Pfizer Receives Approval for LORVIQUA; Shares Rise 2%

Pharmaceutical and biotechnology major Pfizer Inc. (NYSE: PFE) recently revealed that it has received marketing authorization from the European Commission for LORVIQUA as monotherapy for the treatment of adults with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC).

Following the news, shares of the company gained more than 2% to close at $54.50 in Friday’s extended trading session.

The approval was based on the results of the company’s Phase 3 CROWN trial in which LORVIQUA reduced the risk of death by 72% compared to XALKORI.

The CROWN trial is a randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive LORVIQUA monotherapy or XALKORI monotherapy.

Notably, the confirmed objective response rate was 76% with LORVIQUA and 58% with XALKORI. Moreover, in patients with measurable brain metastases, 82% of patients in the LORVIQUA arm experienced an intracranial response, while this figure stood at 23% for XALKORI patients. 

Management Commentary

The President of Pfizer Oncology, Andy Schmeltz, said, “The European Commission’s approval of LORVIQUA as a first-line therapy is a significant milestone that we hope will help bring a needed and meaningful difference to those impacted by this deadly disease in Europe.”

Stock Rating

Recently, J.P. Morgan analyst Chris Schott reiterated a Hold rating on the stock. The analyst, however, raised the price target from $53 to $57, which implies upside potential of 4.9% from current levels.

According to the analyst, Pfizer’s covid offerings is likely to aid growth for the company in the near term.

Consensus among analysts is a Moderate Buy based on 9 Buys and 10 Holds. The average Pfizer stock prediction of $60.06 implies upside potential of 10.5% from current levels. Shares have gained 51.8% over the past year.

Increased Hedge Fund Trading

TipRanks’ Hedge Fund Trading Activity tool shows that 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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