Streetbeat News

Regulatory

AVXL

Anavex Life Sciences has announced a follow-on analysis of the Phase 2B/3 study of Blarcamesine (ANAVEX2-73) which demonstrated a statistically significant slowing in cognitive decline associated with Alzheimer's disease.

Portfolio Pulse from Benzinga Newsdesk

September 14, 2023 | 11:32 am

ALNY

PFE

An FDA advisory committee has voted in favor of Alnylam Pharmaceuticals' patisiran for use in cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis, despite earlier doubts raised by FDA staffers. This could potentially challenge Pfizer's market dominance with tafamidis in treating ATTR-CM. Alnylam's shares are up 4.80% premarket.

Portfolio Pulse from Vandana Singh

September 14, 2023 | 11:26 am

BTCUSD

MSTR

MicroStrategy Inc. CEO Michael Saylor has emphasized the need for Bitcoin as a solution to economic issues such as hyperinflation and reckless monetary policies. This comes in response to a post by Tucker Carlson, who highlighted these issues in Argentina. According to a report by Berenberg, MicroStrategy will soon be able to report its Bitcoin holdings quarterly without recognizing impairment losses in case the cryptocurrency’s price declines during the reporting period.

Portfolio Pulse from Mehab Qureshi

September 14, 2023 | 11:15 am

VERO

Venus Concept has received a 510(K) clearance from the FDA to market its Venus Versa Pro System, a new multi-application platform for several aesthetic and cosmetic procedures.

Portfolio Pulse from Benzinga Newsdesk

September 14, 2023 | 11:05 am

GRAB

Singapore's Land Transport Authority is considering new regulations for ride-hailing companies like Grab Holdings Ltd (NASDAQ:GRAB) and GoTo. The focus will be on supply availability, resilience, inclusivity of services, and adoption of clean-energy vehicles. The number of daily rides in Singapore increased to 613,000 in July 2023 from 517,000 in November 2020. The review is expected to be completed by Q2 2024. Both Grab and GoTo are struggling to break even due to intense competition across Asia.

Portfolio Pulse from Anusuya Lahiri

September 14, 2023 | 10:40 am

AMZN

CHD

Church & Dwight Co Inc (NYSE:CHD) has voluntarily recalled a specific lot of TheraBreath Strawberry Splash for Kids 16oz due to microbial contamination. The product was sold exclusively on Amazon.com Inc (NASDAQ:AMZN) between May 31 and September 02, 2023. The recall could potentially lead to severe or life-threatening adverse events in immunocompromised individuals. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Portfolio Pulse from Shivani Kumaresan

September 14, 2023 | 10:29 am

FWBI

SNY

First Wave Biopharma has entered into a license agreement with Sanofi. Sanofi could potentially receive up to $46M in development and regulatory milestone payments, and up to $235M in potential commercial milestone payments.

Portfolio Pulse from Charles Gross

September 14, 2023 | 10:24 am

FWBI

SNY

First Wave BioPharma Inc (FWBI) has entered into a licensing agreement with Sanofi SA (SNY) for Capeserod, a drug that First Wave plans to repurpose for gastrointestinal indications. This follows disappointing results from First Wave's Phase 2 SPAN trial. The agreement includes a modest upfront payment, backend milestone payments, and single-digit royalties on net sales. First Wave will request a meeting with the FDA to establish a development and regulatory pathway for Capeserod.

Portfolio Pulse from Vandana Singh

September 14, 2023 | 10:00 am

BNBUSD

COIN

ETHUSD

XRPUSD

Ethereum co-founder Joseph Lubin has expressed confidence that the ongoing disputes between the U.S. Securities and Exchange Commission (SEC) and crypto firms over the classification of crypto tokens will be resolved favorably. Lubin's comments come as crypto firms such as Binance, Coinbase, and Ripple continue to face lawsuits from the SEC for alleged law infringements. Lubin insists that ether should be considered more of a commodity, similar to oil.

Portfolio Pulse from Benzinga Neuro

September 14, 2023 | 9:39 am