Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced that PEMGARDA™ is now available for
purchase in the U.S.
On March 22, 2024, PEMGARDA (pemivibart) injection, for
intravenous use, received emergency use authorization (EUA) from
the U.S. Food and Drug Administration (FDA) for the pre-exposure
prophylaxis (prevention) of COVID-19 in adults and adolescents (12
years of age and older weighing at least 40 kg) who have
moderate-to-severe immune compromise due to certain medical
conditions or receipt of certain immunosuppressive medications or
treatments and are unlikely to mount an adequate immune response to
COVID-19 vaccination. Recipients should not be currently infected
with or have had a known recent exposure to an individual infected
with SARS-CoV-2.
"I am very pleased to announce that, in less than two weeks from
receiving EUA, PEMGARDA is now commercially available for order
across the U.S.,” said Dave Hering, Chief Executive Officer. "This
is a remarkable achievement for our organization and for the
immunocompromised individuals we serve. With product now available,
today we are providing initial PEMGARDA net product revenue
guidance in the range of $150 million to $200 million for the full
year 2024. Based on this anticipated net product revenue and our
continued optimization of operating expenses, we expect to end 2024
with at least $55 million in cash and cash equivalents.”
PEMGARDA is available by prescription through a network of
authorized specialty distributors. Healthcare professionals seeking
to obtain PEMGARDA for their patients should contact their primary
vendor for ordering information or contact Invivyd at
1-800-890-3385 for more information. For additional information
about PEMGARDA, please see the full product Fact Sheet for
Healthcare Providers, including important safety information and
boxed warning.
Conference Call & Webcast
Invivyd will host a conference call and webcast today, Thursday,
April 4 at 5 pm ET. A live audio webcast will be available at
https://investors.invivyd.com/. Listeners can register for the
webcast via this link. Analysts wishing to participate in the
question-and-answer session should use this link. A replay of the
webcast will be available in the investor section of the company’s
website approximately two hours after the end of the call. Those
who plan on participating are advised to join 15 minutes prior to
the start time.
About PEMGARDA
PEMGARDA (pemivibart) is a half-life extended investigational
monoclonal antibody (mAb). PEMGARDA was engineered from
adintrevimab, Invivyd’s investigational mAb that has a robust
safety data package and provided evidence of clinical efficacy in a
global Phase 2/3 clinical trial for the prevention of COVID-19.
PEMGARDA has demonstrated in vitro neutralizing activity in
pseudotyped virus-like particle and authentic virus neutralization
assays against major SARS-CoV-2 variants, including JN.1, the
dominant variant in the U.S. currently according to estimates from
the Centers for Disease Control and Prevention. PEMGARDA targets
the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby
inhibiting virus attachment to the human ACE2 receptor on host
cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use
is an investigational mAb that has not been approved, but has been
authorized for emergency use by the U.S. FDA under an EUA for the
pre-exposure prophylaxis (prevention) of COVID-19 in adults and
adolescents (12 years of age and older weighing at least 40 kg) who
have moderate-to-severe immune compromise due to certain medical
conditions or receipt of certain immunosuppressive medications or
treatments and are unlikely to mount an adequate immune response to
COVID-19 vaccination. Recipients should not be currently infected
with or have had a known recent exposure to an individual infected
with SARS-CoV-2. PEMGARDA is not authorized for use for treatment
of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis
has been observed with PEMGARDA and the PEMGARDA Fact Sheet for
Healthcare Providers includes a boxed warning for anaphylaxis. The
most common adverse events (all grades, incidence ≥2%) observed in
participants who have moderate-to-severe immune compromise treated
with PEMGARDA included systemic and local infusion-related or
hypersensitivity reactions, upper respiratory tract infection,
viral infection, influenza-like illness, fatigue, headache, and
nausea. For additional information, please see the PEMGARDA full
product Fact Sheet for Healthcare Providers, including important
safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was
used to determine if PEMGARDA may be effective for pre-exposure
prophylaxis of COVID-19. Immunobridging is based on the serum virus
neutralizing titer-efficacy relationships identified with other
neutralizing human mAbs against SARS-CoV-2. This includes
adintrevimab, the parent mAb of pemivibart, and other mAbs that
were previously authorized for EUA. There are limitations of the
data supporting the benefits of PEMGARDA. Evidence of clinical
efficacy for other neutralizing human mAbs against SARS-CoV-2 was
based on different populations and SARS-CoV-2 variants that are no
longer circulating. Additionally, the variability associated with
cell-based EC50 value determinations, along with limitations
related to pharmacokinetic data and efficacy estimates for the mAbs
in prior clinical trials, impact the ability to precisely estimate
protective titer ranges.
