# Shorla Oncology

> Shorla Oncology is a specialty pharmaceutical company based in Clonmel, Ireland, with a U.S. base in Cambridge, Massachusetts, that develops and commercializes innovative oncology drugs for orphan and pediatric cancers. Founded in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla focuses on indications where existing treatments are limited, in shortage, or poorly suited to patients - reformulating and reinventing cancer therapies into easier-to-administer forms such as oral liquids and ready-to-dilute vials. The company markets four FDA-approved products in the U.S. and is advancing an early-stage pipeline addressing rare cancers.

- **Founded:** 2018
- **Headquarters:** Clonmel, Tipperary, Ireland
- **Founders:** Sharon Cunningham (CEO & Co-Founder), Orlaith Ryan (CTO & Co-Founder)
- **Team size:** ~40 (approx. 35-42 employees across Clonmel, London and Cambridge, Massachusetts)
- **Products:** JYLAMVO (methotrexate oral solution), Nelarabine Injection, TEPYLUTE (thiotepa), IMKELDI (imatinib oral solution), SH-110 (pipeline)
- **Notable:** Four FDA-approved oncology products commercialized in the U.S. within roughly seven years of founding, Sharon Cunningham and Orlaith Ryan named EY Entrepreneur of the Year Ireland 2024 (emerging category and overall winners), IMKELDI - first FDA-approved oral liquid formulation of imatinib (2024)

## Products & services

- **JYLAMVO (methotrexate oral solution)** — A sweet-tasting, ready-to-use oral liquid form of methotrexate that removes the need to crush or split pills or compound a liquid. Used for acute lymphoblastic leukemia, mycosis fungoides, non-Hodgkin lymphoma and rheumatoid arthritis; acquired for the U.S. market from Therakind in 2023.
- **Nelarabine Injection** — An injectable treatment for T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma; Shorla's first U.S. approval and launch, helping address supply of a critical oncology therapy.
- **TEPYLUTE (thiotepa)** — The first and only ready-to-dilute, multi-dose vial formulation of thiotepa for breast and ovarian cancer, stable for 14 days when stored properly. Original approval 2024; 100mg multi-dose vial approved and launched in 2025.
- **IMKELDI (imatinib oral solution)** — The first FDA-approved oral liquid form of imatinib, with a palatable strawberry flavor and a stable formulation not requiring refrigeration, for certain leukemias, gastrointestinal stromal tumors and other indications.
- **SH-110 (pipeline)** — An investigational oral liquid formulation granted FDA Orphan Drug Designation in 2025 for the treatment of a rare brain cancer.

## Achievements

- Four FDA-approved oncology products commercialized in the U.S. within roughly seven years of founding
- Sharon Cunningham and Orlaith Ryan named EY Entrepreneur of the Year Ireland 2024 (emerging category and overall winners)
- IMKELDI - first FDA-approved oral liquid formulation of imatinib (2024)
- TEPYLUTE - first and only ready-to-dilute multi-dose vial of thiotepa (2024-2025)
- FDA Orphan Drug Designation for SH-110 for a rare brain cancer (2025)
- Raised approximately $43.3M in total funding including a $35M Series B in 2023
- Sharon Cunningham recognized as a 2023 AACSB Influential Leader

## Latest updates

- **2025-07** — FDA granted Orphan Drug Designation to SH-110, an oral liquid to treat a rare brain cancer.
- **2025-04** — FDA approved TEPYLUTE 100mg, the first and only ready-to-dilute multi-dose vial of thiotepa, with U.S. commercial launch of 15mg and 100mg vials.
- **2025-03** — Expanded U.S. commercial footprint with a dedicated sales force and market access teams.
- **2024-11** — FDA approved IMKELDI, the first oral liquid imatinib; founders named EY Entrepreneurs of the Year Ireland.
- **2024-06** — FDA approved TEPYLUTE, a novel thiotepa formulation for breast and ovarian cancer.
- **2023-10** — Closed $35M Series B round led by Kurma Partners and acquired U.S. rights to JYLAMVO from Therakind.

## Links

- Website: https://shorlaoncology.com
- LinkedIn: https://www.linkedin.com/company/shorla-pharma
- Twitter/X: https://twitter.com/ShorlaOncology

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Profile page: https://yespress.io/shorla-oncology
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Last updated: 2026-07-18