Travere Therapeutics Announces Transition of Chief Medical Officer
Travere Therapeutics (NASDAQ: TVTX) announced a transition for its chief medical officer, Dr. Noah Rosenberg, to an advisory role by the end of 2021 for personal reasons. Dr. Rosenberg will assist with clinical trial oversight and regulatory submissions throughout 2022. The company has commenced the search for his successor while continuing its clinical programs. CEO Eric Dube praised Dr. Rosenberg's contributions to the ongoing pivotal Phase 3 studies of sparsentan, which are aimed at treating rare diseases.
- Dr. Noah Rosenberg's contributions have been significant in advancing the clinical pipeline.
- The ongoing Phase 3 studies of sparsentan are yielding positive interim results.
- Transition of a key executive may introduce uncertainties in clinical trial management.
- Risks associated with the regulatory approval process for sparsentan remain a concern.
SAN DIEGO, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that its chief medical officer, Noah Rosenberg, M.D., has chosen to transition for personal reasons to an executive advisor role at the end of 2021. Dr. Rosenberg is expected to serve as an advisor to the Company throughout 2022 to assist with clinical trial oversight and regulatory submissions. A search to identify a successor to Dr. Rosenberg is underway while the Company continues to execute its clinical programs as planned.
“On behalf of the Board and our Travere employees, I would like to thank Noah for his many contributions to the advancement of our pipeline,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “Noah has been instrumental in establishing our medical leadership and in building a global clinical network that has delivered high quality, positive interim results from our ongoing pivotal Phase 3 studies of sparsentan. We look forward to working closely with Noah as we continue our clinical trials and the preparation and submission of our planned NDA and MAA applications for sparsentan in 2022.”
“It has been a privilege working alongside the talented and patient-inspired team at Travere. I am proud of our team’s many achievements that have brought us closer to delivering our pipeline to people living with rare diseases who desperately need new treatment options,” said Dr. Rosenberg. “I look forward to working with the teams over the coming months to ensure a smooth transition and to providing ongoing support for the NDA and MAA processes for sparsentan.”
About Travere Therapeutics
At Travere Therapeutics we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com
Forward Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to the Company’s expectations for activities to be conducted in 2022 related to clinical trials and planned regulatory submissions for sparsentan. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the Subpart H accelerated approval pathway. Specifically, the Company faces the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned; risk that the Phase 3 PROTECT Study of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan as planned; and risk that sparsentan will not be approved for efficacy, safety, regulatory or other reasons, and for each of the Company’s programs, risk associated with enrollment of clinical trials for rare diseases and risk that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company’s products, and technological changes that may limit demand for the Company's products. The Company faces additional risks associated with the potential impacts the COVID-19 pandemic may have on its business, including, but not limited to (i) the Company’s ability to continue its ongoing development activities and clinical trials, (ii) the timing of such clinical trials and the release of data from those trials, (iii) the Company’s and its suppliers’ ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of its commercial products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.
Contact:
Chris Cline, CFA
Senior Vice President, Investor Relations & Corporate Communications
888-969-7879
IR@travere.com
FAQ
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