New and positive data for Maia Biotechnology Inc.’s lead candidate for a particularly deadly and advanced lung cancer propelled the stock modestly higher on Feb. 4. The pivotal phase II THIO-101 study of Thio, a telomere-targeting agent sequenced with Regeneron Inc.’s immune checkpoint inhibitor, Libtayo (cemiplimab), as a third-line treatment for advanced non-small-cell lung cancer (NSCLC) showed median overall survival of 16.9 months for the 22 NSCLC patients who received at least one dose of Thio in parts A and B.
A week after the first IPO of the year was priced, obesity treatment developer Metsera Inc. and renal specialist Maze Therapeutics Inc. have begun trading on Nasdaq. Metsera (NASDAQ:MTSR) surged 47% on Jan. 31 to close at $26.50 per share while Maze (NASDAQ:MAZE) barely budged, closing three-tenths of a percentage point lower on the day.
It’s one step backward in order to take two steps forward at Zentalis Pharmaceuticals Inc. In a restructuring to help fund the second part of its potentially registration-enabling Denali study, Zentalis has laid off 40% of its workforce. The clinical trial of azenosertib, Zentalis’ lead candidate and a WEE1 kinase inhibitor, is for treating advanced solid tumors and hematologic malignancies. The therapy is designed to make cancer cells self-destruct.
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). The side effect of lean mass loss has dogged those taking GLP-1s. The study results didn’t support the company’s stock on the day of the data release as it had the previous four weeks.
Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share.
Neomorph Inc. has signed another billion-dollar deal to develop molecular glue degraders, this time with Abbvie Inc. It’s the third agreement in the past year the five-year-old company has signed with big pharma companies in a space with lots of collaborative deals.
Tris Pharma Inc.’s positive top-line data from a pivotal phase III study of cebranopadol in pain relief has the company thinking about an NDA submission later in the year. The company’s goal is to avoid the problems opioids have brought to treating pain.
While Moderna Inc. plans to cut its expenses by $1 billion in 2025, the company has received a little breathing room by a hefty U.S. Department of Health and Human Services (HHS) grant. The Biomedical Advanced Research and Development Authority awarded Moderna roughly $590 million to support late-stage development of its mRNA-based avian-variant vaccines and to increase the number of clinical trials for another five additional subtypes of pre-pandemic influenza.
Can the market justify the hundreds of GLP-1 developers that are working to eventually reach the market? When the dust settles, Minji Kim, CEO of Cross Border Partners and Advisory Service, told attendees at the Biotech Showcase in San Francisco, only a few leading companies will end up dominating the field.