Radius Health Business Update
BOSTON, July 27, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS), provided a business update today on the Company’s progress.
New patient adds for the U.S. TYMLOS business continue to grow. New TYMLOS patients in Q2, 2021 were up over 40% vs. the same period in 2020. New patients are defined as those patients who have been prescribed TYMLOS and subsequently filled their first prescription.
The Company’s focus on fracture patients and corresponding healthcare providers – as the primary patient target for TYMLOS – is deepening. To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.
From a U.S. regulatory point of view, both pivotal studies, ATOM (Osteoporotic Men at High Risk of Fracture) and wearABLe (Transdermal System) are on track for topline readouts in 2H, 2021. Pending the wearABLe trial results and FDA approval, the Company intends to price the Transdermal System at a premium to TYMLOS.
On the European regulatory front, Radius completed scientific consultations with several EU member states in Q1, 2021, submitted a letter of intent to resubmit, completed a dossier review with the EMA, and is on track refile in Q4, 2021.
The Company received clarity from the FDA following the Type C meeting in June. Radius plans to move forward with a seamless Phase 2/3 pivotal trial for PWS. RAD011 had previously been granted Orphan Drug and Fast Track Designation by the FDA.
Based on current plans, the pivotal trial will initiate in Q4, 2021 or Q1, 2022, with anticipated topline readout in the second half of 2024.
There are approximately 22,000 to 24,000 PWS patients in the U.S. To date, there are no approved therapies to treat the hyperphagia experienced with the disease. The Company is committed to working closely with caregivers, advocacy groups, and regulators – globally – to safely advance RAD011 for this orphan disease.
Radius’ goal: through the pivotal trial and subsequent data readout, demonstrate efficacy and safety for FDA approval, and to help patients living with PWS.
About TYMLOS (abaloparatide) injection
About ATOM Phase 3 Study
About the Abaloparatide Transdermal System and wearABLe Phase 3 Study
About Prader-Willi Syndrome
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.
Presentation Details TBA
Industrial IoT: The Innovation Never Stops
CannTech Expo Exhibit Hall Open