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Home » Authors » Randy Osborne

Articles by Randy Osborne

Mighty mitomycin instills hope in bladder, urothelial as Urogen NDA underway

Oct. 28, 2019
By Randy Osborne
With Stifel analysts recently setting a $41 price target for Urogen Pharma Ltd. and interim data in hand from the trial in bladder cancer with UGN-102, hopes are high that the drug's approach – having already proved its mettle in UGN-101 against low-grade upper tract urothelial cancer (UTUC) – will yield durable results. Shares (NASDAQ:URGN) have been trading at around $22, closing Friday at $21.97.
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Keyboard, stethoscope, globe, reports

Gilead's island? Stranded investors awaiting rescue; skipper keeps faith in HIV

Oct. 28, 2019
By Randy Osborne
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
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Come, Pliant: NASH's call obeyed by Novartis, $80M payout for integrin player

Oct. 24, 2019
By Randy Osborne
South San Francisco-based Pliant Therapeutics Inc. CEO Bernard Coulie told BioWorld that Novartis AG was drawn to the $80 million deal in nonalcoholic steatohepatitis (NASH) because other firms working in the integrin space "are very much focused on early stages of the disease, with what we call a metabolic approach. We are addressing with our compound, which is a pure antifibrotic, the late stage of the disease, [categorized as] F3 and F4, where most of the liver is already gone. We think that the real market will be there, because that's where health care costs go up" and where patients facing an increased mortality rate "need proper treatment rather than changing their lifestyle" while using something milder.
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Silhouette with keyhole

No 'adieu' for adu just yet, FDA Engage-ment still on; Biogen to Emerge winner?

Oct. 23, 2019
By Randy Osborne
Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move.
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Shionogi bogey at adcom cefiderocol's death hitch; cUTI drug voted Credible

Oct. 23, 2019
By Randy Osborne
The FDA's Antimicrobial Drugs Advisory Committee last week backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
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TKI TKO? Seagen's player brings brain brawn to BC; Street cites efficacy, ease

Oct. 22, 2019
By Randy Osborne
Benefit for patients with disease that has spread to the brain put a special shine on top-line data rolled out by Seattle Genetics Inc. (Seagen) from the HER2Climb study, an experiment to test the oral small-molecule tyrosine kinase inhibitor (TKI) tucatinib, designed as highly selective for HER2 without significantly knocking down EGFR.
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Heart act to follow: Book examines Termeer legacy of generosity with daring

Oct. 21, 2019
By Randy Osborne
His parents likely expected Henri Termeer to find his position in the shoe business that the family had run for several hundred years but, after his advanced schooling, Termeer had other ideas. Biotech observers today may wonder who can fill the moccasins of the trailblazer that Termeer became.
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Special delivery?

Not lost in translation, Verseau bid with MCMs garners $50M

Oct. 21, 2019
By Randy Osborne
CEO Christine Bunt of Verseau Therapeutics Inc. told BioWorld that the company has prepared a "wave" of prospects from its macrophage checkpoint modulator (MCM) platform ready to crash upon the shores of cancer therapy, with 23 novel targets in the hopper.
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Syros oral CDK7 argument front-seats cancer bid over I.V. prospect; phase I soon

Oct. 18, 2019
By Randy Osborne
The pipeline shift made public Thursday by Syros Pharmaceuticals Inc. may have been presaged by analysts, who in August sounded lukewarm about the Cambridge, Mass.-based firm's prospects as they stood then.
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Shionogi bogey at adcom cefiderocol's death hitch; cUTI drug voted Credible

Oct. 17, 2019
By Randy Osborne
The FDA's Antimicrobial Drugs Advisory Committee backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
Read More
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