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Radius (RDUS), Menarini Submit NDA for Breast Cancer Drug
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Radius Health, Inc. (RDUS - Free Report) and partner The Menarini Group recently announced that the latter has submitted a new drug application (NDA) to the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.
The NDA was submitted on the basis of positive phase III data from the EMERALD study, which met both of its primary endpoints - progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.
We note that elacestrant is an investigational selective estrogen receptor degrader (SERD), which Radius has out-licensed to Menarini Group. The candidate is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced breast cancer.
Concurrently, both the companies have requested Priority Review. If the request is accepted, the companies expect the FDA to conduct an 8-month review, incorporating a 6-month priority designation review.
Per the agreement, following the NDA submission, Menarini takes over activities and will be responsible for registration and commercialization. Menarini plans to use its fully owned subsidiary in the United States, Stemline Therapeutics, to commercialize elacestrant following a potential FDA approval. Radius is eligible to receive various development and regulatory and sales milestones.
The successful development and commercialization of additional drugs will generate an incremental stream of revenues for Radius Health, which is currently facing tough times.
Shares of RDUS have gained 46.3% in the year so far compared with the industry’s decline of 24.2%.
Image Source: Zacks Investment Research
Last month, Radius Health announced that it will cease all work on abaloparatide transdermal system (abalo-TDS) development program. The company had earlier outlined three requirements needed to move the abalo-TDS program forward. These were regulatory clarity, a re-constructed supply chain and CMC agreement/economics and external funding.
However, 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), Menarini Submit NDA for Breast Cancer Drug
Radius Health, Inc. (RDUS - Free Report) and partner The Menarini Group recently announced that the latter has submitted a new drug application (NDA) to the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.
The NDA was submitted on the basis of positive phase III data from the EMERALD study, which met both of its primary endpoints - progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.
We note that elacestrant is an investigational selective estrogen receptor degrader (SERD), which Radius has out-licensed to Menarini Group. The candidate is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced breast cancer.
Concurrently, both the companies have requested Priority Review. If the request is accepted, the companies expect the FDA to conduct an 8-month review, incorporating a 6-month priority designation review.
Per the agreement, following the NDA submission, Menarini takes over activities and will be responsible for registration and commercialization. Menarini plans to use its fully owned subsidiary in the United States, Stemline Therapeutics, to commercialize elacestrant following a potential FDA approval. Radius is eligible to receive various development and regulatory and sales milestones.
The successful development and commercialization of additional drugs will generate an incremental stream of revenues for Radius Health, which is currently facing tough times.
Shares of RDUS have gained 46.3% in the year so far compared with the industry’s decline of 24.2%.
Image Source: Zacks Investment Research
Last month, Radius Health announced that it will cease all work on abaloparatide transdermal system (abalo-TDS) development program. The company had earlier outlined three requirements needed to move the abalo-TDS program forward. These were regulatory clarity, a re-constructed supply chain and CMC agreement/economics and external funding.
However, 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.
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%.