RDUS Radius Health Inc.

10.95
+0.04  (+0%)
Previous Close 10.91
Open 10.56
52 Week Low 10.32
52 Week High 29.89
Market Cap $508,871,981
Shares 46,472,327
Float 46,133,802
Enterprise Value $604,179,980
Volume 808,778
Av. Daily Volume 635,934
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Upcoming Catalysts

Drug Stage Catalyst Date
Elacestrant - EMERALD
Breast cancer
Phase 3
Phase 3
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Abaloparatide-SC ATOM
Male Osteoporosis
Phase 3
Phase 3
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Abaloparatide -Transdermal Patch (wearABLe)
Osteoporosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TYMLOS (Abaloparatide)
Osteoporosis
Approved
Approved
PDUFA date originally scheduled for March 30 2017 delayed by three months to June 30, 2017. Approval announced April 28, 2017.

Latest News

  1. WALTHAM, Mass. and FLORENCE, Italy, Sept. 25, 2020 /PRNewswire/ -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) and the Menarini Group today announced an update on the elacestrant Phase 3 EMERALD trial.


     

    MENARINI Group Logo.

     

    EMERALD Phase 3 Study

    The target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer. The study reached its enrollment goal of 466 patients overall, including 220 (47%) with tumors harboring an ESR1 mutation as detected in circulating tumor DNA by the Guardant Health Guardant360 liquid biopsy test.  

    Patients…

    WALTHAM, Mass. and FLORENCE, Italy, Sept. 25, 2020 /PRNewswire/ -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) and the Menarini Group today announced an update on the elacestrant Phase 3 EMERALD trial.



     



    MENARINI Group Logo.

     

    EMERALD Phase 3 Study

    The target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer. The study reached its enrollment goal of 466 patients overall, including 220 (47%) with tumors harboring an ESR1 mutation as detected in circulating tumor DNA by the Guardant Health Guardant360 liquid biopsy test.  

    Patients will be followed until the required number of events to assess progression-free survival - the primary endpoint of the study - is reached at which time the primary analysis will be performed. It is anticipated that this analysis will take place in the second half of 2021.

    An independent data monitoring committee (IDMC) has been continuously monitoring the safety and efficacy of patients enrolled in the EMERALD trial. After enrollment of 70% of planned patients, the committee formally reviewed results of a futility analysis. In completing their review, the IDMC recommended that the trial continues to advance in an unmodified manner.

    "We are thrilled about the continued progress for the program. Elacestrant continues to be the most advanced oral SERD in Phase 3 development and given that, we aim on being first to deliver Phase 3 data in the class, and upon clinical success, a regulatory submission," said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.

    Commenting further, Barker Ergun added that "the Menarini/Radius partnership has been a tremendous success to date and the completion of patient enrollment in the EMERALD trial brings us one step closer to bringing an oral SERD to women and men with advanced breast cancer."

    Dr. Maureen Conlan, Oncology Therapeutic Area Head for Radius, commented "Completing the enrollment of the EMERALD trial, despite the challenges of the COVID-19 pandemic, has been a great achievement. I am grateful to our team as well as the study investigators and patients for their efforts to date in supporting and participating in this trial."

    In summarizing on recent progress, Dr. Charles Morris, Chief Medical Officer for Radius added "This is an exciting milestone for Radius and our partner, the Menarini Group, with regard to the elacestrant program. We look forward to seeing additional advancement of the program including activities related to various life cycle management opportunities for the compound."

    About Menarini Group

    Menarini Group is a leading international pharmaceutical company with a presence in 140 countries, including a direct presence in over 70 countries. Its global platform extends throughout Europe, U.S., Central America, Africa, the Middle East and Asia Pacific, and generates over $4.2 billion in annual sales. Menarini is committed to oncology, with an already commercialized product in the US and several new investigational drugs in development for the treatment of a variety of tumors. For over 130 years, Menarini has also been investing in the development, production and distribution of pharmaceuticals to serve patients and physicians around the world with a full portfolio of products covering a number of different therapeutic areas.

    About Radius

    Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com

    About elacestrant (RAD1901) and EMERALD Phase 3 Study

    Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study has enrolled 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator's choice of an approved hormonal agent. The primary endpoint of the study is progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

    Forward-Looking Statements             

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

    These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks related to elacestrant's development and, if approved, commercialization, including the impact of the COVID-19 pandemic thereon. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Translations: in the event of any discrepancy, the English language version prevails

    Logo - https://mma.prnewswire.com/media/652491/MENARINI_Group_Logo.jpg

     

    Cision View original content:http://www.prnewswire.com/news-releases/radius-health--menarini-group-provide-elacestrant-update-301138118.html

    SOURCE Menarini I.F.R.

