Streetbeat News

Regulatory

LLY

The U.S. Food and Drug Administration has approved Zepbound, a medication for chronic weight management in adults with obesity or overweight. The drug, developed by Eli Lilly and Co., has been proven effective in two randomized, double-blind, placebo-controlled trials. However, the FDA warns that the safety and effectiveness of coadministration of Zepbound with other medications for weight management have not been established. Zepbound also carries warnings for several potential side effects, including pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, and diabetic retinopathy.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 5:17 pm

DRRX

DURECT Corporation (NASDAQ:DRRX) released topline results from its AHFIRM Phase 2b study of larsucosterol in patients with severe alcohol-associated hepatitis (AH). The results did not achieve statistical significance for the primary endpoint of mortality or transplant at 90 days. However, both doses of larsucosterol showed a clinically meaningful trend in reduction of mortality at 90 days. DURECT plans to discuss the trial results and the Phase 3 registration trial design with the FDA in Q1 2024. DRRX shares are down 75.90% at $0.62.

Portfolio Pulse from Vandana Singh

November 08, 2023 | 4:38 pm

PMBHF

PharmAla Biotech (OTC:PMBHF) is set to ship the first of several batches of psychedelic molecules, including MDMA and psilocybin, to its Australian JV Cortexa for use under the Authorized Prescriber Scheme (APS). This marks the first time any molecules recently re-scheduled under Australia’s APS are imported for use under that scheme, rather than for clinical trials. PharmAla's CEO Nick Kadysh believes Cortexa will become the industry leader in the import, sale, and distribution of psilocybin and MDMA for medical purposes.

Portfolio Pulse from Lara Goldstein

November 08, 2023 | 4:35 pm

BAC

SPY

Bank of America's CEO has stated that financial conditions are tightening and commercial customers are borrowing less. He also mentioned that it's a mistake to think banks drive ESG, as companies are the ones driving it. He warned that higher capital rules will increase the cost of doing business in the U.S.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 4:27 pm

AMD

ASML

MU

NVDA

QCOM

SSNLF

Nvidia Corp is speculated to update its RTX 40 series cards in early 2024, showcasing RTX 4070 Super and RTX 4080 Super GPUs at the Consumer Electronics Show in January 2024. Meanwhile, China's chip self-sufficiency efforts are attracting global industry leaders to the China International Import Expo, including Qualcomm Inc, Micron Technology Inc, ASML Holding NV, and Samsung Electronics Co. Nvidia, subject to the U.S. trade embargo, did not set up a booth. Micron is making its debut at the expo, signaling warming relations with Beijing. Advanced Micro Devices, Inc is also participating, focusing on AI solutions.

Portfolio Pulse from Anusuya Lahiri

November 08, 2023 | 4:22 pm

BTCUSD

Crypto bank SEBA has obtained a license from the Securities and Futures Commission (SFC) in Hong Kong, allowing it to offer a range of regulated activities including traditional securities and crypto-related services. The move is part of SEBA's strategic vision to establish itself in the APAC market. The license allows SEBA Hong Kong to deal and distribute securities, provide advice on securities and virtual assets, and manage assets for discretionary accounts.

Portfolio Pulse from Murtuza Merchant

November 08, 2023 | 4:11 pm

SPY

The Federal Reserve's Loretta Mester announced her retirement effective June 30, 204 due to Fed rules. This may cause some changes in the Federal Reserve's policy stance.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 3:36 pm

SPY

The Federal Reserve Bank of Cleveland has initiated a search for its next President and CEO, as the term of the current President, Loretta Mester, is set to conclude on June 30, in line with the Fed's mandatory retirement policies.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 3:35 pm

MBOT

Microbot Medical Inc. (NASDAQ:MBOT) has been granted a registered trademark from the US Patent and Trademark Office for the feature 'One & Done' of the LIBERTY Robotic Surgical System. This system is being developed to integrate guidewires, microcatheters and other instruments required for complete endovascular procedures. The company continues to expand its proprietary assets, including numerous approved and pending patents worldwide.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 1:15 pm

SILO

Silo Pharma, Inc. (NASDAQ:SILO) has announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD). The study, in collaboration with AmplifyBio, will identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals. The final validation report is expected in 2024. If clinically successful, SPC-15 could qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval.

Portfolio Pulse from Benzinga Newsdesk

November 08, 2023 | 1:11 pm