Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer.
Bad regulatory news didn’t quash hopes for Travere Therapeutics Inc. with sparsentan, its dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors for focal segmental glomerulosclerosis (FSGS), a disease of kidney scarring.
Vectivbio Holding AG’s IPO last month shone light on short bowel syndrome (SBS), where the company has advanced the glucagon-like peptide-2 analogue apraglutide to the phase III stage. The company aims to show an advantage over same-class Gattex (teduglutide) from Takeda Pharmaceuticals Co. Ltd., cleared by the FDA in December 2012 for adults with SBS and in May 2018 for children at least 1 year of age.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Reneo Pharmaceuticals Inc.’s $93.8 million IPO last month brought renewed attention to primary mitochondrial myopathy (PMM), a genetic disorder that impairs oxidative phosphorylation, affecting mainly muscles. The San Diego-based firm sold about 6.2 million shares at $15 each, but the stock (NASDAQ:RPHM) has since taken a dive, closing May 19 at $8.83.
The anti-TIGIT bispecific antibody AGEN-1777’s preclinical status didn’t stand in the way of Bristol Myers Squibb Co.’s whopper deal with Agenus Inc., which is collecting $200 million up front and as much as $1.36 billion in potential milestone payments in trade for development and commercial rights to the Fc-enhanced compound.
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players.
Allogeneic chimeric antigen receptor T cell (AlloCAR T) specialist Allogene Therapeutics Inc.’s promise of data readouts at this year’s American Society of Clinical Oncology meeting, along with the virtual CD19 forum slated by the company for May 19, whetted investor thirst in the space.
