On Friday, H.C. Wainwright maintained a Buy rating and a $57.00 stock price target for Rigel (NASDAQ:RIGL) Pharmaceuticals (NASDAQ:RIGL). This follows the announcement on September 5 that Rigel has begun enrolling patients in a Phase 1b/2 clinical trial. The study is evaluating a triplet therapy that includes decitabine and venetoclax with Rezlidhia (olutasidenib) for the treatment of mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).
The trial, sponsored and conducted by MD Anderson, is a multi-center, open-label, non-randomized study. It aims to assess the safety, tolerability, and optimal dosing of the therapy combination in relapsed/refractory (r/r) mIDH1 AML patients. The Phase 2 segment of the trial is set to enroll 60 patients, split evenly between newly diagnosed and r/r mIDH1 AML cases, with the primary goal of determining the complete remission rate.
This trial marks the first in a series of collaborations between Rigel and MD Anderson. Future studies are planned to explore olutasidenib in various combinations and settings. These include treatment for newly diagnosed r/r AML patients, higher-risk myelodysplastic syndromes (MDS), advanced myeloproliferative neoplasms (MPN), monotherapy in clonal cytopenia of undetermined significance (CCUS), lower-risk MDS, and as maintenance therapy post-hematopoietic stem cell transplant.
The firm's reiteration of Rigel's Buy rating and price target reflects the potential seen in the company's ongoing research and development efforts, particularly in the field of AML treatment. The initiation of this trial is an important step forward in evaluating Rezlidhia's effectiveness as part of a combination therapy for mIDH1 AML patients.
In other recent news, Rigel Pharmaceuticals has made significant strides in expanding its global reach. The company has secured a licensing agreement with Kissei Pharmaceuticals, granting Kissei exclusive rights to develop and commercialize Rigel's drug, Rezlidhia, in Japan, the Republic of Korea, and Taiwan.
This deal, validated by H.C. Wainwright's reiterated Buy rating, could significantly extend Rezlidhia's market reach, considering the estimated 11,000 acute myeloid leukemia patients in Japan.
Rigel is set to receive a $10 million upfront cash payment and could earn up to $152.5 million more if certain development, regulatory, and sales milestones are met. In addition to the upfront payment and potential milestones, Rigel will benefit from product transfer price payments for Rezlidhia.
In the earnings sphere, Rigel reported a notable 40% increase in net product sales for the second quarter of 2024, reaching $33.5 million, primarily attributed to strong sales of Tavalisse and Rezlidhia. The company's ongoing clinical trials and development programs, including the IRAK1 and 4 inhibitor R289 and the RIPK1 inhibitor programs in partnership with Lilly, are also progressing. These recent developments indicate Rigel's commitment to expanding its global footprint and enhancing its product portfolio.
InvestingPro Insights
As Rigel Pharmaceuticals (NASDAQ:RIGL) embarks on its latest clinical trial, investors and industry observers are closely monitoring the company's performance metrics and analyst expectations. According to InvestingPro data, Rigel has a market capitalization of $235.95 million, indicating its position within the biotech sector.
While the company has shown a gross profit margin of 76.1% over the last twelve months as of Q2 2024, it has also reported an operating income margin of -7.0%, reflecting the high costs associated with research and development that are typical in the pharmaceutical industry.
InvestingPro Tips reveal a mixed picture: while analysts have revised earnings upwards for the upcoming period, signaling optimism about Rigel's future performance, they do not anticipate the company will be profitable this year. Furthermore, Rigel has not been profitable over the last twelve months. Despite these challenges, Rigel has demonstrated a strong return over the last month and three months, with price total returns of 43.73% and 39.73%, respectively.
This suggests that investor confidence may be buoyed by the company's recent developments and future prospects. Notably, Rigel does not pay a dividend, which is common for companies focused on reinvesting earnings into growth and development. For those interested in a deeper dive into Rigel's financial health and future outlook, there are additional InvestingPro Tips available at https://www.investing.com/pro/RIGL.
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