BREAKING - Shorla Oncology wins FDA Orphan Drug Designation for SH-110, an oral liquid for a rare brain cancer (Jul 2025) APPROVED - TEPYLUTE 100mg, first ready-to-dilute multi-dose vial of thiotepa, launches in the U.S. AWARD - Founders Sharon Cunningham & Orlaith Ryan named EY Entrepreneurs of the Year Ireland 2024 FUNDING - $35M Series B closed; ~$43M raised to date PORTFOLIO - Four FDA-approved oncology products: JYLAMVO · Nelarabine · TEPYLUTE · IMKELDI
Shorla Oncology logo
Specialty Pharmaceuticals · Clonmel, Ireland

Shorla Oncology

The heart of innovation - reinventing cancer treatments for the patients big pharma tends to overlook.

Founded 2018 4 FDA Approvals Orphan & Pediatric Oncology Team ~40

Sharon Cunningham (CEO) and Orlaith Ryan (CTO) at the helm of the company they built from a Tipperary town of under 20,000 - now competing in the U.S. oncology market from a Cambridge, Massachusetts base.

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The Story

Fixing the gaps in cancer care

Shorla Oncology is a specialty pharmaceutical company that develops and commercializes cancer drugs for orphan and pediatric indications - the corners of oncology where existing treatments are limited, in short supply, or simply wrong for the patient who needs them. Where much of the industry chases new molecules and blockbuster markets, Shorla works a quieter seam: taking therapies that already work and fixing how they are formulated, delivered and supplied.

The company's name is a portmanteau of its two founders - Sharon Cunningham and Orlaith Ryan - former colleagues at EirGen Pharma who left senior roles in 2018 to start something of their own. Their thesis was unglamorous and durable: across oncology there are approved drugs that fail in practice because a child cannot swallow the pill, because a hospital cannot get supply, or because the only available formulation was never designed for the target population.

Shorla's answer is reformulation and re-innovation. It turns tablets into palatable oral liquids, converts unstable powders into ready-to-dilute vials with usable shelf lives, and licenses or acquires products that fit its niche. Each therapy is aimed at a specific unmet need rather than a mass market - a portfolio built patient group by patient group.

Headquartered in Clonmel, County Tipperary, with a commercial base in Cambridge, Massachusetts and an office in London, the company is deliberately lean. Its founders describe the team as "small and mighty," a group of clinicians, scientists and commercial strategists spread across the Atlantic. That structure keeps Shorla close to the two things it cares about most: the science of formulation and the realities of the clinic.

2018
Founded
4
FDA-Approved Drugs
$43M
Total Raised
3
Countries / Offices
The investment will underpin the advancement and commercialization of our oncology drugs, ensuring we continue to deliver on our mission of bringing promising treatments to patients around the globe. - Sharon Cunningham, CEO & Co-Founder
The Problem

Drug shortages and formulation gaps

What it solves

Oncology drug shortages force hospitals to ration critical medicines. Many approved cancer drugs come only as tablets that children and other patients cannot take, or as formats too unstable for practical hospital use. Shorla targets exactly these failures - reformulating drugs into oral liquids and ready-to-dilute vials, and bringing supply to indications where it has become unreliable.

How it's different

Rather than betting on novel molecules, Shorla de-risks by improving therapies with known clinical value. Its edge is formulation science plus regulatory execution: a small team that can identify a neglected need, secure FDA approval, and commercialize directly. That focus on orphan and pediatric niches keeps it out of the path of generic price wars and big-pharma pipelines alike.

A telling detail: IMKELDI, Shorla's oral liquid form of the leukemia drug imatinib, is flavored like strawberries and stable without refrigeration. It is a small design choice with a serious purpose - a patient who will not take their medicine does not get better.

Products & Services

The portfolio

2023

JYLAMVO

A sweet-tasting oral solution of methotrexate that removes the need to crush, split or compound pills. Used for acute lymphoblastic leukemia, mycosis fungoides, non-Hodgkin lymphoma and rheumatoid arthritis. U.S. rights acquired from Therakind.