The emergency use of PEMGARDA is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is commercial-stage company on a
mission to rapidly and perpetually deliver antibody-based therapies
that protect vulnerable people from the devastating consequences of
circulating viral threats, beginning with SARS-CoV-2. The company’s
proprietary INVYMAB™ platform approach combines state-of-the-art
viral surveillance and predictive modeling with advanced antibody
engineering. INVYMAB is designed to facilitate the rapid, serial
generation of new monoclonal antibodies (mAbs) to keep pace with
evolving viral threats. In March 2024, Invivyd received emergency
use authorization (EUA) from the U.S. FDA for its first mAb in a
planned series of innovative antibody candidates. Visit
https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “could,” “expects,”
“intends,” “potential,” “projects,” and “future” or similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Forward-looking statements
include statements concerning, among other things, the potential of
PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of
COVID-19 in certain adults and adolescents (12 years of age and
older weighing at least 40 kg) with moderate-to-severe immune
compromise; the company’s plans related to the commercialization of
PEMGARDA, including expectations regarding availability of
PEMGARDA; 2024 financial guidance, including the company’s
anticipated net product revenue and projected cash and cash
equivalents balance; the company’s anticipated continued
optimization of operating expenses; the company’s ongoing research
and clinical development efforts, and the timing thereof; the
company’s mission to rapidly and perpetually deliver antibody-based
therapies that protect vulnerable people from the devastating
consequences of circulating viral threats, beginning with
SARS-CoV-2; the design of the company’s INVYMAB platform approach
to facilitate the rapid, serial generation of new mAbs to keep pace
with evolving viral threats; the company’s expectation that
PEMGARDA is the first mAb in a planned series of innovative
antibody candidates; and other statements that are not historical
fact. The company may not actually achieve the plans, intentions or
expectations disclosed in the company’s forward-looking statements
and you should not place undue reliance on the company’s
forward-looking statements. These forward-looking statements
involve risks and uncertainties that could cause the company’s
actual results to differ materially from the results described in
or implied by the forward-looking statements, including, without
limitation: how long the EUA granted by the FDA for PEMGARDA will
remain in effect and whether the EUA is revoked or revised by the
FDA; the company’s ability to build and maintain sales, marketing
and distribution capabilities to successfully commercialize
PEMGARDA; changes in expected or existing competition; the timing
and progress of the company’s discovery, preclinical and clinical
development activities; the uncertainties and timing of the
regulatory authorization or approval process, and available
development and regulatory pathways for authorization or approval
of the company’s product candidates; changes in the regulatory
environment; unexpected safety or efficacy data observed during
preclinical studies or clinical trials; the ability to maintain a
continued acceptable safety, tolerability and efficacy profile of
PEMGARDA or any other product candidate following regulatory
authorization or approval; the predictability of clinical success
of the company’s product candidates based on neutralizing activity
in preclinical studies; the risk that results of preclinical
studies or clinical trials may not be predictive of future results,
and interim data are subject to further analysis; the company’s
reliance on third parties with respect to virus assay creation and
product candidate testing and with respect to its clinical trials;
variability of results in models used to predict activity against
SARS-CoV-2 variants; whether PEMGARDA or any other product
candidate is able to demonstrate and sustain neutralizing activity
against major SARS-CoV-2 variants, particularly in the face of
viral evolution; the complexities of manufacturing mAb therapies;
the company’s dependence on third parties to manufacture, label,
package, store and distribute clinical and commercial supplies of
its product candidates; whether the company is able to provide
sufficient commercial supply of PEMGARDA to meet market demand;
whether the company can obtain and maintain third-party coverage
and adequate reimbursement for PEMGARDA or any other product
candidate; the company’s ability to leverage its INVYMAB platform
approach to facilitate the rapid, serial generation of new mAbs to
keep pace with evolving viral threats; any litigation and other
proceedings or government investigations relating to the company;
the company’s ability to continue as a going concern; the company’s
ability to optimize operating expenses; and whether the company has
adequate funding to meet future operating expenses and capital
expenditure requirements. Other factors that may cause the
company’s actual results to differ materially from those expressed
or implied in the forward-looking statements in this press release
are described under the heading “Risk Factors” in the company’s
Annual Report on Form 10-K for the year ended December 31, 2023
filed with the Securities and Exchange Commission (SEC), and in the
company’s other filings with the SEC, and in its future reports to
be filed with the SEC and available at www.sec.gov. Forward-looking
statements contained in this press release are made as of this
date, and Invivyd undertakes no duty to update such information
whether as a result of new information, future events or otherwise,
except as required under applicable law.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Contacts:
Media Relations(781) 208-1747media@invivyd.com
Investor Relations(781) 208-1747investors@invivyd.com
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