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Radius Completes Enrollment in Phase III Osteoporosis Study

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Radius Health, Inc. (RDUS - Free Report) announced the completion of enrollment in its “wearABLe” phase III study. The study is assessing the safety and efficacy of a wearable abaloparatide-transdermal patch in the treatment of postmenopausal women with osteoporosis at high risk for fracture compared with the current subcutaneous formulation, marketed as Tymlos.

The phase III “wearABLe” abaloparatide-patch study is the first study to evaluate treatment with a novel non-injectable delivery of an anabolic therapy. The primary endpoint of the study is the percentage change in lumbar spine BMD at 12 months. The study aimed to enroll 474 postmenopausal women with osteoporosis at high risk for fracture, whereas the actual number enrolled was about 500. These patients will be treated for 12 months and remain in the study for another month for safety assessment afterthe completion of 12 months of therapy.

The enrollment in this study follows the completion of enrollment in the phase III study, ATOM, which is assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis.

Shares of the company have slumped 42.9% year to date compared with the industry’s decline of 10.2%.

The abaloparatide-patch was developed in a collaboration with Kindeva Drug Delivery, a spin-out of the 3M Corporation, with the application of the latter’s microstructured transdermal system. This technology innovation allows the successful delivery of peptides —abaloparatide— across the skin.

This initiative was designed as a patient-centric approach and a differentiating strategy for Radius as part of a multi-year partnership with Kindeva/3M. A successful study and a subsequent regulatory approval would provide patients with a new option of abaloparatide administration. Such an option is typically not available for biological products.

The successful development of the candidate and a potential approval will bring in additional funds for the company.

Zacks Rank & Other Stocks to Consider

Radius currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the sector include CatalentInc. (CTLT - Free Report) , BioLineRx Ltd. (BLRX - Free Report) and BioPath Holdings Inc (BPTH - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Catalent’s earnings per share estimates have increased from $2.08 to $2.38 for 2021 and from $2.40 to $2.80 for 2022 in the past 60 days. Shares of the company have increased 47.5% year to date.

BioLineRx’s loss per share estimates have narrowed from $2.24 to $1.95 for 2020 and from $2.88 to $1.44 for 2021 in the past 60 days. Shares of the company have decreased 23.6% year to date.

BioPath’s loss per share estimates have narrowed from $3.77 to $3.14 for 2020 and from $2.88 to $2.42 for 2021in the past 60 days. Shares of the company have decreased 51.7% year to date.

 

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