Bristol Myers (BMY) Gets Approval of Psoriasis Drug in EU

Bristol Myers Squibb BMY announced that the European Commission approved Sotyktu (deucravacitinib) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor.  The approval was based on results from the phase III POETYK PSO-1 and POETYK PSO-2 clinical studies, demonstrating superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Amgen’s AMGN Otezla (apremilast) at both 16 and 24 weeks with responses maintained through 52 weeks.

In addition, positive data from the long-term extension study, POETYK PSO (LTE), also supported approval. The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment.

In September 2022, the FDA also approved Sotyktu for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Bristol Myers added deucravacitinib to its pipeline when it acquired Celgene in 2019 and had to let go of Otezla. In connection with the regulatory approval process for the transaction, Celgene sold the global rights to Otezla to Amgen.

While the psoriasis market has potential, competition stiffens here from other bigwigs with established market shares.

Shares of Bristol Myers have lost 6.7% in the past year compared with the industry’s decline of 16.5%.

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The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in top line as one of Bristol Myers’ top drugs, Revlimid, is now facing generic competition, which is affecting the top line and threatens to erode sales rapidly.


The FDA had earlier approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo (nivolumab) and relatlimab (novel LAG-3-blocking antibody). It is administered as a single intravenous infusion to treat adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma (a kind of skin cancer) under the brand name Opdualag. The uptake of the drug has been encouraging so far.

Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) was approved in the United States for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

The European Commission recently granted full Marketing Authorization for Reblozyl (luspatercept) for treatment in adult patients of anemia associated with non-transfusion dependent (NTD) beta thalassemia.

Earlier this month, BMY in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson announced the launch of the phase III Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic). Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the overall healthcare sector are Novo Nordisk NVO and Ligand Therapeutics LGND, both sporting a Zacks Rank #1 at present.

In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43. Estimates for 2024 have increased 29 cents to $5.19.

Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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