Completion of three pivotal trials in 2021 enables restructuring of the operating infrastructure
Non-Sales headcount reduced by approximately 20%
Reductions focused on areas that supported abaloparatide clinical and regulatory activities
Company to provide Q4 & FY 2021 results and 2022 outlook during earnings on February 24
BOSTON, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") /zigman2/quotes/200442286/composite RDUS +7.02% , has completed an adjustment of its business.
The catalyst for the changes was the completion of three pivotal trials during the second half of 2021. Those trial readouts included: abaloparatide male study (ATOM) on October 18, elacestrant (EMERALD) on October 20, and abaloparatide transdermal system (abalo-TD) (wearABLe) on December 8.
Both the ATOM and EMERALD studies were positive, having achieved statistical significance vs. all primary endpoints. The wearABLe study failed to meet its pre-determined primary endpoint.
Ongoing U.S. regulatory work is proceeding for the abaloparatide male indication, with the sNDA submission expected in Q1, 2022. Similarly, and with our partner the Menarini Group, we are advancing elacestrant along the regulatory pathway in the U.S. and Europe. As previously mentioned for abalo-TD, over the next several months we will continue the process of collecting and analyzing all components of the data from the wearABLe trial.
The business adjustments were focused on non-Sales functions that directly or indirectly supported abaloparatide and TYMLOS(R). Areas that were part of the restructuring included legal, finance, human resources, regulatory, clinical operations, pharmacovigilance, and health economics.
The Company will report Q4 & FY 2021 results and provide its 2022 business outlook on February 24, 2022.
Radius Health is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuroscience, and oncology. Our team works collaboratively and relentlessly to advance our therapies; all with the goal of improving the lives of patients, their families, and their caregivers. The Radius portfolio consists of commercial and clinical development assets, including early to late-stage drug candidates. Find out more at www.radiuspharm.com .
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including those related to our clinical and regulatory efforts.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2020 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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