Lantern Pharma Inc. (LTRN), a clinical-stage pharmaceutical company, shares surged over 30% to $1.45 in the pre-market after the firm and its subsidiary Starlight Therapeutics announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 paediatric clinical trial.
In addition, the firm is scheduled to report its fiscal Year 2025 financial results today at 4.30 p.m. ET.
Company Profile
Lantern Pharma focuses on the discovery and development of oncology drugs, and STAR-001 is Starlight Therapeutics' central nervous system(CNS) oncology compound, co-developed with Lantern Pharma.
STAR-001's CNS and pediatric CNS indications were initially identified using Lantern's proprietary RADR AI platform.
Lantern's investigational product pipeline includes,
-LP-300, which is in phase 2 clinical trial in combination therapy for never-smokers with non-small cell lung cancer adenocarcinoma;
-LP-184, which is in phase 1 clinical trial for the treatment of solid tumours, breast, bladder, and lung cancer.
- LP-284, which is in phase 1 clinical trial for the treatment of non-Hodgkin lymphomas, including mantle cell lymphoma and double hit lymphoma.
IND Application Clearance For STAR-001
The FDA-cleared planned Phase 1 trial will evaluate STAR-001 as a single agent and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system malignancies. It is designed to enrol approximately 18 to 42 pediatric patients aged 1 to 17 years.
The trial is planned to be conducted in collaboration with the Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC), a multicenter network of 14 children's cancer centres across the United States, Canada, and Israel.
The trial design provides for STAR-001 (LP-184) to be evaluated across a range of aggressive pediatric CNS malignancies, including: Atypical Teratoid/Rhabdoid Tumour, Diffuse Intrinsic Pontine Glioma, Glioblastoma, Ependymoma, and Medulloblastoma.
"This IND clearance is a defining milestone for Starlight Therapeutics and a meaningful step forward for pediatric neuro-oncology." Panna Sharma, CEO & President, Lantern Pharma Inc.; Founder & Chairman, Starlight Therapeutics.
Meanwhile, the planned trial is subject to obtaining additional funding, according to the firm.
For the third quarter ended September 30, 2025, the firm reported a net loss of $4.2 million, or $0.39 per share, narrower than the $4.5 million, or $0.42 per share, in the prior year.
As of September 30, 2025, cash, cash equivalents, and marketable securities were approximately $12.4 million and expected to fund its operating expenses and requirements into the third quarter of 2026.
LTRN has traded between $1.11 and $5.74 in the last year. The stock closed Friday's trade at $1.12, down 46.41%.
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