财务业绩 - 第二季度总收入为3680万美元,包括TAVALISSE净产品销售2640万美元、REZLIDHIA净产品销售520万美元和GAVRETO净产品销售190万美元[1,2,7] - 公司第二季度总收入为36,841,000美元,同比增长36.8%[30] - 产品销售净收入为33,450,000美元,同比增长40.1%[30] - 合作收入为3,391,000美元,同比增长69.1%[30] - 公司上半年总收入为66,375,000美元,同比增长25.4%[30] - 公司上半年净亏损为9,277,000美元,同比减亏45.9%[30,31] - 第二季度净亏损100万美元,同比减少[9,12] - 公司现金、现金等价物和短期投资总额为49,102,000美元[34] - 公司股东权益为负29,914,000美元[34] 产品销售 - TAVALISSE和REZLIDHIA的销售瓶数创历史新高[4] - GAVRETO于2024年6月27日开始在美国上市销售[4] - 成功完成GAVRETO的新药申请(NDA)转让,并于2024年6月27日开始在美国上市销售[3,4] 研发进展 - 公司正在推进R289的1b期临床试验,预计2024年底前获得初步数据[5] - 与德克萨斯大学MD安德森癌症中心合作开展一项1b/2期试验,评估去甲基化药物和venetoclax联合olutasidenib治疗IDH1突变AML的疗效[6] - 公司在2024年EHA和ASCO会议上发表了REZLIDHIA和R289的临床试验数据[6] 费用情况 - 研发费用为5,540,000美元,同比增加16.1%[30] - 销售、一般及管理费用为28,047,000美元,同比增加6.6%[30] - 公司股票期权费用为2,528,000美元,同比增加16.4%[32]

产品销售情况 - 公司第二季度TAVALISSE产品净销售额为4750万美元,同比增长9%[156] - 公司第二季度REZLIDHIA产品净销售额为1000万美元,同比增长150%[157] - 公司于6月底开始销售GAVRETO产品,第二季度末确认净销售额约190万美元[158] - 公司的TAVALISSE和REZLIDHIA产品销售持续增长,GAVRETO新产品也开始贡献收入[225] 新药研发与合作 - 公司与MDACC达成战略合作,共同评估REZLIDHIA在AML和其他血液肿瘤疾病中的应用[161] - 公司与CONNECT合作,开展REZLIDHIA联合替莫唑胺治疗IDH1突变高级胶质瘤的II期临床试验[162] - 公司与礼来公司的RIPK1抑制剂项目正在进行II期临床试验,用于治疗类风湿性关节炎[163] - 公司已向MDACC提供200万美元的合作研究经费,并将在未来5年内提供1500万美元[161] - 公司与CONNECT的合作期限为4年,提供最高300万美元的研究经费和试验用药[162] - 公司宣布R835在第1期临床试验中显示良好的安全性、耐受性和药代动力学特征，并证实了其抑制炎症细胞因子产生的作用机制[210] - 公司推进IRAK 1/4抑制剂项目的开发，正在进行R289(R835的新型前药配方)的第1b期临床试验，预计于2024年底前获得初步数据[211] - 公司与百时美施贵宝合作的RIPK1抑制剂ocadusertib正在进行第2a期临床试验，预计2025年上半年获得初步结果[212] - 公司与BerGenBio合作的AXL受体酪氨酸激酶抑制剂bemcentinib在非小细胞肺癌二线治疗和一线STK11突变患者治疗中取得积极结果[213,214] - 公司授权给Rain Oncology(现已被Pathos AI收购)的MDM2抑制剂milademetan正在进一步开发[215] 产品获批与商业化 - TAVALISSE是用于治疗成人慢性特发性血小板减少症(ITP)的口服药物,通过抑制SYK酶来阻止免疫细胞破坏血小板[167,168] - 公司完成两项III期临床试验,TAVALISSE在提高ITP患者血小板计数方面显示出疗效[169] - TAVALISSE在美国获批上市,并在欧洲、日本、加拿大和以色列等地区获得上市批准[180,182,184] - 公司与Medison、Grifols和Kissei等公司达成许可协议,授权其在特定地区销售TAVALISSE[180,181,183] - 公司新药REZLIDHIA获FDA批准用于治疗复发/难治性急性髓系白血病(R/R AML)患者,具有良好的疗效和安全性[186,187,188] - 公司在2022年12月获得FDA批准,推出用于治疗成人复发/难治性急性髓系白血病(R/R AML)的REZLIDHIA[190] - GAVRETO获批用于治疗成人转移性RET融合阳性非小细胞肺癌和进展期RET融合阳性甲状腺癌[204] 财务情况 - 研发费用在2024年上半年较2023年同期下降,主要是由于完成的COVID-19和wAIHA临床试验以及R289项目临床试验活动减少[235][236] - 公司将继续大幅投入研发费用,用于R289项目、与MDACC和CONNECT的合作以及其他未来临床项目[236][237][238][239][240] - 销售、一般及管理费用在2024年上半年较2023年同期增加,主要是由于人员成本和股份支付费用的增加[247][248] - 公司预计未来销售、一般及管理费用将持续增加,以支持TAVALISSE、REZLIDHIA和GAVRETO的商业化活动[249] - 利息收入增加主要是由于利率上升[252] - 利息费用增加主要是由于中期贷款本金和利率上升[253] - 公司认为现有资金足以支持未来至少12个月的运营[262][263] - 根据现有合作协议,公司可能获得超过13亿美元的潜在付款[264] 其他 - 公司收到Annora Pharma Private Limited提交ANDA申请,请求批准上市TAVALISSE仿制药,公司已就此提起专利侵权诉讼[165] - REZLIDHIA在2021年6月的ASCO年会上报告了中期结果,显示33.3%的患者达到完全缓解(CR)或部分血液学恢复的完全缓解(CRh)[190] - REZLIDHIA在2022年11月的ASH年会上报告了更新的中期分析结果,显示35%的患者达到CR+CRh,中位持续时间为25.9个月[191] - REZLIDHIA被纳入NCCN指南,作为成人R/R AML患者的推荐靶向治疗[193] - REZLIDHIA在R/R mIDH1 AML患者中显示出持久缓解和输血独立性,安全性特征良好[194,195] - REZLIDHIA在既往曾接受过静脉曲美治疗的mIDH1 AML患者中也显示出潜在疗效[197,198] - REZLIDHIA在老年R/R mIDH1 AML患者中也显示出良好耐受性和持久缓解[199] - 公司已于2024年8月2日提交新的注册声明,以取代之前的注册声明[265][266] - 公司与MidCap签有6000万美元的定期贷款信贷协议,该贷款已于2024年6月30日全额提取[267] - 公司需支付Forma公司最高1.67亿美元的里程碑付款和分成[273] - 公司有约70万美元的租赁承诺和1760万美元的贷款利息及费用需在12个月内支付[274][275]

