Johnson & Johnson’s Janssen Receives FDA Approval For PONVORY Therapy; Street Sees Over 19% Upside


Janssen, a Johnson & Johnson (JNJ) company, announced that the US Food and Drug Administration (FDA) has approved its PONVORY (ponesimod) therapy as a first-of-its-kind oral treatment for adults. It is designed to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Janssen said that the approval followed clinical trials, which showed PONVORY’s significant efficacy in reducing annual relapses by 30.5%, compared to teriflunomide (Aubagio) 14 mg in patients with relapsing MS.

PONVORY, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, also prevented disability from worsening for most people. The US regulator’s decision was supported by more than 10 years of cumulative data, which demonstrated the treatment’s efficacy, safety, and favorable tolerability profile.

Janssen R&D Global Head Mathai Mammen said, “Every person with multiple sclerosis is affected differently, given variability in both the underlying disease and emerging symptoms. Continued innovation in this space is critical, and we’re committed to meeting patients’ evolving healthcare needs.”

“We are proud to offer PONVORY as a valuable new option for people with MS that may help them gain better control of their disease,” Mammen added. (See Johnson & Johnson stock analysis on TipRanks)

On March 18, Credit Suisse analyst Matt Miksic reiterated a Buy rating and a price target of $193 (20.6% upside potential) on the stock, following the updated intra-quarter analysis of 1Q script data trends, which suggests Johnson & Johnson’s largest U.S. Pharma franchises are rising at strong levels (up 13-14%), but below the 1Q estimate of 17%.

Miksic stated, “Compared to our previous analysis, trends in Stelara, Tremfya and Xarelto (up 22%, 13% and down 2%) have fallen further behind our estimates (up 27%, 31% and 6%), while Imbruvica (up 4%), is closing the gap to our Q1 projection (up 12%). Prezista/Symtuza and Uptravi continue to trail our estimates, partially offset by continued strength in Darzalex, Erleada and Opsumit.”

The consensus rating among analysts is a Strong Buy based on 9 Buys versus 1 Hold. The average analyst price target stands at $191.22 and implies upside potential of 19.5% to current levels over the next 12 months. Shares have gained 44% over the past year.

On top of this, Johnson & Johnson scores a “Perfect 10” from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.

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