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GSK's Momelotinib Gets Orphan Tag for Rare Hemato-Inflammatory Disorder
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Key Takeaways
GSK received FDA and EMA orphan designations for momelotinib in VEXAS syndrome.
Momelotinib showed potential to ease symptoms, reduce inflammation and address blood disorders.
GSK launched the phase II/III ATLAS study to support potential global regulatory filings.
GSK plc (GSK - Free Report) announced that the FDA and European Medicines Agency (EMA) have granted Orphan Drug Designation (ODD) to its JAK inhibitor, momelotinib, for treating VEXAS syndrome.
ODD is a special status granted by regulatory agencies to promote the development and review of medicines that may treat, prevent, or diagnose rare diseases.
GSK already markets momelotinib in the United States, European Union and some other countries by the name of Ojjaara/Omjjara (brand name outside the United States) for the treatment of myelofibrosis patients with anemia.
Year to date, GSK shares have risen 7.8% against the industry’s 3.9% decline.
Image Source: Zacks Investment Research
VEXAS syndrome is a rare, severe, progressive haemato-inflammatory disorder with a poor prognosis. The disease carries an estimated five-year mortality rate of 30-40% and no approved therapies are currently available for affected patients.
GSK’s ATLAS Study Advances Momelotinib in VEXAS Syndrome
The ODDs were supported by emerging clinical evidence and case reports indicating that momelotinib may improve disease-related symptoms, reduce inflammation and address hematologic abnormalities associated with VEXAS syndrome. Researchers believe that the drug's inhibition of JAK1 and JAK2 signaling pathways may help counter the excessive inflammatory activity that drives the disease.
GSK has initiated the phase II/III ATLAS study evaluating momelotinib in patients with VEXAS syndrome. If successful, the study could support future regulatory submissions globally and potentially pave the way for an expanded label for the drug.
Momelotinib was added to GSK’s oncology portfolio as a late-stage candidate through its acquisition of Sierra Oncology in 2022 for approximately $1.9 billion. Following the acquisition, GSK assumed responsibility for the drug's global development, regulatory filings and commercialization efforts.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $2.10. Over the same period, EPS estimates for 2027 have risen to $4.81 from $4.14. LQDA shares have gained 107.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 were unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 17.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
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GSK's Momelotinib Gets Orphan Tag for Rare Hemato-Inflammatory Disorder
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA and European Medicines Agency (EMA) have granted Orphan Drug Designation (ODD) to its JAK inhibitor, momelotinib, for treating VEXAS syndrome.
ODD is a special status granted by regulatory agencies to promote the development and review of medicines that may treat, prevent, or diagnose rare diseases.
GSK already markets momelotinib in the United States, European Union and some other countries by the name of Ojjaara/Omjjara (brand name outside the United States) for the treatment of myelofibrosis patients with anemia.
Year to date, GSK shares have risen 7.8% against the industry’s 3.9% decline.
Image Source: Zacks Investment Research
VEXAS syndrome is a rare, severe, progressive haemato-inflammatory disorder with a poor prognosis. The disease carries an estimated five-year mortality rate of 30-40% and no approved therapies are currently available for affected patients.
GSK’s ATLAS Study Advances Momelotinib in VEXAS Syndrome
The ODDs were supported by emerging clinical evidence and case reports indicating that momelotinib may improve disease-related symptoms, reduce inflammation and address hematologic abnormalities associated with VEXAS syndrome. Researchers believe that the drug's inhibition of JAK1 and JAK2 signaling pathways may help counter the excessive inflammatory activity that drives the disease.
GSK has initiated the phase II/III ATLAS study evaluating momelotinib in patients with VEXAS syndrome. If successful, the study could support future regulatory submissions globally and potentially pave the way for an expanded label for the drug.
Momelotinib was added to GSK’s oncology portfolio as a late-stage candidate through its acquisition of Sierra Oncology in 2022 for approximately $1.9 billion. Following the acquisition, GSK assumed responsibility for the drug's global development, regulatory filings and commercialization efforts.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $2.10. Over the same period, EPS estimates for 2027 have risen to $4.81 from $4.14. LQDA shares have gained 107.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 were unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 17.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.