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FDA extends review period for Praxis' relutrigine NDA to Dec 27, 2026, no new studies requested.

Market News
29 Jun 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

Praxis Precision Medicines announced that the FDA has extended the review period for its New Drug Application (NDA) for relutrigine, a treatment for SCN2A and SCN8A developmental and epileptic encephalopathies, by three months to December 27, 2026. This extension follows the submission of additional sensitivity analyses, classified as a major amendment by the FDA, allowing more time for review. No new clinical studies were requested, and no safety or manufacturing concerns were cited. Praxis remains confident in the application and is preparing to bring relutrigine to patients with significant unmet needs.

More News

Plum Acquisition Corp. IV postpones shareholder meeting to July 10, extends redemption request deadline.

Plum Acquisition Corp. IV postpones shareholder meeting to July 10, extends redemption request deadline.

Plum Acquisition Corp. IV has postponed its extraordinary general meeting of shareholders from July 2 to July 10, 2026, to allow more time for shareholder engagement. Consequently, the deadline for shareholders to submit redemption requests has been ...

Company Fundamentals
Neutral
1 hour ago
Supreme Court rules government geofence data collection is a Fourth Amendment search.

Supreme Court rules government geofence data collection is a Fourth Amendment search.

The U.S. Supreme Court ruled in Chatrie v. U.S. that government collection of location data via geofence warrants constitutes a search under the Fourth Amendment. This decision overturns a lower court ruling and requires further review of whether the...

Market News
Neutral
2 hours ago
DBV Technologies plans BLA submission for VIASKIN® Peanut patch in kids 4-7 after FDA collaboration.

DBV Technologies plans BLA submission for VIASKIN® Peanut patch in kids 4-7 after FDA collaboration.

DBV Technologies is preparing to submit a Biologics License Application (BLA) for its VIASKIN® Peanut patch aimed at children aged 4 to 7 years. The company has engaged in detailed discussions with the FDA to ensure a thorough and efficient review pr...

Market News
Bullish
3 hours ago
Bron and Noah partner to simplify stablecoin access for self-custody wallets worldwide.

Bron and Noah partner to simplify stablecoin access for self-custody wallets worldwide.

Bron, a self-custody crypto wallet provider, has partnered with Noah, a global stablecoin payments infrastructure company, to enable seamless on- and off-ramp access for stablecoins. This integration allows Bron users to easily fund and withdraw from...

Others
Bullish
3 hours ago
Institutions reduce Bitcoin and Ethereum ETF holdings but increase XRP and HYPE investments.

Institutions reduce Bitcoin and Ethereum ETF holdings but increase XRP and HYPE investments.

Institutional investors have decreased their exposure to Bitcoin and Ethereum ETFs, signaling a shift in their cryptocurrency investment strategies. Despite this reduction, they continue to increase their investments in XRP and HYPE wrappers, which a...

Market News
Neutral
4 hours ago
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