• Second FDA Acceptance for an NDA Filing by Shorla Oncology Announced in 2024
• New Oral Liquid Drug from the U.S. -Ireland Pharmaceutical Company
• Slows or Stops the Growth of Certain Types of Leukemia and Other Cancers

April 08, 2024 7:00 AM Eastern Daylight Time CAMBRIDGE, Mass. - (BUSINESS WIRE) - Shorla Oncology (‘Shorla’), a U.S. - Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of November 30, 2024.

“With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of U.S. patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid, ” said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology. “Submitting this drug to the FDA for review is more than just a milestone for our company, it’s an important moment for all those impacted by this disease including patients, caregivers and clinicians. ”

SH-201 is an oral liquid treatment that slows or stops the growth of certain forms of leukemia and other cancers such as:

• Chronic Myeloid Leukemia - Affects approximately 9,280 new patients each year in the U.S.
• Acute Lymphoblastic Leukemia - Impacts approximately 6,550 new patients each year in the U.S.

“The FDA’s action today ensures that Shorla is well positioned to bring this innovative oral drug to market, ” said Orlaith Ryan, Chief Technical Officer and Co- Founder of Shorla Oncology. “SH-201 addresses key areas of unmet need by providing a palatable liquid treatment option for patients suffering with cancer. ”

This milestone for SH-201 follows acceptance to file announced in January of this year for SH-105, a novel, differentiated ready-to-dilute formulation for the treatment of adenocarcinoma of the breast or ovary. It is progressing through FDA review. The company recently raised $35 million in Series B funding that has allowed Shorla to accelerate the growth of its oncology portfolio. Last year, the company launched Nelarabine for the treatment of T-cell Leukemia and JYLAMVO, the first and only oral methotrexate solution approved in the United States for use in adults for the treatment of acute lymphoblastic leukemia and other indications.