RAD1901

Gurnet Point Capital and Patient Square Capital Complete Their Acquisition of Radius Health, Inc.

Retrieved on: 
Monday, August 15, 2022
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CAMBRIDGE, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Gurnet Point Capital (Gurnet Point) and Patient Square Capital (Patient Square) announced today the completion of their acquisition of Radius Health, Inc. (Nasdaq: RDUS) (Radius).

Key Points: 
  • CAMBRIDGE, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Gurnet Point Capital (Gurnet Point) and Patient Square Capital (Patient Square) announced today the completion of their acquisition of Radius Health, Inc. (Nasdaq: RDUS) (Radius).
  • Pursuant to the terms of the merger agreement, the purchaser entity for Gurnet Point and Patient Square merged with and into Radius, and as a result, Radius has become a wholly-owned indirect subsidiary of Gurnet Point and Patient Square.
  • Gurnet Point Capital is a leading healthcare fund that invests in de-risked life sciences companies.
  • Patient Square invests in businesses that strive to improve patient lives, strengthen communities and create a healthier world.

Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Retrieved on: 
Thursday, August 11, 2022
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The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.

Key Points: 
  • The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.
  • "The FDA's acceptance of our NDA with Priority Review marks an important regulatory milestonefor our company," commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
  • Elacestrant is an investigational selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced or metastatic 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.

 Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Retrieved on: 
Thursday, August 11, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fulvestrant, Woman, PDUFA, HIV disease progression rates, Risk, RAD1901, NDA, Inflammation, ORR, Diagnosis, Population, Blastic plasmacytoid dendritic cell neoplasm, Clinical trial, Cancer, Menarini, Cardiology, CDK, European Medicines Agency, ESR1, Prader–Willi syndrome, Man, Patient, Review, MAA, Infection, Research and development, Breast cancer, Spasm, Angelman syndrome, SERD, SOC, Safety, NASDAQ, Priority review, Research, Mutation, DOR, PFS, Fast Track, Gastroenterology, Progression-free survival, Neuro, New Drug Application, Analgesic, Fracture, Food, Development, Osteoporosis, EMA, Pharmaceutical industry, Radius, Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology

The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.

Key Points: 
  • The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.
  • The FDAs acceptance of our NDA with Priority Review marks an important regulatory milestone for our company, commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
  • Elacestrant is an investigational selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced or metastatic 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.

Radius Health Publishes Investor Presentation Outlining Company’s Progress and Board Process Resulting in Agreement to be Acquired at Significant Premium

Retrieved on: 
Thursday, July 7, 2022
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Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro- orphan diseases, and oncology.

Key Points: 
  • Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro- orphan diseases, and oncology.
  • Radius lead product, 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.
  • The Offer for the outstanding Shares referenced in this presentation has not yet commenced.
  • Holders of Shares can obtain these documents free of charge when they are filed from the SECs website at www.sec.gov or on the Companys website at www.radiuspharm.com .

Radius Announces First Patient Randomized in the RAD011 Pivotal Trial for Prader-Willi Syndrome

Retrieved on: 
Thursday, July 7, 2022
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Currently, 9 US sites are activated for screening and patient recruitment will continue across the US and globally as non-US sites are activated.

Key Points: 
  • Currently, 9 US sites are activated for screening and patient recruitment will continue across the US and globally as non-US sites are activated.
  • RAD011 has Orphan Drug Designation and has been granted Fast Track by the U.S. Food and Drug Administration (FDA).
  • Radius has initiated a seamless pivotal Phase 2/3 study for patients with Prader-Willi Syndrome.
  • These forward-looking statements should not be relied upon as representing Radius views as of any date subsequent to the date of this press release.

Radius Health Announces Agreement to be Acquired by Gurnet Point Capital and Patient Square Capital

Retrieved on: 
Thursday, June 23, 2022
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Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro- orphan diseases, and oncology.

Key Points: 
  • Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro- orphan diseases, and oncology.
  • Gurnet Point Capital is a leading healthcare fund that invests in de-risked life sciences companies.
  • www.gurnetpointcapital.com
    Patient Square Capital ( www.patientsquarecapital.com ) is a dedicated health care investment firm that partners with best-in-class management teams whose products, services and technologies improve health.
  • Patient Square invests in businesses that strive to improve patient lives, strengthen communities and create a healthier world.

Radius Health Expands Non-US Market Footprint for TYMLOS

Retrieved on: 
Wednesday, June 8, 2022
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Three additional market agreements now signed and executed:

Key Points: 
  • Three additional market agreements now signed and executed:
    BOSTON, June 08, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Radius or the Company) (NASDAQ: RDUS) provided an update on the global business expansion of TYMLOS (abaloparatide) subcutaneous injection.
  • In accordance with the terms of the agreements, each company will register, commercialize, and distribute TYMLOS on an exclusive basis in their respective territories.
  • These counterparties will be responsible for all commercial activities related to TYMLOS including sales, marketing, medical affairs, pricing, and reimbursement.
  • Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan neurosciences diseases, and oncology.

Radius Health Update on Abaloparatide Transdermal System

Retrieved on: 
Wednesday, June 1, 2022
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New timeline for earliest possible abalo-TDS launch: 2H 2025

Key Points: 
  • New timeline for earliest possible abalo-TDS launch: 2H 2025
    Eliminates prospective program costs: $100+ million over 3+ years: CMC, clinical, and launch
    Company continues to dynamically manage capital and its allocation, risk, and overall timelines
    BOSTON, June 01, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Radius or the Company) (NASDAQ: RDUS) provided an update on the abaloparatide transdermal system (abalo-TDS) development program.
  • Despite missing the non-inferiority margin, the transdermal system demonstrated a bone building benefit to patients.
  • Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuroscience orphan diseases, and oncology.
  • The abaloparatide transdermal system was developed in a collaboration between Radius and Kindeva Drug Delivery (Kindeva), as successor to 3M Company and 3M innovative Properties Company with the application of Kindevas innovative microstructured transdermal system technology.

Radius Adds Industry Veterans Jennifer A. Jarrett and Susan Vissers Lisa to Board of Directors

Retrieved on: 
Friday, May 20, 2022
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BOSTON, May 20, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS) today announced that it has added two new independent members to the Board of Directors (the “Board”). Effective immediately, Jennifer A. Jarrett and Susan Vissers Lisa have joined the Board as Class I and Class III directors, respectively. In addition, Radius’ Board also announced several corporate governance changes to further enhance shareholder input.

Key Points: 
  • Effective immediately, Jennifer A. Jarrett and Susan Vissers Lisa have joined the Board as Class I and Class III directors, respectively.
  • I am pleased to welcome both Jennifer and Susie to the Radius Board.
  • Six of the Companys current directors, including Ms. Jarrett and Ms. Lisa, have joined the Board in the past two years, reflecting a deliberate refreshment process across the Companys leadership.
  • Susan Vissers Lisa, 53, recently served as Senior Vice President, Investor Relations of CVS Health Corporation through April 2022.

Radius Provides Agenda for Today’s R&D Webcast

Retrieved on: 
Tuesday, April 5, 2022
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A live audio webcast of the call can be accessed from the Investors section of the Companys website, www.radiuspharm.com .

Key Points: 
  • A live audio webcast of the call can be accessed from the Investors section of the Companys website, www.radiuspharm.com .
  • To access the replay, dial (855) 859-2056 or (404) 537-3406 for International, using conference ID number 9678881.
  • The live audio webcast of the call can be accessed from the Investors section of the Companys website, https://ir.radiuspharm.com/events-and-presentations .
  • Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan diseases, and oncology.