at war, handing out free rewards and benefits to win the best customers.
A good cash back card can be worth thousands of dollars a year in free money, not to mention other perks like travel, insurance, and access to fancy lounges.
Our top pick today pays up to 5% cash back, a $200 bonus on top, and $0 annual fee. Click here to apply before they stop offering rewards this generous.
Flywheel Publishing has partnered with CardRatings for our coverage of credit card products. Flywheel Publishing and CardRatings may receive a commission from card issuers.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
Our expert who first called NVIDIA in 2009 is predicting 2025 will see a historic AI breakthrough.
You can follow him investing $500,000 of his own money on our top AI stocks for free.