SOUTH SAN FRANCISCO, Calif. - Rigel (NASDAQ:RIGL) Pharmaceuticals, Inc. (NASDAQ:RIGL) today issued a safety communication regarding GAVRETO (pralsetinib), a treatment for certain types of thyroid and lung cancers. This announcement comes after discussions with the U.S. Food and Drug Administration (FDA) regarding a new safety signal for the medication, which is used in adult and pediatric patients with specific cancer conditions.
GAVRETO is approved for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for those 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who are refractory to radioactive iodine treatment. The safety update has been disseminated through a Dear Health Care Provider (DHCP) letter, which is now available on the GAVRETO Healthcare Provider website.
Rigel emphasizes patient safety as its highest priority and is actively informing healthcare professionals about the latest safety information. Adverse events experienced by patients on GAVRETO should be reported to the Rigel Medical Communications Center or directly to the FDA.
The company completed the transfer of the New Drug Application (NDA) for GAVRETO from Blueprint Medicines (NASDAQ:BPMC) Corporation in June 2024. This transition is part of Rigel's ongoing commitment to providing novel therapies for patients with hematologic disorders and cancer.
While the press release from Rigel Pharmaceuticals includes forward-looking statements about the drug and its potential effects, these are based on current beliefs and expectations, which may change and are subject to risks and uncertainties.
The full Prescribing Information and Patient Information for GAVRETO are available for healthcare providers to review, ensuring they are informed about the indications, safety concerns, and management of adverse effects associated with the treatment.
This update is based on a press release statement from Rigel Pharmaceuticals, Inc. and is intended to inform healthcare professionals and patients about the latest safety information regarding GAVRETO.
In other recent news, Rigel Pharmaceuticals has experienced several significant developments. The company's Q2 2024 earnings report showed a substantial increase of 40% in net product sales, totaling $33.5 million, primarily driven by robust sales of Tavalisse and Rezlidhia. Rigel also announced a strategic licensing agreement with Kissei Pharmaceuticals, which grants Kissei exclusive development and commercialization rights for Rigel's drug, Rezlidhia, in Japan, the Republic of Korea, and Taiwan. This deal could significantly expand Rezlidhia's market reach, considering the estimated 11,000 acute myeloid leukemia patients in Japan. Financial services firm, H.C. Wainwright, has maintained a Buy rating for Rigel, indicating a positive outlook on the company's ongoing research and development efforts. Furthermore, Rigel has begun enrolling patients in a Phase 1b/2 clinical trial, sponsored and conducted by MD Anderson, to evaluate a triplet therapy that includes decitabine and venetoclax with Rezlidhia for the treatment of mutated isocitrate dehydrogenase-1 acute myeloid leukemia. Additionally, Rigel announced the resignation of Dr. Brian Kotzin from its Board of Directors, with no immediate plans for a replacement disclosed.
InvestingPro Insights
As Rigel Pharmaceuticals (NASDAQ:RIGL) navigates the challenges of its GAVRETO safety communication, investors may find additional context in the company's financial metrics and market performance. According to InvestingPro data, Rigel's market capitalization stands at $254.69 million, reflecting the market's current valuation of the company amidst these developments.
Despite the safety concerns for GAVRETO, Rigel has shown strong revenue growth, with a 42.32% increase in quarterly revenue as of Q2 2024. This growth may indicate the company's ability to expand its product reach, potentially offsetting any impact from the safety update. Additionally, the company boasts a robust gross profit margin of 76.1% for the last twelve months, suggesting efficient cost management in its product lineup.
InvestingPro Tips highlight that Rigel has experienced a "Strong return over the last three months," with a 38.56% price total return over that period. This positive momentum could suggest that investors remain optimistic about the company's prospects, even in light of the recent safety communication.
It's worth noting that InvestingPro offers 7 additional tips for Rigel Pharmaceuticals, providing a more comprehensive analysis for investors looking to delve deeper into the company's financial health and market position.
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