Snagging its second U.S. FDA approval since being spun out of Pfizer Inc. in 2017, Springworks Therapeutics Inc. is aiming to position Gomekli (mirdametinib), cleared for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) not amenable to complete resection, as a first-in-class drug for adults and potentially best-in-class option for children. The priority approval, which came after market close Feb. 11, more than two weeks ahead of the Feb. 28 PDUFA date, marks the second MEK1/2 inhibitor to hit the market for NF1-PN, a rare, genetic condition. Read More
Xilio Therapeutics Inc. is banking $52 million up front from Abbvie Inc., including a $10 million equity investment, plus about $2.1 billion in contingent payments for option-related fees and milestones, plus tiered royalties, as the pair embarks on developing tumor-activated, antibody-based immunotherapies, including masked T-cell engagers. Read More
Dealmaking in the Asia Pacific (APAC) region took off this week, with the latest showcasing Genome & Co.’s licensing deal with Ellipses Pharma Ltd. for GENA-104, a phase I-ready immuno-oncology asset, under undisclosed terms Feb. 11. Read More
The BioWorld Cancer Index (BCI) experienced a steep decline in 2024, closing the year down 17.32%. After peaking in late February with an 11.16% gain, the index steadily trended downward, with only brief recoveries that failed to push it back into positive territory. This marked a sharp contrast to 2023, when the BCI soared 76.26% by year-end. In comparison, 2022 saw the index drop by 41.98%, while 2021 closed with a decline of 36.34%. Read More
Biomissile Pharmaceuticals Co. Ltd. is developing multispecific antibodies that overcome resistance associated with antibody-drug conjugates via its next-generation natural killer (NK) cell engagers. “ADCs are very efficacious, but they do have a drawback with side effects and resistance, because ultimately ADCs are similar to chemotherapy because you bring toxins to the tumor site,” Biomissile co-founder and CEO Chao Tu told BioWorld. Read More
With the first company in the world announcing more than $1 billion in annual revenue from pulsed field ablation on Feb. 5, Clarivate plc and BioWorld MedTech’s latest report provides well-timed insight into the stunning growth and bright future of this new medical technology for the treatment of atrial fibrillation. Read More
New hires and promotions in the biopharma industry, including: AI Proteins, Altpep, Ampersand, Bluejay, Cognito, Kala, Lakewood-Amedex, Lycia Orchard. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Ausper, Ausperbio, Convergent, In8bio, Lipella, Pfizer, Spinogenix, Third Harmonic. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biohaven, Bridgebio, Merck, Regeneron, Travere. Read More
