Regulation

The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.

Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.

Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.

Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.

IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.

NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.

The Danish pharma giant raised its full-year adjusted sales and operating profit guidance, citing higher-than-expected demand for its GLP-1 product portfolio.

Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.

Total ASPR backing reaches $17m as the Virginia biotech moves seven API targets toward commercial-scale domestic manufacturing.

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill

The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.