Streetbeat News

Regulatory

COYA

Coya Therapeutics has completed enrollment for a Phase 2 study of low dose Interleukin-2 (LD IL-2) in patients with Alzheimer's Disease. The study, funded by the Gates Foundation and Alzheimer's Association, will evaluate the safety, tolerability, and preliminary efficacy of LD IL-2 in 38 patients over 30 weeks. Previous data showed significant improvement in cognitive function with LD IL-2 treatment. Coya's proprietary LD IL-2 (COYA 301) is being developed as a treatment for Alzheimer's and in combination with CTLA4 Ig (COYA 302) for Amyotrophic Lateral Sclerosis (ALS).

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October 09, 2023 | 12:03 pm

AQST

Aquestive Therapeutics has received comments from the FDA on its Phase 3 pharmacokinetic study protocol for Anaphylm (Epinephrine) Sublingual Film. The FDA indicated that the company's proposed endpoints, sample size, and statistical analysis are reasonable.

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October 09, 2023 | 12:02 pm

JSPR

Jasper Therapeutics has received IND clearance for a Phase 1b/2a study of subcutaneous Briquilimab in Chronic Spontaneous Urticaria. The study will enroll around 40 patients across 6 cohorts, focusing on safety, tolerability, efficacy measures, and pharmacokinetics of Briquilimab.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 12:02 pm

ANAB

AnaptysBio, Inc. (NASDAQ:ANAB) announced positive top-line results from its global Phase 3 GEMINI-1 trial evaluating the safety and efficacy of imsidolimab in patients with generalized pustular psoriasis (GPP). The trial met its primary endpoint with 53.3% of patients achieving clear or almost clear skin at Week 4 after a single dose of 750mg IV imsidolimab, compared to 13.3% of patients on placebo. The company plans to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024 and intends to out-license imsidolimab in 2024.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 12:01 pm

BTCUSD

XRPUSD

Elon Musk, the executive chair and chief technical officer of Twitter, faced criticism for the suspension of an XRP-related account. The suspended account, Digital Asset Investor.XRP, was known for its advocacy of XRP. This suspension has raised questions within the crypto community, especially amidst ongoing controversies and legal disputes surrounding XRP, including a lawsuit by the SEC alleging XRP as an unregistered security. Bitcoin was trading at $27,939.94, down 0.56% in the last 24 hours.

Portfolio Pulse from Mehab Qureshi

October 09, 2023 | 11:38 am

BBIO

BridgeBio Pharma, Inc. (NASDAQ:BBIO) has shared new long-term data from its Phase 2 trial in patients with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The data remains consistent with earlier results, showing a well-tolerated safety profile and encouraging preliminary efficacy. Early changes in glycosylated ⍺DG levels at 3 months appear to be associated with ambulatory improvements at 9 months, supporting the potential use of glycosylated ⍺DG levels as a surrogate endpoint in the ongoing Phase 3 study for accelerated approval.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 11:32 am

AXON

The Federal Trade Commission (FTC) has dismissed its administrative enforcement action against Axon Enterprise related to Axon's 2018 acquisition of body camera competitor Vievu. This follows Axon's U.S. Supreme Court victory in April over its constitutional challenges to the FTC's structure.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 11:32 am

ALNY

Alnylam Pharmaceuticals has received a Complete Response Letter (CRL) from the FDA regarding its Supplemental New Drug Application for Patisiran, used for the treatment of cardiomyopathy of ATTR amyloidosis. The CRL does not affect the commercial availability of ONPATTRO, another drug approved by the FDA for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 11:32 am

COP

CVX

DIS

LMT

MRTX

NOC

NVDA

QQQ

SPY

XOM

The escalating tensions in the Middle East have dampened the risk-on mood, potentially leading to a bleak start to the week for S&P 500 and Nasdaq. However, gains in energy stocks and defense contractors could partially offset the negative sentiment. Traders are also preparing for the start of the third-quarter reporting season and closely monitoring inflation data. The SPDR S&P 500 ETF Trust (NYSE:SPY) and the Invesco QQQ ETF (NASDAQ:QQQ) both fell in premarket trading. Stocks in focus include Walt Disney Co. (NYSE:DIS), Nvidia Corp. (NASDAQ:NVDA), Exxon Mobil Corp. (NYSE:XOM), ConocoPhillips (NYSE:COP), Chevron Corp. (NYSE:CVX), Lockheed Martin Corp. (NYSE:LMT), Northrop Grumman Corporation (NYSE:NOC), and Mirati Therapeutics, Inc. (NASDAQ:MRTX).

Portfolio Pulse from Shanthi Rexaline

October 09, 2023 | 11:28 am

LLY

The FDA has approved FoundationOne CDx as a companion diagnostic for Eli Lilly's Retevmo (selpercatinib) for certain patients with solid tumors. This approval could potentially increase the usage of Retevmo, thereby boosting Eli Lilly's revenues.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2023 | 11:13 am