Latest Contract Research Organisation News

Charles River Laboratories delivered a second consecutive quarter of organic revenue growth and raised its 2026 outlook, despite reported revenue falling after divestitures. The quarter’s sharp GAAP earnings increase was heavily amplified by a US$245.6 million tax reserve reversal.

Radiopharm Theranostics has reached final alignment with the U.S. FDA on a single pivotal Phase 3 trial for RAD101, its brain metastases imaging agent. The approximately 280-patient study is expected to begin dosing in the first half of 2027, moving the program from regulatory planning towards execution.

Pathkey.AI has secured its first Chipforge customer contract ahead of the semiconductor platform’s commercial release, while a $2.8 million placement lifted quarter-end cash to $5.83 million. The company remains early-stage, with just $10,000 in customer receipts during the September quarter and further commercial conversion still to prove.

Cambium Bio has moved Elate Ocular into Phase 3 manufacturing and submitted an updated CAMOMILE-2 protocol to the FDA. The company is targeting First Patient In by year-end, but that timetable depends on a conditional A$7.1 million placement, unsigned CRO agreements and release of the first clinical batch.

Compumedics Limited (ASX:CMP) returned to profit in FY26 as record revenue, stronger cash generation and a sharp rise in MEG and SaaS sales reshaped its earnings profile. The company enters FY27 with A$28.3 million of open orders, but lower gross margins and uneven US and European execution remain key tests.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

Genetic Signatures narrowed its FY2026 net loss by 30% to $14 million amid a strategic overhaul, signing a key 10-year supply deal with Denmark’s Hvidovre Hospital and resetting its US market approach.

EVE Health Group has progressed its Libbo pilot clinical study for erectile dysfunction with dosing set for Q4 2026 and achieved a major solubility breakthrough for apixaban, while appointing Ben Rohr as CEO to drive commercial growth.

Genetic Signatures has completed a major restructure delivering $5 million in annual savings from FY2027 and secured a decade-long supply contract with Denmark’s Hvidovre Hospital, while posting $14.8 million revenue for FY2026 amid market pressures.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.

TrivarX has locked in investigational product supply critical for starting its Phase 1 clinical trial of the Stabl-Im MRI imaging platform, targeting a 2026 trial commencement.

INOVIQ Ltd has revealed significant sample quality problems in its EXO-OC ovarian cancer diagnostic study, prompting a technical review and a refined development approach while maintaining its dual commercialisation strategy.