Quarterly results and guidance from the drugmakers that matter.
The company's PMA supplement for air and ground transport labelling remains under FDA review, with audit readiness expected in mid-December and agency inspections to follow.
The US regulator's designation covers advanced non-squamous NSCLC after anti-PD-(L)1 and platinum chemotherapy, but the company's third-quarter cash position underlines its continuing need for financing.
The oncolytic virus developer reports $3.9M in cash, a headcount-led restructuring expected to save about $3M a year, and a first-patient dose for CLD-401 targeted for H2 2027.
The Nasdaq-listed company says Corexa Pharmacy's GLP-1 dispensing drove growth, and it has regained Nasdaq compliance and launched compounded peptides under an FDA enforcement discretion policy.
The oncology developer says emavusertib is enrolling in CLL and PCNSL, with first CLL combination data due in December 2026, while financing extends runway just into the first quarter of 2027.
The company reported third-quarter 2026 revenue of $5.4 million, with AlterG up 18% while ReWalk exoskeleton sales declined during its shift away from direct sales.
The company reports a $7.9M net loss for the quarter, clears its Oaktree balance and adds a Phase 2 IBS-D asset licensed from Cedars-Sinai.
The US company says payer coverage for its PSVT nasal spray has reached about two-thirds of covered lives, and its cash runway now extends into late 2028.
The US dermatology company also reports a customs ruling on its redesigned RhodoLED XL-C lamp and a new sNDA to widen the actinic keratosis label.
The cannabis operator's Q3 2026 loss stems from a $5.0M charge on acquiring Rogue EBC, while it holds guidance and awaits approvals for a New York deal.
Bavarian Nordic held its upgraded 2026 guidance of about DKK 6.1bn in revenue and a roughly 32% EBITDA margin, with travel vaccines offsetting a flat quarter overall.
Mesoblast says FY2026 net revenue reached US$115M in the first full year of US sales of Ryoncil, while its pipeline and label-expansion studies progressed.
TMC the metals company reports about $123 million in liquidity and a later NOAA timeline for its USA-A application, after the agency said it must review more than 1,600 public comments.
The Nasdaq-listed former biopharma company, now selling fire safety products in Malaysia, also reports an effective S-4 for its proposed Future NRG combination.
The OTCQB-listed niche generics maker reported higher revenue and operating income for the quarter to 30 September 2026, with net income of $17.3m attributable to common shareholders.
Obsidian Therapeutics reported Q3 2026 results alongside updated SITC data on its engineered TIL therapy, and said enrolment in the Agni-01 registration-enabling cohort should complete by end of Q1 2027.
The capsule endoscopy maker reported a $7.3M quarterly net loss, completed enrolment in its CapsoCam Colon study and raised about $17.8M net in September.
The blood purification company reports $9.7M quarterly revenue and a narrower operating loss, while it pursues FDA marketing authorization for DrugSorb-ATR and tries to rebuild German sales.
The ultrafiltration specialist reported flat third-quarter sales of $2.2 million, a higher gross margin and a 24% smaller operating loss, alongside a pediatric filing and two distribution deals.
The RNS System maker cut its full-year revenue outlook to $91–92 million while advancing Remote Care, an idiopathic generalised epilepsy amendment and a new adolescent study.
In its third-quarter MD&A, the company reported a deferred-interest loan extension to licensee Unbuzzd, a cancelled warrant, a larger equity stake and a Nasdaq-only listing.
The designation covers metastatic pancreatic adenocarcinoma, as Erasca reports $947.8M in cash at Q3 2026 after a July public offering of about $632.5M.
Armata Pharmaceuticals also reported Q3 2026 net income of $54.9 million, driven by a loan fair-value gain, while it finalises its Phase 3 protocol with the FDA.
The gene-editing company's unaudited interim accounts show a sharp fall in revenue, higher research spending, lower cash and negative shareholders' equity at 30 September 2026.
In its fiscal 2026 results, Arrowhead reported growth in the US Redemplo launch for FCS and an sNDA for sHTG, with a US launch targeted for Q2 2027.
The renamed Nasdaq-listed company says its oral colon-targeted AhR agonist for ulcerative colitis remains on course for an IND filing and Phase 1a start in the first half of 2027.
The US cell therapy and devices company says it has completed the PMDA process on CardiAMP application materials, while FDA feedback on a revised Helix Pre-Submission is expected within weeks.
Anaptys posted $30.3 million in collaboration revenue for the September quarter, with a rectal cancer approval for Jemperli and a Delaware judgment and an FDA decision both approaching.
The US device maker says its pivotal acute kidney injury trial is about 75% enrolled, while it advances a PMA submission and reports higher third-quarter Quelimmune sales.
CorMedix suspended 2027 DefenCath guidance after CMS reimbursement changes, while its Heron asset acquisition and a REZZAYO FDA Priority Review proceed.