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    • Target enrollment milestone reached in the Phase 3 EMERALD study
    • Life cycle planning advancing in parallel with current Phase 3 monotherapy program

    WALTHAM, Mass. and FLORENCE, Italy, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) and the Menarini Group today announced an update on the elacestrant Phase 3 EMERALD trial.

    EMERALD Phase 3 Study

    The target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer. The study reached its enrollment goal of 466 patients overall, including 220…

    • Target enrollment milestone reached in the Phase 3 EMERALD study
    • Life cycle planning advancing in parallel with current Phase 3 monotherapy program

    WALTHAM, Mass. and FLORENCE, Italy, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) and the Menarini Group today announced an update on the elacestrant Phase 3 EMERALD trial.

    EMERALD Phase 3 Study

    The target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer. The study reached its enrollment goal of 466 patients overall, including 220 (47%) with tumors harboring an ESR1 mutation as detected in circulating tumor DNA by the Guardant Health Guardant360 liquid biopsy test.  

    Patients will be followed until the required number of events to assess progression-free survival - the primary endpoint of the study- is reached at which time the primary analysis will be performed. It is anticipated that this analysis will take place in the second half of 2021.

    An independent data monitoring committee (IDMC) has been continuously monitoring the safety and efficacy of patients enrolled in the EMERALD trial. After enrollment of 70% of planned patients, the committee formally reviewed results of a futility analysis. In completing their review, the IDMC recommended that the trial continues to advance in an unmodified manner.

    "We are thrilled about the continued progress for the program. Elacestrant continues to be the most advanced oral SERD in Phase 3 development and given that, we aim on being first to deliver Phase 3 data in the class, and upon clinical success, a regulatory submission," said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.

    Commenting further, Barker Ergun added that "the Menarini/Radius partnership has been a tremendous success to date and the completion of patient enrollment in the EMERALD trial brings us one step closer to bringing an oral SERD to women and men with advanced breast cancer."

    Dr. Maureen Conlan, Oncology Therapeutic Area Head for Radius, commented "Completing the enrollment of the EMERALD trial, despite the challenges of the COVID-19 pandemic, has been a great achievement. I am grateful to our team as well as the study investigators and patients for their efforts to date in supporting and participating in this trial."

    In summarizing on recent progress, Dr. Charles Morris, Chief Medical Officer for Radius added "This is an exciting milestone for Radius and our partner, the Menarini Group, with regard to the elacestrant program. We look forward to seeing additional advancement of the program including activities related to various life cycle management opportunities for the compound."

    About Menarini Group

    Menarini Group is a leading international pharmaceutical company with a presence in 140 countries, including a direct presence in over 70 countries. Its global platform extends throughout Europe, U.S., Central America, Africa, the Middle East and Asia Pacific, and generates over $4.2 billion in annual sales. Menarini is committed to oncology, with an already commercialized product in the US and several new investigational drugs in development for the treatment of a variety of tumors. For over 130 years, Menarini has also been investing in the development, production and distribution of pharmaceuticals to serve patients and physicians around the world with a full portfolio of products covering a number of different therapeutic areas.

    About Radius



    Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com

    About elacestrant (RAD1901) and EMERALD Phase 3 Study

    Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study has enrolled 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator's choice of an approved hormonal agent. The primary endpoint of the study is progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

    Forward-Looking Statements         

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

    These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks related to elacestrant's development and, if approved, commercialization, including the impact of the COVID-19 pandemic thereon. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Investor Relations Contact:



    Elhan Webb, CFA

    Email: 

    Phone: 617-551-4011

    Primary Logo

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    • Organizational Change within Finance Function
    • Creates Capital, Strategy & Transactions Group

    WALTHAM, Mass., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS), today announced that Jose (Pepe) Carmona will be stepping down as Chief Financial Officer of Radius Health, Inc., with immediate effect.

    "Pepe joined Radius one month after the FDA approval of TYMLOS® in 2017 and he has been instrumental in helping Radius advance from a development company to a commercial company with a late stage pipeline," said Kelly Martin, Radius CEO. "Over the last few months, he has been part of the team that completed the elacestrant business development transaction, which was considered a critical step for the…

    • Organizational Change within Finance Function

    • Creates Capital, Strategy & Transactions Group

    WALTHAM, Mass., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS), today announced that Jose (Pepe) Carmona will be stepping down as Chief Financial Officer of Radius Health, Inc., with immediate effect.

