Everything else moving the pharma business.
The agency has accepted Intellia's BLA for lonvoguran ziclumeran with priority review and does not currently plan an advisory committee, the company said at an investor event.
The company formerly known as Cybin ended September 2026 with $171.1M in cash, up from March, after about $86M in net equity proceeds.
The company's nine-month MD&A says IMC Holdings, including Adjupharm, went to an entity controlled by chief executive Oren Shuster on 29 September 2026.
The company formerly known as FSD Pharma reports a smaller loss for the nine months to September 2026, with cash near $3.6M and digital assets near $8.7M.
Candel Therapeutics now expects to file its aglatimagene besadenovec application in mid-2027, citing assay refinement timelines, and reports cash of $203.1 million.
Ernst & Young's report on the combined 2025 and 2024 accounts of Marea Therapeutics and M2 Therapeutics cites recurring losses and a net stockholders' deficit.
Santhera has granted SteinCares exclusive rights to distribute vamorolone across 31 Latin American and Caribbean countries, with Brazil first in line and ANVISA registration to be pursued.
BioNTech has agreed to pay $205 million in cash for a US priority review voucher, intending to speed FDA review of a future late-stage oncology filing.
Atara Biotherapeutics says the FDA accepted its resubmitted application for tabelecleucel in EBV+ PTLD, while cash of $9.9 million is expected to last into mid-2027.
The US firm says its pre-meal chewable tablet now has a legalised government certificate, and it plans to begin UAE registration with its distribution partner.
The MHRA has issued a Class 4 defect notification for Sandoz's 250/62.5 mg/5 mL co-amoxiclav oral suspension after its SmPC dosing table was found to be wrong, with all batches affected.
A Class 4 defect notice says the weight-based dosing table in Sandoz's co-amoxiclav 250/62.5 mg/5 ml SmPC is wrong, and the document has been withdrawn from MHRA and eMC websites.