Last year, Neurocrine’s Ingrezza failed a phase 2 trial in pediatric Tourette Syndrome patients, prompting the company to use what it learned in designing a new phase 2b. But now Ingrezza has flunked that trial, too.
The San Diego company broke the bad news to investors Wednesday, noting that Ingrezza failed to top placebo at registering a change on the Yale Global Tic Severity Scale (YGTSS). And there was no sugar-coating the drug’s performance.
“This study was well-conducted with a placebo response as expected, but the treatment effect” of Ingrezza “was lower than we had anticipated,” CEO
Investors were, too, and they showed it by sending shares down by about 14% at market close.
RELATED: Tourette was supposed to be Ingrezza's big driver, but a trial flop has forced a detour
The failure was Ingrezza's third in Tourette. After the first—a January 2017 stumble in adult patients—the drugmaker pinned its hopes on pediatric use. But more negative results followed in May.
Still, Neurocrine explained away that flop, admitting it had underestimated the dose needed to deliver benefits in children and blueprinting its phase 2b study. “The program is not dead, in our view,” Leerink Partners analysts wrote at the time.
Now, though? It’s dead to analysts, all right. Neurocrine itself instructed them on a Wednesday investor call to remove Tourette sales from their models, and they tweaked downward accordingly.
RELATED: Neurocrine nabs Ingrezza OK to kick-start tardive dyskinesia market, with Teva waiting in the wings
Jefferies’ Biren Amin, for one, lowered the price target for Neurocrine to $110 from $131. Leerink’s Marc Goodman went even further, noting that he and his colleagues had taken “this opportunity to re-evaluate our model in aggregate.” He slashed his price target to $84 from $110 and revised his sales forecast for the drug in its approved indication, tardive dyskinesia (TD), downward to about $2 billion from about $2.5 billion.
“While management has executed well on the TD launch so far, we believe our peak sales numbers in TD were just too high,” he wrote to clients.
去年，Neurocrine 公司的 Ingrezza 在儿科抽动秽语综合征患者中的一项 2 期试验失败，促使该公司在设计新的 2b 期时使用它学到的东西。不过，现在英格瑞扎也没有通过审判。圣地亚哥公司周三向投资者透露了这一坏消息，指出 Ingrezza 在耶鲁全球抽动严重程度量表 (YGTSS) 上的变化未能超过安慰剂。药物的性能也没有糖衣。“这项研究进行得很好，安慰剂反应如预期，但治疗效果“Ingrezza”低于我们的预期，”首席执行官 Kevin Gorman，Ph。在一份声明中说，公司“非常失望。“像这个故事一样免费的每日通讯？订阅 FiercePharma！Biopharma 是一个快速增长的世界，每天都有大的想法出现。我们的订户依赖 FiercePharma 作为他们的必读来源，了解有关药物及其制造公司的最新消息、分析和数据。今天注册获取药品新闻和更新传送到您的收件箱，并随时阅读。SUBSCRIBE NOW 的投资者也是如此，他们在股市收盘时将其股价下跌了约 14%。与此相关的是：图雷特本来是英格利扎的大司机，但一次试飞令他不得不绕道而行，失败是英格利扎在图雷特的第三名。在第一次——2017 年 1 月在成人患者中跌跌撞撞——制药商将希望寄托在儿科用药上。但更多的负面结果接踵而至。尽管如此，Neurocrine 还是对 flop 进行了解释，承认它低估了为儿童带来益处所需的剂量，并为其 2b 期研究绘制了蓝图。Leerink Partners 分析师当时写道：“在我们看来，这个计划并没有结束。”但现在呢？对分析家来说已经死了，好吧。Neurocrine 本身就指示他们在周三的投资者电话会议上取消其车型的 Tourette 销售，并相应地进行了调整。相关的：Neurocrine nabs Ingrezza 可以启动迟发性运动障碍市场，Teva 在 Jefferies 的 Biren Amin 中等待，将 Neurocrine 的价格目标从 131 美元降低到 110 美元。Leerink 的 Marc Goodman 更进一步，指出他和他的同事们已经抓住了“这个机会来重新评估我们的模型。“他将自己的价格目标从 110 美元大幅削减至 84 美元，并将其获批适应症——迟发性运动障碍 (TD) 的销售预测从约 2 美元下调至约 20 亿美元。50 亿。他写信给客户：“尽管到目前为止，管理部门在 TD 发布时表现良好，但我们认为，我们在 TD 的销售峰值数字太高了。”
扫码实时看更多精彩文章
微博
微信
提交成功！