Welcome to our dedicated page for PHARM news (Ticker: PHARM), a resource for investors and traders seeking the latest updates and insights on PHARM stock.
Pharming Group N.V. (PHARM) is a biotechnology leader developing innovative therapies for rare diseases, including hereditary angioedema (HAE) and activated phosphoinositide 3-kinase delta syndrome (APDS). This page provides investors and healthcare professionals with direct access to the company's latest press releases and official announcements.
Track PHARM's progress through updates on clinical trials, regulatory milestones, and commercialization efforts for therapies like RUCONEST® and Joenja®. Our curated news feed ensures you stay informed about earnings reports, strategic partnerships, and market expansion initiatives without extraneous information.
Discover updates categorized for quick navigation, including product development breakthroughs, financial performance disclosures, and operational strategy refinements. All content is sourced directly from Pharming's verified communications to maintain accuracy and compliance.
Bookmark this page for streamlined access to PHARM's evolving story in rare disease treatment. Check regularly for new developments that demonstrate the company's commitment to addressing unmet medical needs through biopharmaceutical innovation.
Pharming Group N.V. has announced a public cash offer to acquire all shares of Abliva AB for SEK 0.45 per share, valuing the transaction at approximately US$66.1 million. Abliva's lead product, KL1333, is currently in a pivotal clinical trial for treating primary mitochondrial disease (PMD) with mitochondrial DNA mutations, targeting over 30,000 potential patients in the U.S., EU4, and UK.
The acquisition will be funded through existing cash, with Abliva's Board of Directors unanimously recommending shareholders accept the offer. The company has secured acceptance undertakings from the three largest shareholders, representing 49.82% of outstanding shares. The acceptance period is expected to run from January 16, 2025, to February 7, 2025.
Pharming Group announces positive topline results from its Phase III clinical trial of leniolisib in children aged 4-11 years with APDS (activated phosphoinositide 3-kinase delta syndrome), a rare primary immunodeficiency. The trial enrolled 21 children across the US, Europe, and Japan, evaluating the oral PI3Kδ inhibitor's safety, tolerability, and efficacy.
The study met its primary endpoints, showing improvement in lymphoproliferation and immunophenotype correction across all dose levels, consistent with previous results in adolescent and adult patients. All patients completed the 12-week treatment period with only mild to moderate adverse events reported. Pharming plans to include this data in global regulatory filings for pediatric approval starting in 2025.
Pharming Group has announced its participation in the Jefferies London Healthcare Conference 2024, scheduled for November 19-21 in London, U.K. CEO Sijmen de Vries will deliver a presentation on Wednesday, November 20 at 08:00 GMT/09:00 CET. The presentation will be accessible via live webcast, with a replay available in the 'Upcoming Events' and 'News' sections of Pharming's website. Interested parties can arrange one-to-one meetings with Pharming's management team by contacting their Investor Relations team or Jefferies representative.
Pharming Group reported strong Q3 2024 financial results with total revenues increasing 12% to US$74.8 million. RUCONEST® revenue grew 6% to US$63.6 million, while Joenja® revenue jumped 72% to US$11.2 million. First nine months revenues rose 25% to US$204.5 million. Operating profit increased to US$4.1 million from US$1.9 million in Q3 2023. The company maintains its 2024 revenue guidance of US$280-295 million. CEO Sijmen de Vries announced he will not seek reappointment at the May 2025 AGM. The company also announced the start of a Phase II trial evaluating leniolisib in primary immunodeficiencies.
Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced that it will release its preliminary (unaudited) third quarter 2024 financial results on Thursday, October 24, 2024. The results will cover the period ended September 30. The company will host a presentation for analysts and investors at 13:30 CEST/07:30 am EDT on the same day.
To participate in the conference call, interested parties must register in advance using the provided link. Upon registration, dial-in information and a unique PIN will be provided for call access. The company will only take questions from dial-in attendees. Additionally, a live webcast of the presentation will be available, with a separate registration link provided for those who wish to watch online.
Pharming Group (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) has initiated a Phase II clinical trial to evaluate leniolisib in primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kẟ signaling in lymphocytes. The trial will include patients with ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency, and PTEN deficiency, among others. These PIDs have a prevalence of approximately seven patients per million, compared to one to two per million for APDS.
The study, conducted at the National Institutes of Health (NIH), is a single arm, open-label, dose range-finding study with approximately 12 patients. It aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy of leniolisib in the targeted PID population. This trial represents Pharming's second PID clinical program for leniolisib, expanding beyond its current approved use for APDS in adults and pediatric patients 12 years and older.
Pharming Group N.V. announces that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Leniolisib is the first treatment approved in the U.K. specifically for APDS, a rare and progressive primary immunodeficiency. It is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.
The MHRA evaluated the Marketing Authorisation Application (MAA) for leniolisib through the International Recognition Procedure (IRP) pathway based on the U.S. Food and Drug Administration (FDA) approval received in March 2023. This marks Pharming's third country approval for APDS.
Pharming Group (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced its participation in two major investor conferences in September 2024. The company will be present at the 2024 Wells Fargo Healthcare Conference in Boston from September 4-6, where CEO Sijmen de Vries will engage in a fireside chat on September 6 at 08:45 AM ET. Additionally, Pharming will attend the H.C. Wainwright 26th Annual Global Investment Conference in New York from September 9-11, with de Vries presenting on September 9 at 10:30 AM ET.
Both presentations will be available via live webcast and replay on Pharming's website. Investors interested in one-to-one meetings with Pharming's management team can contact the company's Investor Relations team or their Wells Fargo or H.C. Wainwright representatives.
Pharming Group reported a 35% increase in Q2 2024 revenues to US$74.1 million, driven by strong sales of RUCONEST® and Joenja®. RUCONEST® revenues rose 23% to US$63 million, while Joenja® increased 16% to US$11.1 million from Q1 2024. First half 2024 revenues reached US$129.7 million, up 33% from 1H 2023. The company is on track to meet its 2024 revenue guidance of US$280 million - US$295 million.
However, cash and marketable securities dropped to US$161.8 million due to convertible bond refinancing. Pharming's operating loss narrowed, but net loss was US$1.2 million in Q2 2024, down from a US$1.3 million profit in Q2 2023. The company continues to expand Joenja® availability and expects a decision from the UK MHRA in Q4 2024.
Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced it will report its preliminary (unaudited) second quarter and first half 2024 financial results on Thursday, August 1, 2024. The report will cover the period ended June 30. The company will host a presentation for analysts and investors at 13:30 CEST/07:30 am EDT on the same day.
Interested parties can participate in the conference call by registering in advance. Upon registration, dial-in information and a unique PIN will be provided for call access. The company will only take questions from dial-in attendees. Additionally, a live webcast of the presentation will be available for those who prefer to watch online. Both the conference call and webcast require pre-registration through the provided links.