    "Pepe joined Radius one month after the FDA approval of TYMLOS® in 2017 and he has been instrumental in helping Radius advance from a development company to a commercial company with a late stage pipeline," said Kelly Martin, Radius CEO. "Over the last few months, he has been part of the team that completed the elacestrant business development transaction, which was considered a critical step for the company," added Martin. "I would like to thank Pepe for his efforts and contributions, and we wish him nothing but the very best as he moves forward," concluded Martin.

    Mr. Dan Dolan, who has served as Head of Financial Planning and Analysis since he joined the company in 2017, will become the Principal Financial and Accounting Officer. Dan was instrumental in the launch of TYMLOS® and works closely with all of the business functions within the company. In this role, Dan will report directly to Kelly Martin.

    Mr. Jim Chopas, currently the Company's Controller, will continue in that role with oversight of all finance functions including accounting, audit, tax, and treasury. Jim has been with Radius since 2018 and will also report directly to Kelly Martin.

    In addition to these changes within the finance group, the Company is establishing a new group: Capital, Strategy, and Transactions (CST). This cross functional team will integrate several important and related functions including financial modeling and analytics, capital structure and balance sheet management, investor relations, banking and analyst interactions, business development, and alliance/project management.

    The Company expects to add a select number people to this group with skill sets that extend our current capabilities.

    About Radius

    Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com

    About TYMLOS (abaloparatide) injection

    TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

    These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the Company's expectations in connection with the organizational change in the finance function and the creation of the CST group and the Company's expectations in connection with the addition of new members of the CST group. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Investor Relations Contact:

    Elhan Webb, CFA

    Email: 

    Phone: 617-551-4011

    Primary Logo

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  2. WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) today announced data presentations on abaloparatide-SC at the upcoming American Society for Bone and Mineral Research (ASBMR) 2020 Annual Virtual Meeting which will take place between September 11-15. 

    "We are excited that data from our histomorphometry study, showing that treatment with abaloparatide results in significant increase in bone formation in postmenopausal women with osteoporosis after 3 months of treatment, has been selected as an oral presentation," said Dr. Charles Morris, Radius Health's Chief Medical Officer. "We are also excited that our partner Teijin Pharma Limited will be sharing detailed data from the Phase…

    WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) today announced data presentations on abaloparatide-SC at the upcoming American Society for Bone and Mineral Research (ASBMR) 2020 Annual Virtual Meeting which will take place between September 11-15. 

    "We are excited that data from our histomorphometry study, showing that treatment with abaloparatide results in significant increase in bone formation in postmenopausal women with osteoporosis after 3 months of treatment, has been selected as an oral presentation," said Dr. Charles Morris, Radius Health's Chief Medical Officer. "We are also excited that our partner Teijin Pharma Limited will be sharing detailed data from the Phase III clinical study of abaloparatide-SC in Japan which included osteoporosis patients at high risk for fracture and met its primary efficacy endpoint. Helping more women with postmenopausal osteoporosis at high risk for fracture is our ultimate goal."

    Abaloparatide-SC Presentations at ASBMR 2020

    • Abaloparatide, A Novel Selective Agonist of PTH/PTHrP Receptor, Increases Lumbar, Total Hip and Femoral Neck BMD in Japanese Patients with Osteoporosis - A Phase III Randomized Clinical Trial ACTIVE-J (Matsumoto)

      P-342; Friday, September 11, 10:00 AM - 04:00 PM



    • Abaloparatide, A Novel Selective Agonist for PTH/PTHrP Receptor, Effectively Improved Hip Geometry and Biomechanical Properties Assessed by Hip Structural Analysis in Elderly Osteoporotic Patients - Results of the Japanese Phase 3 Trial, ACTIVE-J (Sone)

      P-671;  Friday, September 11, 10:00 AM - 04:00 PM



    • Effects of Abaloparatide on Modeling and Remodeling Based Bone Formation (Dempster)

      TYMLOS Phase 2 Histomorphometry study results

      Oral Presentation #1040; Saturday, September 12, 11:00AM



    • Heterogenicity in the Cortical Response to Abaloparatide and Teriparatide in the Proximal Femur by DXA-Based 3D Modeling (Winzenrieth)

      P-463; Friday, September 11, 10AM-4PM



    • Abaloparatide is more effective than PTH in restoring bone formation and bone structural properties, but both agents similarly correct the impaired bone material properties and citrate content in mice with Type 1 Diabetes (Teguh)

      P-053; Friday, September 11, 10AM-4PM



    • Abaloparatide Improves Bone Mass and Microarchitecture Without Increasing Resorption in Adult Rats Subjected to Hindlimb Unloading (Ozgurel)

      P-707; Friday, September 11, 10AM-4PM



    • Abaloparatide Promotes Bone Repair of Vertebral Defects in an Ovariectomized Rat Model of Osteoporosis (Makino)

      P-607; Friday, September 11, 10AM-4PM

    About Postmenopausal Osteoporosis

    Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs. Osteoporotic fractures create a significant healthcare burden and represent a significant unmet medical need. The majority of osteoporosis-related fractures in the U.S. among those 50 and older occur in women.  Individuals who had a fracture are at increased risk for refracture yet many remain unevaluated and untreated.

