The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
Sanofi SA is getting deeper into oncology and immunology therapy development through buying Dren Bio Inc.’s myeloid cell engager for deep B-cell depletion, DR-0201. The deal could reach as high as $1.9 billion for privately held Dren. Sanofi is paying a hefty $600 million up front, and milestone payments to come could add up to $1.3 billion.
Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies followed a failure from December. New results from the Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, have encouraged the company to pursue a phase III study.
Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension propelled Mineralys Therapeutics Inc.’s stock sharply upward on March 10. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. On March 10, the Radnor, Pa.-based company’s shares (NASDAQ:MLYS) closed 42% upward at $14.96 each.
There have been plenty of multi-billion-dollar mega mergers in the past few years but most have fallen short of their goals. In the latest edition of the BioWorld Insider podcast, Karen Carey, BioWorld’s senior managing editor and chief analyst, unpacked the details in 21 of the biggest M&As and found very few have turned out to be good deals for the buyer.
Jazz Pharmaceuticals plc is buying Chimerix Inc. for $8.55 a share in cash, bringing the deal in at about $935 million. Jazz expands its cancer pipeline with the new acquisition’s lead candidate, dordaviprone, a small molecule for treating a rare, aggressive glioma that’s often found in children and young adults.
With the closing of its $350.7 million series D, Eikon Therapeutics Inc. has notched two financial high marks for the still young year. The funding is the biggest venture capital round of 2025 and it’s also the first series D.
In Regeneron Pharmaceuticals Inc.’s phase I/II Chord study of 12 children with genetic hearing loss, 10 out of 11 have shown improvements after being treated with a gene therapy. “What is really remarkable about this type of therapeutic approach is that the first people who are going to see the impact are not actually the physicians – it’s the families,” Jonathon Whitton, vice president and Regeneron’s auditory global program head, told BioWorld.
Artificial intelligence (AI) technology developer Genesis Therapeutics Inc. has brought in another larger partner to go on a search for the right therapeutic small molecules. The company is getting an up-front $30 million payment from Incyte Corp. and could bring in as much as $295 million per target in development, regulatory and commercial milestones, bringing the deal to about $620 million total.
The phase IIb study results of Supernus Pharmaceuticals Inc.’s SPN-820 in treatment-resistant depression had pulled the company’s stock (NASDAQ:SUPN) down 15.6% on Feb. 19. The randomized, double-blind, placebo-controlled study of adults failed to show a statistically significant improvement on the primary endpoint of change from baseline on the Montgomery-Åsberg Depression rating scale. Shares closed at $33.52 apiece on Feb. 19.
