PHAR

If approved, J oenja would be available to eligible patients aged 4 years and older with APDS who weigh 13 kg or more Decision follows recent approval of Joenja for children aged 4 to 11 years with APDS weighing at least 27 kg PDUFA target action date of January 30, 2027 Leiden, the Netherlands, September 25,  2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for lower doses of Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, for children aged 4 years and older who weigh between 13 kg and 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.

FDA approval expands Joenja indication to include children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) ages 4 to 11 who weigh at least 27kg Newly approved Joenja doses are expected to be available in October Leiden, the Netherlands, September 11, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for 40 mg and 50 mg twice-daily dosing of Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years weighing at least 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. With this approval, Joenja becomes the first FDA-approved treatment for children aged 4 to 11 years with APDS in the U.S. The newly approved Joenja doses are expected to be available to eligible pediatric patients in the U.S. in October through Pharming's established specialty distribution network and patient-support infrastructure.

Pharming Group told investors to expect up to $425 million in 2026 revenue. The Company now expects as little as $375 million -- and the stock lost 22% in a single session.

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Pharming Group N.V. (“Pharming” or the “Company”) (NASDAQ: PHAR) on behalf of investors concerning the Company's possible violations of federal securities laws.IF YOU ARE AN INVESTOR WHO LOST MONEY ON PHARMING GROUP N.V. (PHAR), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS.What Is The Investigation About? On July 30, 2026, the Company reported second quarter earnings, inc.

Pharming Group shares fell 22% on July 30, 2026 after the Company reported a Q2 revenue decline and reduced its full-year 2026 outlook by roughly $30 million. Levi & Korsinsky is investigating potential securities law violations on behalf of PHAR investors Pharming Group shares fell 22% on July 30, 2026 after the Company reported a Q2 revenue decline and reduced its full-year 2026 outlook by roughly $30 million. Levi & Korsinsky is investigating potential securities law violations on behalf of PHAR investors

Pharming Group's legacy product RUCONEST posted a 10% year-over-year sales decline in Q2 2026 -- and PHAR shares fell 22% the day it was reported. Levi & Korsinsky is investigating potential securities law violations on behalf of PHAR shareholders.

Pharming Group N.V. (PHAR) Q2 2026 Earnings Call Transcript

Pharming Group NASDAQ: PHAR reported second-quarter revenue of $90.2 million, down 3% from a year earlier, as growth from its Joenja treatment partly offset lower sales of hereditary angioedema therapy RUCONEST. The company reduced its full-year revenue outlook by $30 million but said it expects RUCONEST sales to stabilize and return to growth during the second half of 2026.

Pharming Group NASDAQ: PHAR executives said first-quarter 2026 results reflected an expected decline in RUCONEST revenue tied largely to specialty pharmacy inventory movements and the company's planned exit from certain non-U.S. markets, while Joenja continued to post strong growth and the company advanced regulatory and clinical milestones across its pipeline. Get Pharming Group alerts:Sign UpRUCONEST revenue declined as inventory dynamics played out CEO Fabrice Chouraqui said quarterly revenue fell primarily due to RUCONEST, a decline he said was “largely expected due to inventory drawdown at specialty pharmacy,” which the company previously discussed on its fourth-quarter 2025 call.

Pharming Group N.V. (PHAR) Q1 2026 Earnings Call Transcript