Sorrento Announces It Has Submitted An Emergency Use Authorization (EUA) Application to the FDA for COVI-STIX™ Rapid Test f...
December 22 2020 - 06:59PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that an Emergency Use Authorization (EUA) Application has
been submitted to the US Food and Drug Administration for its
COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2
virus nucleocapsid antigen in nasal samples of patients.
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.
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 ("ADCs"), 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 StatementsThis
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 EUA for COVI-STIX; 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; the ease and
flexibility of COVI-STIX and the potential for the ease and
flexibility thereof to allow for large scale use; Sorrento’s
manufacturing capacity and expectations regarding the number of
tests that can be produced per month; 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 EUA 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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