GSK (GSK)

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Share Price:
1,855.00p
Market Cap:
£75,043m
Change Today:
41.00p
Sector:
Pharma and Biotech

GSK's momelotinib receives orphan drug designation from US and EU watchdogs

By Iain Gilbert

Date: Friday 12 Jun 2026

LONDON (ShareCast) - (Sharecast News) - Drugmaker GSK said on Friday that its JAK inhibitor momelotinib has been granted orphan drug designation by both the US Food and Drug Administration and the European Medicines Agency for the treatment of VEXAS syndrome, a rare and severe autoinflammatory condition with no approved therapies.
GSK said the designations were supported by retrospective case studies suggesting JAK inhibitors may offer clinical benefit, as well as a case report indicating improvements in symptoms, inflammation and haematological markers with momelotinib.

The FTSE 100-listed company plans to evaluate the drug in VEXAS through its upcoming phase II/III ATLAS trial, which will support future global regulatory submissions. The trial forms part of a broader development programme assessing momelotinib across multiple haematological conditions.

Momelotinib, marketed as Ojjaara/Omjjara, has already been approved in the US for intermediate‑ or high‑risk myelofibrosis in adults with anaemia, and in the EU, UK and Japan for myelofibrosis with splenomegaly or disease‑related symptoms in patients with moderate to severe anaemia.

As of 0815 BST, GSK shares were up 1.14% at 1,984.80p.





Reporting by Iain Gilbert at Sharecast.com

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GSK Market Data

Currency UK Pounds
Price 1,855.00p
Change Today 41.00p
52 Week High 2,208.00p
52 Week Low 1,735.50p
Volume 13,548,350
Shares Issued 4,045.43m
Market Cap £75,043m

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