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Home » Authors » Randy Osborne

Articles by Randy Osborne

Leukemia illustration

Sierra club membership to widen as myelofibrosis Momentum builds?

Aug. 27, 2020
By Randy Osborne
Vancouver, British Columbia-based Sierra Oncology Inc. during its recent earnings call offered an update on momelotinib, in phase III development for myelofibrosis. Enrollment in the study won’t be finished until the fourth quarter of 2021.
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Foot pain

GA on their mind: Annexon C1q field of view ‘unique’

Aug. 26, 2020
By Randy Osborne
Annexon Biosciences Inc.’s handsome $250 million IPO this summer verified the mounting interest in its two front-running C1q inhibitors: ANX-005, which has turned up promising phase Ib data in Guillain-Barre syndrome (GBS), with a phase II/III effort planned for next year, and ANX-007, due to enter a phase II experiment in geographic atrophy (GA) during 2021 as well.
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Tesetaxel broken axle? Odonate’s Contessa barefoot despite phase III endpoint win

Aug. 24, 2020
By Randy Osborne
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.
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Sinuses

IL-33 RPM slowing? Anaptysbio, Regeneron data fail to move needle

Aug. 21, 2020
By Randy Osborne
San Diego-based Anaptysbio Inc.’s phase II blowup with anti-IL-33 monoclonal antibody etokimab in chronic rhinosinusitis with nasal polyps (CRwNP), disclosed Aug. 10, followed the compound’s mid-stage atopic dermatitis (AD) fizzle in November of last year, and raised questions not only about the lead candidate but also about the target.
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FDA Approved stamp

New pen pal? Novartis’ Kesimpta greenlighted in relapsing MS with autoinjector

Aug. 20, 2020
By Randy Osborne
Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
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Neurology illustration

Backup drive: Karuna motivated in schizophrenia, adds second phase III just to be sure

Aug. 20, 2020
By Randy Osborne
Karuna Therapeutics Inc. remains on track to launch a phase III study by the end of this year with Karxt against acute psychosis in schizophrenia by way of the broad-based program called Emergent, and the company continues planning for a phase II study testing the combo drug as adjunctive therapy with standard of care in the same indication.
Read More
Barbara Weber, CEO, Tango

Tango’s evasive tactics confronted by wider Gilead terms: $6B-plus potential in cancer deal

Aug. 18, 2020
By Randy Osborne
Tango Therapeutics Inc. CEO Barbara Weber told BioWorld that Gilead Sciences Inc.’s decision to greatly expand their 2018 deal in oncology – a pact then valued as high as $1.7 billion – was based on brisker than expected progress in the original, five-target effort.
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Un-Enspryng? Street hails Roche’s new subcu but still enthused re infused for NMOSD

Aug. 17, 2020
By Randy Osborne
The FDA’s go-ahead for Roche Holding AG’s Enspryng (satralizumab-mwge) in anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder had watchers of the space weighing its market odds against two therapies approved earlier: Soliris (eculizumab) from Boston-based Alexion Pharmaceuticals Inc., and the more recently cleared Uplizna (inebilizumab-cdon) from Viela Bio Inc., of Gaithersburg, Md.
Read More

Roche joins Alexion, Viela in NMOSD market with Enspryng approval

Aug. 17, 2020
By Randy Osborne
Rays of light beaming from eye

Delivering the goods: Regenxbio, Adverum explore alternate routes in AMD

Aug. 14, 2020
By Randy Osborne
Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
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