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Savara Announces Molgradex Received Fast Track Designation by FDA for Treatment of Autoimmune Pulmonary Alveolar Proteinosis


(NASDAQ:SVRA), an orphan lung disease company, today announced
that the U.S. Food and Drug Administration (FDA) granted Fast Track
designation for Molgradex, an inhaled formulation of recombinant human
granulocyte-macrophage colony-stimulating factor (GM-CSF). Molgradex,
the Company's lead product candidate, is being investigated in a pivotal
Phase 3 study, called IMPALA, for the treatment of autoimmune pulmonary
alveolar proteinosis (aPAP). Topline results from the study are expected
in June 2019. Positive results would facilitate the submission of a
Biologics License Application (BLA) in the first half of 2020, with an
anticipated commercial launch later in 2020 or early 2021.

The Fast Track program facilitates the expedited development and review
of new drugs or biologics that are intended to treat serious or
life-threatening conditions and demonstrate the potential to address
unmet medical needs. A drug granted Fast Track designation may be
eligible for Priority Review or Rolling Review of the BLA, if relevant
criteria are met.

"We are excited by this designation as it reinforces that a better
treatment option is needed for people living with aPAP," said Rob
Neville, Chief Executive Officer, Savara. "With the potential for
Priority or Rolling Review, we are optimistic about the opportunity to
accelerate the submission of Molgradex on behalf of patients with this
devastating disease."

About Savara

Savara is an orphan lung disease company. Savara's 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's strategy involves expanding its pipeline of potentially
best-in-class products through indication expansion, strategic
development partnerships and product acquisitions, with the goal of
becoming a leading company in its field. The most recent acquisition is
aerosolized amikacin/fosfomycin, a Phase 2-ready, proprietary
combination antibiotic, which has demonstrated potent and broad-spectrum
antibacterial activity against highly drug resistant pathogens. Savara's
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. More information can be found at
(Twitter: @SavaraPharma,

Forward Looking Statements

Savara cautions you that statements in this press release that are not a
description of historical fact are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words
referencing future events or circumstances such as "expect," "intend,"
"plan," "anticipate," "believe," and "will," among others. Such
statements include, but are not limited to, that positive results from
IMPALA would facilitate the submission of a Biologics License
Application in the first half of 2020, with an anticipated commercial
launch later in 2020 or early 2021, our optimism about the opportunity
to accelerate the submission of Molgradex on behalf of patients with
aPAP, and Savara's strategy. Savara may not actually achieve any of the
matters referred to in such forward-looking statements, and you should
not place undue reliance on these forward-looking statements. These
forward-looking statements are based upon Savara's current expectations
and involve assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as
a result of various risks and uncertainties, which include, without
limitation, risks and uncertainties associated with the outcome of our
ongoing and planned clinical trials for our product candidates, the
ability to project future cash utilization and reserves needed for
contingent future liabilities and business operations, the availability
of sufficient resources for Savara's operations and to conduct or
continue planned clinical development programs, the ability to obtain
the necessary patient enrollment for our product candidates in a timely
manner, the ability to successfully identify product acquisition
candidates, the ability to successfully develop our product candidates,
the risks associated with the process of developing, obtaining
regulatory approval for and commercializing drug candidates such as
Molgradex that are safe and effective for use as human therapeutics and
the timing and ability of Savara to raise additional equity capital as
needed to fund continued operations. All forward-looking statements are
expressly qualified in their entirety by these cautionary statements.
For a detailed description of our risks and uncertainties, you are
encouraged to review our documents filed with the SEC including our
recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned
not to place undue reliance on forward-looking statements, which speak
only as of the date on which they were made. Savara undertakes no
obligation to update such statements to reflect events that occur or
circumstances that exist after the date on which they were made, except
as may be required by law.

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