RADIUS HEALTH, INC. (NASDAQ:RDUS) Files An 8-K Other Events
Item 8.01
Other Events. |
On March 10, 2017, Radius Health, Inc. (the Company) issued a
press release announcing that the U.S. Food and Drug
Administration (FDA) has extended the Prescription Drug User Fee
Act date for the Companys New Drug Application (NDA) for
abaloparatide-SC by three months to June 30, 2017 to allow time
to review information submitted by the Company in response to
information requests from the FDA.The Companys submission of the
additional information has been determined by the FDA to
constitute a Major Amendment to the NDA.A copy of the press
release is filed as Exhibit 99.1 and is incorporated herein by
reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
Description |
99.1 |
Press Release dated March 10, 2017. |
About RADIUS HEALTH, INC. (NASDAQ:RDUS)
Radius Health, Inc. is a biopharmaceutical company focused on developing therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Its product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase III development for use in the reduction of fracture risk in postmenopausal women with osteoporosis. Its clinical pipeline also includes an investigational abaloparatide transdermal patch for use in osteoporosis and the investigational drug RAD1901 for use in hormone-driven and hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Its preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for use in cancer. RADIUS HEALTH, INC. (NASDAQ:RDUS) Recent Trading Information
RADIUS HEALTH, INC. (NASDAQ:RDUS) closed its last trading session down -2.62 at 40.49 with 997,244 shares trading hands.