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BioWorld - Saturday, February 7, 2026
Home » Topics » Small molecule, BioWorld

Small molecule, BioWorld
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Oral medication

Vanda’s tradipitant has phase II success but a court setback

Nov. 18, 2025
By Lee Landenberger
No Comments
Top-line results from a midstage study of Vanda Pharmaceuticals Inc.’s tradipitant hit its primary endpoint by preventing the nausea and vomiting that can be caused by the GLP-1 receptor agonist Wegovy (tirzepatide, Eli Lilly and Co.) in overweight and obese adults. The positive phase II study data prompted Vanda to look at a phase III study of the oral neurokinin-1 receptor antagonist next year.
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Mammogram

CERAN wrap: Roche phase III BC win seals thesis, boosts Olema

Nov. 18, 2025
By Randy Osborne
No Comments
Roche AG’s Genentech unit landed another clinical victory with giredestrant that provided a major stock boost for competitor Olema Pharmaceuticals Inc. Made public were positive phase III data from the Lidera study testing selective estrogen receptor degrader and complete estrogen receptor antagonist (CERAN) as an adjuvant endocrine treatment for people with ER-positive, HER2-negative, early stage breast cancer (BC).
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Merck & Co. Inc. headquarters in Rahway, N.J.

Merck buys Cidara for $9.2B as Keytruda patent loss looms

Nov. 14, 2025
By Lee Landenberger
No Comments
Merck & Co. Inc. is buying Cidara Therapeutics Inc. for $9.2 billion to acquire a late-stage flu candidate and also to outrace blockbuster Keytruda’s looming patent expiration. CD-388, Cidara’s lead candidate, is in a phase III study of adolescents and adults for preventing influenza A and B in those who are at a high risk of developing complications.
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Komzifti packaging

FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML

Nov. 13, 2025
By Tamra Sami
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
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Mosquito

With malaria numbers rising, Novartis has phase III success

Nov. 13, 2025
By Lee Landenberger
No Comments
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
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Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

Nov. 12, 2025
By Marian (YoonJee) Chu
No Comments
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
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Man falling asleep in car

Alkermes’ alixorexton hits endpoints in narcolepsy phase II

Nov. 12, 2025
By Lee Landenberger
No Comments
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
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Stomach cross-section on scientific background

A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
No Comments
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
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Liver over digital lens background

MASH prospects from Rivus, Metavia show promise in phase II

Nov. 7, 2025
By Karen Carey
No Comments
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
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Wegovy and Zepbound autoinjectors

Lilly, Novo MFN deals expected to ‘democratize’ obesity drugs

Nov. 6, 2025
By Mari Serebrov
No Comments
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
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