Chiasma Announces FDA Acceptance of MYCAPSSA® New Drug Application Resubmission
13 Janeiro 2020 - 9:00AM
Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical
company focused on improving the lives of patients with rare and
serious chronic diseases, today announced that the U.S.
Food and Drug Administration
(FDA) accepted for review the New Drug
Application (NDA) resubmission for its oral octreotide
capsules investigational product candidate, conditionally
trade named MYCAPSSA®. Chiasma is developing MYCAPSSA for
the maintenance treatment of adults with acromegaly. The FDA
assigned a Prescription Drug User-Fee
Act (PDUFA) target action date of June 26, 2020,
which is a six-month review.
“The FDA acceptance of our NDA
resubmission marks the achievement of the first planned
2020 milestone for Chiasma and is a significant step
towards making MYCAPSSA available to eligible patients,” said
Raj Kannan, Chief Executive Officer of Chiasma. “If approved, we
believe MYCAPSSA, as the first oral somatostatin analog, has the
potential to change the standard of pharmacological care in the
management of patients with acromegaly. We look forward to
working with the FDA during the review process towards a potential
approval.”
About Acromegaly
Acromegaly typically develops when a benign
tumor of the pituitary gland produces too much growth hormone,
ultimately leading to significant health problems. Common features
of acromegaly are facial changes, intense headaches, joint pain,
impaired vision and enlargement of the hands, feet, tongue and
internal organs. Serious health conditions associated with the
progression of acromegaly include type 2 diabetes, hypertension,
respiratory disorders and cardiac and cerebrovascular disease. We
believe that approximately 8,000 adult acromegaly patients are
chronically treated with somatostatin analogs in the United
States.
About Chiasma
Chiasma is focused on improving the lives of
patients who face challenges associated with their existing
treatments for rare and serious chronic diseases. Employing its
Transient Permeability Enhancer (TPE®) technology platform, Chiasma
seeks to develop oral medications that are currently available only
as injections. In July 2019, the company reported positive topline
data from its CHIASMA OPTIMAL Phase 3 clinical trial for its
octreotide capsules product candidate, conditionally trade named
MYCAPSSA, for the maintenance therapy of adult patients with
acromegaly in whom prior treatment with somatostatin analogs has
been shown to be effective and tolerated. Prior to trial
initiation, the company reached agreement with the FDA on the
design of the trial through a special protocol assessment. In
January 2020, the FDA accepted the company’s NDA resubmission
seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target
action date is June 26, 2020. Chiasma is headquartered in
Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE
and CHIASMA are registered trademarks of Chiasma. For more
information, please visit the company’s website at
www.chiasma.com.
Forward-Looking Statements
This release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements
regarding the company’s development of octreotide capsules,
conditionally named MYCAPSSA, for the treatment of acromegaly,
statements regarding the timing of regulatory review and potential
approval, statements concerning the nature of the FDA’s review of
the NDA resubmission, statements concerning the commercial or
therapeutic potential of MYCAPSSA, if approved, including the
potential to change the standard of pharmacological care in the
management of patients with acromegaly, and other statements that
are not historical facts. Such statements are subject to numerous
important factors, risks and uncertainties, many of which are
beyond the company’s control, that may cause actual events or
results to differ materially from the company’s current
expectations. For example, there can be no guarantee that the
FDA will agree that MYCAPSSA qualifies for marketing approval in
the United States based on the results from the CHIASMA OPTIMAL
trial and other information contained in the NDA.
Management’s expectations and, therefore, any forward-looking
statements in this press release could be affected by risks and
uncertainties relating to a number of factors. For a discussion of
these and other risks and uncertainties, and other important
factors, any of which could cause the company’s actual results to
differ from those contained in the forward-looking statements, see
the section entitled “Risk Factors” in Chiasma’s Annual Report on
Form 10-K for the year ended December 31, 2018, and in subsequent
filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release,
and Chiasma undertakes no duty to update this information unless
required by law.
Corporate Contact:Dawn SchottlandtVice
President, Investor Relations and Corporate
Communications617-928-5208dawn.schottlandt@chiasmapharma.com
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