Streetbeat News

Regulatory

SGMO

Sangamo Therapeutics' shares rise as the FDA approves an accelerated pathway for their ST-920 treatment for Fabry disease, with a BLA submission expected in 2025.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 1:43 pm

BMY

CVM

MRK

CEL-SCI Corporation's Multikine shows promise as a combination therapy with checkpoint inhibitors like Keytruda, especially for patients with low PD-L1 expression. The FDA's ODAC meeting raised concerns about the risk-benefit profile of PD-L1 inhibitors, potentially benefiting Multikine's development.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 1:26 pm

AVYA

CHKP

MIME

UIS

The SEC has charged Unisys, Avaya, Check Point, and Mimecast for misleading cybersecurity disclosures. Unisys also faces additional charges for controls violations. The companies will pay civil penalties of $4M, $1M, $995K, and $990K respectively.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 1:23 pm

NRXS

NeurAxis, Inc. (NYSE:NRXS) announced a new CPT Category I code for its PENFS technology, IB-Stim, effective January 1, 2026. This FDA-cleared device addresses functional abdominal pain in adolescents with IBS, offering a non-drug alternative.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 1:17 pm

SF

Stifel Financial Corp. has received final federal approval for its Stifel North Atlantic AM-Forward Fund, aimed at investing in small and mid-sized American manufacturers in the aerospace and defense industries. The fund has earned an SBIC license, allowing it to leverage SBA support.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 1:16 pm

TSLA

XRPUSD

Elon Musk discussed the potential of the XRP Ledger in a town hall, amid Ripple's co-founder Chris Larsen's $10 million donation to Kamala Harris' campaign. Musk's comments were neutral, emphasizing the value of cryptocurrency against centralized control. Ripple's CEO highlighted the importance of pro-crypto policies. The news comes as XRP faces SEC scrutiny and fluctuating prices.

Portfolio Pulse from Pooja Rajkumari

October 22, 2024 | 1:12 pm

CELU

Celularity plans to file its Form 10-Q for the second quarter of 2024 in the coming weeks. This filing will provide detailed financial information and performance metrics for the company.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 12:42 pm

CELU

Celularity Inc. (NASDAQ:CELU) has provided a corporate update, highlighting the acquisition of Rebound, a placental-derived product, and its impact on their portfolio. The company reported sales of over $24 million for the first half of 2024 and expects combined net sales of $50M-$56M. Celularity is working to regain Nasdaq compliance and plans to submit FDA notifications for new products in 2025-2026.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 12:33 pm

COCH

Envoy Medical, Inc. (NASDAQ:COCH) announced the approval of five Category III CPT codes by the AMA for its FDA-approved Esteem® device, a totally implantable active middle ear implant. This development could enhance market adoption and reimbursement opportunities for the device.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 12:19 pm

NUKK

Nukkleus, Inc. (NASDAQ:NUKK) will implement a 1-for-8 reverse stock split effective October 24, 2024, to meet Nasdaq's $1.00 minimum bid price requirement. The stock will trade on a split-adjusted basis under the same symbol with a new CUSIP number.

Portfolio Pulse from Benzinga Newsdesk

October 22, 2024 | 12:17 pm