NCBiotech News

Three young Triangle-based medical technology companies with roots in Duke University research labs are getting major global attention from their industry.

They’re among the 65 cutting-edge companies from around the world that were recently chosen to participate in the 2025 Accelerator Cohort of MedTech Innovator (MTI), the world's largest accelerator for medical device, digital health, and diagnostic companies. 

For the third time in four years, CNBC has ranked North Carolina as “America’s Top State for Business” in 2025. “The Tar Heel State is on a roll,” writes CNBC special correspondent Scott Cohn, who created the business news network’s annual competitiveness study of states in 2007. “It captured top honors in the annual CNBC rankings in 2022 and 2023, and it was runner-up in 2021 and 2024 — missing the top spot last year by just three points to Virginia, which slips this year to its lowest position among states since 2018.”

Charles E. Hamner Jr., a highly respected and accomplished scientist, university administrator and pharmaceutical executive who led the North Carolina Biotechnology Center during its formative years, from 1988 to 2002, died July 4 in Chapel Hill. He was 90. “Dr. Hamner was so instrumental in building North Carolina’s life sciences industry that he is often referred to as ‘the Father of North Carolina’s Life Sciences,’” said Doug Edgeton, president and CEO of the North Carolina Biotechnology Center.

Verona Pharma, a year after receiving regulatory approval for its landmark chronic obstructive pulmonary disease (COPD) treatment, is being acquired by pharmaceutical giant Merck in a deal worth about $10 billion.

London-based Verona, with U.S. headquarters in Raleigh, has seen strong results from its new drug, Ohtuvayre (ensifentrine), since launching it in August 2024. It’s the first new inhaled COPD treatment to hit the U.S. market in more than 20 years.

Durham-based GeneCentric Therapeutics, a cancer diagnostics company, has closed on an $8 million round of venture capital to launch and commercialize a novel liquid biopsy platform for guiding precision cancer therapy. Proceeds from the Series C financing will be used to support GeneCentric’s GenomicsNext. This platform provides thousands of gene-expression measurements and high-fidelity DNA variant detection from tumor DNA that circulates in the blood. The company said in a news release that the novel gene-expression platform would accelerate the growth of GeneCentric’s pipeline of “predictive response signatures” for oncology therapeutics development.

Morrisville-based Liquidia Corp., a biopharmaceutical company spun out of the University of North Carolina at Chapel Hill in 2004, is launching its first commercial therapy.

In May, the U.S. Food and Drug Administration approved Yutrepia, the company’s inhalation powder form of treprostinil, for the treatment of two types of cardiopulmonary disease: pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Serving twice as commissioner of the U.S. Food and Drug Administration has made Robert Califf, M.D., pretty much immune to getting tripped up by difficult or controversial questions.

“People should not feel shy about asking me questions,” he said at a recent public seminar held by the North Carolina Regulatory Affairs Forum. “I’ve been through two Senate confirmations. There was a strange love affair between (Senator) Bernie Sanders and the right-wing Republicans about nutrition. So, you know, there’s nothing you could ask that would be offensive.”

The North Carolina Biotechnology Center awarded eight grants and loans totaling more than $1.2 million to universities and life sciences companies in the second quarter of its current fiscal year.

The awards, made in October, November and December 2024, will support life science research, technology commercialization and entrepreneurship throughout North Carolina. The funding will also help universities and companies attract follow-on funding from other sources.

An online marketplace connecting life sciences companies with workforce talent in North Carolina has been retooled to better serve employers and job seekers throughout the state. The North Carolina Biotechnology Center’s newly relaunched Career Center site is now fully automated. On one recent day, the site listed nearly 2,000 jobs – about 15 times more jobs than the previous version of the site typically posted. “The increased number and diverse types of roles allow job seekers to quickly and easily find relevant opportunities,” said Pearl Sullivan, NCBiotech’s life sciences community engagement manager.

The U.S. Food and Drug Administration (FDA) has accepted Durham-based BioCryst Pharmaceuticals’ application to expand the use of ORLADEYO (berotralstat) to treat children ages 2 to 11 with a rare genetic condition known as hereditary angioedema (HAE). The FDA also granted the application Priority Review with a Prescription Drug User Fee Act date of September 12, 2025. HAE causes sudden and severe swelling in various parts of the body, including the face, hands, stomach and airways, which can be painful and sometimes life-threatening.

The recent Accelerate NC Career Celebration at the North Carolina Biotechnology Center brought together key players in the growing ecosystem that makes North Carolina a global leader in life sciences manufacturing. The third biannual event recognized 121 individuals who have successfully leveraged Accelerate NC initiatives to secure a life sciences career. Many of their peers, teachers, employers, family and friends also attended the celebration. Laura Rowley, vice president of life sciences economic development at NCBiotech, opened the ceremony by congratulating the newest members of the state’s life sciences community.

Following a regulatory setback last year, Satsuma Pharmaceuticals Inc. has won approval for its nasal powder migraine treatment device from the U.S. Food and Drug Administration. Satsuma Pharmaceuticals, a unit of a Japanese drugmaker with U.S. headquarters in Durham, said its treatment, called Atzumi, received its new drug application approval from the FDA. The approval covers Atzumi for treatment of acute migraine in adults both with and without aura, or sensory disturbances that sometimes accompany migraine. Atzumi is a device that includes Satsuma’s formulation of a standard, decades-old migraine treatment called dihydroergotamine (DHE).

Durham-based Atsena Therapeutics has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ATSN-201, its gene therapy product for the treatment of X-linked retinoschisis (XLRS). XLRS is a rare inherited retinal disease with no approved treatments. ATSN-201 uses AAV. SPR, the company’s novel spreading capsid, delivers the gene therapy directly to the photoreceptors in the central retina, achieving therapeutic levels of gene expression while minimizing surgical risks, such as foveal detachment. ATSN-201 has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations from the FDA.

When Damon Race, a Raleigh-based biopharmaceutical entrepreneur and investor, wanted to start a new company, he didn’t have to go far to find the founding technologies. After looking at “30 to 40 assets” nationally, in October of 2020 Race chose to in-license a gene therapy devised within a half-hour’s drive, at the University of North Carolina at Chapel Hill. In April 2025 he licensed a gene-editing therapy from Duke University, also a half-hour’s drive away, in Durham. Together, these gene therapy programs make up the product pipeline for GeneVentiv Therapeutics, a pre-clinical gene therapy company founded in 2020 in Raleigh. There was no need to look further or to move elsewhere, said Race, the company’s president and chief executive officer.

The U.S. Food and Drug Administration (FDA) has granted Incyclix Bio Fast Track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer. INX-315, the company’s lead compound, is being evaluated in an ongoing, first-human Phase 1/2 clinical trial. “The FDA’s decision to grant Fast Track designation for INX-315 reflects the best-in-class potential of our CDK2 inhibitor, the strength of our preclinical and early clinical data and the urgency to address significant unmet need in patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer,” said Patrick Roberts, PharmD., Ph.D., chief executive officer and co-founder of Incyclix Bio.