A biotech boom in North Carolina's Research Triangle

North Carolina's Research Triangle has become ground zero for a biomanufacturing surge that's defying national industry trends.

Pharmaceutical giants like Genentech, Amgen, and FUJIFILM Diosynth and their contractors committed more than $10 billion last year alone in new facilities in Raleigh, Durham, Holly Springs, and other nearby towns, STAT's Allison DeAngelis writes from the region. They're lured by a deep talent pool, available land, and decades of state planning that transformed tobacco country into a life sciences hub.

"It's unbelievable, actually. [It] seems like every day I hear of another large pharma company building a $2 billion plant down here," Norman "Ned" Sharpless, former acting commissioner of the Food and Drug Administration commissioner, told STAT.

But the region's rapid ascent isn't without risks: Automation threatens future jobs, startups face a funding drought, and NIH cuts could undermine academic innovation. Still, after 65 years of effort, the dream of marrying research with large-scale drug production is finally coming to life in the region.

oncology

Tubulis raises $356 million to advance ADC chemistry

German biotech Tubulis has secured a hefty $356 million Series C to expand trials of its lead antibody-drug conjugate, TUB-040, beyond ovarian and non-small cell lung cancers. It also plans on bolstering its broader pipeline, STAT's Andrew Joseph writes.

The Munich-based company, which has partnered with Gilead and Bristol Myers Squibb, will unveil its first clinical data at this weekend's ESMO meeting in Berlin.

CEO Dominik Schumacher told STAT that Tubulis' edge lies in its precision chemistry — fine-tuning antibodies, linkers, and payloads to deliver chemo directly to tumors with fewer side effects. Although ADCs are not exactly a new technology, investor enthusiasm for these platforms continues to surge.

hair loss

Pelage raises $120 million for treatment to regrow hair

Los Angeles-based Pelage Pharmaceuticals said this morning that it has raised $120 million in a Series B round co-led by ARCH Venture Partners and GV — Google Ventures — to advance PP405, a topical small molecule that reactivates dormant hair follicle stem cells to spur regrowth.

Backed by Phase 2a safety data from this summer and early signs of efficacy in androgenetic alopecia, the company plans to launch Phase 3 trials in 2026 in both men and women. The midstage results showed that PP405 was well tolerated, the company said, with no systemic absorption detected in the blood, and no systemic adverse events.

The drug works on a metabolic switch in follice stem cells, stemming from work conducted by scientists at UCLA.

REGULATION

The exodus from FDA's upper ranks goes on

After losing 3,500 employees to layoffs in April, the FDA continues to lose top talent to pharmaceutical companies and law firms. Around 20% of the agency's workers have left since January, according to ProPublica. And at least 10 top officials from across the agency have left since June, according to STAT's newly updated tracker.

Know of other senior officials who have left recently? STAT's Lizzy Lawrence is accepting all tips! Contact her at lizzy.lawrence@statnews.com or lizzylaw.53 on Signal.

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