Rigel Pharmaceuticals Publishes Final Data on Pralsetinib Study
Rigel Pharmaceuticals announced publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection fusion-positive non-small cell lung cancer, or NSCLC, in the Journal of Clinical Oncology. Pralsetinib is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in metastatic NSCLC and advanced or metastatic thyroid carcinoma. "The final data from the ARROW study shows robust and durable responses with a manageable safety profile in patients with RET fusion-positive NSCLC, emphasizing the importance of early biomarker testing and suggesting that pralsetinib may be a valuable tool in the treatment armamentarium," said Phase 1/2 trial investigator Justin Gainor. Pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia, no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies. Overall response rate was 70%, including 7% complete responses and 63% partial responses. ORR was 78% among treatment-naive patients and 63% among patients receiving prior platinum-based chemotherapy. At final data lock, median treatment duration was 15.0 months. Median overall survival was 44.3 months in the overall measurable disease patient population, 50.1 months in treatment-naive patients, and 39.7 months in prior-platinum patients. Median overall progression-free survival was 13.1 months in the overall measurable disease patient population.
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- FDA Approval: Vepdegestrant, branded as Veppanu, received FDA approval earlier this month, becoming the only FDA-approved oral PROTAC therapy, which is expected to drive Rigel's cancer treatment portfolio expansion and enhance market competitiveness.
- Financial Gains from Agreement: Rigel will receive $70 million upfront and an additional $15 million upon completion of transition activities, along with potential future milestone payments of up to $320 million, significantly improving the company's financial outlook and investor confidence.
- Positive Stock Reaction: Rigel's shares surged over 15% following the announcement of the agreement, reflecting investor optimism regarding the new drug's market potential and indicating the company's growth prospects in oncology.
- Clinical Data Support: Veppanu demonstrated a 43% reduction in disease progression risk in Phase 3 studies, with a median progression-free survival of five months compared to 2.1 months for the comparator drug Fulvestrant, highlighting its significant therapeutic advantage.
- Agreement Reached: Arvinas (ARVN) and Pfizer (PFE) have finalized an agreement to sell global licensing rights for their jointly developed breast cancer therapy, Veppanu, to Rigel (RIGL), marking a significant advancement in breast cancer treatment.
- Cash Inflow: Rigel (RIGL) will provide $70 million upfront to Arvinas (ARVN) and Pfizer (PFE), along with an additional $15 million contingent on specific development and manufacturing milestones, significantly enhancing the funding capabilities for ongoing R&D activities.
- Milestone Payments: The agreement includes up to $320 million in milestone payments and tiered royalties on net sales ranging from the mid-teens to mid-20s, indicating substantial market potential for the therapy and promising long-term revenue for the partners.
- Global Market Expansion: Rigel (RIGL) will receive global rights to Veppanu, including sublicensing rights in overseas territories, which not only broadens market reach but also provides Arvinas (ARVN) and Pfizer (PFE) with additional revenue streams, further solidifying their positions in the global biopharmaceutical market.
- Sales Growth: In Q1 2026, Rigel Pharmaceuticals reported net product sales of nearly $55 million, reflecting a 26% increase year-over-year, despite seasonal impacts, with expectations for sequential growth resuming in Q2, thereby boosting market confidence.
- Revenue Guidance Maintained: The company maintains its 2026 revenue guidance at $275 million to $290 million, with net product sales projected between $255 million and $265 million, indicating management's confidence in future performance despite challenges from the termination of a collaboration.
- Improved Financial Position: The first quarter net income was $8.7 million, with cash and short-term investments totaling $146.7 million, demonstrating robust financial management that supports future R&D and market expansion initiatives.
- Collaboration Termination Impact: The termination of the collaboration with Eli Lilly effective June 15, 2026, introduces uncertainty regarding the RIPK1 program; however, management indicated plans to reassess the strategic direction of the project, showcasing adaptability to market changes.
- Earnings Decline: Rigel Pharmaceuticals reported a first-quarter net income of $8.65 million, translating to an EPS of $0.44, which represents a significant decline of 24.5% and 30.2% from last year's $11.45 million and $0.63 per share, indicating a notable weakening in profitability.
- Revenue Growth: Despite the drop in earnings, the company's revenue increased by 10.3% year-over-year to $58.82 million from $53.33 million last year, suggesting resilience in sales performance potentially driven by new product launches.
- Full-Year Guidance: Rigel has provided a full-year revenue guidance of $275 million to $290 million, reflecting a cautiously optimistic outlook for future performance, aiming to achieve growth despite current earnings challenges.
- Market Reaction: The decline in earnings may lead to a negative market response towards Rigel, prompting investors to closely monitor how the company addresses profitability challenges and its strategies for future growth.
- Disappointing Earnings: Rigel Pharmaceuticals reported a Q1 GAAP EPS of $0.44, missing expectations by $0.28, indicating pressure on profitability that may affect investor confidence.
- Lackluster Revenue Growth: The company generated $58.8 million in revenue for the quarter, a 10.3% year-over-year increase, yet fell short of expectations by $3.6 million, reflecting intensified market competition and sales challenges.
- Cash Flow Concerns: As of March 31, 2026, Rigel's cash and short-term investments totaled $146.7 million, down from $155.0 million as of December 31, 2025, suggesting potential liquidity issues.
- 2026 Outlook: Rigel reaffirms its revenue guidance for 2026 at approximately $275 to $290 million, and while it anticipates reporting positive net income for the full year, ongoing funding for clinical development programs remains a critical concern.
- Earnings Announcement: Rigel Pharmaceuticals will report its Q1 2026 financial results after market close on May 5, 2026, highlighting the company's latest advancements in the biotechnology sector.
- Management Conference Call: Following the earnings release, Rigel's senior management will hold a conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and provide business updates, aiming to bolster investor confidence.
- Participation Details: Investors can join the call by dialing 877-407-3088 (domestic) or 201-389-0927 (international), ensuring broad investor engagement and transparency of information.
- Webcast and Replay: The call will be webcast live on the company's investor relations page and will be available for replay for 90 days post-call, allowing investors who cannot attend live to access the information.








