Savara Announces Molgradex Received Fast Track Designation by FDA for Treatment of Autoimmune Pulmonary Alveolar Proteinosis
May 06 2019 - 8:02AM
Business Wire
Savara Inc. (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
www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn:
www.linkedin.com/company/savara-pharmaceuticals/)
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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version on businesswire.com: https://www.businesswire.com/news/home/20190506005250/en/
Savara Inc. IR & PRAnne Erickson
(anne.erickson@savarapharma.com)(512) 851-1366
For IR: Solebury TroutGitanjali Jain Ogawa
(Gogawa@troutgroup.com)(646) 378-2949
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