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Bristol Myers (BMY) Gets FDA Approval for Psoriasis Candidate

·3 min read

Bristol Myers BMY announced that the FDA approved its experimental candidate deucravacitinib to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, was approved under the brand name Sotyktu for the said indication.

The approval is based on results from the phase III POETYK PSO-1 and POETYK PSO-2 studies, demonstrating superior efficacy of once-daily Sotyktu over placebo and twice-daily Amgen’s AMGN Otezla (apremilast) in 1,684 patients, aged 18 years and above, with moderate-to-severe plaque psoriasis.

Sotyktu demonstrated superior efficacy compared to placebo and Otezla at both 16 and 24 weeks and persisted through 52 weeks.

Psoriasis, a chronic, systemic immune-mediated disease, is widely prevalent and the approval will significantly boost Bristol Myers.

Sotyktu is also under regulatory review of the European Medical Association and other health authorities around the world.

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 gained 12.5% in the year so far against the industry’s decline of 20.9%.

 

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The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters. This is understandable 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 initial 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.

However, results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian, announced last month, were disappointing. The candidate is being developed to prevent new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel, following an acute ischemic stroke or transient ischemic attack.

Bristol Myers currently carries a Zacks Rank #3 (Hold).  A few better-ranked stocks in the sector are Bolt Pharmaceuticals BOLT and Dynavax DVAX, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters and missed in the remaining one, the average beat being 2.39%.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters and missed in the remaining two, the average beat being 70.57%.


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