Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.
Coming out of the IPO gate strong was Lausanne, Switzerland-based ADC Therapeutics SA, which priced about 12 million shares at $19 each, for gross proceeds of about $232.7 million in an upsized deal. Shares (NYSE:ADCT) ended the day at $29.65, up $10.65, or 56%.
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
Dermtech Inc., of La Jolla, Calif., has had a busy couple of weeks, revealing late last month that its noninvasive melanoma detection test is available for use via telemedicine. Now, the company has unveiled first-quarter results that saw assay revenue of $0.8 million, a 238% increase from the first quarter of 2019.
Shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) leapt 36% higher to $42.12 on Thursday after limited data from a small number of relapsed/refractory (r/r) non-Hodgkin lymphoma patients showed a combination of the company's anti-CD19 allogeneic CAR T candidate, ALLO-501, and an anti-CD52 monoclonal antibody, ALLO-647, met with an overall response rate of 78%.
New data show Johnson & Johnson’s Erleada (apalutamide) and Xtandi (enzalutamide) from Pfizer Inc. and Astellas Pharma Inc. both prolonged overall survival in men with non-metastatic castration-resistant prostate cancer (nmCRPC).