Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS
22 Agosto 2023 - 9:00AM
Business Wire
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced that the United States
Food and Drug Administration (FDA) has assigned a standard review
and a Prescription Drug User Fee Act (PDUFA) action date of June
16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for
the treatment of transfusion-dependent anemia in patients with
lower risk myelodysplastic syndromes (MDS). In addition, the FDA
informed the Company that it is currently planning to hold an
advisory committee meeting as part of the NDA review.
“We look forward to working with the FDA to complete the NDA
review process on a timely basis,” said John A. Scarlett, M.D.,
Geron’s Chairman and Chief Executive Officer. “With the PDUFA date
now set, we continue to expect an imetelstat launch in the United
States by the end of the first half of 2024, subject to FDA
approval.”
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
malignancies. Data from non-clinical studies and clinical trials of
imetelstat provide strong evidence that imetelstat targets
telomerase to inhibit the uncontrolled proliferation of malignant
stem and progenitor cells in myeloid hematologic malignancies
resulting in malignant cell apoptosis and potential
disease-modifying activity. Imetelstat has been granted Fast Track
designation by the U.S. Food and Drug Administration for both the
treatment of adult patients with transfusion dependent anemia due
to Low or Intermediate-1 risk MDS that is not associated with
del(5q) who are refractory or resistant to an erythropoiesis
stimulating agent, and for adult patients with Intermediate-2 or
High-risk MF whose disease has relapsed after or is refractory to
janus associated kinase (JAK) inhibitor treatment. Imetelstat is
currently not approved by any regulatory authority.
About Geron
Geron is a late-stage biopharmaceutical company pursuing
therapies with the potential to extend and enrich the lives of
patients living with hematologic malignancies. Our first-in-class
telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning
science in a treatment that may alter the underlying drivers of
disease. Geron currently has two Phase 3 pivotal clinical trials
underway evaluating imetelstat in lower risk myelodysplastic
syndromes (LR MDS), and in relapsed/refractory myelofibrosis (MF).
To learn more, visit www.geron.com or follow us on LinkedIn.
Use of Forward-Looking Statements
Except for the historical information contained herein, this
press release contains forward-looking statements made pursuant to
the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that such statements,
include, without limitation, those regarding: (i) that FDA has
assigned a PDUFA action date of June 16, 2024; (ii) that FDA is
currently planning to hold an advisory committee meeting as part of
the NDA review; (iii) that the Company looks forward to working
with the FDA to complete the NDA review process on a timely basis;
(iv) that the Company continues to expect an imetelstat launch in
the United States by the end of the first half of 2024, subject to
FDA approval; (v) that imetelstat may alter the underlying drivers
of disease and has the potential to demonstrate disease-modifying
activity in patients; and (vi) other statements that are not
historical facts, constitute forward-looking statements. These
forward-looking statements involve risks and uncertainties that can
cause actual results to differ materially from those in such
forward-looking statements. These risks and uncertainties, include,
without limitation, risks and uncertainties related to: (a) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, without any clinical holds; (b)
whether any future safety or efficacy results cause the
benefit-risk profile of imetelstat to become unacceptable; (c)
whether imetelstat actually demonstrates that it alters the
underlying drivers of disease and has disease-modifying activity in
patients; (d) whether the FDA will hold an advisory committee
meeting and the discussions at and outcome of that meeting; and (e)
whether the FDA will extend the PDUFA action date or approve
imetelstat for the treatment of transfusion-dependent anemia in
patients with lower risk MDS. Additional information on the above
risks and uncertainties and additional risks, uncertainties and
factors that could cause actual results to differ materially from
those in the forward-looking statements are contained in Geron’s
filings and periodic reports filed with the Securities and Exchange
Commission under the heading “Risk Factors” and elsewhere in such
filings and reports, including Geron’s quarterly report on Form
10-Q for the quarter ended June 30, 2023 and future filings and
reports by Geron. Undue reliance should not be placed on
forward-looking statements, which speak only as of the date they
are made, and the facts and assumptions underlying the
forward-looking statements may change. Except as required by law,
Geron disclaims any obligation to update these forward-looking
statements to reflect future information, events or
circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20230822600509/en/
Aron Feingold Investor and Media Relations investor@geron.com
media@geron.com
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