帕尔维拉的药物在罕见淋巴畸形试验中表现出显著效果,提升了市场份额,并为FDA提交程序铺平了道路。
Palvella's drug showed strong results in rare lymphatic malformation trial, boosting shares and paving way for FDA submission.
在SELVA第3阶段试验后,Palvella治疗药物股份猛涨33%,显示QTORIN3.9%的拉帕米辛凝胶在治疗微细胞性淋巴畸形方面达到初级和二级终点,这是罕见的,没有经过批准的治疗方法。
Palvella Therapeutics' shares surged 33% after its Phase 3 SELVA trial showed QTORIN 3.9% rapamycin gel met primary and secondary endpoints in treating microcystic lymphatic malformations, a rare condition with no approved therapies.
对49名病人的试验显示有显著改善,95%的病人在关键评估方面至少达到一分增益,86%的病人评分很高或大大改善。
The trial of 49 patients showed significant improvement, with 95% achieving at least a one-point gain on key assessments and 86% rated much or very improved.
专题治疗是良好的,没有严重的与药物有关的副作用。
The topical treatment was well-tolerated, with no serious drug-related side effects.
Palvella计划于2026年底向林业发展局提交一份新的药物申请,有可能在2027年初获得批准。
Palvella plans to file a New Drug Application with the FDA in late 2026, potentially leading to approval by early 2027.