EMERYVILLE, Calif. - XOMA Royalty Corporation (NASDAQ: XOMA), a biotech royalty aggregator, announced today that Zevra Therapeutics has received U.S. Food and Drug Administration (FDA) approval for MIPLYFFA™ (arimoclomol). This treatment, used in combination with miglustat, is designated for the neurological manifestations of Niemann-Pick disease type C (NPC) in patients aged two and older. MIPLYFFA™ is the first FDA-approved therapy for NPC, a rare and progressive neurodegenerative disorder.
The FDA approval marks the addition of the sixth commercial asset to XOMA Royalty's portfolio, which includes more than 70 assets comprising rights to future economics from underlying therapeutic candidates. XOMA Royalty's CEO, Owen Hughes, expressed optimism about MIPLYFFA™'s potential to improve patient outcomes and slow disease progression.
XOMA Royalty's financial interest in MIPLYFFA™ stems from a deal made in June 2023 with LadRx, involving a $5 million upfront payment and a mid-single digit royalty on arimoclomol's commercial sales. Additionally, XOMA may receive up to $52.6 million in milestone payments from Zevra.
XOMA Royalty specializes in acquiring future economic rights associated with pre-commercial therapeutic candidates and commercial assets licensed to pharmaceutical or biotechnology companies. These acquisitions provide non-dilutive, non-recourse funding to the sellers, which they can utilize for advancing internal drug candidates or for other corporate purposes.
The approval of MIPLYFFA™ provides a new treatment option for NPC patients in the United States. This announcement is based on a press release statement and includes forward-looking statements subject to risks inherent in the biotechnology industry, including the development and market viability of licensed products.
Investors are cautioned not to place undue reliance on these forward-looking statements, which reflect XOMA Royalty's views only as of today. The company disclaims any obligation to update any forward-looking statement, except as required by law.
In other recent news, XOMA Corporation reported significant financial developments, including an $8.1 million milestone payment from Viracta Therapeutics linked to the sale of a Priority Review Voucher by Day One Biopharmaceuticals. This is part of a larger agreement where XOMA initially invested $13.5 million to secure up to $54 million in potential milestones plus mid-single-digit royalties on OJEMDA™. Following the U.S. Food and Drug Administration's approval of Day One Biopharmaceuticals' New Drug Application for OJEMDA™, XOMA secured an additional $9 million milestone payment.
H.C. Wainwright recently raised its price target for XOMA shares to $117, maintaining a Buy rating. The firm's decision reflects a positive view of XOMA's financial future, influenced by recent major transactions, including deals involving products like Vabysmo and Ojemda, which have improved XOMA's financial prospects.
In addition to these developments, XOMA announced its rebranding to XOMA Royalty Corporation, a change that won't affect the company's operations or financial standing. The renaming is a significant step for XOMA as it positions itself in the pharmaceutical industry under the new moniker. These are all recent developments in the company's operations.
InvestingPro Insights
XOMA Royalty Corporation's recent FDA approval for MIPLYFFA™ has generated a positive outlook among market analysts. Reflecting on the company's performance and potential, here are some key insights drawn from InvestingPro:
InvestingPro Data shows that XOMA's market capitalization stands at approximately $329.95 million, indicating a solid presence in the biotech sector. The company's revenue has seen an impressive growth, with a surge of 277.95% in the last twelve months as of Q2 2024. This growth is further exemplified by a quarterly revenue increase of 568.64% in Q2 2024. Additionally, XOMA's gross profit margin remains high at 91.84% for the same period, underscoring the company's efficiency in managing its cost of goods sold.
An InvestingPro Tip points out that analysts expect sales to continue to grow in the current year, which could be a promising sign for the company's future financial performance. This anticipated growth could be fueled by the recent FDA approval and the subsequent commercialization of MIPLYFFA™.
Another InvestingPro Tip highlights that XOMA is not expected to be profitable this year. While this may seem concerning, it's worth noting that the company operates with a moderate level of debt and has liquid assets that exceed its short-term obligations. This financial stability, along with the potential for revenue from MIPLYFFA™ and other assets in its portfolio, may offer a cushion as the company works towards profitability.
Investors interested in further analysis and additional InvestingPro Tips can find more detailed information on https://www.investing.com/pro/XOMA, which includes a total of 11 tips for XOMA Royalty Corporation. These insights can help investors make more informed decisions by considering both the opportunities and the challenges that the company may face.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.