Benzinga | Jul 27, 2021 11:13AM EDT

Radius Health Says Added 5,000+ New TYMLOS Patients In Q2

Added 5,000+ new TYMLOS patients in Q2, 2021, up 40+% vs. Q2, 2020 and 3% vs. Q1, 2021 ATOM and wearABLe abaloparatide Phase 3 trial readouts remain on track for 2H, 2021 EU * Added 5,000+ new TYMLOS patients in Q2, 2021, up 40+% vs. Q2, 2020 and 3% vs. Q1, 2021

* ATOM and wearABLe abaloparatide Phase 3 trial readouts remain on track for 2H, 2021

* EU abaloparatide regulatory resubmission remains on schedule for Q4, 2021

* Prader-Willi Syndrome (PWS) pivotal Phase 2/3 study to be initiated in Q4, 2021 or Q1, 2022

* Q2, 2021 earnings results scheduled for August 5, 2021

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.

Abaloparatide

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.

RAD011

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.