Deals, pipeline readouts and company news from across biotech and pharma.
The US device company reported third-quarter revenue of $1.07m, held its 2026 guidance, and confirmed full enrolment in its Phase III TIGeR-PaC pancreatic cancer trial.
The rare-disease company lifted its 2026 outlook and flagged two 2027 FDA decision dates, for a KHINDIVI label expansion and the newly licensed LIBERVANT NDA.
The company ended the quarter with $272.2m in cash, while partners Novo, Roche and Bristol Myers Squibb progress late- and mid-stage trials.
The US cell therapy company reported about $122M in third-quarter revenue and raised its full-year outlook from $350M-$370M, citing growth in Amtagvi treatment sites.
Gyre Therapeutics affirmed full-year guidance after Q3 results, with an NMPA ruling on hydronidone (F351) for CHB-induced liver fibrosis possible by end-2026 or Q1 2027.
Rigel Pharmaceuticals reported Q3 net income of $13.2 million and raised its full-year revenue guidance after the US launch of VEPPANU, the first FDA-approved PROTAC.
Higher Medicaid and 340B deductions and increased R&D spending cut profit, even as NERLYNX sales grew; Puma also began a Phase II lung cancer trial.
The organ-transplant technology company reported third-quarter revenue of $203.0 million and net income of $17.1 million, alongside FDA IDE approvals and a first European logistics tender win in Italy.
The cell and gene therapy logistics provider reported third-quarter revenue of $50.2 million, a net loss of $10.9 million and adjusted EBITDA of $1.1 million.
MannKind reported $45.0m in commercial product revenue, as the newly shipping Furoscix ReadyFlow and the paediatric Afrezza launch lifted sales, alongside early inhaled-pipeline data and a new licensing deal.
The US genetic testing company reported third-quarter revenue of $794M and a surge in clinical MRD oncology volumes, and raised its full-year revenue guidance.
ARS Pharmaceuticals posted $37.7M total third-quarter revenue, cut SG&A sharply and said interim Phase 2b data for ARS-2 in chronic spontaneous urticaria flares are due in Q1 2027.
The company has no product revenue yet, as gedatolisib shipments began only on 30 September, while payer coverage is reported at 91% of US commercial and Medicare lives.
The US diagnostics company lifted its full-year outlook to $1.36-1.37 billion as Oncology volumes grew and Shield screening tests rose to 83,000, alongside new FDA companion diagnostic approvals.
Protagonist Therapeutics says the FDA's August approval of rusfertide for polycythemia vera drove milestone income, while icotrokinra gained approvals in China, Japan and the EU.
The cell therapy maker reported third-quarter net income of $14.2m, raised full-year revenue and adjusted EBITDA margin guidance, and said a possible 2027 UK launch of MACI remains on track.
The US vaccine developer reported $68 million in third-quarter revenue and a $31 million net loss, with cash of $627 million at the end of the period.
Viatris reported third-quarter revenue of $3.75bn and a GAAP net loss, citing a US approval, a Japanese approval and a product launch.
The radiopharmaceutical company reported third-quarter results, cited two FDA approvals and a CMS reimbursement decision, and suspended 2026 guidance because of its pending Curium merger.
The medtech group also reports FDA Breakthrough Device Designation for its Freesolve magnesium scaffold and a completed OEM divestiture, with the Intersurgical sale still awaiting regulatory approval.
Growth in the ADHD portfolio offset an 18% fall in pain products, and the company reaffirmed its 2026 guidance.
The model-informed drug development company narrowed its 2026 revenue growth outlook to 2% to 3% and appointed Grant Peterson as Chief Product Officer.
The US insulation-materials maker booked $15.1 million of incident-related costs and expects restoration of its East Providence facility to finish in the first half of 2027.
The US device maker reaffirmed its 2026 revenue guidance, lowered its operating expense outlook and began a full commercial launch of its AYON power liposuction handpiece.
Akebia reported a $14.4M third-quarter net loss as growth in Vafseo use among dialysis patients failed to offset falling sales of Auryxia.
The CAR-T developer says Descartes-08 data in AChR antibody-positive myasthenia gravis are due in the first quarter of 2027, ahead of a planned FDA filing, as it reports Q3 2026 results.
Amtagvi sales of about $102M in the US drove an roughly 80% year-on-year rise, while UK and Swiss decisions are possible in the first quarter of 2027.
The animal health company reported third-quarter revenue of $2.4B, with US companion animal sales down 8%, and flagged new FDA actions including a screwworm emergency authorisation for Simparica Trio.
BeOne Medicines reported third-quarter revenue of $1.9bn, with BRUKINSA sales of $1.4bn, and lifted its full-year revenue and operating income guidance.
The gene therapy company reported net income of $35.8 million and positive cash flow, with an EMA marketing application for Papzimeos under review.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.