Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals (Nasdaq: JAZZ) will host a webcast on July 20, 2021, at 4:30 p.m. ET to discuss the recent FDA approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), which occurred on June 30, 2021. This drug is intended for patients with acute lymphoblastic leukemia (ALL) who are hypersensitive to E. coli-derived asparaginase. The event aims to provide insights into the drug's commercial launch and the ongoing need for alternative asparaginase treatments. The webcast will be accessible through Jazz's investor site.

Jazz Pharmaceuticals has received FDA approval for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli-derived asparaginase. This unique recombinant product maintains active levels throughout treatment and addresses urgent patient needs. Rylaze is expected to be available in mid-July 2021. The approval, part of the Real-Time Oncology Review program, is based on positive clinical trial data, ensuring reliable supply for patients.

The U.S. FDA has granted Xywav seven years of Orphan Drug Exclusivity for treating cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy. This drug features a unique composition that provides 92% less sodium than the previous treatment, Xyrem. The FDA cites Xywav's clinical superiority due to its greater safety profile, potentially reducing cardiovascular risks for patients. The exclusivity period began on July 21, 2020, following FDA approval.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has updated its full-year 2021 financial guidance following the acquisition of GW Pharmaceuticals on May 5, 2021. The new guidance anticipates revenues of $3,020 - $3,180 million, boosting predictions for strong product growth, especially for Epidiolex. The company expects accelerated revenue diversification with double-digit growth and non-GAAP EPS accretion starting in the first full year post-acquisition. However, the acquisition also brings increased expenses and potential dilution concerns that could impact 2021 earnings per share.

Jazz Pharmaceuticals (Nasdaq: JAZZ) launched the Nothing Small About It program, a dedicated online hub for small cell lung cancer (SCLC) patients and caregivers. Developed in collaboration with notable cancer organizations, this platform aims to address the emotional, social, and physical health needs of those affected by SCLC. The initiative offers user-friendly resources, interactive content, and personal stories to empower patients and caregivers. Approximately 30,000 to 35,000 new SCLC cases are reported annually in the U.S. The program aims to enhance awareness and support for the SCLC community.

Jazz Pharmaceuticals announced the presentation of 13 abstracts at SLEEP 2021, the 35th annual meeting of the Associated Professional Sleep Societies, from June 10-13, 2021. Highlights include a late-breaking abstract on Xywav’s effects on idiopathic hypersomnia and results from studies on narcolepsy and Sunosi. CEO Robert Iannone emphasized the company’s commitment to addressing unmet needs in sleep disorders. However, Xywav is not yet approved for treating idiopathic hypersomnia, raising questions about its market potential.

Jazz Pharmaceuticals (Nasdaq: JAZZ) will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 1:00 p.m. ET. The management team will discuss the company's business and financial updates. The live webcast will be accessible on the Jazz Pharmaceuticals website, with a replay available for one week.

Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing innovative medicines for patients with serious diseases.

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced new research findings to be presented at the upcoming virtual ASCO Annual Meeting (June 4-8, 2021) and EHA2021 (June 9-16, 2021). The presentations will include four abstracts at ASCO and five at EHA, featuring data on Zepzelca®, JZP351 (formerly CPX-351), and Defitelio®.

Key highlights involve studies on lurbinectedin combined with irinotecan in endometrial carcinoma and JZP351 in acute myeloid leukemia. Jazz aims to enhance understanding of its therapies to meet the needs of patients with rare hematologic and oncologic diseases.

Jazz Pharmaceuticals has successfully completed its acquisition of GW Pharmaceuticals, enhancing its portfolio with cannabinoid-based medicines, including Epidiolex, which had over $500 million in sales in 2020. The deal is expected to accelerate top-line revenue growth and add substantial value for shareholders. The combined entity will address significant unmet medical needs in neuroscience and oncology. Jazz anticipates providing 2021 financial guidance for the integrated organization shortly.