This week, the FDA approved J&J’s JNJ Tremfya for its second inflammatory bowel disease (“IBD”) condition, Crohn’s disease (“CD”), and Novartis’ NVS Fabhalta for its third indication, C3 glomerulopathy (C3G). Pfizer PFE sold its remaining 7.3% stake in Haleon, thus fully exiting the consumer health company. Sanofi SNY and AstraZeneca AZN announced small acquisition deals.
Here's a recap of the week’s most important stories.
Pfizer Divests Remaining Stake in Haleon
Pfizer divested 7.3% remaining stake in Haleon, or approximately 662 million shares, to institutional investors and Haleon itself for £3.85 per ordinary share (around £2.5 billion). Pfizer sold 618 million ordinary shares of HLN to institutional investors worth around $3.1 billion (around £2.4 billion). Per a previous share buyback plan, Pfizer sold around 44.14 million shares worth approximately $220 million (£170 million) directly to Haleon.
Haleon was a consumer health joint venture jointly created by Pfizer and GSK in 2019. GSK owned a controlling stake of 68% in the Consumer Healthcare JV (CHC JV). GSK/Pfizer divested the CHC JV to form Haleon in July 2022. GSK, which initially owned a nearly 13% stake in Haleon, sold its entire stake in May 2024. Pfizer originally held a 32% stake in Haleon, which it had started gradually reducing since 2022.
FDA Approves J&J’s Tremfya for Crohn’s Disease
The FDA approved J&J’s IL-23 inhibitor Tremfya for its second IBD condition — moderately to severely active CD for both subcutaneous (SC) and intravenous (IV) induction regimens. The approval for the CD indication was based on data from the phase III GALAXI and GRAVITI studies, which demonstrated the robust efficacy of SC or IV Tremfya in achieving clinical and endoscopic endpoints.
Tremfya was approved for its first IBD condition, moderately to severely active ulcerative colitis (“UC”), in September 2024. It is already approved to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. CD marks the fourth indication for Tremfya in the United States. Tremfya is under review in the EU for both UC and CD indications.
J&J announced that the FDA has granted Fast Track designation to its key pipeline candidate, nipocalimab, for treating moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody disease with no approved advanced therapies.
Earlier, the FDA had granted Breakthrough Therapy Designation to nipocalimab for SjD in November 2024. In February this year, J&J had announced positive top-line data from a phase II study in SjD. Nipocalimab met the primary endpoint of the phase II DAHLIAS dose-ranging study in SjD. J&J is now enrolling patients in the phase III DAFFODIL study
Nipocalimab is in mid- and late-stage development for several rare autoantibody-driven rare diseases.
FDA Approves NVS’ Fabhalta for Rare Kidney Disease
The FDA approved Novartis’ Fabhalta for the treatment of adults with C3G, an ultra-rare, progressive kidney disease. The approval for the C3G indication was based on robust data from the APPEAR-C3G study. With the approval, Fabhalta, an oral alternative complement pathway inhibitor, became the first and the only drug approved to treat the underlying cause of C3G. Similar applications seeking approval of Fabhalta for C3G are under review in the EU, China and Japan. The drug is already approved for treating paroxysmal nocturnal hemoglobinuria and for reducing the risk of rapid disease progression in proteinuria adults with primary IgA nephropathy.
Novartis is evaluating Fabhalta in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis and lupus nephritis.
AZN to Acquire EsoBiotec; EU Nod for Imfinzi Expanded Use
AstraZeneca announced a definitive agreement to acquire Belgium-based, EsoBiotec, a leading vivo cell therapy company for a total consideration of up to $1 billion in cash and on a debt-free basis. The acquisition will integrate EsoBiotec’s proprietary ENaBL platform, used to develop transformative cell therapy treatments, which can be delivered in just minutes, in contrast to traditional cell therapies that take weeks. The transaction is expected to be closed in the second quarter of 2025.
AstraZeneca is in-licensing worldwide rights to Alteogen’s novel hyaluronidase enzyme, ALT-B4, for developing subcutaneous formulations of multiple oncology assets. ALT-B4 has been developed utilizing the Hybrozyme platform technology. For the deal, AstraZeneca will make an undisclosed upfront payment to Alteogen, with the latter also being entitled to development, regulatory and sales-related milestone payments.
The European Commission granted approval for the expanded use of AstraZeneca’s blockbuster drug, Imfinzi, as a monotherapy for the treatment of adults with limited-stage small cell lung cancer in patients whose disease has not progressed following platinum-based chemoradiation therapy. This approval was based on data from the phase III ADRIATIC study. The FDA approved Imfinzi for a similar indication in December 2024.
AstraZeneca’s pipeline candidate, eneboparatide, met its primary endpoint of normalizing serum calcium levels at 24 weeks, with statistical significance, in the phase III CALYPSO study. The study evaluated eneboparatide in adults with chronic hypoparathyroidism, a rare endocrine disease. Eneboparatide was added to AstraZeneca’s pipeline following the acquisition of Amolyt Pharma last year. The study will continue for 52 weeks to further characterize the risk-benefit profile, after which the data will be shared with global health authorities.
SNY’s New Acquisition to Strengthen Immunology Pipeline
Sanofi is acquiring private biotech, Dren Bio’s targeted bispecific myeloid cell engager (MCE), DR-0201 for an upfront payment of $600 million. In clinical studies, DR-0201 has shown robust B-cell depletion. B-Cell depletion is believed to have the potential to reset the adaptive immune system, which can be a game changer for treating autoimmune diseases, particularly for patients refractory to existing treatments. DR-0201 is being evaluated in two phase I studies. In addition to the upfront payment, Dren Bio will also be entitled to potential milestone payments of up to $1.3 billion. The transaction is expected to be closed in the second quarter of 2025.
Pfizer, Novartis, Sanofi and J&J carry a Zacks Rank #3 (Hold) each, while AstraZeneca is a #4 Ranked (Sell) stock.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NYSE ARCA Pharmaceutical Index has risen 2.09% in the past five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the previous five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
In the last five trading sessions, Lilly rose the most (5.1%) while JNJ, MRK and AZN were flat.
In the past six months, AbbVie rose the most (9.4%), while Novo Nordisk declined the most (36.3%).
(See the last pharma stock roundup here: RHHBY Obesity Drug Rights Buyout, NVO Pipeline Update)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
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