SOUTH SAN FRANCISCO, Calif., July 30, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its second quarter 2024 financial results after market close on Tuesday, August 6, 2024. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.Participants can access the live conference call by dialing 877-407-3088 ...

sanjeriRigel Pharmaceuticals, Inc. (NASDAQ:RIGL) is a biotechnology company focused on discovering and commercializing innovative therapeutics for hematological conditions and cancers. RIGL’s main FDA-approved products are Tavalisse, Rezlidhia, and Gavreto. Tavalisse targets SYK, Rezlidhia rrAML, and Gavreto NSCLC. In my analysis, I conclude that RIGL’s current valuation seems quite undervalued relative to its peers, particularly considering that it has a reasonable pathway toward becoming cash flow pos ...

SOUTH SAN FRANCISCO, Calif., July 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL) today announced that it has granted awards pursuant to Rigel's Inducement Plan, approved by the Compensation Committee of Rigel's Board of Directors and granted as an inducement material to employees' entering into employment with Rigel, in accordance with NASDAQ Listing Rule 5635(c)(4). Specifically, Rigel granted 79,890 stock options to eleven non-executive employees vesting over four years with ...

SOUTH SAN FRANCISCO, Calif., June 25, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will effect a reverse stock split of its issued and outstanding shares of common stock at a ratio of 1-for-10 (the "Reverse Stock Split"), effective at 12:01 a.m. Eastern Time on Thursday, June 27, 2024. The company's common stock will begin trading on a post-split basis on The Nasdaq Global Select Market under the same symbol (RIGL) when the market opens on Thursday, June 27, 2024, ...

GAVRETO will be available from Rigel in the U.S. beginning June 27, 2024SOUTH SAN FRANCISCO, Calif., June 24, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL) today announced the completion of the transfer to Rigel of the New Drug Application (NDA) for GAVRETO® (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by a U.S. Food and Drug Administration (FDA) approved test ...

-     Oral presentation highlighting final five-year efficacy data from the registrational Phase 2 trial of REZLIDHIA® (olutasidenib) in heavily pretreated patients with R/R mIDH1 AML, including those receiving prior venetoclax-     New data shows clinically meaningful effect of olutasidenib in patients with mIDH1 AML secondary to MPN and as bridge-to-transplant treatment in patients with R/R mIDH1 AML SOUTH SAN FRANCISCO, Calif., June 14, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) toda ...

-       Long-term efficacy data from the registrational Phase 2 trial of REZLIDHIA® (olutasidenib) in heavily pretreated patients with R/R mIDH1 AML, including those receiving prior venetoclax-       Data from a subgroup analyses of elderly R/R mIDH1 AML patients treated with olutasidenib shows consistent CR/CRh results-       Overview of the Phase 1b trial of R289 in patients with lower-risk MDS SOUTH SAN FRANCISCO, Calif., June 3, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today annou ...

SOUTH SAN FRANCISCO, Calif., May 30, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that Raul Rodriguez, the company's president and CEO, will present a company overview at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 9:30 am ET in New York, NY. To access the live webcast or archived recording, visit the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website prior to the start of the live webcast to ...