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Home » Authors » Randy Osborne

Articles by Randy Osborne

Layoff illustration

Synlogic pulls plug after peek at phenylketonuria phase III data

Feb. 9, 2024
By Randy Osborne
Synlogic Inc. jolted Wall Street with news that the firm is scrapping for futility Synpheny-3, its pivotal study with labafenogene marselecobac (SYNB-1934) for phenylketonuria, and will evaluate strategic options. Shares of the Cambridge, Mass.-based firm (NASDAQ:SYBX) fell 48.7%, or $1.68, to end Feb. 9 at $1.77. Synlogic will cease operations and reduce its workforce by more than 90%, retaining only certain employees to help with the wind-down.
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Hands holding holographic intestine

IBD landscape shifts as developers seek safe cures that last

Feb. 9, 2024
By Randy Osborne
The approval by the U.S. FDA in October of Pfizer Inc.’s Velsipity (etrasimod), an oral sphingosine-1-phosphate receptor modulator for moderately-to-severely active ulcerative colitis, brought renewed attention to the inflammatory bowel disease (IBD) landscape, where the hunt goes on for new alternatives. Among the promising soldiers in the march is Paris-based Abivax SA, which closed its IPO the same month.
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Eye and DNA illustration

Street likes Luna wet AMD phase II but Adverum wanes

Feb. 8, 2024
By Randy Osborne
With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”
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3D illustration of cancer in crosshairs

ROR1s, roar twice: ADC pro Siegall takes on tricky target at Immunome

Feb. 7, 2024
By Randy Osborne
Immunome Inc. gained renewed attention for its pipeline by way of the Feb. 6 deal to buy from Ayala Pharmaceuticals Inc. the phase III-stage small-molecule gamma secretase inhibitor AL-102 (plus related drug candidate AL-101).
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Liver

Pliant dips on positive phase II data with bexotegrast in PSC

Feb. 5, 2024
By Randy Osborne
As the company’s phase II study in idiopathic pulmonary fibrosis continues, Pliant Therapeutics Inc.’s investors looked hard at 12-week interim data from the 320-mg dose group of Integris-PSC, a multinational, randomized, double-blind, placebo-controlled phase II trial testing bexotegrast in primary sclerosing cholangitis and suspected moderate to severe liver fibrosis.
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Eye and financial charts

TOI story creates buzz in RP as Kiora seals $301M deal

Feb. 1, 2024
By Randy Osborne
Kiora Pharmaceuticals Inc.’s development and commercialization deal with Théa Open Innovation (TOI), a sister company of Laboratoires Théa, for KIO-301 in degenerative retinal diseases “takes a bit of an industry-standard type of approach” in terms of structure, said CEO Brian Strem.
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Leqembi

Aduhelm kaput in Alzheimer’s, Biogen leans into Leqembi

Jan. 31, 2024
By Randy Osborne
Biogen Inc.’s problematic trip with Aduhelm (aducanumab-avwa) for Alzheimer’s disease (AD) at last came to an end as the company, probably surprising few on Wall Street, said it’s quitting sales and development of the amyloid-beta directed antibody. The drug won accelerated approval by the U.S. FDA in July 2021. The phase III Envision study with Aduhelm will be stopped, and Cambridge, Mass.-based Biogen chalked a one-time charge of about $60 million related to close-out costs for the program in the fourth quarter of 2023. AD efforts have turned toward Leqembi (lecanemab-irmb), also an amyloid-beta directed antibody.
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As ODAC questions loom, 2seventy ‘doubles down’ on Abecma

Jan. 30, 2024
By Randy Osborne
2seventy bio Inc. shares (NASDAQ:TSVT) rose 15% or 52 cents, to close Jan. 30 at $4.01 on word that the Cambridge, Mass.-based firm is selling its R&D pipeline to Regeneron Pharmaceuticals Inc., which will move the work forward by way of a new company called Regeneron Cell Medicines.
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Immaculate inception? Vera’s Origin phase IIb OLE in IgAN augurs well for ongoing phase III

Jan. 25, 2024
By Randy Osborne
Wall Street got what it wanted from Vera Therapeutics Inc. with atacicept in IgA nephropathy (IgAN) and rewarded shares of the Brisbane, Calif.-based firm (NASDAQ:VERA), pushing them to close Jan. 25 at $25.31, up $8.29, or 49%.
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Buntanetap data gap uncapped in Parkinson’s; Annovis to report phase III ‘very soon’

Jan. 24, 2024
By Randy Osborne
About two months after reporting that enrollment of its phase II/III study with buntanetap in Alzheimer’s disease had completed enrollment, Annovis Bio Inc. disappointed Wall Street by saying that findings from the phase III in Parkinson’s disease – hoped for by the end of this month – would be delayed for data-cleaning reasons.
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