{"id":18287,"date":"2022-01-03T10:29:05","date_gmt":"2022-01-03T18:29:05","guid":{"rendered":"https:\/\/marketdepth.com\/?p=18287"},"modified":"2022-01-03T10:29:06","modified_gmt":"2022-01-03T18:29:06","slug":"fda-grants-rpd-to-immix-biopharma","status":"publish","type":"post","link":"https:\/\/marketdepth.com\/fda-grants-rpd-to-immix-biopharma\/","title":{"rendered":"FDA Grants RPD to Immix Biopharma"},"content":{"rendered":"\n
Immix Biopharma, Inc. (Nasdaq: IMMX) announced <\/a>earlier today the U.S. Food and Drug Administration\u2019s decision to grant a Rare Pediatric Disease (RPD) designation for the company’s IMX-110 as a treatment for life-threatening pediatric cancer in children.<\/p>\n\n\n\n IMX-110 is currently being evaluated in a Phase 1b\/2a clinical trial and should the company’s\u00a0New Drug Application in the United States for IMX-110 be approved, ImmixBio may be eligible to receive a Priority Review Voucher, granting it the ability to obtain priority review for any subsequent marketing application.<\/p>\n\n\n\n \u201cWe are pleased by FDA\u2019s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease.\u201d<\/p>ImmixBio\u2019s Chief Executive Officer Ilya Rachman, M.D., PhD<\/cite><\/blockquote>\n\n\n\n Additionally, IMX-110 has already been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of soft tissue sarcoma, and is the first clinical-stage product of ImmixBio\u2019s SMARxT Tissue-Specific\u2122 Platform.\u00a0<\/p>\n\n\n\n \u201cWe are encouraged by our Phase 1b\/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional \u2018single target, single mutation\u2019 development model.\u201d<\/p>ImmixBio\u2019s Chief Executive Officer Ilya Rachman, M.D., PhD<\/cite><\/blockquote>\n","protected":false},"excerpt":{"rendered":"Immix Biopharma, Inc. (Nasdaq: IMMX) announced earlier today the U.S. Food and Drug Administration\u2019s decision to grant a Rare Pediatric Disease (RPD) designation for the company’s IMX-110 as a treatment for life-threatening pediatric cancer in children. Urgent Application IMX-110 is currently being evaluated in a Phase 1b\/2a clinical trial and should the company’s\u00a0New Drug Application… View Article<\/a>","protected":false},"author":3,"featured_media":17705,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":0,"footnotes":""},"categories":[17,8,11,16],"tags":[],"acf":[],"yoast_head":"\nUrgent Application<\/h5>\n\n\n\n