    The National Osteoporosis Foundation (NOF) has estimated that nearly 8.2 million women in the U.S. over the age of 50 have osteoporosis, and nearly one in two women over the age of 50 will have a fragility fracture (or low-impact fracture that is often the result of a fall from standing height or lower) in her remaining lifetime.

    The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease or breast cancer.

    About TYMLOS (abaloparatide) injection

    TYMLOS® (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF OSTEOSARCOMA

    • Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown if TYMLOS will cause osteosarcoma in humans.
    • The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
    • Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.

    Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

    Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

    Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

    Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo.

    INDICATIONS AND USAGE

    TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.

    Limitations of Use

    Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.

    For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com 

    About Radius



    Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com 

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the incidence of osteoporotic fractures and the health burden associated with osteoporosis and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch.

    These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the adverse impact the COVID-19 pandemic may have on our business; availability of additional capital; uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; the risk of litigation or other challenges regarding our intellectual property rights; success of any collaboration or partnership agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Investor Relations & External Communications Contact:

    Elhan Webb, CFA

    Email:  

    Phone: 617-551-4011

    Primary Logo

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    • Innovative transdermal technology enables delivery of abaloparatide molecule – a peptide - across the skin
    • Trial success followed by regulatory approval would provide a completely unique drug administration option for postmenopausal women with osteoporosis.
    • wearABLe progress follows recent male study enrollment completion

    WALTHAM, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) today announced completion of enrollment in its "wearABLe" phase 3 trial.

    The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device ("abaloparatide-patch") compared with the current subcutaneous formulation, marketed as TYMLOS®. The study aimed…

    • Innovative transdermal technology enables delivery of abaloparatide molecule – a peptide - across the skin
    • Trial success followed by regulatory approval would provide a completely unique drug administration option for postmenopausal women with osteoporosis.
    • wearABLe progress follows recent male study enrollment completion

    WALTHAM, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS) today announced completion of enrollment in its "wearABLe" phase 3 trial.

    The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device ("abaloparatide-patch") compared with the current subcutaneous formulation, marketed as TYMLOS®. The study aimed to enroll 474 postmenopausal women with osteoporosis at high risk for fracture. Actual patients enrolled, based on demand, was approximately 500. These patients will be treated for 12 months and have a further one month on study for safety assessment at the completion of 12 months of therapy.

    "We are delighted to have completed enrollment of the wearABLe study," commented Dr. Charles Morris, Radius' Chief Medical Officer. "This brings us one step closer to potentially having the ability to deliver osteoanabolic therapy through an alternative to daily subcutaneous injection," he continued. "I am grateful to our teams, our investigators, and their patients who have helped us reach this milestone. We will share top-line data results in the fourth quarter of 2021."

    The abaloparatide-patch leverages the technology advances of the solid microstructured transdermal system, which was developed by Kindeva Drug Delivery, a spin-out of the 3M Corporation.  This technology innovation allows the successful delivery of peptides – in our case, abaloparatide - across the skin. To date, this has not been proven possible by traditional transdermal patch capabilities.

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

    "This drug delivery technology is being developed to provide a favorable experience for patients with osteoporosis treated with TYMLOS," commented Dr. Bruce Mitlak, recently named Head of Discovery Science for the areas of musculoskeletal, endocrinology, and metabolic for Radius.

    About Radius

    Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics.

    For more information, please visit www.radiuspharm.com.

    About TYMLOS (abaloparatide) injection

    TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

    About Abaloparatide-Patch and wearABLe Phase 3 Study

    Abaloparatide-patch was developed in a collaboration between Radius and Kindeva Drug Delivery ("Kindeva") (formerly 3M Drug Delivery Systems) with the application of Kindeva's innovative microstructured transdermal patch technology. The Phase 3 wearABLe abaloparatide-patch study is the first pivotal study to evaluate treatment using a novel non-injectable delivery of an anabolic therapy. The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density ("BMD") non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 500 patients with postmenopausal osteoporosis at high risk for fracture. The primary endpoint of the study is the percentage change in lumbar spine BMD at 12 months.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

    These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the adverse impact the COVID-19 pandemic may have on our business; availability of additional capital; uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; the risk of litigation or other challenges regarding our intellectual property rights; success of any collaboration or partnership agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Investor Relations Contact:

    Elhan Webb, CFA

    Email: 

    Phone: 617-551-4011

     

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