The BioWorld Cancer Index closed 2025 up 72.35%, outpacing gains in the Nasdaq Biotechnology Index (up 32.4%) and the Dow Jones Industrial Average (up 12.97%). The year featured standout gains, led by Terns Pharmaceuticals Inc., which surged 620%.
Researchers from Chimerix, now part of Jazz Pharmaceuticals, presented preclinical data on ONC-206, a compound that functions as both an agonist of the mitochondrial protease Caseinolytic peptidase P (CLPP) and an antagonist of the G protein-coupled receptor DRD2, in models of triple-negative breast cancer (TNBC).
The BioWorld Biopharmaceutical Index extended its autumn rally after a more modest September, finishing November up 23.41% for the year. The gain lagged the Nasdaq Biotechnology Index, which surged 34.97% in the first 11 months of the year, but outpaced the broader Dow Jones Industrial Average, which rose 12.16% in the same period.
A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.
Having reached peace with Jazz Pharmaceuticals plc over litigation related to its U.S. FDA-approved drug, Lumryz (sodium oxybate), Avadel Pharmaceuticals plc agreed to a cash takeover by Alkermes plc valued at about $2.1 billion, a deal Alkermes CEO Richard Pops said “puts us in the sleep market immediately on closing,” which is expected in the first quarter of 2026. All three players are based in Dublin.
A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorldfor the period, after 2024’s high of 159.
Jazz Pharmaceuticals plc is prepped and ready for launch following U.S. FDA accelerated approval of dordaviprone as the first systemic therapy for H3 K27M-mutant diffuse glioma. Branded Modeyso, the orally administered first-in-class imipridone was acquired via Jazz’s acquisition earlier this year of Chimerix Inc. in a deal valued at about $935 million.
Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
