Latest Market Access News

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

Osteopore Limited has inked an exclusive collaboration with Majeton to commercialise its cutting-edge 3D-printed bioresorbable implants across China, Hong Kong, and Macau, unlocking significant growth potential in the region.

Osteopore Limited has secured an exclusive multi-year distribution agreement with Majeton to commercialise its dental and maxillofacial products in China, Hong Kong, and Macau, marking a major step in its Asia-Pacific expansion.

ReNerve Limited has secured market approval for its NervAlign® Nerve Cuff in Malaysia, marking a key milestone in its Asia-Pacific expansion strategy. This approval follows earlier clearances in Hong Kong and Thailand, positioning the company to tap into a growing regional nerve repair market.

Vitrafy Life Sciences has entered a 12-month exclusive partnership with IMV Technologies to integrate cryopreservation technologies, securing up to A$930k in fees and milestone payments.

Vitrafy Life Sciences has secured a 12-month exclusive partnership with global animal reproduction leader IMV Technologies to co-develop and commercialise next-generation cryopreservation solutions for farm animals and aquaculture.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Vanguard Investments Australia has announced final distribution amounts and key dates for 27 of its ETFs, with payments scheduled for mid-January 2026. Investors can also participate in the Distribution Reinvestment Plan across all funds.

BPH Global reported a seasonal dip in December revenue due to rainy conditions affecting seaweed supply, yet maintains strong growth momentum with A$1.77 million gross revenue over seven months.

Memphasys Limited has completed a $579K shortfall placement, boosting total funds raised to over $1.12 million to support the commercial rollout of its Felix™ System following recent regulatory approvals.

Kinetiko Energy has secured approval to trade on the North American OTCQB Market, aiming to boost investor access and liquidity as it advances its South African gas projects.