Yahoo Finance MorphoSys Up on Finishing Early Enrolment in Myelofibrosis Study
Shares of MorphoSys MOR increased 16.2% on Apr 5 after management announced that it has completed enrolment in the ongoing phase III MANIFEST-2 study evaluating pelabresib plus Jakafi (ruxolitinib) in myelofibrosis patients.
The enrolment in the MANIFEST-2 study was completed ahead of the company’s schedule. As a result of this early completion, top-line data that was expected next year is now expected by this year’s end. The stock is likely to have increased as investors cheered for the earlier-than-expected data availability.
In the year so far, shares of MorphoSys have risen 28.2% against the industry’s 5.5% fall.
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The MANIFEST-2 study will enroll patients with myelofibrosis who were previously treated with a JAK inhibitor. The study will randomly divide the study participants into two equal groups — one who will receive the combination of pelabresib and ruxolitinib and another group which will receive placebo plus ruxolitinib.
The primary endpoint of the MANIFEST-2 study is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24 (“SVR35”). Reduction in spleen size is an important clinical endpoint in myelofibrosis because spleen enlargement reflects disease activity and can cause significant pain and discomfort. Secondary endpoints include a proportion of patients achieving a 50% or greater improvement in total symptom score.
Myelofibrosis is a form of blood cancer that has limited treatment options. Currently, treatments with JAK inhibitors are the standard of care for treating symptoms of myelofibrosis rather than acting as a cure.
Management believes that combining a JAK inhibitor like Jakafi and a BET inhibitor like pelabresib suggests synergistic benefits. The initiation of the MANIFEST-2 study is based on positive data from the phase II MANIFEST study, which evaluated this combination in myelofibrosis patients. Data from the study showed that treatment with pelabresib plus Jakafi provided prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks.
Jakafi is marketed by Incyte INCY, which is approved by the FDA to treat patients with polycythemia vera (“PV”), who have had an inadequate response to or are intolerant to hydroxyurea. The drug is marketed by Incyte in partnership with Novartis.
Apart from the MANIFEST-2 study, management also announced that the phase III frontMIND study has also completed enrolment. This study is evaluating tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in first-line diffuse large B-cell lymphoma (DLBCL). The top-line data from this study is expected in second-half 2025.
Tafasitamab is marketed by MorphoSys in partnership with Incyte under the trade Monjuvi. The drug was approved by the FDA in 2020 in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. While Incyte and MorphoSys co-commercialize Monjuvi in the United States, Incyte is solely responsible for marketing the drug outside the country under the brand name Minjuvi.
MorphoSys AG Unsponsored ADR Price
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Zacks Rank & Other Stock to Consider
MorphoSys currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Certara CERT and CRISPR Therapeutics CRSP. While Certara sports a Zacks Rank #1 (Strong Buy), CRISPR Therapeutics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 42.4% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.
In the past 60 days, estimates for CRISPR Therapeutics’ 2023 loss per share have narrowed from $8.21 to $7.35. Shares of CRISPR Therapeutics have risen 10.2% in the year-to-date period.
Earnings of CRISPR Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 3.19%, on average. In the last reported quarter, CRISPR Therapeutics’ earnings beat estimates by 39.22%.
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