Latest Clinical Data News

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.

Radiopharm Theranostics has bolstered its cash position with an $8 million placement from Lantheus Holdings, now its largest shareholder. New clinical data highlight promising advances in brain metastases detection and HER2-targeted radiopharmaceutical therapies.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

Nova Eye Medical reported a 27% rise in Q3FY25 sales excluding China, driven by record US performance and a sharp reduction in glaucoma segment losses. The company confirmed FY25 revenue guidance and unveiled plans to expand its iTrack™ technology into ocular drug delivery.

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Race Oncology has opened a second Australian clinical site for its Phase 1 trial of RC220 combined with doxorubicin in advanced solid tumours, aiming to speed patient enrolment and gather critical safety and efficacy data.

PYC Therapeutics has launched a A$145.8 million pro-rata accelerated non-renounceable entitlement offer to fund late-stage clinical trials across its pipeline targeting rare diseases with high unmet needs. The capital raise aims to extend the company’s cash runway beyond FY27, supporting four drug candidates through critical human safety and efficacy milestones.

Imugene’s Phase 1b trial of azer-cel, an off-the-shelf CD19 CAR T therapy, reports a 57% complete response rate in heavily pretreated diffuse large B-cell lymphoma patients, signaling a promising new option in a challenging cancer landscape.

AVITA Medical's Q4 2024 earnings reveal strong commercial growth alongside the launch of Cohealyx, a novel collagen-based skin substitute that promises to transform acute wound care.

Memphasys has completed the final patient visit in its Felix™ clinical trial, with data lock expected within two weeks and preliminary results slated for early March 2025. This milestone paves the way for CE Mark submission and imminent commercialisation in Europe.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.