The Independent Data Monitoring Committee (IDMC) has recommended to continue the study as planned as there are no safety concerns seen in the data reviewed Continued momentum with completed patient enrollment for the 6-week interim analysis (N=24) and over two-thirds enrollment completed for the overall trial Results on track for interim data in Q2 2025 and topline data in Q3 2025 Management releases “What This Means” segment discussing the interim biomarker data; Access Here LA JOLLA, CA, May 08, 2025 (GLO ...

Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled Company on track to report interim biomarker data from the first 12 patients imminently Completion of patient enrollment and topline results expected Q3 2025 LA JOLLA, CA, May 07, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic a ...

LA JOLLA, CA, April 16, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that its abstract has been selected for poster presentation in a poster discussion session at the 2025 ATS International Conference being held May 18-21, 2025 in San Francisco, CA.Details of the presentation are as foll ...

LA JOLLA, CA, April 02, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the closing of its previously announced public offering of an aggregate of 1,388,888 shares of its common stock (or common stock equivalents in lieu thereof), Series E-1 warrants to purchase up to 1,388,888 shares of co ...

文章核心观点 - 4月1日GRI Bio公司宣布500万美元公开发行股票定价后股价暴跌36.9%，此前因IIa期研究积极中期安全结果股价一度飙升，公司今年股价已暴跌85.7%，行业增长2.9%，公司还获得两项全球专利，目前评级为持有，同时推荐了两只排名更好的生物技术股 [1][4][13] 股票表现 - 4月1日公司宣布500万美元公开发行股票定价后股价暴跌36.9% [1] - 当日早些时候公司公布IIa期研究积极中期安全结果后股价飙升 [1] - 今年以来公司股价暴跌85.7%，而行业增长2.9% [4] 股票发行 - 公司以每股3.60美元的公开发行价格发售139万股普通股及相关认股权证，包括E - 1、E - 2、E - 3系列认股权证，各系列认股权证可分别购买多达139万股普通股 [5] - 认股权证行使价为每股3.20美元，发行后可立即行使，预计发行于2025年4月2日左右完成 [6] - 2月公司宣布1比17反向股票分割以提高普通股每股交易价格，恢复符合纳斯达克资本市场最低出价价格要求 [6] IPF研究结果 - 公司主要候选产品GRI - 0621是1型不变自然杀伤T细胞口服抑制剂，也是他扎罗汀口服制剂，美国已批准其用于银屑病和痤疮局部治疗 [7] - 正在进行的IIa期生物标志物研究两周安全性结果的预先计划中期分析显示，GRI - 0621（每日口服4.5mg）在首批12名按方案评估患者中安全且耐受性良好 [8] - 独立数据监测委员会建议按计划继续研究，因审查数据未见安全问题 [9] - IIa期研究将招募约36名IPF患者，按2:1比例随机接受GRI - 0621 4.5mg或安慰剂治疗 [10] - 子研究将检查多达12名符合条件受试者支气管肺泡灌洗液中NKT细胞数量和活性 [11] - 预计2025年第二季度报告中期生物标志物数据，第三季度公布IIa期生物标志物研究 topline 结果 [11] 专利情况 - 公司获得两项全球专利，加强了知识产权组合，一项涵盖用于治疗自身免疫性疾病的新型人类2型多样NKT细胞激活剂GRI - 0803，另一项涵盖调节dNKT和/或iNKT细胞的组合物和方法 [13] 评级与推荐股票 - 公司目前Zacks排名为3（持有） [14] - 生物技术领域排名更好的股票有Amicus Therapeutics和ANI Pharmaceuticals，目前Zacks排名均为1（强力买入） [14] Amicus Therapeutics情况 - 过去60天，2025年每股收益估计从42美分增至52美分，2026年从70美分增至78美分 [15] ANI Pharmaceuticals情况 - 过去60天，2025年每股收益估计从5.54美元增至6.35美元，2026年从6.75美元增至7.21美元 [16] - 今年以来股价上涨23%，过去四个季度盈利均超预期，平均惊喜率为17.32% [16]

LA JOLLA, CA, April 01, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the pricing of a public offering of an aggregate of 1,388,888 shares of its common stock (or common stock equivalents in lieu thereof), Series E-1 warrants to purchase up to 1,388,888 shares of common stock, short-term ...

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side- effects, limited patient compliance and no impact on survival LA J ...

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side- effects, limited patient compliance and no impact on survival LA J ...

Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases LA JOLLA, CA, March 31, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the granting of two global patents. T ...

报告日期相关 - 报告日期为2025年3月17日[1] - 附件99.1日期为2025年3月17日[7] 财年财务结果相关 - 公司公布2024年12月31日财年的财务结果[5] 公司上市信息相关 - 公司普通股每股面值为0.0001美元，交易代码为GRI，在纳斯达克资本市场上市[3] 公司类型相关 - 公司是新兴成长型公司[4] 报告附件相关 - 公司发布的新闻稿作为附件99.1附于本报告[5] 报告签署相关 - 公司首席财务官为Leanne Kelly，于2025年3月17日签署报告[10]