RCS - hVIVO PLC - MSD to acquire Cidara

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RNS Number : 1281J  hVIVO PLC  27 November 2025

REACH

27 November 2025

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

  MSD to acquire Cidara following Positive Results from Phase IIb Trial

 

hVIVO plc (AIM: HVO), a full-service early phase Contract Research
Organisation (CRO) and the world leader in human challenge clinical trials,
congratulates its client Cidara Therapeutics, Inc ("Cidara" or the "partner")
which has entered into a definitive agreement under which Merck Sharp &
Dohme LLC ("MSD"), through a subsidiary, will acquire Cidara for a total
transaction value of approximately $9.2 billion. This transaction underscores
the value of hVIVO's unique capabilities in accelerating drug development and
validates the Company's strategic role in supporting breakthrough therapies.

 

Cidara's lead candidate, CD388 is an investigational, long-acting,
strain-agnostic antiviral agent designed to prevent influenza infection in
individuals at higher risk of complications and offers protection against both
influenza A and B. CD388 is currently in Phase III clinical development and
has received Breakthrough Therapy Designation and Fast Track Designation from
the U.S. FDA.

 

hVIVO has partnered with Cidara throughout the development of CD388,
delivering critical data that enabled its progression from early
proof-of-concept to late-stage trials. Completed in 2023, hVIVO conducted a
randomized, double-blind influenza human challenge study in healthy
volunteers, providing early proof-of-concept data for CD388 ahead of later
stage trials. 59 study participants were enrolled into the study and the
primary efficacy analysis comparing the total viral load (area under the curve
/ AUC) showed a reduction in the CD388 treated arm compared to placebo.
Similarly, the peak viral loads measured by both qPCR and cell culture were
lowered in CD388 treated participants compared to placebo.

 

Building on this success hVIVO continued to support the development of CD388,
participating as the only UK site in Cidara's Phase IIb field study conducted
over the 2024 / 2025 flu season assessing the protective efficacy of CD388 in
healthy adults. During the study, hVIVO delivered its largest-ever number of
participants enrolled into a field trial, screening more than 1,100
participants and dosing 817 within six weeks, achieving the highest recruiting
numbers of all sites across the globe. This achievement demonstrated hVIVO's
ability to execute large-scale field studies with speed and precision. The
Phase IIb data read-out showed that all the primary and secondary endpoints
were met. The Company continues to support Cidara through Phase III
development, acting as a major clinical site for the ongoing multi-site trial.

 

In addition, hVIVO has acted as the central Virology Laboratory for both of
Cidara's CD388 Phase IIb and Phase III programs. As part of this service
provision hVIVO has provided scientific consultancy, assembled sample
collection kits, managed global virology sample logistics, and is responsible
for multiple virology and immunology assays including the primary endpoint
analysis.

 

Dr Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We congratulate
Cidara on this landmark transaction in the infectious disease space with MSD.
For hVIVO, this demonstrates that our human challenge trial expertise can
indeed lead to significant downstream value creation. It also validates
hVIVO's diversification into field studies and standalone laboratory services,
facilitated by our highly efficient patient recruitment and site services
along with our extensive infectious disease knowledge and capabilities. We are
proud to have supported CD388 from early proof-of-concept through Phase IIb
and into Phase III, and we look forward to patients benefitting from this
innovative therapy."

For further information please contact:

 

 hVIVO plc                                       +44 (0)20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser                                                  +44 (0)20 7220 0500

and Joint Broker)
 Geoff Nash, Callum Davidson,

Trisyia Jamaludin, Harriet Ward

 Nigel Birks - Life Science Specialist Sales

 Louise Talbot - Sales

 Peel Hunt LLP (Joint Broker)                                               +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (Joint Broker)                                                        +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0)20 7933 8780 or hvivo@walbrookpr.com (mailto:hvivo@walbrookpr.com)

 Paul McManus / Alice Woodings /                 +44 (0)7980 541 893 / +44 (0)7407 804 654/

+44 (0)7584 391 303
 Lianne Applegarth

 

 

Notes to Editors

hVIVO plc (https://hvivo.com/)  (Ticker: HVO) is full-service early phase
Contract Research Organisation (CRO) and the global leader in human challenge
trials. The company delivers end-to-end clinical development services to a
diverse and expanding client base, including seven of the world's ten largest
biopharma companies.

 

hVIVO specialises in conducting human challenge trials across multiple
infectious and respiratory indications, leveraging its state-of-the-art
quarantine facility in London-the largest of its kind worldwide. The Company
also offers comprehensive virology and immunology laboratory services under
the hLAB (https://hlabservices.com/)  brand.

 

Through its German subsidiary, CRS (https://crs-earlyphase.com/) , hVIVO
operates a 120-bed capacity across Mannheim and Kiel, providing early-phase
clinical trial services, including first-in-human and proof-of-concept
studies. Its second subsidiary, Venn Life Sciences
(https://www.vennlifesciences.com/) , offers Early Drug Development
Consulting and Biometry services to the biopharma sector.

 

The Group provides fully integrated drug development solutions from
preclinical stages through Phase II trials, alongside patient recruitment
via FluCamp (https://flucamp.com/) . Additionally, its five clinical sites
support outpatient Phase II and III trials, ensuring a seamless and
efficient pathway from discovery to late-stage development.

 

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