OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023
25 Oktober 2023 - 10:25PM
OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical
data on RAYALDEE® extended-release calcifediol (ERC) at the
American Society of Nephrology (ASN) Kidney Week in Philadelphia on
Thursday, November 2, 2023. These data will be presented in a
poster, “Control of Secondary Hyperparathyroidism with
Extended-release Calcifediol is Associated with Slower CKD
Progression” (#TH-PO1152) at 10:00 a.m. Eastern time in Exhibit
Halls B-D by authors Charles W. Bishop Ph.D., Stephen A. Strugnell
Ph.D. and Akhtar Ashfaq, M.D., FACP, FASN.
OPKO Health will present two other posters at
ASN Kidney Week summarizing additional new clinical data on
RAYALDEE. One poster, “Extended-release Calcifediol Overcomes
Impact of Low eGFR on Vitamin D Metabolism” (#FR-PO319), will be
presented in the “Bone and Mineral Metabolism: Basic” session at
10:00 a.m. Eastern time on Friday, November 3, 2023, in Exhibit
Halls B-D. The data demonstrate that RAYALDEE effectively and
reliably raises serum levels of 25-hydroxyvitamin D (25D) and
1,25-dihydroxyvitamin D in non-dialysis patients with secondary
hyperparathyroidism (SHPT), making it an attractive alternative to
vitamin D hormone therapies (i.e., calcitriol, paricalcitol and
doxercalciferol).
The other poster, “Extended-Release Calcifediol:
A Data Journey from Phase 3 Studies to Real-World Evidence
Highlights the Importance of Early Treatment of Secondary
Hyperparathyroidism” (#FR-PO972), will be presented in the “CKD
Interventions: Trials and Quality Improvement” session at 10:00
a.m. Eastern time on Friday, November 3, 2023 in Exhibit Halls B-D.
The data demonstrate that effective control of SHPT has been
achieved with RAYALDEE treatment in both randomized clinical trials
and in a real-world clinical experience trial. Data from these
trials support early initiation of SHPT treatment with RAYALDEE in
order to delay disease progression.
About RAYALDEE®
RAYALDEE is an extended-release (ER) oral
formulation of calcifediol, a prohormone of calcitriol, the active
form of vitamin D3. The product is the first and only medicine
approved by the U.S. Food and Drug Administration for raising serum
total 25D and lowering blood levels of intact parathyroid hormone
(iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3
or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European
countries. Slowing CKD progression with RAYALDEE treatment is not
currently an approved indication.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and
diagnostics company that seeks to establish industry-leading
positions in large, rapidly growing markets by leveraging its
discovery, development, and commercialization expertise and novel
and proprietary technologies. For more information, visit
www.opko.com.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains "forward-looking
statements," as that term is defined under the Private Securities
Litigation Reform Act of 1995 (PSLRA), which statements may be
identified by words such as "expects," "plans," "projects," "will,"
“could,” "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including
statements regarding the market for RAYALDEE, and our strategies or
prospects and expectations about RAYALDEE, the therapeutic
benefits, safety profile or effectiveness of RAYALDEE or whether
early initiation of SHPT treatment with RAYALDEE would delay
disease progression. Many factors could cause our actual activities
or results to differ materially from the activities and results
anticipated in forward- looking statements. These factors include
those described in our Annual Reports on Form 10-K filed and to be
filed with the Securities and Exchange Commission and in our other
filings with the Securities and Exchange Commission, as well as the
risks that the accuracy and effectiveness of the data may not be
reproducible or indicative of future results and that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. In
addition, forward-looking statements may also be adversely affected
by general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press
release speak only as of the date the statements were made, and we
do not undertake any obligation to update forward- looking
statements. We intend that all forward-looking statements be
subject to the safe- harbor provisions of the PSLRA.
Contacts:
LHA Investor RelationsYvonne Briggs,
310-691-7100ybriggs@lhai.com
or
Bruce Voss, 310-691-7100bvoss@lhai.com
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