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Radius (RDUS) to Stop Work on Abaloparatide Transdermal System
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Radius Health, Inc. (RDUS - Free Report) provided an update on the abaloparatide transdermal system (abalo-TDS) development program.
RDUS’ first commercial product abaloparatide subcutaneous injection is approved as Tymlos in the United States for treating postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture or patients who failed or are intolerant to other available osteoporosis therapy.
Radius Health is developing an abaloparatide transdermal system for potential use in treating postmenopausal women with osteoporosis.
In December 2021, Radius Health announced disappointing phase III top-line results from the wearABLe study, which evaluated the non-inferiority (NI) of abalo-TDS compared to Tymlos in postmenopausal women with osteoporosis. The study did not meet its primary endpoint of NI for abalo-TDS 300 micrograms (ug) versus Tymlos 80 ug in the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at 12 months.
Shares of RDUS plunged due to unimpressive results. Radius Health outlined three requirements needed to move the abalo-TDS program forward. These are regulatory clarity, a re-constructed supply chain and CMC agreement/economics and lastly, external funding.
Shares of RDUS have lost 10.3% in the year so far compared with the industry’s decline of 23.7%.
Image Source: Zacks Investment Research
Radius Health completed its internal analysis and sought regulatory feedback on the prospective paths for abalo-TDS. Further updates on the same will be provided by the end of this month.
A response from the FDA had indicated that an additional pivotal trial will be required to move forward with any regulatory filing.
Hence, given the clarity on the regulatory pathway, delayed commercial timelines and more than $100 million of additional capital required over the next three years, Radius Health will cease all work on abalo-TDS.
Last month, Radius Health reported a wider loss for the first quarter of 2022 on lower revenues. Tymlos is most likely facing challenges.
Competition is stiff for Tymlos from Eli Lilly & Co's (LLY - Free Report) Forteo and Amgen's (AMGN - Free Report) Prolia.
Eli Lilly’s Forteo generated sales of $137 million in the first quarter.
Amgen’s Prolia sales increased 12% year over year in the March quarter, driven by 10% volume growth and a higher net selling price. AMGN’s Evenity is also approved for treating osteoporosis in women post menopause, who are at high risk of fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
GERN’s loss estimates for 2022 have narrowed 6 cents in the past 60 days. Geron surpassed on earnings in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.
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Radius (RDUS) to Stop Work on Abaloparatide Transdermal System
Radius Health, Inc. (RDUS - Free Report) provided an update on the abaloparatide transdermal system (abalo-TDS) development program.
RDUS’ first commercial product abaloparatide subcutaneous injection is approved as Tymlos in the United States for treating postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture or patients who failed or are intolerant to other available osteoporosis therapy.
Radius Health is developing an abaloparatide transdermal system for potential use in treating postmenopausal women with osteoporosis.
In December 2021, Radius Health announced disappointing phase III top-line results from the wearABLe study, which evaluated the non-inferiority (NI) of abalo-TDS compared to Tymlos in postmenopausal women with osteoporosis. The study did not meet its primary endpoint of NI for abalo-TDS 300 micrograms (ug) versus Tymlos 80 ug in the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at 12 months.
Shares of RDUS plunged due to unimpressive results. Radius Health outlined three requirements needed to move the abalo-TDS program forward. These are regulatory clarity, a re-constructed supply chain and CMC agreement/economics and lastly, external funding.
Shares of RDUS have lost 10.3% in the year so far compared with the industry’s decline of 23.7%.
Image Source: Zacks Investment Research
Radius Health completed its internal analysis and sought regulatory feedback on the prospective paths for abalo-TDS. Further updates on the same will be provided by the end of this month.
A response from the FDA had indicated that an additional pivotal trial will be required to move forward with any regulatory filing.
Hence, given the clarity on the regulatory pathway, delayed commercial timelines and more than $100 million of additional capital required over the next three years, Radius Health will cease all work on abalo-TDS.
Last month, Radius Health reported a wider loss for the first quarter of 2022 on lower revenues. Tymlos is most likely facing challenges.
Competition is stiff for Tymlos from Eli Lilly & Co's (LLY - Free Report) Forteo and Amgen's (AMGN - Free Report) Prolia.
Eli Lilly’s Forteo generated sales of $137 million in the first quarter.
Amgen’s Prolia sales increased 12% year over year in the March quarter, driven by 10% volume growth and a higher net selling price. AMGN’s Evenity is also approved for treating osteoporosis in women post menopause, who are at high risk of fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Zacks Rank & Stock to Consider
Radius Health currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Geron (GERN - Free Report) , which at present carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GERN’s loss estimates for 2022 have narrowed 6 cents in the past 60 days. Geron surpassed on earnings in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.