BioCryst to Present New Berotralstat Data at European Academy of Allergy and Clinical Immunology Digital Congress
May 26 2020 - 7:00AM
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that
the company will present new data on berotralstat (BCX7353), an
oral, once-daily therapy under regulatory review in the United
States, Japan and the European Union for the prevention of
hereditary angioedema (HAE) attacks, at the upcoming digital
congress of the European Academy of Allergy and Clinical Immunology
(EAACI) June 6-8. EAACI plans to make content from the
congress available at 9:00a CET on June 6.
- Long-Term Safety and Tolerability of Berotralstat (BCX7353) for
Hereditary Angioedema (HAE) Prophylaxis: APeX-S Study Results; oral
abstract session 21 (#484)
- Berotralstat (BCX7353) Treatment Demonstrates Robust and
Durable Reduction in the Rate of Hereditary Angioedema (HAE)
Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; poster
discussion session 06 (#1406)
- Berotralstat (BCX7353) Treatment Following 24-Weeks of Placebo
Results in Rapid and Sustained Reduction in the Rate of Hereditary
Angioedema (HAE) Attacks: APeX-2 Study Results; thematic poster
session 07 (#1219)
- Berotralstat (BCX7353) Treatment Demonstrates Robust and
Durable Reduction in the Rate of Hereditary Angioedema (HAE)
Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; thematic poster
session 07 (#1241)
- Hereditary Angioedema Patients in the United States Report
Expanded Use of Prophylaxis, but Continue to Experience Attacks;
thematic poster session 07 (#196)
“As berotralstat gets closer to potential
approval in Japan and the U.S. later this year, and the EU early
next year, it is exciting to share additional data highlighting the
meaningful impact an oral, once-daily medicine is having for HAE
patients in our clinical program,” said Dr. William Sheridan, chief
medical officer of BioCryst.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule
medicines that treat rare diseases in which significant unmet
medical needs exist and an enzyme plays a key role in the
biological pathway of the disease. BioCryst has several ongoing
development programs including berotralstat (BCX7353), an oral
treatment for hereditary angioedema, BCX9930, an oral Factor D
inhibitor for the treatment of complement-mediated diseases,
galidesivir, a potential treatment for COVID-19, Marburg virus
disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the
treatment of fibrodysplasia ossificans progressiva. RAPIVAB®
(peramivir injection), a viral neuraminidase inhibitor for the
treatment of influenza, is BioCryst's first approved product and
has received regulatory approval in the U.S., Canada, Australia,
Japan, Taiwan, Korea and the European Union. Post-marketing
commitments for RAPIVAB are ongoing. For more information, please
visit the Company's website at www.BioCryst.com.
Forward-Looking StatementsThis
press release contains forward-looking statements, including
statements regarding future results, performance or achievements.
These statements involve known and unknown risks, uncertainties and
other factors which may cause BioCryst’s actual results,
performance or achievements to be materially different from any
future results, performances or achievements expressed or implied
by the forward-looking statements. These statements reflect our
current views with respect to future events and are based on
assumptions and are subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect
the forward-looking statements contained herein include: that the
ongoing COVID-19 pandemic could create challenges in all aspects of
our business, including without limitation delays, stoppages,
difficulties and increased expenses with respect to our and our
partners’ development, regulatory processes and supply chains,
could negatively impact our ability to access the capital or credit
markets to finance our operations, or could have the effect of
heightening many of the risks described below or in the documents
we file periodically with the Securities and Exchange Commission;
that developing any HAE product candidate may take longer or may be
more expensive than planned; that ongoing and future preclinical
and clinical development of BCX9930, BCX9250 and galidesivir may
not have positive results; that BioCryst may not be able to enroll
the required number of subjects in planned clinical trials of
product candidates; that BioCryst may not advance human clinical
trials with product candidates as expected; that the FDA, EMA, PMDA
or other applicable regulatory agency may require additional
studies beyond the studies planned for product candidates, or may
not provide regulatory clearances which may result in delay of
planned clinical trials, or may impose a clinical hold with respect
to such product candidates, or withhold market approval for product
candidates; that actual financial results may not be consistent
with expectations, including that 2020 operating expenses and cash
usage may not be within management's expected ranges. Please
refer to the documents BioCryst files periodically with the
Securities and Exchange Commission, specifically BioCryst’s most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q,
and Current Reports on Form 8-K, all of which identify important
factors that could cause the actual results to differ materially
from those contained in BioCryst’s projections and forward-looking
statements.
BCRXW
Contact:John Bluth+1 919 859
7910jbluth@biocryst.com
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