Pharming Group shares maintain Buy rating on UK drug from Investing.com

On Friday, HC Wainwright maintained its Buy rating and $37.00 price target on Pharming Group (NASDAQ: PHAR) shares following the UK's regulatory approval of Joenja for the treatment of activated phosphoinositide 3-kinase delta. Syndrome (APDS). The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Joenja, marking the first specific approval for APDS treatment in the country. This development expands Joenja's global footprint, with the drug already approved in the US and Israel.

The UK approval complements Pharming Group's ongoing regulatory efforts in multiple regions. The European Union, Canada and Australia are currently testing the drug. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a list of outstanding issues in May that Pharming is addressing with an extended deadline until January 2026. However, the company expects to complete these tasks before the deadline.

In Canada, the deadline for regulatory approval has been extended beyond 2024. This follows Pharming's response to a deficiency notice from Health Canada in July 2024. Despite this delay, the company maintains its positive outlook on the company's shares traded as American Depositary Receipts (ADRs) in the US market.

The approval of Joenja by the MHRA is a significant regulatory milestone for Pharming Group, as it is the first specific treatment for APDS in the UK. The company is actively working to meet the requirements of the CHMP in the EU and is making progress in its manufacturing activities to meet the extended deadline.

The HC Wainwright analyst reiterated his confidence in the company's prospects, as reflected in the unchanged Buy rating and price target for Pharming Group's US-traded ADRs. 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 significant growth in its financial results and patient recruitment for its key products RUCONEST and Joenja. RUCONEST's sales increased by 23% in the second quarter, while Joenja also saw a significant increase in sales. The company has completed enrollment in the first leniolisib trial and is starting a phase 2 trial. Full-year revenue guidance remains between $280 million and $295 million, with second quarter revenue growth of 35% and gross profit stable at 89%.

Operating costs have increased due to investments in Joenja and other areas. However, both RUCONEST and Joenja are experiencing strong sales growth and patient recruitment. The company is optimistic about Joenja's commercial potential in APDS and other indications.

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