Investing.comDoubao · 实盘可交易 · 做多市场:美股▼ 亏 -1.81% · 已结算把握 5/10
北京时间·🕒 发布 20:04:32·⟳ 抓取 20:05:45 +1m13s·⚡ 决策 10-12 20:08:18 +2m33s·15.2 天前
Mirum的LIVMARLI（maralixibat）III期EXPAND研究达主要终点，拟2027上半年提交胆道闭锁适应症sNDA
真实阳性III期、全部次要终点达标且打开胆道闭锁更大适应症，方向明确；但读出日已被公司提前预告、上周五已抢涨5.73%、盘前再升约9%且冲高回落，近端风险溢价已部分消化，故只给小仓条件回调单而非追高。
📄 原文Investing.com↗ 原文
Mirum’s maralixibat meets primary endpoint in liver disease trial
By Investing.com Advertisement Advertisement Mirum’s maralixibat meets primary endpoint in liver disease trial Company…
▼ 亏 -1.81%入场 10-12 盘前首笔 @87.53 → 离场 10-13 开盘 @86.06
日 K 取自复盘打分切片 · 蓝点/蓝虚线 = 纸面入场价 · 灰虚线 = 纸面离场 · 持有期红底 = 赚(价格在入场线上方)、绿底 = 亏
💡 交易逻辑III期EXPAND阳性打开胆道闭锁标签，等回调不追盘前+9%高开
怎么买 回调买入 回落到 89 才买、2 个交易日内有效
怎么卖 止盈 +8%(半仓)/+14%(清仓) · 止损 -7% · 时间止损 5日
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
分时走势
做多 MIRM.US Mirum Pharmaceuticals
5 个交易日均已收盘,数据完整 · 美股含盘前盘后(灰底:美东 04:00 至收盘后 4 小时)
- 发布 10-12 20:04 北京(美东 10-12 08:04)
- 抓取 10-12 20:05 北京(美东 10-12 08:05)
- 入场 10-12 20:08 北京(美东 10-12 08:08) · 盘前首笔 @87.53
- 决策 10-12 20:08 北京(美东 10-12 08:08)
- 离场 10-13 21:30 北京(美东 10-13 09:30) · 开盘 @86.06
时间轴只含交易时段(午休、隔夜已压缩);横轴为北京时间,悬停看当地时间;蓝虚线 = 纸面入场价;建仓日图红线在昨收上方、绿线在下方
成交明细 · 纸面
做多 MIRM.US Mirum Pharmaceuticals
| 收益状态 | -1.81% 已平仓 |
|---|---|
| 进场成交 | 2026-10-12 · 盘前首笔 · 10-12 20:08 北京 · @87.5275 |
| 离场成交 | 2026-10-13 · 开盘 · @86.06 |
| 毛收益 | -1.68% |
| 成本 | +0.13% |
| 净收益 | -1.81% |
| 计入收益 | -1.81% |
| 建仓日 | 2026-10-12 · 进场不早于新闻时刻 + 2 分钟 |
收益口径 event_time_plus_2min_10min_walk_open_topup_to_next_open_exchange_calendar_fill_model_local_notional_v9 · method_id m8db1cbc8f2d · 截至 2026-10-27 23:47
研究档案
结论摘要
maralixibat III期EXPAND阳性（主要+全部次要终点，p值强），拟2027H1提交sNDA扩展至胆道闭锁这一更大超罕见适应症，属实质管线利好；但读出日期提前预告、周五已抢跑、盘前+9%且从+14%回落，追高风险大，以小仓回调单参与。
消息传播链
- 公司10月11日公告将于投资者电话会公布EXPAND顶线结果，使读出日期成为明牌，次日（10月9日周五）MIRM +5.73%部分抢跑
- 美东盘前08:04发布阳性顶线：主要及全部次要终点达标、计划2027H1提交sNDA市场反应:盘前从参考86.01最高冲至98（约+14%），08:06回落至约93.9（+9.2%），竞价区间87.35-98，量仅约2103股，冲高回落显示获利兑现
关键理由
- III期主要终点及全部5项次要终点均显著（瘙痒差值0.98分p=0.0004、胆汁酸69%差值p<0.0001），胆道闭锁亚组效应更强，降低监管与扩展标签风险
- 胆道闭锁患者池大于现有ALGS/PFIC超罕见适应症，标签扩展可抬升LIVMARLI中长期峰值销售，公司55.8亿美元市值对此仍有重估空间
主要风险
- 读出日为公司10月11日预告的既定事件，上周五已+5.73%、盘前一度+14%后回落至约+9%，存在sell-the-news/高开低走风险
- sNDA要到2027H1才提交、收入兑现在更后期，且腹泻发生率64%（安慰剂11.1%）可能影响完整数据评价与标签
反向证据
