Shares of Radius Health, Inc. (RDUS - Free Report) jumped 16.36% after the company and partner Menarini Group announced that the late-stage EMERALD study on pipeline candidate elacestrant was successful.
Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group. It was being evaluated in the phase III EMERALD study as a potential once daily, oral treatment, in patients with ER+/ HER2- metastatic breast cancer (mBC). Approximately 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation.
There were two primary endpoints — progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring ESR1 mutations.
The study met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup.
Per the company, ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/ HER2- mBC patients. Elacestrant is the first oral SERD to show positive top-line results in a pivotal trial as a monotherapy versus standard of care in the targeted patient population.
The safety profile of elacestrant observed in the study was similar to that of the previous clinical study.
Regulatory submissions for elacestrant in both the United States and the European Union are planned in 2022.
Please note that elacestrant received fast track designation from the FDA in 2018.
Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need and hence the development of the candidate will be a significant boost.
The stock has gained 0.8% so far this year against the industry’s decrease of 16.2%.
The successful development of other candidates will also reduce Radius’ dependence on lead drug Tymlos (abaloparatide) injection, which was approved by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The pipeline progress has been impressive as well. The company recently announced positive top-line results from the ATOM study evaluating abaloparatide 80mcg subcutaneous (SC) for use in males with osteoporosis.
However, competition is stiff for Tymlos from Eli Lilly & Co's (LLY - Free Report) Forteo and Amgen's (AMGN - Free Report) Prolia. Hence, it is looking to diversify its revenue base.
Radius currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare sector is Regeneron Pharmaceuticals (REGN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised upward by 1.97% for 2021 and 0.3% for 2022 over the past 30 days. The stock has surged 16.5% year to date.
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Shares of Radius Health, Inc. (RDUS - Free Report) jumped 16.36% after the company and partner Menarini Group announced that the late-stage EMERALD study on pipeline candidate elacestrant was successful.
Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group. It was being evaluated in the phase III EMERALD study as a potential once daily, oral treatment, in patients with ER+/ HER2- metastatic breast cancer (mBC). Approximately 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation.
There were two primary endpoints — progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring ESR1 mutations.
The study met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup.
Per the company, ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/ HER2- mBC patients. Elacestrant is the first oral SERD to show positive top-line results in a pivotal trial as a monotherapy versus standard of care in the targeted patient population.
The safety profile of elacestrant observed in the study was similar to that of the previous clinical study.
Regulatory submissions for elacestrant in both the United States and the European Union are planned in 2022.
Please note that elacestrant received fast track designation from the FDA in 2018.
Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need and hence the development of the candidate will be a significant boost.
The stock has gained 0.8% so far this year against the industry’s decrease of 16.2%.
The successful development of other candidates will also reduce Radius’ dependence on lead drug Tymlos (abaloparatide) injection, which was approved by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The pipeline progress has been impressive as well. The company recently announced positive top-line results from the ATOM study evaluating abaloparatide 80mcg subcutaneous (SC) for use in males with osteoporosis.
However, competition is stiff for Tymlos from Eli Lilly & Co's (LLY - Free Report) Forteo and Amgen's (AMGN - Free Report) Prolia. Hence, it is looking to diversify its revenue base.
Radius currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare sector is Regeneron Pharmaceuticals (REGN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised upward by 1.97% for 2021 and 0.3% for 2022 over the past 30 days. The stock has surged 16.5% year to date.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How To Profit From Trillions On Spending For Infrastructure >>
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