FDA Granted Orphan Drug Designation To Cabaletta Bio's CABA-201 For Treatment Of Systemic Sclerosis
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The FDA has granted Orphan Drug Designation to Cabaletta Bio's CABA-201 for the treatment of systemic sclerosis, potentially accelerating its development and approval process.
March 20, 2024 | 11:03 am
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Cabaletta Bio's CABA-201 receiving Orphan Drug Designation from the FDA for systemic sclerosis treatment marks a pivotal advancement, potentially speeding up its development and approval.
Orphan Drug Designation is a significant regulatory milestone that can enhance a drug's development path by providing benefits such as tax credits, user fee waivers, and eligibility for seven years of market exclusivity upon approval. For Cabaletta Bio, this designation for CABA-201 could lead to increased investor interest and potentially higher stock prices in the short term due to the positive implications for the drug's development timeline and market potential.
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