Latest Biotechnology News

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Chimeric Therapeutics has appointed Hawkesbury Partners to lead a strategic review aimed at exploring options to enhance shareholder value, reflecting concerns that its market cap undervalues its clinical assets and infrastructure.

Biome Australia has posted a 30% increase in FY26 sales revenue to $23.9 million, driven by strong domestic demand and strategic moves into onshore manufacturing and international markets.

Imugene Limited reports a complete response in the first patient treated with azer-cel combined with BTK inhibitors in its Phase 1b trial, highlighting potential for resistant follicular lymphoma.

BCAL Diagnostics has locked in an additional $4.9 million under its existing convertible note facility alongside a $1.4 million R&D tax offset tranche, reinforcing its funding runway into FY2027 for early cancer detection test development.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

Skin Elements Limited has secured a $900,000 placement at a 25% discount to recent prices, bolstering its balance sheet to advance its natural biotechnology product range. The company also appointed Rod Nicholas as non-executive chairman and engaged Phoenix Global Investments for investor relations.

Mesoblast has drawn US$50 million from a new five-year facility that reduces its interest burden and retires expensive short-term debt, strengthening its financial position ahead of commercial expansion.

INOVIQ Limited’s CAR-exosome platform demonstrated potent tumour-killing activity in ovarian cancer cell lines, eliminating up to 90% of cancer cells within 48 hours and reinforcing its potential against hard-to-treat solid tumours.

TALi Digital is transforming its established educational programs into an AI-driven platform, leveraging a validated cognitive technology and a national footprint in over 500 schools to tap a largely under-penetrated market.

Cynata Therapeutics (ASX: CYP) has had its trading suspension lifted immediately following the publication of results from its Phase 3 Osteoarthritis and Phase 2 Graft versus Host Disease clinical trials.