Novartis Delays Submission of Myelofibrosis Drug Pelabresib Amid Data Concerns
核心洞察
Novartis has increased its full-year operating profit growth forecast due to strong sales of key drugs.
The submission of pelabresib, an experimental drug for myelofibrosis (搜索) acquired from MorphoSys, will be delayed by a couple of years.
Ongoing questions regarding the drug's data profile are the reason for the delay, pushing back the original plan for submission this year.
Novartis has revised its earnings guidance upwards for the third time this year, citing robust sales performance of its leading pharmaceutical products. The company now projects full-year operating profit to grow by a percentage in the high teens, an increase from the previously forecasted mid- to high teens.
However, in a separate announcement, Novartis CEO Vas Narasimhan communicated that the regulatory submission of pelabresib, an experimental drug intended for the treatment of a rare bone marrow cancer known as myelofibrosis (搜索), will be delayed. The delay extends to "a couple more years" before the company can file with regulatory bodies. Pelabresib was a centerpiece of Novartis's nearly $3 billion acquisition of MorphoSys.
Originally, Novartis aimed to submit the drug for approval this year. The decision to postpone the submission is attributed to unresolved questions surrounding the drug's data profile. Further investigations and analyses are underway to address these concerns and ensure a robust and approvable data package.