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RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy
Globenewswire· 2025-09-29 09:00
SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with ...
盘前暴涨超38%!80亿美元!Genmab官宣收购Merus
美股IPO· 2025-09-29 08:51
当地 时间 2 0 2 5 年 9 月 2 9 日 清早 , Genmab 官宣 将 收购 Merus N.V. ( 以下简称 为 " Merus " ) 。 根据协议,Genmab 将 以每股97.00美元的现金收购Merus的全部股份, 交易价值 约80亿美元 。这是 Genmab自成立以来最大的一笔收购( 去年收购普方生物总价为18 亿美元) 。 图片来源 : Genmab 官网 Merus最早创立于2003年,总部位于荷兰 , 核心 资产 是 一 款 EGFR / LGR5双抗 —— petosemtamab ( M C L A - 1 5 8 ) 。 2 0 2 5 年 A S C O 上 , Merus公布 了 petosemtamab 联合 K 药 对比 K 药 单药 一线 治 疗 局部晚期头颈部鳞状细胞癌 (HNSCC) 的 I I 期 临床数据 。 具体 来看 , 这项 I I 期 研 究 共 纳入 4 5 名 局部 晚期 HNSCC 患者 。 最 终 4 3 名 可 评估 患者 数据 显示 , 联合 用药 组 经实体瘤反应评估标准 的 总体缓解率 ( O R R ) 达 6 3 % (27 ...
Inventiva reports its unaudited 2025 first-half financial results and provides a corporate update
Globenewswire· 2025-09-29 06:30
Cash and cash equivalents at €146.7 million including €24.6 million in short-term deposits1 as of June 30, 2025Receipt of the gross proceeds of €115.6 million from the second tranche of the structured financing of up to €348 million2, following in particular the completion in April 2025 of enrolment of the Phase 3 clinical trial NATiV3 evaluating lanifibranor in patients with MASHCash runway currently planned until the end of the third quarter of 2026Revenues of €4.5 million recorded in the first half of 20 ...
Savara Presents New Data From the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the European Respiratory Society (ERS) Congress 2025
Businesswire· 2025-09-29 06:00
LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (the "Company†) (Nasdaq: SVRA), a clinical- stage biopharmaceutical company focused on rare respiratory diseases, today announced additional analyses from its pivotal Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP were presented as poster presentations at the ERS Congress 2025 in Amsterdam, The Netherlands. ERS 2025 Posters Savara Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP). ...
君实生物:有希望的候选药物等待临床数据以降低风险
2025-09-29 03:06
**公司概况** - 上海君实生物 一家处于商业化阶段的生物科技公司 专注于肿瘤学和自身免疫性疾病领域 拥有超过15种临床阶段资产[11][55] - 核心商业化产品包括PD-1抑制剂特瑞普利单抗(拓益)、阿达木单抗(自免疾病)、民得维(抗新冠)和昂戈瑞西单抗(降血脂)[11][55] **核心产品与收入驱动** - 特瑞普利单抗(PD-1)是未来三年主要收入驱动力 2024年中国销售额达15亿元(同比增长66%) 2025年上半年销售额达9.54亿元(同比增长42.3%)[4][29] - 2024年新增四大适应症纳入国家医保目录(NRDL):围手术期非小细胞肺癌(NSCLC)、一线肾细胞癌(RCC)、一线广泛期小细胞肺癌(ES-SCLC)和一线PD-L1阳性三阴性乳腺癌(TNBC) 其中围手术期NSCLC贡献显著增量销售[9] - 2025年将参与一线肝细胞癌(HCC)和一线黑色素瘤的NRDL谈判 预计未来两年中国获批适应症将扩至16-17个(当前12个)[9] - 预计2025-27年销售额复合年增长率(CAGR)达20% 2027年实现盈亏平衡[4][34] **研发管线与关键候选药物** - JS207(PD-1/VEGF双抗)是核心关注点 已启动8项II期临床试验 覆盖鳞状/非鳞状NSCLC、TNBC、结直肠癌(CRC)和肝细胞癌(HCC)[3][12] - 预计2025年底/2026年初公布早期数据(如客观缓解率ORR) 临床数据读出是验证其潜力和对外授权(BD)的关键[3][15] - 其他重要临床阶段资产包括: - 全球首创BTLA抗体tifcemalimab(JS004) 正在进行全球III期小细胞肺癌(LS-SCLC)研究 预计2026年中期完成患者入组[16][17] - DKK1抗体JS015 是肿瘤治疗领域唯一积极进展的DKK1药物 早期数据显潜力(一线CRC ORR 75% 一线胃癌ORR 60%)[19][20] - CD20/CD3双抗JS203 早期数据显示80% ORR和40%完全缓解率(CR) grade 3+ TEAE为21.7%[22][24] - PD-1/IL-2(JS213)和EGFR/HER3 ADC(JS212)等早期候选药物等待临床数据去风险[27] **财务预测与估值** - 收入预测:2025年25.51亿元(+31%) 2026年31.97亿元(+25%) 2027年38.56亿元(+21%)[6][39] - 盈利预测:2025年净亏损9.02亿元 2026年净亏损3.46亿元 2027年实现净利润0.92亿元[6][39] - 