Shorla Oncology

What Shorla Oncology does

Shorla Oncology is an Irish specialty pharmaceutical company founded in 2018 by Sharon Cunningham and Orlaith Ryan, headquartered in Clonmel, Ireland, with a US commercial office in Cambridge, Massachusetts. The company develops and commercializes innovative oncology drugs targeting indications where existing treatments are limited, in shortage, or inadequate for the patient population, with a particular focus on women's and pediatric cancers.

The company's core technology centers on pharmaceutical formulation innovation, including ready-to-dilute injectables (TEPYLUTE/thiotepa), oral liquid formulations (JYLAMVO/methotrexate, SH-110 for glioma), and optimized dosing formats (Nelarabine Injection in a new 375mg vial). Shorla has secured four FDA-approved products (TEPYLUTE, IMKELDI, JYLAMVO, Nelarabine Injection) and a pipeline of three NDA-stage candidates (SH-110, SH-105, SH-201), with several holding orphan drug, Fast Track, or priority review designations. The company has received FDA approvals for rare and underserved oncology indications including T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma, breast and ovarian cancer, chronic myeloid leukemia, and pediatric acute lymphoblastic leukemia.

Shorla's business model combines direct pharmaceutical product sales through specialty pharmacy distribution channels with licensing and partnership revenue. The company partners with EVERSANA for commercial launch support, distributes through Walgreens Specialty Pharmacy's limited distribution network, and operates a dedicated US sales force and market access team. Revenue is generated primarily from FDA-approved product sales, supplemented by drug licensing arrangements and co-development partnerships for pipeline assets. The company has raised approximately $64.5M in venture capital across Series A, Series B, and a 2026 round, and is backed by Goodman and the Irish Venture Capital Association.

Name

Shorla Oncology

Legal name

Shorla Pharma Ltd

Website

https://shorlaoncology.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Shorla Oncology is a Clonmel, Ireland-based specialty pharmaceutical company developing and commercializing innovative oncology drugs targeting women's and pediatric cancers in indications with limited existing treatments. The company has four FDA-approved products and a pipeline of NDA-stage candidates.

Ownership category

akta.pro rank

Product category

Oncology Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

akta.pro secondary industries

Oncology & Hematology Pharmaceuticals (HLAIAAAC), Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

Keywords

• Oncology pharmaceuticals
• Cancer drug development
• Specialty oncology treatments
• Pediatric oncology drugs
• FDA approved cancer therapies

Headquarters

HQ city

Clonmel

HQ country

Ireland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

1. Pharmaceutical Product Sales: Revenue generated from sale of FDA-approved oncology drugs including Tepylute, IMKELDI, JYLAMVO, and Nelarabine Injection through specialty pharmacy distribution channels
2. Drug Licensing and Partnerships: Strategic partnerships for licensing and co-development of pipeline products including SH-110, SH-105, SH-201 with potential regulatory milestones and royalties

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Shorla Oncology develops and commercializes innovative oncology drugs targeting indications where existing treatments are limited, in shortage, or inadequate for the target population. The company focuses on women's and pediatric cancers, producing FDA-approved formulations including ready-to-dilute, oral liquid, and optimized dosing options for breast cancer, ovarian cancer, T-cell leukemia, and lymphoma. The portfolio spans four marketed products and an active pipeline of candidates in oncology and rare diseases.

Product overview

Shorla Oncology is a pharmaceutical company developing and commercializing innovative oncology drugs with a focus on indications where existing treatments are limited, in shortage, or inadequate for the target population. The company's current marketed products include Nelarabine Injection (T-cell leukemia/lymphoma treatment), JYLAMVO (oral methotrexate for oncology and autoimmune diseases), TEPYLUTE (thiotepa for breast and ovarian cancer), and IMKELDI (imatinib mesylate). The pipeline includes SH-110 (glioma), SH-105 (breast/ovarian cancer), and SH-201 (leukemia/cancers). Products target underserved patient populations including pediatric patients.

Differentiator

Problem solved

Functional benefit

Products and services

• Nelarabine Injection A nucleoside metabolic inhibitor FDA-approved for the treatment of adult and pediatric patients with T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) after two prior chemotherapy regimens. Available in 375mg vial size approved January 2026.
• JYLAMVO An oral liquid formulation of methotrexate for oncology and autoimmune indications. FDA expanded approval includes treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) and acute lymphoblastic leukemia (ALL) as part of combination chemotherapy maintenance regimen.
• TEPYLUTE A ready-to-dilute formulation of thiotepa, FDA approved for the treatment of breast and ovarian cancer. Available in 15mg and 100mg vials.
• IMKELDI An FDA-approved formulation of imatinib mesylate, an oncology drug for the treatment of certain cancers.
• SH-110 An oral liquid formulation for glioma treatment receiving FDA orphan drug designation and Fast Track designation.
• SH-105 Breast and ovarian cancer treatment candidate. FDA accepted NDA for review.
• SH-201 Treatment candidate for certain leukemias and cancers. FDA accepted NDA for review with priority review granted.
• PIP-101 Chemotherapy drug licensed for rights to market in the United States through strategic partnership.

