We share weekly commentaries with investors on stocks in our strategies that have appreciated or dropped more than 15% in a day during the course of the week. We hope you find this commentary useful.
|Iovance Biotherapeutics (IOVA)|
|-39%||Iovance Biotherapeutics (IOVA), a leader in tumor-infiltrating lymphocyte (TIL) immunotherapy, closed down 39% on Wednesday. On Tuesday, Iovance announced that it was delaying its Biologics License Application (BLA) from the second half of 2021 to the first half of 2022 because of FDA feedback on its potency assays.On Wednesday, the company disclosed that Maria Fardis, CEO of the company for the last five years, was leaving “to pursue other opportunities,” and that General Counsel Frederick Vogt would be stepping in as interim CEO.We believe that Iovance’s TILs will continue to be the most compelling therapy for solid tumors in the market and that Iovance has the most robust TIL data set. Furthermore, in our view, Iovance is trail-blazing the FDA regulatory process and likely will get FDA approval for its TIL therapy to treat melanoma, a very difficult-to-treat disease with high unmet need.|
注: 肿瘤浸润淋巴细胞（TIL）免疫疗法的领导者Iovance Biotherapeutics（IOVA）周三收盘下跌39%。周二，Iovance宣布将其生物制品许可申请（BLA）从2021年下半年推迟到2022年上半年，因为FDA对其效力测定的反馈。 周三，该公司披露，过去五年的公司首席执行官Maria Fardis将离开，”以寻求其他机会”，总法律顾问Frederick Vogt将担任临时首席执行官。我们认为，Iovance的TIL将继续成为市场上最引人注目的实体瘤疗法，Iovance拥有最强大的TIL数据集。此外，我们认为，Iovance公司正在开拓美国食品和药物管理局的监管程序，其治疗黑色素瘤的TIL疗法很可能会得到美国食品和药物管理局的批准，这是一种非常难以治疗的疾病，其需求尚未得到满足。