目标价34.70港元 基于风险调整后DCF模型(WACC 12.3% 永续增长率4%) 对应2.4倍风险调整后市销率(P/S) 与生物科技同行中位数(2.3倍)一致[2][5][38] - 估值敏感性分析: - 上行情景(45.20港元):JS207中国/海外风险调整峰值销售额达33/170亿元[47][49] - 下行情景(17.60港元):JS207中国/海外风险调整峰值销售额仅10/51亿元[47][51] **风险与催化剂** - 主要风险:关键临床试验失败、商业化药物价格竞争加剧、特瑞普利单抗销售不及预期、对外授权进度或付款低于预期[57] - 潜在催化剂:JS207的早期临床数据读出、PD-1/IL-2和EGFR/HER3 ADC的首次人体数据、DKK1和CD3/CD20的III期试验启动、BTLA III期入组完成[3][60] **市场表现与同业对比** - 年初至今股价上涨167%(同期HSBIO指数上涨100%) 自5月20日3SBio与辉瑞达成PD-1/VEGF合作后上涨约100% 市场已部分反映JS207对外授权预期[2][9] - 当前市值317亿港元(40.8亿美元) 2025年预测市销率10.9倍 2027年预测市盈率302.3倍 估值高于部分同行(如恒瑞医药、信达生物)但低于康方生物(Akeso)[7][45] **其他重要信息** - 2025年股权激励计划解锁条件:2025-27年累计收入达到24/54/90亿元 或2025/26年净亏损较2024年收窄29%/76% 2027年实现盈亏平衡[34][35] - 现金状况:2024年底现金25亿元 预计2025年底降至24亿元 2026年进一步降至17亿元[6][52]
MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab
Globenewswire· 2025-09-28 16:04
VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the resul ...
Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM
Globenewswire· 2025-09-28 15:15
- By Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo - Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a 49% hazard reduction (p<0.0001) - The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (95% CI:29–79) PALO ALTO, Calif., Sept. 28, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“Bridge ...
Why Bristol-Myers Squibb (BMY) Deserves a Spot in Passive Income Portfolios
Yahoo Finance· 2025-09-28 01:07
Bristol-Myers Squibb Company (NYSE:BMY) is included among the 12 Best Stocks to Buy Now for Passive Income. Why Bristol-Myers Squibb (BMY) Deserves a Spot in Passive Income Portfolios Bristol-Myers Squibb Company (NYSE:BMY) is a global biopharmaceutical company that many consider worth investing in and holding long-term. Its history dates back to the early 1800s, shaped by decades of drug innovation and strategic mergers. Today, the company focuses on treatments in oncology, cardiovascular health, immun ...
The Saturday Spread: 3 Beaten-Down Stocks Making a Statistical Case for a Comeback
Yahoo Finance· 2025-09-27 14:15
While biopharmaceutical giant Amgen (AMGN) managed to eke out a modest gain on Friday, the past week has been rough, with AMGN stock losing 4%. Adding insult to injury, the equity is rated as a 72% Strong Sell by the Barchart Technical Opinion indicator. Despite the volatility risks, contrarians could be justified in betting on the healthcare juggernaut.Just like in America’s favorite pastime, the use of sabermetrics doesn’t guarantee that you’ll win baseball games. However, a consistent, empirical framewor ...
Piper Sandler Reaffirms Jazz Pharmaceuticals (JAZZ) Price Target Ahead of Trial Data
Yahoo Finance· 2025-09-27 04:59
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ranks among the most undervalued NASDAQ stocks to buy now. Piper Sandler reaffirmed its Overweight rating and $147 price target for Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on September 15 in expectation of data from the upcoming clinical trial. Jazz is gearing up to report progression-free survival data from its HERIZON-GEA-01 study in the fourth quarter of 2025. The trial assesses zanidatamab as the first-line therapy for advanced/metastatic gastroesophageal adenocarc ...