Flare Therapeutics Inc. raised $123 million in an oversubscribed series B round to take its lead compound, FX-909, a potentially first-in-class peroxisome proliferator-activated receptor gamma inhibitor, into clinical trials in patients with advanced urothelial cancer and to advance additional pipeline candidates acting on other transcription factor targets with genetically validated links to disease biology.
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas.
Voltron Therapeutics Inc., a portfolio company of Lucius Partners LLC, has signed a new sponsored research agreement (SRA) with the Vaccine and Immunotherapy Center at Massachusetts General Hospital (MGH), Harvard Medical School to initiate a preclinical immuno-oncology study targeting prostate stem cell antigen (PSCA) in prostate, renal cell and urothelial cancers.
Atreca Inc. and Xencor Inc. have mutually selected the first program from their strategic collaboration combining an Atreca-discovered antibody with Xencor's Xmab bispecific Fc domain and a cytotoxic T-cell binding domain (CD3).
CSPC Pharmaceutical Group Ltd. has received IND approval from the FDA for a phase I study in the U.S. of its antibody-drug conjugate CPO-204 in patients with locally advanced or metastatic urothelial cancer.
Legochem Biosciences Inc. has licensed out its antibody-drug conjugate (ADC) LCB-14 to Iksuda Therapeutics Ltd. in the duo’s latest deal that is worth $1 billion. Daejeon, South Korea-based Legochem will receive $50 million in an up-front payment and near-term milestones, and up to $950 million in developments, regulatory and commercial milestones.
LONDON – Bridgebio Inc. has made a huge turn on the initial $65 million it invested in 2018 to acquire rights to infigratinib from Novartis AG, sealing a $2 billion commercialization deal with Swiss oncology specialist Helsinn Group for the fibroblast growth factor receptor (FGFR) inhibitor just four years later. Helsinn will work with Bridgebio affiliate QED Therapeutics Inc. on U.S. co-commercialization of infigratinib in oncology and all other indications apart from skeletal dysplasias, with profits and losses shared on a 50-50 basis.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
With Stifel analysts recently setting a $41 price target for Urogen Pharma Ltd. and interim data in hand from the trial in bladder cancer with UGN-102, hopes are high that the drug's approach – having already proved its mettle in UGN-101 against low-grade upper tract urothelial cancer (UTUC) – will yield durable results. Shares (NASDAQ:URGN) have been trading at around $22, closing Friday at $21.97.
