Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detect...
December 30 2020 - 12:47PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that a Marketing Authorization Application has been
submitted by its agents in Mexico to Comisión Federal para la
Protección contra Riesgos Sanitarios (COFEPRIS), the health
regulatory authority for Mexico, for its COVI-STIX rapid diagnostic
test for the detection of the SARS-CoV-2 virus nucleocapsid antigen
in nasal samples of patients, "Inmunoensayo de flujo lateral para
la detección cualitativa de la proteína nucleocápside del
SARS-CoV-2".
In testing conducted to date, COVI-STIX has provided results
within 15 minutes, with positive detection as quickly as two
minutes for patient samples with high viral load.
An independent study conducted by researchers of the Facultad de
Medicina, UNAM demonstrated high sensitivity and specificity in
Mexico patients with COVID-19 symptoms.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat
cancers. Sorrento's multimodal, multipronged approach to fighting
cancer is made possible by its extensive immuno-oncology platforms,
including key assets such as fully human antibodies (“G-MAB™
library”), clinical stage immuno-cellular therapies (“CAR-T”,
“DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage
oncolytic virus (“Seprehvir®”). Sorrento is also developing
potential antiviral therapies and vaccines against coronaviruses,
including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™,
COVI-MSC™ and COVI-DROPS™; and diagnostic test solutions, including
COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
Sorrento's commitment to life-enhancing therapies for patients
is also demonstrated by our effort to advance a first-in-class
(TRPV1 agonist) non-opioid pain management small molecule,
resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium
phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation
of a widely used corticosteroid for epidural injections to treat
lumbosacral radicular pain, or sciatica, and to commercialize
ZTlido® (lidocaine topical system) 1.8% for the treatment of
post-herpetic neuralgia. RTX has completed a phase IB trial for
intractable pain associated with cancer and a phase 1B trial in
osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for
the treatment of lumbosacral radicular pain, or sciatica. ZTlido®
was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting contain forward-looking statements related
to Sorrento Therapeutics, Inc., under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995
and subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward-looking
statements include statements regarding the potential receipt of
any clearance for COVI-STIX from COFEPRIS; the speed at which
COVI-STIX provides results or is able to provide results, including
positive detection of the SARS-CoV-2 virus nucleocapsid antigen;
the specificity and sensitivity of COVI-STIX; and Sorrento’s
potential position in the diagnostics testing industry. Risks and
uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
related to Sorrento's and its subsidiaries', affiliates’ and
partners’ technologies and prospects and collaborations with
partners, including, but not limited to risks related to conducting
pre-clinical studies and seeking regulatory approval for COVI-STIX,
including the timing for receipt of any such approval; conducting
and receiving results of clinical trials; clinical development
risks, including risks in the progress, timing, cost, and results
of clinical trials and product development programs; risk of
difficulties or delays in obtaining regulatory approvals; risks
that clinical study results may not meet any or all endpoints of a
clinical study and that any data generated from such studies may
not support a regulatory submission or approval; risks that prior
test results may not be replicated in future studies and trials;
risks of manufacturing and supplying drug product; risks related to
leveraging the expertise of its employees, subsidiaries, affiliates
and partners to assist the company in the execution of its COVID-19
therapeutic product candidates’ strategies; risks related to the
global impact of COVID-19; and other risks that are described in
Sorrento's most recent periodic reports filed with the Securities
and Exchange Commission, including Sorrento's Annual Report on Form
10-K for the year ended December 31, 2019, and subsequent Quarterly
Reports on Form 10-Q filed with the Securities and Exchange
Commission, including the risk factors set forth in those filings.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release and we undertake no obligation to update any
forward-looking statement in this press release except as required
by law.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, COVI-GUARD™, COVI-AMG™,
COVI-SHIELD™, Gene-MAb™, COVI-DROPS™, COVI-MSC™, COVI-TRACK™,
COVI-TRACE™ and COVI-STIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2020 Sorrento Therapeutics, Inc. All Rights
Reserved.
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