A metastatic renal cell carcinoma (RCC) trial once expected to pave a path to registration for the Calithera Biosciences Inc. candidate telaglenastat failed to show a benefit from the drug in a new analysis of the pivotal phase II study, Cantata. While company executives voiced confidence in the drug's prospects in another indication, non-small-cell lung cancer (NSCLC), analyst and investor faith appeared less sturdy, as company shares (NASDAQ:CALA) fell 44.6% to $2.72 on Jan. 4.
Following a better-than-expected commercial liftoff for the overactive bladder medicine Gemtesa (vibegron) in its first market, Japan, the Dec. 23 FDA approval for the medicine opens a new commercial chapter for Urovant Sciences, a company that’s on its way to being a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd.'s Sumitovant Biopharma Ltd.
Shares of Aprea Therapeutics Inc. (NASDAQ:APRE), a company focused on developing therapies that reactivate the mutant tumor suppressor protein p53, fell 78.1% to $5.50 on Dec. 28, just north of its cash balance, after a pivotal trial of its lead candidate missed its endpoint, leaving the asset's future hazy and likely scuttling plans the company had for a first quarter 2021 NDA filing.
Following a better-than-expected commercial liftoff for the overactive bladder medicine Gemtesa (vibegron) in its first market, Japan, the Dec. 23 FDA approval for the medicine opens a new commercial chapter for Urovant Sciences, a company that’s on its way to being a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd.'s Sumitovant Biopharma Ltd.
Shares of Voyager Therapeutics Inc. and its partner, Neurocrine Biosciences Inc., fell in early trading Dec. 23 after Voyager announced an FDA clinical hold on the phase II Restore-1 trial of VY-AADC, an adeno-associated virus-based gene therapy Neurocrine is developing as NBIb-1817 for the treatment of Parkinson's disease. The trial had been paused since at least November as its data safety monitoring board reviewed MRI abnormalities in some study participants.
Agios Pharmaceuticals Inc., a company that has until now revolved primarily around its FDA-approved acute myeloid leukemia drug, Tibsovo (ivosidenib), is selling that drug and the rest of its oncology business to Servier Pharmaceuticals LLC in a deal valued at up to $2 billion, plus royalties. The agreement includes $1.8 billion cash up front for the portfolio and as much as $200 million in regulatory milestone payments for the investigational glioma treatment vorasidenib.
Following a priority review of Orgovyx (relugolix), an oral hormone therapy developed by Myovant Sciences GmbH, the FDA has approved the medicine for the treatment of adults with advanced prostate cancer. The first success among three indications for which Myovant has developed the gonadotropin-releasing hormone (GnRH) receptor agonist, the green light marks Myovant’s transformation into a commercial-stage company, SVB Leerink analyst Ami Fadia noted. Company shares (NYSE:MYOV) fell 4.5% to $23.61 following the Dec. 18 approval.
As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission.
