Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025
RESEARCH TRIANGLE PARK, N.C., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, today announced that Fierce Biotech has named it as one of 2025’s Fierce 15 biotechnology companies, designating it as one of the most innovative and promising private biotechnology companies in the industry.
“We’re honored to be named one of 2025’s Fierce 15 biotechnology companies,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “We have made great strides in our research and clinical development of a potential best-in-class CDK2 inhibitor, never losing sight of our ultimate goal to get treatments to patients. This recognition comes at a pivotal moment at Incyclix as we work to complete our critical study of INX-315 for the treatment of patients with treatment-resistant breast and ovarian cancers who are in critical need of new options.”
Incyclix Bio aims to advance precision treatments that target the aberrant proliferation driving many cancers. The Company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. At the 2024 San Antonio Breast Cancer Symposium, the Company announced interim clinical data demonstrating the safety and efficacy of INX-315 from the ongoing Phase 1/2 clinical trial, INX-315-01, in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumors. In April 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer. With additional financing from a recent series B extension, the Company is on track to complete INX-315-01 (NCT05735080) in mid-2026.
The Fierce 15 celebrates the spirit of being “fierce” – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 23rd annual Fierce 15 selection.
“Over the past 23 years, our Fierce 15 special report has spotlighted the private biotechs pushing science into uncharted territory, whose approaches and discoveries represent genuine leaps forward,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare, “This year we’ve selected 15 pre-commercial biotechs that are advancing transformative science in an unrelenting industry landscape. These companies exemplify the innovation and determination driving the next generation of therapies that will hopefully benefit patients worldwide.”
An internationally recognized daily report reaching a network of over 300,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day's top stories. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.
About Fierce Biotech
Fierce Biotech covers the biopharma waterfront, from drug development through the entire lifecycle—tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations and regulation, M&A deals and beyond. Our aim is to analyze the day's news, showing readers not only what they need to know, but why they need to know it. Beyond the daily, the Fierce Biotech team produces special reports that take stock of the industry's products and finances and shed new light on industry trends.
www.fiercebiotech.com
About Incyclix Bio
Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.
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