2023

Nelarabine Injection

An injectable therapy for T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma - Shorla's first U.S. approval and launch, helping shore up supply of a critical oncology treatment.

2024–25

TEPYLUTE

The first and only ready-to-dilute, multi-dose vial of thiotepa for breast and ovarian cancer, stable for 14 days when stored correctly. The 100mg multi-dose vial was approved and launched in 2025.

2024

IMKELDI

The first FDA-approved oral liquid form of imatinib - strawberry-flavored and refrigeration-free - for certain leukemias, gastrointestinal stromal tumors and other indications.

PIPELINE
SH-110 - an investigational oral liquid granted FDA Orphan Drug Designation in July 2025 for the treatment of a rare brain cancer.

Business model

Shorla identifies oncology indications with unmet need, then develops, reformulates, licenses or acquires therapies, secures FDA approval, and commercializes them in the U.S. through its own sales and market-access teams. Revenue comes from product sales, with venture funding advancing the pipeline.

Who it serves

Oncologists, hematologists, hospitals, cancer centers and pharmacists across the United States who treat orphan, pediatric and hard-to-treat cancers - and ultimately the patients, including children, who receive its therapies. A dedicated U.S. sales force launched in 2025.

Where it fits in the market

Shorla sits between big-pharma innovators and commodity generics: a specialty player competing with the likes of Eton, Azurity and Amneal on reformulations and niche indications, differentiated by its orphan and pediatric focus.

Expertise

Deep experience in pharmaceutical development, formulation science, regulatory affairs and oncology commercialization - carried over from the founders' EirGen Pharma background and built into a transatlantic team.

Funding

Backed to build

2020 · Series A
~$8M
2023 · Series B
$35M
Total raised
~$43M

Series B led by Kurma Partners' Growth Opportunities Fund, with participation from Seroba Life Sciences, Enterprise Ireland, and Irish, U.S. and Canadian family offices.

Milestones

Seven years, four approvals

2018

Shorla Oncology founded

Sharon Cunningham and Orlaith Ryan launch the company in Clonmel, Tipperary, focused on orphan and pediatric oncology.

2020

Early funding secured

Backed by Seroba Life Sciences and Enterprise Ireland to build out the oncology pipeline.

2023

Series B and first approvals

Closed a $35M Series B led by Kurma Partners, acquired U.S. rights to JYLAMVO, and launched Nelarabine Injection.

2024

TEPYLUTE and IMKELDI approved

FDA approval for a novel thiotepa formulation and the first oral liquid imatinib; founders named EY Entrepreneurs of the Year Ireland.

2025

Commercial scale-up

Launched a dedicated U.S. sales force, gained TEPYLUTE 100mg approval, and received Orphan Drug Designation for SH-110.

Recognition

On the record

Watch & Learn

Interviews & demos

FAQ

Common questions

What does Shorla Oncology do?

It develops and commercializes innovative oncology drugs for orphan and pediatric cancers, focusing on indications where existing treatments are limited, in shortage, or poorly formulated - often reformulating therapies into oral liquids or ready-to-dilute vials.

Who founded Shorla Oncology and when?

It was founded in 2018 by Sharon Cunningham (CEO) and Orlaith Ryan (CTO), former colleagues at EirGen Pharma. The name "Shorla" blends their first names.

What products does Shorla Oncology sell?

Four FDA-approved U.S. products: JYLAMVO (oral methotrexate), Nelarabine Injection, TEPYLUTE (thiotepa) and IMKELDI (oral imatinib), plus a pipeline candidate, SH-110, for a rare brain cancer.

Where is Shorla Oncology based?

It is headquartered in Clonmel, Tipperary, Ireland, with a U.S. commercial base in Cambridge, Massachusetts, and an office in London.

How much funding has Shorla Oncology raised?

Approximately $43 million in total, including a $35 million Series B in 2023 led by Kurma Partners with participation from Seroba Life Sciences and Enterprise Ireland.

Connect

Links & sources