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Home » Authors » Randy Osborne

Articles by Randy Osborne

Vim’s vigor in TGCT verified in phase III as Deciphera ‘pex’ at Daiichi’s heels

Oct. 31, 2023
By Randy Osborne
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
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Vim’s vigor in TGCT verified in phase III as Deciphera ‘pex’ at Daiichi’s heels

Oct. 30, 2023
By Randy Osborne
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
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Green approved stamp

Lilly gains FDA nod for Omvoh in ulcerative colitis; Stelara era ending in EU?

Oct. 27, 2023
By Randy Osborne
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
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Gold dollar sign

Junction functions fine for Triveni with $92M series A to push atopic dermatitis program

Oct. 26, 2023
By Randy Osborne
The atopic dermatitis space gained another player in Triveni Bio Inc., which pulled down a $92 million series A financing co-led by Atlas Venture and Cormorant Asset Management to pay for a proof-of-concept study with lead program, TRIV-509, and boost the Waltham, Mass.-based firm’s broader pipeline.
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DNA in drug capsules

$85M series A fortifies Rampart push in DNA-based therapies

Oct. 24, 2023
By Randy Osborne
Emerging from stealth mode, Rampart Bioscience Inc. pulled down $85 million in series A money for work on DNA-based drugs – a round that was led by Forbion with participation from seed investor Orbimed and new backers RA Capital Management and Healthcap.
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Cancer diagnostic illustration

Players talking TRK-y in NSCLC as ROS1, ALK zones cook up data

Oct. 24, 2023
By Randy Osborne
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4.
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Updated phase I/II ESMO data show promise for Harpoon’s DLL3 prospect in SCLC

Oct. 23, 2023
By Randy Osborne
Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO). Wall Street immediately began comparing the compound, which takes aim at delta-like ligand 3 (DLL3) with a similar prospect from Amgen Inc. that recently yielded promising results.
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Pfizer wins FDA nod for pentavalent meningitis vaccine Penbraya

Oct. 20, 2023
By Randy Osborne
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
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Cancer diagnostic illustration

Players talking TRK-y in NSCLC as ROS1, ALK zones cook up data

Oct. 20, 2023
By Randy Osborne
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4.
Read More
Women handshake with virology graphics

Assembly room: Gilead deal’s $100M up front aims to build antiviral arsenal

Oct. 17, 2023
By Randy Osborne
What CEO Jason Okazaki called Assembly Biosciences Inc.’s “monumental” deal for new antivirals with Gilead Sciences Inc. brings $100 million right away, consisting of an $84.8 million up-front payment and a $15.2 million equity investment. Wall Street liked it, and shares of South San Francisco-based Assembly (NASDAQ:ASMB) closed Oct. 17 at $1.25, up 52 cents or 72%, on word of the 12-year arrangement. Gilead (NASDAQ:GILD) ended at $80.48, up $1.28.
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