Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

News
1

FDA has rejected it.

1 Like
2
1 Like
3
1 Like
4
1 Like
5

Looks like bad news for a penny stock. The company may not have funds for further trials.

2 Likes
6

The Minerva Neurosciences laboratory published this on its website (among other things).

‘‘The FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms. Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.’’

2 Likes
7

Roluperidone failed and Ulotaront failed. We have KarXT left, which will surely be approved, and we have to look at pimavanserin, which has its use for negative symptoms.

2 Likes
8

Ulotaront has additional trials unless all of those failed I wouldn’t call it fail

2 Likes