FDA Greenlights Expanded Use Of Neurocrine Biosciences' Ingrezza: Analysts Weigh In Depression Warning

The FDA approved Neurocrine Biosciences Inc's NBIX Ingrezza (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).

Ingrezza is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient's healthcare provider based on response and tolerability, with no complex titration.

Only Ingrezza offers simple dosing that is always one capsule, once daily.

The FDA approval is supported by data from two clinical studies in collaboration with the Huntington Study Group, including the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial.

Related: Confidence Boost From Ingrezza Sales: Analyst Upgrades Neurocrine Biosciences.

William Blair analysts Myles Minter, Sarah Schram, and Tiffany Marchell said the most notable was the inclusion of the VMAT inhibitor classwide black box warning for depression and suicidality in HD. 

Management has previously commented that it did not see any increased risk of suicidality and that the active metabolic profile of valbenazine differs from peer molecules, but other VMAT2 inhibitors have received the same label, and chorea patients receiving Ingrezza did show a slight imbalance in depression incidence relative to placebo (4.7% vs. 1.6%). 

Overall the analysts anticipated that Ingrezza would be given a classwide warning. William Blair writes that the prescribing community is well aware of this warning and won't hinder its adoption for HD chorea or its approved use for tardive dyskinesia.

After excluding approximately 20% of patients deemed unsuitable due to suicidality, we calculate a potential patient pool of around 23,000. With a projected peak reach of 30%, revenue by 2030 could surpass $500 million from HD chorea alone. 

Still, William Blair anticipates a gradual introduction of Ingrezza to this group, with its presence increasing over the upcoming months and 2024 marked as a major growth year.

HC Wainwright raised the price target from $140 to $146. The analyst Andrew Fein notes that despite Ingrezza having a black box warning related to depression, it isn't deemed unsuitable for patients displaying suicidal tendencies, those with untreated depression (a condition prevalent among HD patients), or those on medications like monoamine oxidase inhibitors, reserpine, or tetrabenazine. 

This could lead to quicker adoption of Ingrezza among the HD chorea patient group, even more so than Teva Pharmaceutical Industries Limited's TEVA Austedo XR.

Price Action: NBIX shares are up 1.49% at $108.55 on the last check Monday.