Business, energy, technology, markets and global industry news from Business News Today

Phase 1 clinical trial

PharmaDeviceNews Phase 1 clinical trial
Representative image: Endoscopic bladder procedure scene highlighting UroGen Pharma’s UGN-501 clearance and the next-stage search for intravesical oncolytic virus therapy in non-muscle invasive bladder cancer.
Pharma & Biotech

Could UroGen Pharma’s oncolytic virus open the next chapter in bladder cancer therapy?

UroGen Pharma Ltd. (Nasdaq: URGN) has received U.S. Food and Drug Administration clearance of its Investigational New Drug application for UGN-501, an investigational next-generation oncolytic virus for non-muscle invasive bladder cancer. The clearance enables the urothelial cancer-focused biotechnology company to begin a planned Phase 1 trial of local intravesical administration, with patient enrollment expected to

Read More
Pharma & Biotech

ITI-9001 enters Phase 1 as Immunomic Therapeutics tests disease-modifying allergy vaccine

See how ITI-9001 could reshape Japanese cedar allergy treatment and what its Phase 1 trial must prove on safety, efficacy and durability.

Read More
Representative image: Samsung Bioepis’ SB27 Keytruda biosimilar trial results highlight a potentially important step toward lower-cost pembrolizumab competition in the global oncology market.
Pharma & Biotech

Samsung Bioepis SB27 meets Phase 3 endpoint as Keytruda biosimilar competition accelerates

Read how Samsung Bioepis SB27’s positive Phase 1 and Phase 3 data could reshape the Keytruda biosimilar race and oncology access.

Read More
Pharma & Biotech

Marea Therapeutics targets acromegaly treatment burden with long-acting MAR002 antibody

Daily acromegaly injections face a convenience challenge. Marea’s MAR002 could reset expectations if Phase 1 durability translates.

Read More
Pharma & Biotech

How Tenvie Therapeutics is testing whether neuroinflammation can become the next obesity treatment frontier

Tenvie Therapeutics begins Phase 1 dosing of TNV262. Find out why this CNS-penetrant NLRP3 inhibitor could reshape obesity and CVD treatment.

Read More
Pharma & Biotech

XtalPi and ReviR Therapeutics push AI-designed RTX-117 into human trials for rare neurological disorders

RTX-117 enters Phase 1 trials as an AI-designed therapy for Charcot-Marie-Tooth disease and VWM. Discover what this milestone means for rare disease drug discovery.

Read More
Pharma & Biotech

Avacta (AIM: AVCT) FAP-Exd data challenges Enhertu on tumor selectivity ahead of Phase 1 start

Avacta Therapeutics (AIM: AVCT) has published preclinical data showing that its FAP-targeted payload delivery platform, FAP-Exd (AVA6103), outperforms the marketed antibody drug conjugate trastuzumab deruxtecan across three pharmacokinetic measures, with a Phase 1 clinical trial expected to begin in the first quarter of 2026. What the AI-generated comparator actually enables The methodological choice here deserves

Read More
Pharma & Biotech

How United Therapeutics is betting on scaffold-based liver support in high-mortality ALF

United Therapeutics’ miroliverELAP showed positive phase 1 safety results in acute liver failure. Find out what this could mean for future liver support strategies.

Read More
Pharma & Biotech

PAQ Therapeutics initiates Phase 1 for PT0511 pan-KRAS degrader, raises $77m in Series B

PAQ Therapeutics begins Phase 1 trial for PT0511 pan-KRAS degrader and raises $77M. Find out what this means for the future of KRAS-targeted cancer therapy.

Read More
Pharma & Biotech

What makes LNK01006 a potentially best-in-class TYK2 inhibitor with central immune impact?

Lynk Pharmaceuticals and Formation Bio have entered an exclusive licensing and development agreement for LNK01006, a next-generation, central nervous system (CNS)-penetrant TYK2 inhibitor. The deal gives Formation Bio global rights to the asset outside Greater China, with plans to initiate a Phase 1 clinical trial in the United States during the first half of 2026.

Read More