Incyte's NDA for Pemigatinib Gets FDA's Priority Review Tag

因塞特(Incyte)胆管癌晚期药物pemiatinib获FDA优先审评资格

2019-11-29 10:10:01 Zacks

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Incyte Corporation INCY announced that the FDA has accepted its new drug application for its investigational FGFR inhibitor pemigatinib as a second-line treatment of locally advanced or metastatic cholangiocarcinoma also known as bile-duct cancer. With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on May 30, 2020. The priority review of pemigatinib will reduce its review time to eight months from the standard duration of 12 months. The NDA was based on data from the phase II FIGHT-202 study, which evaluated the safety and efficacy of pemigatinib in the given patient population. Data from the study showed that treatment with pemigatinib monotherapy led to an overall response rate (ORR) of 36% (primary endpoint) and median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. No serious adverse side effects were reported. Shares of Incyte have soared 48% so far this year compared with the industry’s rise of 4.5%. Cholangiocarcinoma is often diagnosed at an advanced stage when the prognosis is poor. Hence a potential approval of pemigatinib will provide a new treatment option for patients suffering this dreadful disease and drive growth for Incyte in the future. In June 2019, the company initiated a phase III study on pemigatinib for the first-line treatment of patients with FGFR2 translocated cholangiocarcinoma. The candidate is also being evaluated in a phase II study for bladder cancer. Several other mid-stage studies on pemigatinib are underway as well. We remind investors that Agios Pharmaceuticals AGIO is also evaluating its leukemia drug Tibsovo for addressing previously treated patients with IDH1 mutant cholangiocarcinoma. The company plans to file a supplemental new drug application (sNDA) to the FDA by this year-end for Tibsovo to treat cholangiocarcinoma. Zacks Rank & Other Stocks to Consider Incyte currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Anika Therapeutics Inc. ANIK and Vertex Pharmaceuticals Incorporated VRTX, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 71.1% so far this year. Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 32.8% year to date. Breakout Biotech Stocks with Triple-Digit Profit Potential The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better. See these 7 breakthrough stocks now>>
因塞特(Incyte) Corporation INC .宣布, FDA 已接受其研究 FGFR 抑制剂 pemiatinib 的新药申请,作为局部晚期或转移性胆管癌(亦称胆管癌)的二线治疗。 随着 FDA 对 NDA 给予优先审评,预计监管机构将于2020年5月30日做出决定。 培美他替尼的优先审评将使其审评时间从标准持续时间12个月缩短为8个月。 NDA 是基于第二阶段 FIGHT-202研究的数据,该研究评估了 pemigitalinib 在给定患者人群中的安全性和有效性。 研究数据显示,用 Pemigitalib 单药治疗导致总有效率( ORR )为36%(主要终点)和平均持续时间( DOR )为7.5个月(次要终点),平均随访15个月。没有报告严重的副作用。 今年迄今为止,因塞特(Incyte)的股价已飙升48%,而该行业的涨幅为4.5%。 当预后差时,胆管癌常常被诊断为晚期.因此, Pemigiatinib 的潜在批准将为患有这种可怕疾病的患者提供一种新的治疗选择,并推动因塞特(Incyte)在未来的增长。 2019年6月,公司启动了培米格列汀的 III 期研究,用于 FGFR2易位胆管癌患者的一线治疗。该候选人也正在进行第二期膀胱癌研究的评估。其他几项关于胃泌素的中期研究也在进行中。 我们提醒投资者, Agios PharmaceuticalAGIO 也在评估其白血病药物 Tibsovo 用于治疗 IDH1突变胆管癌患者。公司计划在今年年底前向 FDA 提交补充新药申请( sNDA ),用于替布索沃治疗胆管癌。 ZackRank &其他需要考虑的股票 因塞特(Incyte)目前拥有 Zacks 排名第二(购买)。生物技术领域的其他顶级股票包括 Anika Therapeutics Inc . ANIK 和福泰(Vertex) Pharmaceuticals Incorporated VRTX ,这两家公司都拥有 Zacks 排名第一的股票( Strong Buy )。你可以在这里看到今天 Zacks 1号股票的完整列表。 安妮卡的收益预期在过去的60天里,2019年和2020年分别增长了16%和17.4%。该股今年迄今已飙升71.1%。 福泰(Vertex)的盈利预期在过去60天里上调了2019年的5%和2020年的10.6%。该股今年迄今已飙升32.8%。 三位数利润潜力的生物技术股票 到2024年,随着科学家开发出治疗数千种疾病的方法,生物技术产业预计将突破7750亿美元。他们还找到了编辑人类基因组的方法,从字面上消除我们对这些疾病的脆弱性。Zacks 刚刚发布的世纪生物学:7生物技术股票购买权利现在,以帮助投资者从7个股票盈利准备好跑赢。我们最近的生物技术推荐在短短一个月内就实现了+98%、+119%和+164%的增长。本报告中的股票可能表现更好。 现在看这7只突破性股票>

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