Loading...Loading...Tuesday, Crinetics Pharmaceuticals Inc CRNX released topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of paltusotine for acromegaly.Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood.The 111-participant study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN) compared to those taking placebo (5%). All secondary endpoints also met statistical significance.In PATHFNDR-2, paltusotine was generally well-tolerated, and no serious adverse events were reported in participants who were treated with paltusotine. The company plans to submit a New Drug Application to the FDA in the second half of 2024 and is preparing for a potential 2025 launch. 'Paltusotine continues to exceed expectations.

正在加载。。。正在加载。。。周二，Crinetics Pharmaceuticals Inc CRNX发布了PATHFNDR-2的topline结果，这是评估帕妥司汀治疗肢端肥大症疗效和安全性的两项3期研究中的第二项。肢端肥大症是一种激素紊乱，成年后垂体产生过多的生长激素时会发展。111名参与者的研究在主要终点上具有统计学意义（p<0.0001），这是基于服用帕洛司汀的参与者比例（56%）达到胰岛素样生长因子1（IGF-1）水平≤正常上限（xULN）的1.0倍与服用安慰剂的人（5%）相比。所有次要终点也符合统计学意义。在PATHFNDR-2中，帕洛司汀通常耐受性良好，并且在接受帕洛司汀治疗的参与者中未报告严重不良事件。该公司计划在2024年下半年向FDA提交新药申请，并准备在2025年推出。'Paltusotine继续超出预期。

Today, PATHFNDR-2 delivered statistically significant topline results across the board,' said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. Last week, Crinetics Pharmaceuticals announced topline results from its open-label Phase 2 carcinoid syndrome study of paltusotine for acromegaly and carcinoid syndrome.The data showed that paltusotine treatment demonstrated rapid and sustained reductions in the frequency and severity of flushing episodes and bowel movements.Paltusotine was generally well-tolerated and showed an overall PK profile consistent with prior studies.Price Action: CRNX shares are up 19.30% at $45.23 on the last check Tuesday.Loading...Loading....

Crinetics创始人兼首席执行官斯科特·斯特拉瑟斯（ScottStruthers）博士说，如今，PATHFNDR-2在各方面都取得了具有统计学意义的重要成果。上周，Crinetics Pharmaceuticals宣布了paltusotine治疗肢端肥大症和类癌综合征的开放标签2期类癌综合征研究的结果。数据显示，帕洛司汀治疗显示，潮红发作和排便的频率和严重程度迅速持续降低。Paltusotine通常耐受性良好，并显示出与先前研究一致的总体PK谱。价格走势：CRNX股价周二上涨19.30%，至45.23美元。正在加载。。。正在加载。。。。