- 做多前查反向 · 来源 web · 日期 2026-10-12 · 影响 weakens
腹泻64%对11.1%为主要安全性瑕疵，1例停药；未见数据造假、试验失败或指引下修，但盘前冲高回落反映预期已较高
检索:Mirum EXPAND maralixibat safety diarrhea sell-the-news disappointment analyst 原文 ↗ - 做多前查反向 · 来源 kb_search · 影响 none
内部KB未检索到针对本次EXPAND的额外反方纪要；行情显示周五+5.73%、近20日-12.4%，属事件前反弹而非长期抢跑，拥挤度中等
检索:MIRM stock pre-readout rally October 9 2026 anticipation EXPAND
先例如何影响了这次决策
对本次决策的影响:先例不足直接导致仓位降为small、不追开盘、改用BUY_DIP条件单并收紧止损
方向:未取得可锚定首发时刻的同主体/同机制III期阳性读出先例，不据记忆编造方向胜率
涨幅量级:无干净对齐先例，不据此设定激进止盈幅度，tp取生物科技小盘阳性读出的保守区间
形态:本事件自身轨迹（周五抢跑5.73%+盘前冲高+14%回落至+9%）已提示见光死/高开低走风险，作为压仓与回调入场依据
工具执行结果 · 成功 5 · 降级 0 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 10 ms
{"result": "search_processed_events:agent query=`mirm expand trial cholestatic pruritus snda 2027 | mirum maralixibat phase 3 expand primary endpoint biliary atresia`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 0.0/72 小时、0 条本臂决策(完整)，返回 0 条候选。未命中只表示这些 agent query 表达式没有召回候选，不能据此证明消息首发或不是重复；按当前事件继续正常研判。"} - fetch_decision_experience 成功 stock_tools_inprocess · 1 ms
{ - web_search 成功 doubao_search · 1,911 ms
豆包搜索结果（原始查询:Mirum Pharmaceuticals EXPAND maralixibat Phase 3 biliary atresia primary endpoint press release；API SearchType:web） - stock_quote 成功 stock_tools HTTP · 9,974 ms
{ - web_search 成功 doubao_search · 2,069 ms
豆包搜索结果（原始查询:Mirum MIRM maralixibat positive Phase 3 topline stock reaction ALGS ICONIC 2021 announcement date；API SearchType:web）
原文全文
展开原文 · 7,634 字
Mirum’s maralixibat meets primary endpoint in liver disease trial By Investing.com
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Mirum’s maralixibat meets primary endpoint in liver disease trial
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Oct 12, 2026, 08:04 AM
Mirum’s maralixibat meets primary endpoint in liver disease trial
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Mirum’s maralixibat meets primary endpoint in liver disease trial
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© Reuters
In this article:
MIRM
+
5.73%
FOSTER CITY, Calif. -
Mirum Pharmaceuticals
Inc. (
NASDAQ:MIRM
) announced today that its Phase 3 EXPAND study of maralixibat met its primary endpoint for treating cholestatic pruritus in patients with ultra-rare cholestatic liver diseases, including biliary atresia.
