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Pharming Group’s Leniolisib Receives FDA Priority Review for Pediatric APDS Treatment

Story Highlights
  • Pharming Group’s leniolisib receives FDA Priority Review for treating APDS in children.
  • The decision could make leniolisib the first approved treatment for APDS in young children.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Pharming Group’s Leniolisib Receives FDA Priority Review for Pediatric APDS Treatment

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Pharming Group ( (PHAR) ) has shared an update.

On October 1, 2025, Pharming Group announced that the U.S. FDA has accepted and granted Priority Review to its supplemental New Drug Application for leniolisib, aimed at treating children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. This decision, based on positive Phase III study results, marks a significant step for young patients in the U.S. as leniolisib could become the first approved treatment for this age group, potentially altering the disease’s progression and offering new hope to affected families.

The most recent analyst rating on (PHAR) stock is a Hold with a $13.00 price target. To see the full list of analyst forecasts on Pharming Group stock, see the PHAR Stock Forecast page.

Spark’s Take on PHAR Stock

According to Spark, TipRanks’ AI Analyst, PHAR is a Neutral.

Pharming Group’s overall stock score is driven by strong technical analysis and positive earnings call sentiment, indicating potential growth. However, financial performance challenges, particularly in profitability and valuation, weigh down the score. The company’s stable balance sheet and cash flow improvements provide a foundation for future growth if profitability can be enhanced.

To see Spark’s full report on PHAR stock, click here.

More about Pharming Group

Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for rare, debilitating, and life-threatening diseases. The company offers a portfolio of small molecules and biologics and is headquartered in Leiden, the Netherlands, with a significant presence in the U.S.

Average Trading Volume: 11,084

Technical Sentiment Signal: Buy

Current Market Cap: $969.9M

See more insights into PHAR stock on TipRanks’ Stock Analysis page.

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