XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
31 Oktober 2023 - 12:30PM
XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator,
announced today it has earned a $5 million milestone related to the
U.S. Food and Drug Administration’s (FDA) acceptance of Day One
Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a
monotherapy for relapsed or progressive pediatric low-grade glioma
(pLGG). The FDA has granted tovorafenib Priority Review and
established a Prescription Drug User Fee Act (PDUFA) date of April
30, 2024.
“Tovorafenib has the potential to address a key unmet need in
children whose low-grade gliomas with BRAF alterations have
relapsed or progressed,” stated Owen Hughes, Executive Chairman of
XOMA. “A novel, targeted, orally available option has the
opportunity to set a new standard-of-care in this patient
population.”
In March 2021, XOMA paid $13.5 million upfront plus a share of a
future event-based milestone, to acquire the $54 million in
potential milestones and mid-single digit royalties associated with
tovorafenib, in addition to the economics associated with
vosaroxin, from Viracta Therapeutics.
About XOMA CorporationXOMA is a biotechnology
royalty aggregator playing a distinctive role in helping biotech
companies achieve their goal of improving human health. XOMA
acquires the potential future economics associated with
pre-commercial and commercial therapeutic candidates that have been
licensed to pharmaceutical or biotechnology companies. When
XOMA acquires the future economics, the seller receives
non-dilutive, non-recourse funding they can use to advance their
internal drug candidate(s) or for general corporate purposes.
The Company has an extensive and growing portfolio with more than
70 assets (asset defined as the right to receive potential future
economics associated with the advancement of an underlying
therapeutic candidate). For more information about the
Company and its portfolio, please visit
www.xoma.com.
Forward-Looking Statements/Explanatory
NotesCertain statements contained in this press release
are forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, including statements regarding the timing and
amount of potential commercial payments to XOMA and other
developments related to tovorafenib and the potential of XOMA’s
portfolio of partnered programs and licensed technologies
generating substantial milestone and royalty proceeds over
time. In some cases, you can identify such forward-looking
statements by terminology such as “expect,” “may,” “will”, or
“could,” the negative of these terms or similar expressions.
These forward-looking statements are not a guarantee
of XOMA’s performance, and you should not place undue
reliance on such statements. These statements are based on
assumptions that may not prove accurate, and actual results could
differ materially from those anticipated due to certain risks
inherent in the biotechnology industry, including those related to
the fact that our product candidates subject to out-license
agreements are still being developed, and our licensees may require
substantial funds to continue development which may not be
available; we do not know whether there will be, or will continue
to be, a viable market for the products in which we have an
ownership or royalty interest; if the therapeutic product
candidates to which we have a royalty interest do not receive
regulatory approval, our third-party licensees will not be able to
market them; and the impact to the global economy as a result of
the COVID-19 pandemic. Other potential risks to XOMA meeting
these expectations are described in more detail in XOMA's most
recent filing on Form 10-K and in other filings with the Securities
and Exchange Commission. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement
in this press release represents XOMA's beliefs and assumptions
only as of the date of this press release and should not be relied
upon as representing its views as of any subsequent date.
XOMA disclaims any obligation to update any forward-looking
statement, except as required by applicable law.
EXPLANATORY NOTE: Any references to “portfolio” in this press
release refer strictly to milestone and/or royalty rights
associated with a basket of drug products in development. Any
references to “assets” in this press release refer strictly to
milestone and/or royalty rights associated with individual drug
products in development.
As of the date of this press release, all assets in XOMA’s
milestone and royalty portfolio, except VABYSMO® and IXINITY®, are
investigational compounds. Efficacy and safety have not been
established. There is no guarantee that any of the
investigational compounds will become commercially
available.
XOMA
Investor Contact |
XOMA
Media Contact |
Juliane Snowden |
Kathy Vincent |
XOMA Corporation |
KV Consulting & Management |
+1 646-438-9754 |
+1 310-403-8951 |
juliane.snowden@xoma.com |
kathy@kathyvincent.com |
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