Streetbeat News

Regulatory

SPY

The Federal Open Market Committee (FOMC) is expected to maintain its current interest rates in the range of 5.25%-5.5%, with a 99% chance of rates staying unchanged. The market assigns a 70% probability of another hold in the Nov. 1 meeting. Analysts are divided on whether the Fed will pencil in an additional rate hike for 2023. The FOMC meeting will unveil updated summary economic projections, incorporating data on GDP growth, inflation, and the unemployment rate for the coming years. This scenario has the potential to introduce volatility in the stock market, including the S&P 500, which is closely tracked by the SPDR S&P 500 ETF Trust (NYSE:SPY).

Portfolio Pulse from Piero Cingari

September 20, 2023 | 1:22 pm

SNY

SPRY

The FDA has rejected ARS Pharmaceuticals' New Drug Application for neffy, an epinephrine nasal spray intended as an alternative to EpiPen and Sanofi's Auvi-Q. The FDA has requested additional studies to support approval. ARS Pharma plans to resubmit in the first half of 2024, with an anticipated FDA action date in the second half of 2024. The company expects to have approximately $195 million in cash and short-term investments at the time of the anticipated launch. The news has caused ARS Pharma's shares to drop by 58.5%.

Portfolio Pulse from Vandana Singh

September 20, 2023 | 1:21 pm

BTCUSD

ETHUSD

Grayscale Investments has submitted a new application to the U.S. Securities and Exchange Commission (SEC) for an Ether futures ETF. This follows Grayscale's recent court victory against the SEC regarding their spot Bitcoin ETF application. The SEC has previously approved Bitcoin futures ETFs under both the Securities Act of 1933 and the Investment Company Act of 1940.

Portfolio Pulse from Murtuza Merchant

September 20, 2023 | 1:20 pm

TSLA

Elon Musk's Neuralink has begun recruiting participants for its first human trials of a brain-computer interface aimed at helping paralyzed individuals control devices. The trial, known as 'The PRIME Study', has received approval from an independent institutional review board and the initial hospital site. The trial aims to evaluate the safety of the implant and surgical robot, and assess the initial functionality of the implant. The trial is expected to last approximately six years. Last month, Neuralink announced a $280 million funding investment led by Founders Fund.

Portfolio Pulse from Vandana Singh

September 20, 2023 | 1:13 pm

NRSN

NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) has been granted the Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA), which offers significant benefits leading up to and following drug regulatory approval. The company has opened an EU Office and plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. The EMA has already granted PrimeC Orphan Drug Status for the treatment of ALS. Topline results from its Phase 2b study are expected at the end of 2023.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 1:09 pm

CDIO

Cardio Diagnostics Holdings, Inc (NASDAQ:CDIO) has published a peer-reviewed article outlining scalable pathways that leverage precision epigenetics to revolutionize coronary heart disease (CHD) care globally. The company's PrecisionCHD™ test uses digital PCR laboratory assays to quantify epigenetic signatures that are interpreted by artificial intelligence (AI) to determine the presence or absence of CHD. The test can be performed within hours using standard laboratory equipment.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 1:07 pm

AQST

Aquestive Therapeutics has reaffirmed its timeline and pathway for the Anaphylm Sublingual Film, with trials set to commence in Q4 following alignment with the FDA.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 1:07 pm

ICCM

IceCure's shares are trading lower following the FDA's denial of its De Novo Classification request for breast cancer, which was based on interim analysis from its ICE3 study.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:59 pm

TSHA

Taysha Gene Therapies has announced that it will discontinue the development of its TSHA-120 program for the treatment of giant axonal neuropathy, following feedback from the FDA. This has led to a decrease in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:51 pm

EXAI

PINS

SPRY

Exscientia announced a drug discovery collaboration with Merck KGaA, leading to a 36% increase in its stock. The FDA issued a complete response letter for ARS Pharma's neffy® Epinephrine Nasal Spray, causing a 66% drop in SPRY's stock. Pinterest's stock rose by 4.3% after announcing a $1 billion stock repurchase program and an upgrade from Citigroup.

Portfolio Pulse from ryanfaloona@benzinga.com

September 20, 2023 | 12:34 pm