Regulation

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.

The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.

The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.

New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.

PharmAla Biotech has been granted a US process patent for enantioselective MDMA production and pulled its APA-01 licensing deal with Restora Neurosciences.

TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial

Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.

TOMI Environmental's iHP decontamination technology is now authorised in Ireland, bringing its EU market approvals to 11 countries.

BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.

The Belgian particle accelerator group posted a €9.3m net profit in H1 2026, reversing a prior-year loss, with proton therapy order intake more

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.

The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.

The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.

Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.

Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing

The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed

The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.

The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.