PDUFA Date is April 2, 2025
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the resubmitted New Drug Application (NDA) for
topical ocular reproxalap, a first-in-class investigational new
drug candidate, for the treatment of the signs and symptoms of dry
eye disease. The FDA assigned a Prescription Drug User Fee Act
(PDUFA) date of April 2, 2025. In conjunction with the acceptance
of the NDA for review, Aldeyra announced the expansion of its
exclusive option agreement with AbbVie Inc. (AbbVie).
“Based on the FDA’s acceptance of the NDA resubmission of
reproxalap for dry eye disease for review, we are pleased to
announce an expansion of our option agreement with AbbVie,
highlighting the commitment of both companies to accelerating the
potential availability of a novel dry eye disease therapy to
patients and physicians,” stated Todd C. Brady, M.D., Ph.D.,
President and Chief Executive Officer of Aldeyra.
On October 31, 2023, Aldeyra entered into an option agreement
with AbbVie. Under the terms of the agreement, AbbVie has the
option to obtain a co-exclusive license to develop, manufacture,
and commercialize reproxalap in the United States. Upon exercise of
the option, AbbVie would pay Aldeyra a $100 million upfront cash
payment, less previously paid option fees of $6 million. In
addition, Aldeyra would be eligible to receive up to $300 million
in regulatory and commercial milestone payments, inclusive of a
$100 million milestone payment payable if the FDA approval for
reproxalap for dry eye disease is received. In the United States,
Aldeyra would share profits and losses with AbbVie from the
commercialization of reproxalap according to a split of 60% for
AbbVie and 40% for Aldeyra.
Per the expansion of the option agreement, Aldeyra will initiate
certain pre-commercial activities, 60% of which will be paid by
AbbVie and 40% of which will be paid by Aldeyra if the option is
exercised. AbbVie has also independently initiated certain
pre-commercial planning activities. The parties have also agreed to
amend the expiration of the option to 10 business days from the
date of FDA approval, if any, of reproxalap for dry eye
disease.
About Reproxalap
Reproxalap is an investigational new drug candidate in
development for the treatment of dry eye disease and allergic
conjunctivitis, two of the largest markets in ophthalmology.
Reproxalap is a first-in-class small-molecule modulator of RASP,
which are elevated in ocular and systemic inflammatory diseases.
The mechanism of action of reproxalap has been supported by the
demonstration of statistically significant and clinically relevant
activity in multiple physiologically distinct late-phase clinical
indications. Reproxalap has been studied in more than 2,500
patients with no observed safety concerns; mild and transient
instillation site irritation is the most commonly reported adverse
event in clinical trials.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
and metabolic diseases. Aldeyra’s approach is to develop
pharmaceuticals that modulate protein systems, instead of directly
inhibiting or activating single protein targets, with the goal of
optimizing multiple pathways at once while minimizing toxicity.
Aldeyra’s product candidates include RASP (reactive aldehyde
species) modulators ADX-629, ADX-248, ADX-743, ADX-631, and
chemically related molecules for the potential treatment of
systemic and retinal immune-mediated and metabolic diseases.
Aldeyra’s late-stage product candidates are reproxalap, a RASP
modulator for the potential treatment of dry eye disease and
allergic conjunctivitis, and ADX-2191, a novel formulation of
intravitreal methotrexate for the potential treatment of retinitis
pigmentosa. For additional information, please visit
www.aldeyra.com.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding Aldeyra’s
future expectations, plans, and prospects, including without
limitation statements regarding: the goals, opportunity, and
potential for reproxalap; the outcome and timing of the FDA’s
review, or approval of the resubmitted NDA for reproxalap by the
PDUFA date and the adequacy of the data included in the original
NDA and the resubmitted NDA; the likelihood and timing of the
exercise of the Option; and Aldeyra’s expectations regarding the
labeling for reproxalap, if approved. Aldeyra intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. In some cases, you can identify
forward-looking statements by terms such as, but not limited to,
“may,” “might,” “will,” “objective,” “intend,” “should,” "could,"
“can,” “would,” “expect,” “believe,” “anticipate,” “project,” “on
track,” “scheduled,” “target,” “design,” “estimate,” “predict,”
“contemplates,” “likely,” “potential,” “continue,” “ongoing,”
“aim,” “plan,” or the negative of these terms, and similar
expressions intended to identify forward-looking statements. Such
forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions, and
uncertainties. Aldeyra is at an early stage of development and may
not ever have any products that generate significant revenue. All
of Aldeyra's development timelines may be subject to adjustment
depending on recruitment rate, regulatory review, preclinical and
clinical results, funding, and other factors that could delay the
initiation, enrollment, or completion of clinical trials. Important
factors that could cause actual results to differ materially from
those reflected in Aldeyra's forward-looking statements include,
among others, the timing of enrollment, commencement and completion
of Aldeyra's clinical trials, the timing and success of preclinical
studies and clinical trials conducted by Aldeyra and its
development partners; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates, including as a result of
the FDA not accepting Aldeyra’s regulatory filings, issuing a
complete response letter, or requiring additional clinical trials
or data prior to review or approval of such filings or in
connection with resubmissions of such filings; the ability to
maintain regulatory approval of Aldeyra's product candidates, and
the labeling for any approved products; the risk that prior
results, such as signals of safety, activity, or durability of
effect, observed from preclinical or clinical trials, will not be
replicated or will not continue in ongoing or future studies or
clinical trials involving Aldeyra's product candidates in clinical
trials focused on the same or different indications; the scope,
progress, expansion, and costs of developing and commercializing
Aldeyra's product candidates; uncertainty as to Aldeyra’s ability
to commercialize (alone or with others) and obtain reimbursement
for Aldeyra's product candidates following regulatory approval, if
any; the size and growth of the potential markets and pricing for
Aldeyra's product candidates and the ability to serve those
markets; Aldeyra's expectations regarding Aldeyra's expenses and
future revenue, the timing of future revenue, the sufficiency or
use of Aldeyra's cash resources and needs for additional financing;
the rate and degree of market acceptance of any of Aldeyra's
product candidates; Aldeyra's expectations regarding competition;
Aldeyra's anticipated growth strategies; Aldeyra's ability to
attract or retain key personnel; Aldeyra’s commercialization,
marketing and manufacturing capabilities and strategy; Aldeyra's
ability to establish and maintain development partnerships;
Aldeyra’s ability to successfully integrate acquisitions into its
business; Aldeyra's expectations regarding federal, state, and
foreign regulatory requirements; political, economic, legal,
social, and health risks, public health measures, and war or other
military actions, that may affect Aldeyra’s business or the global
economy; regulatory developments in the United States and foreign
countries; Aldeyra's ability to obtain and maintain intellectual
property protection for its product candidates; the anticipated
trends and challenges in Aldeyra's business and the market in which
it operates; and other factors that are described in the “Risk
Factors” and “Management's Discussion and Analysis of Financial
Condition and Results of Operations” sections of Aldeyra's Annual
Report on Form 10-K for the year ended December 31, 2023, and
Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2024, which are on file with the Securities and
Exchange Commission (SEC) and available on the SEC's website at
https://www.sec.gov/.
In addition to the risks described above and in Aldeyra's other
filings with the SEC, other unknown or unpredictable factors also
could affect Aldeyra's results. No forward-looking statements can
be guaranteed and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Aldeyra undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20241118246408/en/
Investor & Media Contact: Laura Nichols Tel: (781) 257-3060
investorrelations@aldeyra.com
Aldeyra Therapeutics (NASDAQ:ALDX)
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