Hemogenyx Pharmaceuticals PLC Announces Clearance to Proceed with Pediatric Expansion

NYSE - LSE

CMSC	0.4%	22.314	$
CMSD	0.11%	22.285	$
RBGPF	0%	69.04	$
SCS	0.37%	10.74	$
RELX	0.06%	53	$
RIO	-0.24%	59.33	$
GSK	0.31%	41.45	$
NGG	0.38%	71.48	$
BP	0.58%	30.4	$
BTI	1.48%	48.215	$
BCC	0.87%	91.02	$
JRI	0.15%	13.13	$
VOD	0.1%	9.85	$
BCE	-0.27%	22.445	$
RYCEF	0.83%	12	$
AZN	-0.16%	73.71	$

Hemogenyx Pharmaceuticals PLC Announces Clearance to Proceed with Pediatric Expansion

BOULEVARD 17.06.2025

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Regulatory Clearance to Proceed with Pediatric Expansion of HG-CT-1 Clinical Trial

Text size:

LONDON, UK / ACCESS Newswire / June 17, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that the 30-day review period by the U.S. Food and Drug Administration (FDA) for the Company's previously submitted amendment to the clinical protocol of its ongoing Phase I trial of HG-CT-1 has concluded without a clinical hold. As a result, the Company is now cleared to proceed with the next steps required to initiate pediatric enrolment in the trial.

The protocol amendment expands the eligibility criteria for the Phase I trial of HG-CT-1, Hemogenyx's proprietary CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML), to include children and adolescents with this aggressive and hard-to-treat disease.

The Company will now move forward with Institutional Review Board (IRB) submissions and associated site activation procedures to enable the opening of pediatric cohorts.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Regulatory clearance to proceed with the pediatric expansion of our HG-CT-1 clinical trial is a significant milestone. It reflects continued momentum in our development program and underscores our commitment to delivering innovative therapies to patients across age groups. This expansion broadens the potential impact and value of HG-CT-1 as we continue to advance toward key inflection points in the clinic. Importantly, it also reinforces the value of Company's robust intellectual property portfolio, which underpins our pipeline and supports long-term strategic growth."

The Company will update the market as further progress is made in pediatric site activation and patient enrolment.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement. The person responsible for arranging for the release of this announcement on behalf of Hemogenyx Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.

Enquiries:

Hemogenyx Pharmaceuticals plc	https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder	[email protected]
Peter Redmond, Director	[email protected]
SP Angel Corporate Finance LLP	Tel: +44 (0)20 3470 0470
Matthew Johnson, Vadim Alexandre, Adam Cowl
Peterhouse Capital Limited	Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey, Charles Goodfellow

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.

SOURCE: Hemogenyx Pharmaceuticals PLC

View the original press release on ACCESS Newswire

X.Karnes--AMWN

American Marconi Wireless News - Hemogenyx Pharmaceuticals PLC Announces Clearance to Proceed with Pediatric Expansion

Hemogenyx Pharmaceuticals PLC Announces Clearance to Proceed with Pediatric Expansion

Featured

Australian mushroom murder suspect told 'lies upon lies': prosecutor

Vetnique Founder Dr. James Bascharon Named EY 2025 Midwest Entrepreneur of the Year

ESSE Care Expands to Manhattan, New York, With New Location at Shafer Clinic Fifth Avenue

DEA Marijuana “Do-Nothing” Team Rewarded with Dubai Trips While MS and HD Patients Waited