U.S. Food And Drug Administration Approves Orphan Drug Designation For Immix Biopharma NXC-201 As A Treatment For Amyloid Light Chain Amyloidosis
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The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Immix Biopharma's NXC-201 for the treatment of Amyloid Light Chain (AL) Amyloidosis. The designation qualifies NXC-201 for 7 years of U.S. market exclusivity after approval, tax credits for qualified clinical testing, and a waiver of the Prescription Drug User Fee. The Amyloidosis market was $3.6 billion in 2017 and is expected to reach $6 billion in 2025.
September 21, 2023 | 12:55 pm
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Immix Biopharma's NXC-201 has been granted Orphan Drug Designation by the FDA for the treatment of AL Amyloidosis. This could lead to significant market exclusivity and financial benefits for the company.
The FDA's Orphan Drug Designation for NXC-201 could lead to significant financial benefits for Immix Biopharma, including 7 years of U.S. market exclusivity, tax credits for qualified clinical testing, and a waiver of the Prescription Drug User Fee. This could potentially increase the company's revenues and profitability, positively impacting its stock price.
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