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Savara Shares Double After FDA Grants Breakthrough Therapy Status for aPAP Treatment

Streetwise Reports, Streetwise Reports
0 Comments| January 2, 2020

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Shares of Savara opened nearly 140% higher today after the orphan lung disease company advised that the FDA has granted Breakthrough Therapy designation for the firm's Molgradex for treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

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This morning orphan lung disease company Savara Inc. (SVRA:NASDAQ) announced that "the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)."

The company advised that "the Molgradex Breakthrough Therapy designation is based on data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex for the treatment of aPAP." According to the report, the data from the study was recently presented in Madrid to the 2019 European Respiratory Society International Congress.

Savara explained in the release that "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 various clinically significant endpoints".

The company's CEO Robert Neville 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."

Savara is an orphan lung disease company headquartered in West Lake Hills, Tex., and states that "its management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization." The company listed that "its pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF."

Savara has a market capitalization of about $71.3 million with approximately 41.2 million shares outstanding. SVRA shares opened nearly 140% higher today at $4.12 (+$2.39, +138.15%) compared to Friday's $1.73 closing price. The stock has traded today between $3.26 and $4.87/share on extremely high relative volume and currently is trading at $4.07 (+$2.34, +135.26%).


Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.



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