Pfizer Receives FDA Approval for CIBINQO

Pharmaceutical and biotechnology corporation Pfizer Inc. (NYSE:PFE) recently revealed that it has received approval from the U.S. Food and Drug Administration (FDA) for its oral, once-daily, Janus kinase 1 (JAK1) inhibitor, CIBINQO, to treat adults with moderate-to-severe atopic dermatitis (AD).

Following the news, shares of the company declined 1.1% on Friday. The stock pared its losses slightly to close at $55 in the extended trading session.

Safety & Efficacy

The approval was based on results from a large-scale clinical trial program of more than 1,600 patients, with the safety and efficacy of CIBINQO evaluated in three randomized, placebo-controlled, Phase 3 trials.

During the trials, CIBINQO displayed a consistent safety profile as well as profound improvements in itch after two weeks.

CIBINQO is approved at the recommended doses of 100 mg and 200 mg. The 200 mg dose is being recommended for the patients who are unresponsive to the 100 mg dose.

Management Commentary

The Global President of Pfizer Inflammation & Immunology, Mike Gladstone, said, “The FDA’s approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled. CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials.”

Analyst‘s Rating

Recently, BMO Capital analyst Evan Seigerman reiterated a Buy rating on the stock. The analyst, however, raised the price target from $60 to $76, which implies upside potential of 38.3% from current levels.

According to the analyst, Paxlovid sales is expected to give the company a shot-in-the-arm. The analyst expects Paxlovid to generate sales of about $30 billion during the year.

The Wall Street community is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 8 Buys and 10 Holds. The average Pfizer stock prediction of $59.24 implies that the stock has upside potential of 7.8% from current levels. Shares have gained about 49.6% over the past year.

Increased Hedge Fund Trading

TipRanks’ Hedge Fund Trading Activity tool shows that the confidence in Pfizer is currently Very Positive, as some of the top hedge funds that were active in the last quarter increased their cumulative holdings by 4.4 million shares.

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