financetom
Business
financetom
/
Business
/
US FDA expands use of J&J's Caplyta as add-on depression drug
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
US FDA expands use of J&J's Caplyta as add-on depression drug
Nov 6, 2025 4:54 AM

Nov 6 (Reuters) - The U.S. Food and Drug Administration

has approved the expanded use of Johnson & Johnson's ( JNJ )

drug Caplyta as an add-on treatment for adults with major

depressive disorder, the company said on Thursday.

J&J gained access to Caplyta with its $14.6 billion

acquisition of neurological drugmaker Intra-Cellular Therapies

in January. The FDA's decision marks the first approval for a

drug from the Intra-Cellular stable after the deal.

Caplyta can now be used as an adjunctive therapy for

patients with depression in combination with oral

antidepressants.

Major depressive disorder, or clinical depression, is one of

the most common psychiatric disorders, affecting about 22

million American adults, according to the company.

Caplyta is already approved in the U.S. to treat

schizophrenia and depressive episodes associated with bipolar

disorder.

The expanded approval was based on data from two late-stage

studies in which the drug showed significant improvement in

depression symptoms compared to an oral antidepressant plus

placebo.

Caplyta is an oral, once-daily atypical antipsychotic whose

mechanism of action is currently unknown.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
AIM ImmunoTech Gets NYSE American Notice of Noncompliance
AIM ImmunoTech Gets NYSE American Notice of Noncompliance
Jun 20, 2025
04:32 PM EDT, 06/20/2025 (MT Newswires) -- AIM ImmunoTech ( AIM ) said Friday it has received a notification from NYSE American stating that the company is not in compliance with the stock exchange's minimum stockholders' equity requirements. NYSE American had issued a warning on Dec. 17, 2024, for the same reasons and has issued the latest letter because the...
Auddia Files $150 Million Mixed Shelf
Auddia Files $150 Million Mixed Shelf
Jun 20, 2025
04:32 PM EDT, 06/20/2025 (MT Newswires) -- Auddia ( AUUD ) filed a registration statement Friday for the sale of $150 million of securities from time to time in one or more offerings. The securities cover common and preferred stock, warrants, debt securities, units, and subscription rights. ...
Google agrees $36 million fine for anti-competitive deals with Australia telcos
Google agrees $36 million fine for anti-competitive deals with Australia telcos
Aug 17, 2025
SYDNEY, Aug 18 (Reuters) - Google agreed on Monday to pay a A$55 million ($35.8 million) fine in Australia after the consumer watchdog found it had hurt competition by paying the country's two largest telcos to pre-install its search application on Android phones, excluding rival search engines. The fine extends a bumpy period for the Alphabet-owned internet giant in Australia,...
Roblox Insider Sold Shares Worth $63,249,257, According to a Recent SEC Filing
Roblox Insider Sold Shares Worth $63,249,257, According to a Recent SEC Filing
Jun 20, 2025
04:33 PM EDT, 06/20/2025 (MT Newswires) -- David Baszucki, 10% Owner, Director, President & CEO, on June 17, 2025, sold 628,674 shares in Roblox ( RBLX ) for $63,249,257. Following the Form 4 filing with the SEC, Baszucki has control over a total of 226,044 Class A common shares of the company, with 211,559 shares held directly and 14,485 controlled...
Copyright 2023-2026 - www.financetom.com All Rights Reserved