Name change to "Talphera" reflects a new era
of the Company in partnership with the medical community developing
novel solutions for medically supervised settings
Talphera will begin trading on Nasdaq under
the trading symbol "TLPH" effective January 10
SAN
MATEO, Calif., Jan. 9, 2024
/PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX),
(AcelRx), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for use
in medically supervised settings, today announced the rebranding of
the Company, with a name change to Talphera, Inc. ("Talphera"). The
rebrand decision was made to reflect the Company's strategy of
developing and commercializing products to support advancing care
to optimize outcomes in medically supervised settings, moving
beyond the original focus on acute pain. The Company's lead
nafamostat product candidate, Niyad, is expected to have a
Premarket Approval (PMA) submission to the FDA in the second half
of 2024.
The name Talphera was derived from "Talisman", meaning a strong
leader, and reflects the new "pharmaceutical era" for the Company.
The company's new mission at Talphera is to support healthcare
providers by developing and commercializing products in medically
supervised settings that deliver advances in care to patients.
Talphera will commence trading on the Nasdaq Global Market under
the ticker symbol "TLPH" effective January
10, 2024.
"We were a company founded on acute pain treatments with the
understanding that patient outcomes depend on the quality of the
tools available to a patient's medical team. This understanding
remains the focal point of our product candidates in development.
Rebranding to Talphera represents a new era of the company where we
have a broader mission to develop and commercialize innovative
therapies for use in medically supervised settings beyond acute
pain," said Vince Angotti, Chief Executive Officer of
Talphera.
Talphera's lead product candidate, Niyad, has been granted FDA
Breakthrough Designation and is currently being studied under an
investigational device exemption, or IDE, as an anticoagulant for
the extracorporeal circuit. If approved, Niyad would be the
first-ever regional anticoagulant approved by the FDA for use in
the dialysis circuit.
Talphera expects to initiate the registrational study of
Niyad™, the NEPHRO CRRT
(Nafamostat Efficacy in Phase
3 Registrational Continuous Renal Replacement Therapy)
Study, shortly. The study has already received
central Institutional Review Board (IRB) approval. The
study is designed as a prospective, double-blinded trial to be
conducted at up to 10 U.S. hospital intensive care units. The study
will enroll and evaluate 166 adult patients undergoing renal
replacement therapy, who cannot tolerate heparin or are at risk for
bleeding. The primary endpoint of the study is mean post-filter
activated clotting time using Niyad versus placebo over the first
24 hours. Key secondary endpoints include filter lifespan, number
of filter changes over 72 hours, number of transfusions over 72
hours and dialysis efficacy (based on urea concentration) over the
first 24 hours.
The first patient is expected to be enrolled for the NEPHRO
study in the first quarter of 2024. Since the end of last
year, the company has completed all sponsor actions and is awaiting
activation from registered sites. A PMA submission for Niyad is
expected to be filed with the FDA in the second half of 2024.
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on
the development and commercialization of innovative therapies for
use in medically supervised settings. Talphera's lead product
candidate, Niyad™ is a lyophilized formulation of nafamostat and is
currently being studied under an investigational device exemption,
or IDE, as an anticoagulant for the extracorporeal circuit, and has
received Breakthrough Device Designation status from the FDA.
Talphera is also developing two pre-filled syringes in-licensed
from its partner Aguettant: Fedsyra™, a pre-filled ephedrine
syringe, and PFS-02, a pre-filled phenylephrine syringe. This
release is intended for investors only. For additional information
about Talphera, please visit www.talphera.com.
About Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease
inhibitor with anticoagulant, anti-inflammatory and potential
anti-viral activities. Niyad™ is a lyophilized formulation of
nafamostat and is currently being studied under an investigational
device exemption, or IDE, as an anticoagulant for the
extracorporeal circuit, and has received Breakthrough Device
Designation Status from the FDA. LTX-608 is a proprietary
nafamostat formulation for direct IV infusion that will be
investigated and developed as a potential anti-viral for the
treatment of COVID, acute respiratory distress syndrome (ARDS),
disseminated intravascular coagulation (DIC) and acute
pancreatitis.
Forward-Looking Statements
This press release contains forward-looking statements based
upon Talphera's current expectations. These and any other
forward-looking statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by the use of forward-looking
terminology such as "potential," "believe," "expects," "expected,"
"anticipate," "awaiting," "may," "will," "would," "seek,"
"approximately," "if," "intends," "intended," "plans,"
"planning," "estimates," or the negative of these words or
other comparable terminology. The discussion of strategy, plans or
intentions may also include forward-looking statements, which are
predictions, projections and other statements about future events
that are based on current expectations and assumptions. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
projected, anticipated or implied by such statements, including:
(i) risks relating to Talphera's product development activities and
ongoing commercial business operations; (ii) risks related to the
ability of Talphera and its business partners to implement
development plans, launch plans, forecasts and other business
expectations; (iii) risks related to unexpected variations in
market growth and demand for Talphera's commercial and
developmental products and technologies; (iv) risks related to
Talphera's liquidity and its ability to maintain capital resources
sufficient to conduct the required clinical studies; (v) Talphera's
ability to retain its listing on the Nasdaq exchange; and (vi)
risks relating to Talphera's ability to obtain regulatory approvals
for its developmental product candidates. Although it is not
possible to predict or identify all such risks and uncertainties,
they may include, but are not limited to, those described under the
caption "Risk Factors" and elsewhere in Talphera's annual,
quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form
8-K) as filed or furnished with the Securities and Exchange
Commission (SEC) and any subsequent public filings. You are
cautioned not to place undue reliance on any such forward-looking
statements, which speak only as of the date such statements were
first made. To the degree financial information is included in this
press release, it is in summary form only and must be considered in
the context of the full details provided in Talphera's most recent
annual, quarterly or current report as filed or furnished with the
SEC. Talphera's SEC reports are available at www.Talphera.com under
the "Investors" tab. Except to the extent required by law, Talphera
undertakes no obligation to publicly release the result of any
revisions to these forward-looking statements to reflect new
information, events or circumstances after the date hereof, or to
reflect the occurrence of unanticipated events.
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SOURCE Talphera, Inc.