Lantern Pharma Awarded Orphan Designation Status For "(+)N-hydroxy-N-(methylacylfulvene)urea" For The Treatment Of Diffuse Large B-Cell Lymphoma/High-Grade B-Cell Lymphoma With MYC And BCL2 Rearrangements
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Lantern Pharma has received Orphan Drug Designation from the FDA for its drug '(+)N-hydroxy-N-(methylacylfulvene)urea' aimed at treating Diffuse Large B-Cell Lymphoma/High-Grade B-Cell Lymphoma with MYC and BCL2 rearrangements. This status can provide certain benefits, including market exclusivity upon approval, assistance in clinical trial design, tax credits, and exemption from FDA application fees.
November 28, 2023 | 2:50 pm
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Lantern Pharma's Orphan Drug Designation for its B-Cell Lymphoma treatment could lead to market exclusivity, support in clinical trials, tax advantages, and fee waivers, potentially enhancing the drug's commercial prospects and providing a positive catalyst for the company's stock.
Orphan Drug Designation is a significant positive development for biotech companies as it can lead to market exclusivity for seven years post-approval, which protects against competition. It also offers tax credits for clinical research costs, exemption from FDA application fees, and assistance in clinical trial design, all of which can reduce costs and accelerate the development process. This news is likely to be viewed positively by investors and could lead to an increase in Lantern Pharma's stock price in the short term.
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