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Home » Authors » Randy Osborne

Articles by Randy Osborne

Brexafemme

Scynexis makes good on Brexafemme out-licensing promise in $593M GSK pact

March 30, 2023
By Randy Osborne
The advance of antifungals – a class long needful of new therapies – continued with Scynexis Inc.’s potential $593 million exclusive license agreement with GSK plc for Brexafemme (ibrexafungerp), first cleared by the U.S. FDA in June 2021 and indicated for vulvovaginal candidiasis (VVC) as well as for reduction of recurrent VVC.
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Silhouette made of crumpled paper illustrating depression

Caplyta scores again; results anything but mixed from Intra-Cellular phase III in depression

March 28, 2023
By Randy Osborne
Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur well for the ongoing, late-stage program with the compound as an adjunctive treatment in MDD.
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DNA, drug development concept art.

Data divided in Unity’s AMD phase II; Envision another study as DME data due soon

March 27, 2023
By Randy Osborne
Hopes remain for Unity Biotechnology Inc.’s UBX-1325 in diabetic macular edema (DME) following a phase II miss in wet age-related macular degeneration (AMD), where data from part A of the study called Envision fell short of the non-inferiority threshold when compared to Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) through 24 weeks.
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Leukemia illustration

Can’t resist? Beigene, Nurix ploys in BTK may dodge blood cancer problems

March 24, 2023
By Randy Osborne
Phase II data that rolled out from Merck KGaA with its Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in relapsed multiple sclerosis (MS) put more eyeballs on the mechanism. It’s already well validated in oncology, but resistance has arisen there, and at least two firms – Beigene Ltd. and Nurix Therapeutics Inc. – are striving for solutions with degrader candidates.
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Shiver me LIMBER: Incyte’s once-a-day Jakafi meets rough seas with CRL from FDA

March 24, 2023
By Randy Osborne
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
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Candida auris

Cidara prevails with US FDA approval of Rezzayo in candidemia, IC; partner Melinta to launch this summer

March 23, 2023
By Randy Osborne
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
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89bio’s phase IIb outcome Enlivens NASH space, whets enthusiasm for phase III

March 22, 2023
By Randy Osborne
89bio Inc.’s top-line phase IIb data from the 216-subject study called Enliven testing pegozafermin in nonalcoholic steatohepatitis (NASH) pushed shares (NASDAQ:ETNB) to a closing price March 22 of $13.68, up $2.75, or 25%. The drug, due next for phase III investigation, is a glycopegylated analogue of fibroblast growth factor 21.
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Foot pain

Gout doubts Dissolve with dual phase III outcomes from Selecta, Sobi

March 21, 2023
By Randy Osborne
Selecta Biosciences Inc. and Swedish Orphan Biovitrum AB unveiled top-line phase III data from the Dissolve I and II trials testing SEL-212 in adults with chronic refractory gout (CRG) – results that position the companies for a regulatory filing in the U.S. during the first half of next year. SEL-212 could take on Horizon Therapeutics plc’s Krystexxa (pegloticase), a pegylated uric acid specific enzyme cleared by the U.S. FDA for CRG in September 2010.
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Mental illness illustration

Karxt PANSS out again for Karuna; NDA slated for midyear

March 20, 2023
By Randy Osborne
With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week.
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DNA in drug capsules

Oh drat, OTAT: FDA’s turnaround on adcom for DMD prospect clips Sarepta shares

March 17, 2023
By Randy Osborne
Sarepta Therapeutics Inc. CEO Doug Ingram said the U.S. FDA has promised to schedule “expeditiously” an advisory committee meeting on the BLA related to SRP-9001 (delandistrogene moxeparvovec) for Duchenne muscular dystrophy (DMD).
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