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Dimerix (ASX: DXB) secures A$34m funding but lenders get 30% of milestones
Dimerix Limited has secured A$34 million of loan commitments and initially plans to draw only A$17 million, saying existing cash and the facility can fund its ACTION3 Phase 3 and DMX-652 Phase 2 programmes. The structure avoids immediate equity dilution but carries 10% compounded interest and gives lenders a share of future DMX-200 licensing milestones.
Cipla bets on Qilu’s Keytruda biosimilar as $31.7bn oncology franchise nears expiry
Cipla has secured exclusive U.S. commercialization rights to Qilu Pharmaceutical’s Phase 3 pembrolizumab biosimilar, positioning the Indian drugmaker for competition around Merck & Co.’s $31.7 billion Keytruda franchise.
Zanvastro approval validates Ionis Pharmaceuticals neurology strategy, but how large is the market?
Ionis Pharmaceuticals has secured the first FDA approval for Alexander disease with Zanvastro, a quarterly RNA-targeted treatment priced at $285,000 per dose, while the ultra-rare population limits its standalone commercial ceiling.
Mabwell’s COPD antibody cuts exacerbations up to 81% as Phase III approaches
Mabwell has reported early Phase Ib/IIa data showing its experimental anti-ST2 antibody 9MW1911 reduced annualised moderate-to-severe COPD exacerbations by 81% at the highest tested dose versus placebo, but the 80-patient study was primarily designed for safety and remains far too small to establish definitive efficacy.
Novartis pelacarsen fails 8,323-patient Phase III test despite lowering Lp(a)
Novartis’ pelacarsen has failed the primary endpoint in the 8,323-patient Phase III Lp(a)HORIZON trial despite lowering lipoprotein(a), delivering a major setback to one of cardiovascular medicine’s most closely watched drug-development hypotheses and raising new questions for competing Lp(a)-lowering programmes.
VERAXA has a $27.5m note and $50m funding facility. Why is Raju Willener becoming CFO now?
VERAXA Biotech has appointed capital-markets veteran Raju Willener as chief financial officer less than three months after its Nasdaq debut, with oncology programmes moving toward clinical development and financing strategy becoming increasingly important.
FDA advisers voted 6-3 against AstraZeneca’s breast cancer strategy. The drug was just approved anyway
The U.S. Food and Drug Administration has granted accelerated approval to AstraZeneca’s Etcamah after a Phase III trial showed a 56% reduction in progression or death, creating the first U.S. cancer treatment strategy triggered by a resistance mutation found in blood before imaging shows disease progression.
Gilead’s Bixlenvo approval extends lenacapavir from prevention into daily HIV treatment
Gilead has secured FDA approval for Bixlenvo, combining bictegravir and lenacapavir in a once-daily tablet aimed particularly at virologically suppressed adults who remain on complex multi-pill HIV regimens.
AMT-130 reaches FDA as uniQure targets first disease-modifying Huntington’s therapy
uniQure files AMT-130 for accelerated FDA approval after a 75% slowing in Huntington’s disease progression. See the key catalysts ahead.
GSK licenses HUTCHMED’s HMPL-A830 cancer therapy in deal worth up to $1.295bn
GSK plc has licensed HUTCHMED’s experimental KRAS-EGFR cancer therapy HMPL-A830 for up to $1.295 billion, giving the Chinese biotech a $110 million upfront payment before the drug enters its first human trial.