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BioWorld - Wednesday, December 31, 2025
Home » Topics » Drugs » Small molecule

Small molecule
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CDC adopts ACIP recommendations for HBV vaccine

Dec. 17, 2025
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The U.S. CDC has adopted the recommendations of its Advisory Committee for Immunization Practices (ACIP) regarding the hepatitis B virus (HBV) vaccine scheduling for infants, determining that immunization should be an individual-based decision rather than the universal birth dosing practice that has been in place for the past 30 years.
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Kim Woo-youn, CEO and cofounder, Hits
Drug design, drug delivery & technologies

Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

Dec. 17, 2025
By Marian (YoonJee) Chu
No Comments
Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.
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Kim Woo-youn, CEO and cofounder, Hits
Newco news

Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.
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Prostate cancer cells

GSPT1 chat favorable as Monte Rosa scores in prostate phase I/II

Dec. 16, 2025
By Randy Osborne
No Comments
Monte Rosa Therapeutics Inc. plans a signal-verifying phase II trial next year after making known the positive interim data from an ongoing phase I/II trial testing molecular glue degrader MRT-2359 in combination with androgen receptor (AR) inhibitor Xtandi (enzalutamide, Astellas Pharma Inc.). The investigation targeted heavily pretreated patients with metastatic castration-resistant prostate cancer bearing AR mutations.
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KRAS protein

D3 Bio raises $108M series B to move KRAS G12C into phase III

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
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Multiple sclerosis

Formation loads new Bleecker division with Lynk’s TYK2 inhibitor

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
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Concept of business partnership

Zealand Pharma, OTR, in $2.5B small-molecule metabolic deal

Dec. 16, 2025
By Karen Carey
No Comments
The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.
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Immunome’s phase III results in desmoid tumors point to NDA

Dec. 15, 2025
By Lee Landenberger
No Comments
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
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Drug capsule spilling onto brain

Cycle buying Applied Therapeutics to develop CNS drugs

Dec. 12, 2025
By Lee Landenberger
No Comments
Cycle Group Holdings Ltd. is buying Applied Therapeutics Inc. for a small fraction of the company’s value when it went public in 2019. Cycle is paying $0.088, nearly 9 cents, in cash per share plus a contingent value right (CVR).
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Concept of business partnership

Zealand Pharma, OTR, in $2.5B small-molecule metabolic deal

Dec. 11, 2025
By Karen Carey
No Comments
The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.
Read More
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