Quantifiable outcome

• FDA approval for larger 375mg nelarabine vial to address dosing challenges for T-ALL and T-LBL patients
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Walgreens Specialty PharmacycoreChannel Partner/ Reseller/ Distributor · 19 August 2025Walgreens Specialty Pharmacy expanded its limited distribution drug network to 265 products, positioning itself among leading specialty pharmacy networks. The expansion includes products from Shorla Oncology such as Nelarabine Injection for T-cell leukemia and lymphoma treatment.
• Gilead SciencesminorChannel Partner/ Reseller/ Distributor · 19 August 2025Gilead products included in Walgreens Specialty Pharmacy expanded limited distribution network alongside Shorla Oncology products.
• GaldermaminorChannel Partner/ Reseller/ Distributor · 19 August 2025Galderma products included in Walgreens Specialty Pharmacy expanded limited distribution network alongside Shorla Oncology products.
• EVERSANAcoreChannel Partner/ Reseller/ Distributor · 1 January 2021Strategic commercial partnership for launch and commercialization of T-cell leukemia treatment nelarabine injection. EVERSANA provides commercial launch support and commercialization services for Shorla's FDA-approved oncology products.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Eagle Pharmaceuticals: Eagle Pharmaceuticals is a US specialty pharma focused on reformulating existing injectable and oncology drugs to improve administration, dosing, and patient experience. Highly comparable to Shorla given shared strategy of improving legacy molecules (e.g., ready-to-dilute, novel formulations) for hospital and oncology channels.
• Helsinn Group: Helsinn is a privately-held Swiss specialty pharma focused on oncology and supportive care, often reformulating or repurposing established molecules for niche cancer indications. Closely matches Shorla's niche-cancer reformulation model and European heritage.
• Spectrum Pharmaceuticals: Spectrum Pharmaceuticals is a US specialty oncology company commercializing differentiated oncology products, including reformulated chemotherapeutics. Comparable to Shorla in target market (oncology specialists) and approach of addressing drug shortages and unmet needs in oncology.
• Acrotech Biopharma: Acrotech is a specialty pharma focused on differentiated oncology therapies, including reformulations of established chemotherapeutics for niche hematology and solid tumor indications. Highly comparable niche-oncology reformulation play with similar specialty distribution model.
• Verastem Oncology: Verastem is a US oncology company commercializing therapies for rare and difficult-to-treat cancers, including hematologic malignancies. Comparable to Shorla given shared focus on underserved oncology patient populations and US specialty distribution.
• MEI Pharma: MEI Pharma is a small-cap oncology company developing and commercializing therapies for hematologic cancers. Comparable to Shorla as a similarly-sized specialty oncology company with reformulation/repurposing strategies and US specialty pharma infrastructure.
• Karyopharm Therapeutics: Karyopharm is a specialty oncology company commercializing therapies for hematologic malignancies and solid tumors. Comparable to Shorla as a similarly-sized oncology-focused pharma with niche cancer indications and US specialty distribution.

Broad incumbents

• Jazz Pharmaceuticals: Jazz Pharmaceuticals is a larger specialty pharma with a meaningful oncology and rare disease portfolio, including hematology/oncology assets and commercial infrastructure in the US. Comparable to Shorla as a broader incumbent pursuing orphan oncology indications with established commercial reach.

Emerging players

• Puma Biotechnology: Puma Biotechnology is a small-cap oncology company focused on developing and commercializing therapies for HER2-positive cancers, including breast cancer. Comparable overlap with Shorla's breast cancer indications (TEPYLUTE, SH-105) and similar commercial-scale oncology pharma profile.

Others

• Therakind (Jylamvo originator): Therakind is a UK-based specialty pharma that originally developed JYLAMVO before Shorla acquired US rights. Comparable as a related pediatric-friendly drug developer and prior counterparty; not a direct competitor but an enabling/licensing counterparty relevant to Shorla's portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/ShorlaOncology
• LinkedInlinkedin.com/company/shorla-pharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Shorla Oncology