FDA Approves Johnson & Johnson IV Drug

Janssen, a Johnson & Johnson (JNJ) company, announced that the U.S. Food and Drug Administration (FDA) has approved its UPTRAVI (selexipag) injection for intravenous (IV) use in adults. The injection is designed to treat pulmonary arterial hypertension (PAH, WHO Group I) in patients with WHO functional class (FC) II–III, who are temporarily incapable of taking oral therapy.

Janssen said that the approval followed data from the prospective, multi-center, open-label single sequence cross-over Phase 3 study, which was designed to assess the safety, tolerability and pharmacokinetics of temporarily switching between UPTRAVI tablets and UPTRAVI IV. Notably, in 2015, the FDA approved UPTRAVI tablets for the first time to delay disease progression and reduce the risk of hospitalization for PAH, which indicates high blood pressure in the arteries of lungs.

Janssen’s Global Therapeutic Area Head Neil Davie said, “Today marks an important day for patients who rely on UPTRAVI, as this new intravenous formulation meets a current unmet need for these patients. As part of our commitment to investing in research and understanding the science around the potential of UPTRAVI, we’re inspired by this approval and are proud to be paving the way to advance treatment options and care for patients with PAH.” (See Johnson & Johnson stock charts on TipRanks)

On July 22, Argus Research analyst David Toung reiterated a Buy rating and increased the price target to $190 (10.3% upside potential) from $180.

Earlier last month, Cantor Fitzgerald analyst Louise Chen maintained a Buy rating on and a price target of $200 (16.1% upside potential) following the company’s “positive” new data for its single-shot COVID-19 vaccine.

Chen said that the vaccine reflected “strong” neutralizing antibody activity against the Delta variant and other variants. Additionally, people who took the vaccine showed continual immune responses through at least eight months.

The analyst believes that newly announced data indicates that Johnson & Johnson’s innovation has been underappreciated.

The consensus rating among analysts is a Strong Buy, based on 7 Buys versus 1 Hold. The average Johnson & Johnson price target stands at $190.86 and implies upside potential of 10.8% to current levels. Shares have gained 16.9% over the past year.

Investors should always be aware of the risks involved in any stock. According to the new TipRanks’ Risk Factors tool, the JNJ stock is at risk mainly from two factors: Legal and Regulatory, and Production, which contribute 29% and 24%, respectively, to the total risk for the stock. Within the Legal and Regulatory risk category, Johnson & Johnson has 5 risks.