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Vectus Biosystems Limited (ASX:VBS)

ALERT: Price-sensitive ASX Announcement for VBS
Current share price for VBS : $0.090 -0.02 (-18.18%)+
Announcement
Release
30 Sep 2026 9:12AM
Price at Release
$0.110
Full Release
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Summary
Vectus Biosystems Limited announced that the US Food and Drug Administration has granted its request for a pre-Investigational New Drug (pre-IND) Type B meeting for VB0004 in idiopathic pulmonary fibrosis, marking an important step in the program’s US regulatory pathway. The company said written FDA responses on its proposed development program are expected by mid-November 2026 and, with support from Cardinal Health Regulatory Services, it will now finalise and submit its meeting package. Vectus described VB0004 as a first-in-class oral vasoactive intestinal peptide-mimetic and natriuretic peptide receptor C agonist, or antifibrotic candidate, for IPF, and noted that it has already completed a Phase Ia study in healthy volunteers showing a favourable safety and pharmacokinetic profile. The announcement also states that Vectus is an Australian clinical-stage biotechnology company focused on fibrotic diseases, with a broader pipeline spanning cardiovascular, renal and liver fibrosis, and that it aims to create shareholder value through the advancement, partnering and commercialisation of these therapies.
Key Points
  • FDA granted Vectus Biosystems' request for a pre-IND Type B meeting for VB0004 in idiopathic pulmonary fibrosis.
  • The FDA's written responses to Vectus' proposed development program are expected by mid-November 2026.
  • Vectus will finalise and submit its meeting package to the FDA with support from Cardinal Health Regulatory Services.
  • CEO and CTO Dr Tara Speranza said the meeting request grant is an important step in progressing the US regulatory pathway for VB0004.
  • VB0004 is described as a first-in-class oral VIP-mimetic and NPR-C agonist being developed for IPF.
  • Vectus has completed a Phase Ia clinical study in healthy volunteers that established a favourable safety and pharmacokinetic profile for VB0004.
  • The company is an Australian clinical-stage biotechnology business focused on novel therapies for fibrotic diseases.
  • Vectus also has a broader antifibrotic pipeline targeting cardiovascular, renal and liver fibrosis.
  • The company noted external validation of its platform through a licensing agreement for one of its renal fibrosis assets.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.