Pharming Group shares hold Buy rating on UK drug nod By Investing.com

On Friday, H.C. Wainwright maintained its Buy rating and $37.00 price target for shares of Pharming Group (NASDAQ: PHAR), following the U.K.’s regulatory approval of Joenja for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS). The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. has authorized Joenja, marking the first specific approval for APDS treatment in the country. This development expands Joenja’s global presence, with the drug already approved in the United States and Israel.

The U.K. approval adds to Pharming Group’s ongoing regulatory efforts in multiple regions. The European Union, Canada, and Australia are currently reviewing the drug, with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) having issued a List of Outstanding Issues in May, which Pharming is addressing with a deadline extended to January 2026. However, the company anticipates completing these tasks before the deadline.

In Canada, the timeline for regulatory approval has been extended beyond 2024. This follows Pharming’s response to a Notice of Deficiency from Health Canada in July 2024. Despite this delay, the firm maintains a positive outlook on the company’s shares traded as American Depositary Receipts (ADRs) on the U.S. market.

The authorization of Joenja by the MHRA is a significant regulatory milestone for Pharming Group, as it represents the first specific treatment for APDS in the U.K. The company is actively working to address the CHMP’s requirements in the E.U. and is making progress on its manufacturing activities to meet the extended deadline.

The analyst from H.C. Wainwright reiterated confidence in the company’s prospects, as seen in the maintained Buy rating and price target for Pharming Group’s U.S.-traded ADRs. The ongoing regulatory reviews in other countries indicate the potential for further expansion of Joenja’s market reach in the near future.

In other recent news, Pharming Group, a biopharmaceutical company, reported substantial growth in its financial results and patient enrollment for its key products, RUCONEST and Joenja. RUCONEST sales saw a rise of 23% in Q2, while Joenja also experienced a significant sales increase. The company completed enrollment for the first leniolisib study and is initiating a Phase 2 study. Full-year revenue guidance remains between $280 million and $295 million, with a Q2 revenue growth of 35% and a stable gross profit of 89%.

Operating expenses have increased due to investment in Joenja and other areas. However, both RUCONEST and Joenja are showing strong sales growth and patient enrollment. The company is optimistic about the commercial potential of Joenja in APDS and other indications.

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