Pfizer Receives EC Approval for Cibinqo

Pfizer, Inc. (PFE) has bagged the European Commission’s (EC) approval for 100 mg and 200 mg doses of Cibinqo (abrocitinib). Cibinqo is a once-daily oral Janus kinase 1 (JAK1) treatment for adults with moderate-to-severe atopic dermatitis (AD), a chronic inflammatory skin disease. These patients include individuals who are candidates for systemic therapy.

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Additionally, the regulator approved a 50 mg dose for the treatment of moderate-to-severe AD, particularly in patients with moderate and severe renal impairment (kidney failure), as well as in patients undergoing treatment with cytochrome P450 (CYP) 2C19 inhibitors.

Approximately 5-10% of adults in Europe and up to 10% worldwide are affected by AD, with 1 in 3 adults suffering from moderate-to-severe symptoms.

Clinical Trial Update

The regulator’s approval followed the results from five clinical studies of more than 2,800 patients. These included four Phase 3 studies and an ongoing long-term open-label extension study. With a consistent safety profile across trials, Cibinqo showed significant improvements in symptom relief and disease control versus placebo.

Approvals

Earlier this year, Cibinqo had been authorized for marketing by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the Japanese Ministry of Health, Labour and Welfare (MHLW), and Korea’s Ministry of Food and Drug Safety (MFDS).

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Official Comments

Global President of Pfizer Inflammation & Immunology, Mike Gladstone, said, “There have been few treatment innovations over the last decade for those in the European Union suffering with the daily discomfort, distress, and pain caused by moderate-to-severe atopic dermatitis. The safety and efficacy established through a rigorous clinical trial program, designed to evaluate measures of symptom relief most important to patients, gives us great confidence in the positive impact Cibinqo could have on those living with this debilitating immuno-inflammatory condition.” (See Pfizer stock charts on TipRanks)

Analysts Recommendation

On December 10, Barclays analyst Carter Gould maintained a Hold rating on the stock but lifted the price target to $54 (2.31% upside potential) from $44.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 6 Buys and 9 Holds. The average Pfizer price target of $53.17 implies that shares are fully valued at current levels. Shares have gained 34.6% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 25%, 25%, and 17%, respectively to the total 24 risks identified for the stock.