Following a priority review, partners Astrazeneca plc and Merck & Co. Inc. have gained a green light from the FDA for U.S. marketing of the oral MEK1/2 inhibitor Koselugo (selumetinib), the first FDA-approved treatment for the rare genetic disorder neurofibromatosis type 1 (NF1).
Princeton, N.J.-based Urogen Pharma Ltd. is transforming itself into a commercial operation in anticipation of an FDA approval for UGN-101 this week. Wall Street also apparently expects a positive decision by the April 18 PDUFA date, as listed in BioWorld’s Drugs on Deck record. Urogen’s stock (NASDAQ:URGN) has climbed 40% since the month began, and 11.31%, or $2.41, on April 13, closing out the day at $23.71.
Boston-based Pieris Pharmaceuticals Inc., during its March 12 earnings call, talked up gastric cancer prospect PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, which has turned up single-agent and checkpoint-combination antitumor activity.
A little more than eight months after Pfizer Inc.'s $11.2 billion acquisition of Array Biopharma Inc., a combination of Array-developed Braftovi (encorafenib) and cetuximab has won FDA approval for the second-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC), becoming the first approved therapy specifically targeting that mutation.
Backers in Tango Therapeutics Inc.’s $60 million series B round represent “a group of really smart crossovers who normally don’t come in quite this early” and “hung in there” during some especially hard times on Wall Street recently, CEO Barbara Weber told BioWorld. “We were about to sign the term sheet the first time the market crashed, which was a little nerve-wracking.”
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. reported interim data showing that lead candidate paxalisib (formerly GDC-0084) saw a positive overall survival signal in its phase II glioblastoma trial, and the company raised AU$7.2 million (US$4.4 million) days after the data were released.
HONG KONG – China and U.S.-based Zai Lab Ltd. has signed on to develop and commercialize REGN-1979, a CD20xCD3 bispecific antibody from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y.
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