Janssen Submits Biologics License Application for Teclistamab

Janssen, a Johnson & Johnson (NYSE: JNJ) company, announced that it submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for teclistamab. 

Teclistamab is an investigational antibody designed to treat patients with relapsed or refractory (R/R) multiple myeloma, an incurable blood cancer. It has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. 

According to the company, the BLA submission is supported by data from the MajesTEC-1 clinical trial, evaluating the safety and efficacy of teclistamab in adults with R/R multiple myeloma. 

Other approvals  

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation in Europe.

Official Comments 

Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, commented, “The deep expertise, creativity and persistence of the entire Janssen R&D organization enabled the expeditious advancement of teclistamab for multiple myeloma. Today’s submission is another important step in our commitment to bring to patients truly transformational medicines that profoundly impact their health.” 

Wall Street’s Take 

Recently, Goldman Sachs analyst Chris Shibutani initiated coverage of Johnson & Johnson with a Hold rating and a price target of $161 (6.15% downside potential).  

Consensus among analysts is a Strong Buy based on 6 Buys versus 1 Hold. The average Johnson & Johnson price target of $189.83 implies 10.66% upside potential from current levels. Shares have gained 9.9% over the past year. 

Hedge Fund 

TipRanks’ Hedge Fund Trading Activity tool shows that confidence in Johnson & Johnson is currently Very Positive, as the cumulative change in holdings across all 27 hedge funds that were active in the last quarter was an increase of 757,500 shares.

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