Reporting sales of its hepatitis B vaccine Heplisav-B pretty much in line with consensus and a phase I/II shingles prospect moving along, Dynavax Technologies Corp. scored a takeover deal with Sanofi SA, which is paying $15.50 per share in cash for a total equity value of about $2.2 billion. The amount is a 39% premium to Dynavax’s closing share price yesterday, Dec. 23.
Recludix Pharma Inc. has obtained IND clearance from the FDA to advance REX-8756 (SAR-448755), an oral STAT6 inhibitor for inflammatory diseases, into phase I testing. REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain.
ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a U.S. phase I study.
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
Sanofi SA reported more hitches in the development of Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis (MS) and that the ongoing U.S. regulatory review in non-relapsing secondary progressive MS likely will extend beyond the targeted PDUFA date of Dec. 28.
Indupro Inc. has announced a strategic equity investment and research collaboration with Sanofi SA. The agreement with Sanofi includes the right of first negotiation for Indupro’s bispecific PD-1 agonist program.
As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are growing. Claiming that Kennedy has turned his back on science and is endangering public health, Rep. Haley Stevens, D-Mich., formally introduced articles of impeachment against him Dec. 10 for “high crimes and misdemeanors.” Under the Constitution, federal officials can only be impeached for treason, bribery and “other high crimes and misdemeanors.”
The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.
The BioWorld Biopharmaceutical Index extended its rebound through August and September, closing the third quarter (Q3) slightly in positive territory after losing ground earlier in the year.
In September 2025, BioWorld recorded 230 clinical trial updates spanning phases I through III, up sharply from 95 in August, 140 in July and just below 254 in June. Among these, 22 phase III trials reported positive outcomes, while four ended in failure and another three produced mixed results.
