STOCKHOLM, Oct. 7, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm:
CALTX) ("Calliditas") today announced that the company now
controls 100% of the share capital of Genkyotex SA ("Genkyotex"),
after the completion of a centralized squeeze out offer to all
minority shareholders.
Genkyotex's lead product candidate, setanaxib, is a
first-in-class NOX inhibitor that targets NOX 1 and NOX 4, which
are major drivers of fibrogenesis in multiple organs. In Q4 2021,
Calliditas plans to initiate a 52-week, randomized,
placebo-controlled, double-blind, trial with an adaptive phase
2b/3 design with setanaxib in 318
patients with primary biliary cholangitis (PBC). As previously
announced in August 2021, Calliditas
received FDA fast track designation for setanaxib in PBC.
Calliditas will also initiate a Phase 2 proof-of-concept study in
head and neck cancer in 2021, which will investigate the
administration of setanaxib in conjunction with immunotherapy
targeting cancer associated fibroblasts (CAFs).
"We are delighted to have completed our acquisition of
Genkyotex, which means that we now can fully integrate the business
and thereby leverage the platform optimally", said CEO Renée
Aguiar-Lucander.
Subsequent to the squeeze-out, Genkyotex has become a wholly
owned subsidiary of Calliditas and have been delisted from the
Euronext stock exchanges.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on October 7, 2021 at 8:00
a.m. CET.
About Calliditas
Calliditas Therapeutics is a specialty pharmaceutical company
based in Stockholm, Sweden focused
on identifying, developing and commercializing novel treatments in
orphan indications, with an initial focus on renal and hepatic
diseases with significant unmet medical needs. Calliditas' lead
product candidate, Nefecon, is a proprietary, novel oral
formulation of budesonide, an established, highly potent local
immunosuppressant, for the treatment of the autoimmune renal
disease IgA nephropathy, or IgAN, for which there is a high unmet
medical need and there are no approved treatments. Calliditas is
running a global Phase 3 study within IgAN and, if approved, aims
to commercialize Nefecon in the United
States. Calliditas is also planning to start clinical trials
with NOX inhibitors in primary biliary cholangitis and head and
neck cancer. Calliditas is listed on Nasdaq Stockholm
(ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT).
Visit www.calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding Calliditas' strategy, business plans, regulatory
submissions and focus. The words "may," "will," "could," "would,"
"should," "expect," "plan," "anticipate," "intend," "believe,"
"estimate," "predict," "project," "potential," "continue," "target"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements in this
press release are based on management's current expectations and
beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, any related to Calliditas' business, operations, the
potential for FDA acceptance for and the success and timeline of
the development of setanaxib, clinical trials, supply chain,
strategy, goals and anticipated timelines, competition from other
biopharmaceutical companies, and other risks identified in the
section entitled "Risk Factors" in Calliditas' reports filed with
the Securities and Exchange Commission. Calliditas cautions you not
to place undue reliance on any forward-looking statements, which
speak only as of the date they are made. Calliditas disclaims any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent Calliditas' views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date.
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SOURCE Calliditas Therapeutics