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Home » Authors » Randy Osborne

Articles by Randy Osborne

Clinical research concept with medical icons on light bulb

AC turns on Aldeyra backers in phase III as DED space heater reproxalap awaits November PDUFA

June 15, 2023
By Randy Osborne
With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out.
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Phase II-to-III transfer protocol unriddled? Newamsterdam writing new book of ester in anti-lipid class

June 13, 2023
By Randy Osborne
Since late 2006, when hiked levels of aldosterone and increases in blood pressure foiled Pfizer Inc.’s torcetrapib, researchers have been wary of cholesteryl ester transfer protein (CETP) inhibitors. But not all researchers. Among the still-hopeful is Newamsterdam Pharma NV, which recently rolled out positive phase II data with obicetrapib, and the company is forging ahead despite other CETPs that have not fared well in late-stage testing after performing nicely in phase II, including candidates from Merck & Co. Inc. and Eli Lilly and Co.
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Test tubes with blood samples

EHA 2023: Developer finesse to beat Scenesse? Phase II outlook sunny for Disc’s oral bitopertin in EPP, XLP

June 12, 2023
By Randy Osborne
Disc Medicine Inc.’s positive phase II data from an ongoing, open-label trial called Beacon with oral bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) whetted investor appetite for the results of the other mid-stage Disc experiment known as Aurora with the compound, due early next year.
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Elderly woman holding illustration of brain with missing puzzle piece

As diagnostics advance, Parkinson’s sector waits for better therapy

June 8, 2023
By Randy Osborne
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
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Elderly woman holding illustration of brain with missing puzzle piece

As diagnostics advance, Parkinson’s sector waits for better therapy

June 7, 2023
By Randy Osborne
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
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Eikon-ography? Art of dealmaking on display as three signed, $106M raised

June 1, 2023
By Randy Osborne
Having banked almost $775 million since its inception in 2019, Eikon Therapeutics Inc. closed three transactions to beef up its pipeline and raised nearly $106 million in a series C round. And the dealmaking will continue, said Alfred Bowie, chief financial officer. “We still have well over a half-billion in cash on our balance sheet,” he told BioWorld. “We’re active.” The new funds “add more fuel to the fire,” and let the company “make sure we aren’t cannibalizing some of the funding we’ve raised to help push forward the internal pipeline,” which is “advancing very nicely.”
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Cardiovascular illustration

Lexicon gets FDA sugar, targets HF ‘sweet spot’ with newly approved Inpefa

May 30, 2023
By Randy Osborne
With rising rates of disease and established guidelines for treatment, officials at Lexicon Pharmaceuticals Inc. have “the wind at our backs” as they go about commercializing Inpefa (sotagliflozin) for heart failure (HF), after the drug was cleared late May 26 by the U.S. FDA, said CEO Lonnel Coats. Shares of The Woodlands, Texas-based Lexicon (NASDAQ:LXRX), which had risen significantly after hours on word of the Inpefa go-ahead, closed May 30 at $2.90, down 28 cents. Regulators gave their nod to the inhibitor of renal sodium-glucose co-transporter 2 (SGLT2) and intestinal SGLT1 with a broad label across the full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes.
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US FDA says yes to Lexicon’s Inpefa in HF

May 27, 2023
By Randy Osborne
Eye and financial charts

Annexon sights BCVA benefit in missed-endpoint GA phase II

May 25, 2023
By Randy Osborne
On the strength of upside in best corrected visual acuity (BCVA) in patients with geographic atrophy (GA), Annexon Inc. officials will meet with the U.S. FDA to talk about what’s next for ANX-007, after the C1q inhibitor missed the phase II trial’s primary endpoint: mean rate of change, or slope, in the GA lesion area compared to sham.
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Central nervous system

PTC stays the course after phase III Friedreich’s miss; sky clearer for Skyclarys?

May 24, 2023
By Randy Osborne
“We clearly see an active drug here,” PTC Therapeutics Inc. CEO Matthew Klein said of the 15-lipoxygenase inhibitor vatiquinone for Friedreich’s ataxia (FA), tested in a phase III study called Move-FA that missed the primary endpoint of statistically significant change in modified FA Rating Scale score at 72 weeks. The company will “take one step at a time” decisions about the drug, analyzing the results and then consulting with the U.S. FDA regarding how to proceed, he said. Meanwhile, Wall Street wasn’t happy, and South Plainfield, N.J.-based PTC’s shares (NASDAQ:PTCT) closed May 24 at $46.95, down $11.46, or 19.6%.
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