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Regulatory

BHC

Bausch Health has filed a patent infringement lawsuit against Norwich Pharmaceuticals in the U.S. District Court for the District of New Jersey. The lawsuit is in response to Norwich's ANDA submission to the FDA for a generic version of XIFAXAN® (rifaximin) 550 mg tablets, used to treat IBS-D.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 9:31 pm

SRPT

Trading halt status for SRPT was updated at 5:30 PM ET. The news and resumption times have been provided.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 9:30 pm

OKLO

Oklo has provided an update on its recent Form S-1 filing, stating that management and AltC sponsor shares remain subject to long-term lock-up agreements.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 9:29 pm

SRPT

Sarepta Therapeutics has received expanded FDA approval for its drug ELEVIDYS to treat Duchenne Muscular Dystrophy (DMD) in patients aged 4 and above. The FDA granted traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients, with continued approval contingent on a confirmatory trial. ELEVIDYS is contraindicated for patients with deletions in exon 8 and/or exon 9 in the DMD gene.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 9:04 pm

SRPT

Trading for SRPT was halted at 4:53:59 p.m. ET due to pending news. Investors should stay tuned for updates as this could significantly impact the stock price.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:54 pm

T

The California Public Utilities Commission has rejected AT&T's request to withdraw as a telecommunications carrier for 580,000 households in the state.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:50 pm

JNJ

Johnson & Johnson has submitted an application to the FDA for the approval of TREMFYA for the treatment of moderately to severely active Crohn's disease. The submission is backed by 48-week results from the Phase 3 GALAXI and GRAVITI programs, showing strong endoscopic outcomes with both subcutaneous and intravenous induction therapies.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:30 pm

ASNS

Actelis Networks has regained compliance with Nasdaq's minimum bid price requirement, ensuring its continued listing on the exchange.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:30 pm

SPY

Federal Reserve's Goolsbee stated that the Fed does not need annual inflation to hit 2% before considering a rate cut, although the 2% inflation target remains a 'sacred vow'.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:29 pm

SPY

Chicago Fed President Austan Goolsbee indicated in a Fox News interview that more positive inflation reports could lead to rate cuts. This statement suggests potential easing of monetary policy if inflation continues to show favorable trends.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 8:27 pm