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In this episode of Denatured, you’ll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.
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IPO
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.
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FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
FDA
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
While there had been hope layoffs would slow down in 2025, they continued at a fast pace, affecting even more people than in 2024, based on BioSpace tallies.
Insmed’s freshly approved lung condition drug soared past sales expectations for 2025, netting $144.6 million in its first full quarter of sales.
Roche first partnered with MediLink in January 2024, likewise for an antibody-drug conjugate for solid tumors.
Rampart Bioscience was working on a platform to deliver gene therapies without the need for viral vectors.
Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.
Aside from the layoffs, InflaRx will deprioritize Gohibic, a COVID-19 antibody that was granted emergency use authorization in 2023. The therapy failed a late-stage trial in a rare skin disease last year.
Rumors of a Revolution buyout come as the industry gears up for one of its biggest trade conferences, where observers expect many such deals to be announced.