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BioWorld - Tuesday, December 30, 2025
Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Connecting puzzle pieces

STAT6 stat sig? Kaken, J&J $1.2B-plus deal adds oomph to space

Dec. 31, 2024
By Randy Osborne
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
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Head and neck anatomy

Pick Pyxis in head and neck despite pullback on ADC phase I?

Dec. 30, 2024
By Randy Osborne
Though Pyxis Oncology Inc.’s preliminary phase I data with antibody-drug conjugate (ADC) PYX-201 in solid tumors were characterized as positive, findings sent the Boston-based firm’s stock (NASDAQ:PYXS) into a tailspin. Shares dropped from $3.82 to $2.01 between Nov. 20 and the morning of Nov. 21, even as experts along with Wall Street agreed that the compound shows particular promise in head and neck squamous cell carcinoma – a space where developers aplenty remain busy.
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Connecting puzzle pieces

STAT6 stat sig? Kaken, J&J $1.2B-plus deal adds oomph to space

Dec. 27, 2024
By Randy Osborne
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Read More

Any Betta? FDA adds Ensacove to ALK lung cancer weaponry

Dec. 24, 2024
By Randy Osborne
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
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US FDA opens gate to Vertex’s Alyftrek in cystic fibrosis

Dec. 23, 2024
By Randy Osborne
Laptop displaying FDA logo

Lexicon Zynquista vista narrows with diabetes CRL; gain due in pain?

Dec. 23, 2024
By Randy Osborne
As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), with analysts mulling the potential label.
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Alyftrek specs check out in cystic fibrosis as Vertex wins FDA nod

Dec. 23, 2024
By Randy Osborne
Vertex Pharmaceuticals Inc.’s chief operating officer Stuart Arbuckle said during the Stifel Healthcare Conference in November that his firm’s launch last year of Casgevy (exagamglogene autotemcel) for sickle cell disease and transfusion-dependent beta-thalassemia “was the beginning of diversifying on top of our cystic fibrosis [CF] base” – a base that itself continues to grow.
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Hope alive in DPNP as Lexicon CRL arrives for Zynquista

Dec. 20, 2024
By Randy Osborne
FDA Approved stamp

Ionis notches Arrowhead win; Tryngolza cleared for FCS

Dec. 20, 2024
By Randy Osborne
Ionis Pharmaceuticals Inc. CEO Brett Monia predicted that diagnoses of familial chylomicronemia syndrome (FCS) will “accelerate fairly quickly” now that the firm has gained U.S. FDA clearance for Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with the rare form of severe hypertriglyceridemia (sHTG) that can lead to life-threatening acute pancreatitis (AP).
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FDA says yes to Ionis’ Tryngolza in rare disease FCS

Dec. 20, 2024
By Randy Osborne
View All Articles by Randy Osborne

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