Janssen Pharmaceuticals, the wholly-owned subsidiary of Johnson & Johnson (JNJ), has bagged the U.S. Food and Drug Administration’s (FDA) approval for INVEGA HAFYERA, an injectable drug to treat schizophrenia in adults.
“The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries,” the company said.
The study reflected that after 12 months about 92.5% of patients treated with INVEGA HAFYERA and 95% treated with INVEGA TRINZA did not face any recurrence of symptoms. J&J also said that there were no safety-related issues with the trial.
However, during the clinical trials of INVEGA HAFYERA, some adverse reactions faced were respiratory tract infection, injection site reaction, weight increase, headache and parkinsonism. (See J&J stock charts on TipRanks)
The Medical Director at ATP Clinical Research and six-month paliperidone palmitate clinical trial investigator, Gustavo Alva (M.D., DFAPA), said, “The Phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”
“This approval further underscores our steadfast commitment to addressing critical unmet needs, including treatment adherence concerns, faced by adults living with schizophrenia,” said the Global Head of Janssen Research & Development, Mathai Mammen (M.D., Ph.D).
On August 20, Morgan Stanley analyst Matthew Harrison maintained a Buy rating on the stock with a price target of $187 (7.6% upside potential from current level).
Harrison is of the opinion that J&J has performed well this year across all its business segments as it continues to recover from the pandemic.
The rest of the Street is optimistic about the stock with a Strong Buy consensus rating based on 6 Buys and 1 Hold. The average J&J price target of $190.50 implies 9.7% upside potential to current levels.
Furthermore, J&J scores a “Perfect 10” from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.