Press Release
Protara Therapeutics Receives Rare Pediatric Disease Designation for TARA-002 for the Treatment of Lymphatic Malformations
“Receipt of Rare Pediatric Disease designation from the FDA for TARA-002 in LMs further underscores the significant unmet medical need for the children that are affected by this rare and serious disease,” said
About FDA Rare Pediatric Disease Designation
The FDA grants Rare Pediatric Disease designation for serious diseases that primarily affect children ages 18 years or younger and fewer than 200,000 persons in
About TARA-002 for Lymphatic Malformations
TARA-002, Protara’s lead product candidate, is an investigational cell-based therapy based on the broad immunopotentiator OK-432. OK-432 is approved in
TARA-002 has been granted Rare Pediatric Disease designation by the
About
Protara is committed to identifying and advancing transformative therapies for people with rare and specialty diseases who have limited treatment options. Protara’s portfolio includes its lead program, TARA-002, an investigational cell-based therapy being developed for the treatment of lymphatic malformations, and IV Choline Chloride, an investigational phospholipid substrate replacement therapy for the treatment of IFALD. For more information, visit www.protaratx.com
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential that Protara will receive a priority review voucher from the FDA. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; and uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Protara's filings and reports with the
Company Contact:
Blaine.Davis@protaratx.com
646-844-0337
Source: Protara Therapeutics