The study enrolled 52 patients, including 46 pediatric and six adult patients, who were randomized during a 20-week double-blind period to receive maralixibat 285 µg/kg twice daily or placebo.
Maralixibat demonstrated a mean 1.81-point improvement from baseline in average worst-daily ItchRO(Obs) severity score during Weeks 13-20 compared with a 0.83-point improvement for placebo, corresponding to a placebo-adjusted treatment difference of 0.98 points (p=0.0004). The drug also resulted in a 70.1% reduction from baseline in serum bile acids, compared with 3.5% for placebo, representing a 69% treatment effect versus placebo (p<0.0001).
In patients with biliary atresia and a native liver, maralixibat showed a 2.16-point improvement in pruritus severity score compared with 1.01 points for placebo, a difference of 1.15 points (p=0.0002). This subgroup also experienced a 75.5% reduction in serum bile acids versus 9% for placebo (p<0.0001).
The study achieved statistical significance across all five prespecified secondary endpoints, according to the company’s press release statement.
Safety findings were consistent with prior clinical experience with maralixibat. Diarrhea occurred in 64% of maralixibat-treated patients compared with 11.1% in the placebo group. One patient discontinued treatment due to an adverse event.
Maralixibat is currently approved in the United States for treating cholestatic pruritus in patients with Alagille syndrome aged three months and older and progressive familial intrahepatic cholestasis in patients 12 months and older.
Mirum plans to submit a supplemental New Drug Application in the United States in the first half of 2027 based on the EXPAND results.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Mirum’s maralixibat meets primary endpoint in liver disease trial
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Mirum’s maralixibat meets primary endpoint in liver disease trial
Company News
Published
Oct 12, 2026, 08:04 AM
Mirum’s maralixibat meets primary endpoint in liver disease trial
View all comments (0)
0
Mirum’s maralixibat meets primary endpoint in liver disease trial
View all comments (0)
0
© Reuters
In this article:
MIRM
+
5.73%
FOSTER CITY, Calif. -
Mirum Pharmaceuticals
Inc. (
NASDAQ:MIRM
) announced today that its Phase 3 EXPAND study of maralixibat met its primary endpoint for treating cholestatic pruritus in patients with ultra-rare cholestatic liver diseases, including biliary atresia.
The study enrolled 52 patients, including 46 pediatric and six adult patients, who were randomized during a 20-week double-blind period to receive maralixibat 285 µg/kg twice daily or placebo.
Maralixibat demonstrated a mean 1.81-point improvement from baseline in average worst-daily ItchRO(Obs) severity score during Weeks 13-20 compared with a 0.83-point improvement for placebo, corresponding to a placebo-adjusted treatment difference of 0.98 points (p=0.0004). The drug also resulted in a 70.1% reduction from baseline in serum bile acids, compared with 3.5% for placebo, representing a 69% treatment effect versus placebo (p<0.0001).
In patients with biliary atresia and a native liver, maralixibat showed a 2.16-point improvement in pruritus severity score compared with 1.01 points for placebo, a difference of 1.15 points (p=0.0002). This subgroup also experienced a 75.5% reduction in serum bile acids versus 9% for placebo (p<0.0001).
The study achieved statistical significance across all five prespecified secondary endpoints, according to the company’s press release statement.
Safety findings were consistent with prior clinical experience with maralixibat. Diarrhea occurred in 64% of maralixibat-treated patients compared with 11.1% in the placebo group. One patient discontinued treatment due to an adverse event.
Maralixibat is currently approved in the United States for treating cholestatic pruritus in patients with Alagille syndrome aged three months and older and progressive familial intrahepatic cholestasis in patients 12 months and older.
Mirum plans to submit a supplemental New Drug Application in the United States in the first half of 2027 based on the EXPAND results.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Mirum’s maralixibat meets primary endpoint in liver disease trial
View all comments (0)
0
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eb616eba0b· 2026-10-12 20:08 · doubao / doubao-seed-evolving-latest-version · 策略包2226518bfdee当前