Novartis waits for more data before filing pelabresib for myelofibrosis

Novartis unveiled its second-quarter financial results on Thursday, but hopes among investors for significant updates on the BET inhibitor pelabresib were dampened. The Swiss pharmaceutical giant, which acquired pelabresib through a €2.7 billion ($2.9 billion) acquisition of MorphoSys earlier this year, provided only a brief mention of potential delays in the myelofibrosis program. The acquisition had initially raised questions, especially given the mixed outcomes in the Phase III MANIFEST-2 study and recent, unverified concerns about potential safety risks. Despite these issues, Novartis has maintained confidence in pelabresib, initially indicating it would submit the treatment to the FDA in the latter half of the year.

In its quarterly financial report, Novartis described pelabresib as being in Phase III trials rather than advancing it to "in registration" status. The timeline for the "first planned submissions" remains unspecified. Speaking to the press, Chief Financial Officer Harry Kirsch remarked that the company is waiting for longer-term data on pelabresib expected in the upcoming months, making it premature to determine whether an FDA application will be submitted this year.

Ignoring the pelabresib uncertainties, Novartis demonstrated its continued strong performance, often referred to as "beat-and-raise" quarters. This time, only the core operating income outlook saw an enhancement. The company now anticipates its core operating income to grow by mid- to high-teen percentages, an upgrade from the earlier guidance of low-double digits to mid-teens growth. Annual sales are still projected to rise by high-single to low-double digits.

CEO Vas Narasimhan emphasized that the updated forecast "reflects continued strong momentum of our key growth drivers, both in the US and internationally," highlighting products such as Entresto, Kesimpta, and Leqvio.