Novartis Faces a Pivotal Week as FDA Nod and Earnings Loom

Novartis reports Q2 earnings on July 21 after FDA full approval for Fabhalta, acquisition of Myricx Bio, and digital RLT network; analysts expect EPS of $2.16 after Q1 miss.

The Swiss pharma giant heads into its second-quarter earnings report on Tuesday with momentum from a regulatory win and a freshly completed acquisition, but also with the burden of proving that a lacklustre start to the year was an anomaly. Novartis shares closed at €135.06 on Friday, up 1.5% after the US Food and Drug Administration converted the accelerated approval of Fabhalta (iptacopan) into a full, regular authorisation for the treatment of IgA nephropathy.

The decision, announced on 19 July 2026, marks a significant milestone for Novartis’s renal pipeline. IgA nephropathy is a chronic kidney disease in which deposits of immunoglobulin A gradually damage kidney tissue and impair organ function. Fabhalta – the first oral complement inhibitor in its class – had secured an accelerated green light in August 2024, but the latest FDA action gives it full regulatory status. The conversion rests on data from the phase-III APPLAUSE-IgAN study, which showed that the drug slowed kidney function loss significantly: the estimated glomerular filtration rate declined by an average 3.0?ml/min/1.73?m² per year over two years, compared with 5.7?units in the placebo arm. The most common side effects reported were abdominal pain, dizziness and nausea, and a REMS safety programme is in place, as is standard for complement inhibitors. Novartis is building a renal disease franchise around Fabhalta, Vanrafia (atrasentan) and the investigational agent Zigakibart.

Alongside the regulatory progress, Novartis has closed its acquisition of the British biotech Myricx Bio, expanding its stable of antibody-drug conjugates (ADCs) for oncology. ADCs are designed to deliver chemotherapy more precisely to tumour cells, and the deal slots into a broader push to strengthen the company’s cancer portfolio. In Germany, the group also launched a digital network for radioligand therapy in partnership with Klinikum Bayreuth and myon.clinic, aiming to improve care for cancer patients – a field where Novartis already claims a leading position with its radioligand platform. On the personnel front, Tatjana Dreyer has taken over as Head of Communications & Patient Advocacy for Novartis Germany.

All of this sets the stage for the financial results due on 21 July. The first quarter of 2026 was a disappointment: revenue slipped to 10.28?billion Swiss francs from 11.90?billion a year earlier, earnings per share came in at 1.29 francs (or $1.99, missing the consensus estimate of $2.07 by 3.86%). The profit per share of $1.99 compared unfavourably with $2.28 in the year-ago quarter. For the second quarter, analysts are pencilling in EPS of $2.16. Novartis has guided for low single-digit percentage revenue growth for the full year, a target that the management team must now underpin with tangible half-year numbers.

There is some positive clinical news to point to as well. At the EHA congress in June, the company presented long-term phase-III data from the ASC4FIRST trial, confirming a sustained benefit-risk profile for the leukaemia drug Scemblix in newly diagnosed chronic myeloid leukaemia – a result that could bolster its competitive position.

After Friday’s close, the stock sits 6.4% below its 52-week high of €144.30 reached in late February, but has climbed 14.28% since the start of the year and 36.8% over the past twelve months. The 52-week low of €97.06 recorded last August is now comfortably in the rear-view mirror. With a market capitalisation of approximately €254.44 billion and a relative strength index of 53.4 – squarely in neutral territory – the shares offer little directional signal ahead of the earnings release. Investors will be watching closely to see whether the Q1 revenue decline was a temporary setback or the beginning of a trend, and whether the full approval of Fabhalta can provide a fresh catalyst for the broader renal franchise.