Despite a newly signed $645 million commercialization deal with Neuraxpharm Group for multiple sclerosis drug Briumvi (ublituximab) in Europe, shares of TG Therapeutics Inc. (NASDAQ:TGTX) tanked by 50% in early trading on Aug. 1 due to a perceived miss in U.S. net sales for the anti-CD20 monoclonal antibody during its first full quarter on the market. Briumvi, which was approved in the U.S. in December 2022 and in the EU in June 2023, earned $16 million in the second quarter (Q2), bringing the total to about $24 million since its January launch for relapsing forms of multiple sclerosis. While the consensus estimate had been $14.6 million for Q2, Wall Street raised it to $17.4 million earlier this week. “It’s obviously a little disheartening when folks change the consensus two days before the reporting and then assume that it was a bad quarter,” said Michael Weiss, chairman, president and CEO of TG, which will receive $150 million in up-front and near-term milestone payments through the European deal.
Borisy’s Revolution and Eqrx will merge in $1B deal
Revolution Medicines Inc. is acquiring Eqrx Inc. in an all-stock transaction designed to add more than $1 billion in net cash for Revolution. Serial biotech entrepreneur and investor Alexis Borisy co-founded Eqrx to deliver new medicines for cancer and other conditions at "radically lower prices." Borisy also co-founded Revolution, where he remains as executive chairman. The transaction is expected to close in November. Eqrx hit a wall late in 2022 when, based on U.S. FDA feedback, the company decided there was no commercially viable path in the U.S. for sugemalimab plus chemotherapy in treating stage IV non-small-cell lung cancer but moved ahead in finding non-U.S. approvals. Eqrx’s stock (NASDAQ:EQRX) had jackrabbited 15% upward at midday, with shares going for $1.97 each.
FDA approves Anaptysbio’s GSK-partnered biologic Jemperli in combination with chemo
About two months ahead of the planned PDUFA date, the U.S. FDA has granted expanded approval of PD-1 antibody Jemperli (dostarlimab) from partners Anaptysbio Inc. and GSK plc for use in combination with standard-of-care chemotherapy. GSK said the drug would be the only frontline immuno-oncology treatment for endometrial cancer available in combination with carboplatin and paclitaxel. The supporting supplemental BLA for the expanded indication previously received priority review.
Newco news: Renaissance launches with neuroblastoma antibody candidate
Newco Renaissance Pharma Ltd. has been formed to take a new treatment for neuroblastoma developed at St Jude’s Children’s Research Hospital through to market. The product, Hu14.18, has been in-licensed following a phase II trial conducted at the hospital in which patients with newly diagnosed high-risk neuroblastoma had a three-year event-free survival of 73.7% and an overall survival of 86%. That is a marked improvement on current overall survival of around 50%, according to Simon Ball, CEO and co-founder of Renaissance. “It’s really rare to look at data and think this is a step shift change from a survival perspective,” he told BioWorld.
Celloram nabs $176M deal with Genfit for inflammasome inhibitor
Celloram Inc., the U.S. subsidiary of the Seoul, South Korea-based Medpacto Inc., signed a €160 million (US$175.88 million) licensing deal with Genfit SA to develop Celloram’s inflammasome inhibitor, CLM-022, for liver disease. Celloram said it would receive clinical, regulatory and commercial milestone payments from Genfit for the asset, although payout details could not be disclosed according to contract terms. Genfit, meanwhile, gains global rights to develop CLM-022, the small-molecule drug that inhibits the NLRP3 pathway known to affect various diseases like autoinflammatory disorders, metabolic syndrome and neurodegeneration.
‘Made in America’ executive order steers clear of Titanic-sized iceberg
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order, issued last week, that’s intended to shore up domestic manufacturing requirements for products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing requirement for exclusive licenses for products that were to be marketed in the U.S. Instead, the new executive order seeks more accountability from government agencies on how they respond to domestic manufacturing waiver requests and provides guidelines to encourage “Made in America.”