Streetbeat News

Regulatory

ALDX

Aldeyra Therapeutics' shares are trading lower after the FDA identified substantive review issues with the New Drug Application (NDA) for reproxalap.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:49 pm

BNTX

CFRX

LQR

PCSA

PCTI

Several stocks are experiencing significant pre-market movements. LQR House Inc. shares surged 109% after delivering an inaugural order to Costco. Processa Pharmaceuticals, Inc. shares rose 84.4% following a 45% jump on Friday. PCTEL, Inc. shares climbed 47.4% after Amphenol Corp agreed to acquire PCTEL for around $139.7 million. ContraFect Corporation shares jumped 30% after the company reported FDA clearance of CF-370 IND application to proceed with Phase 1 clinical study. On the downside, BioNTech SE fell 6% after Pfizer, its partner, cut its COVID-19 vaccine and therapy sales outlook.

Portfolio Pulse from Lisa Levin

October 16, 2023 | 12:47 pm

APRE

Aprea Therapeutics, Inc. (NASDAQ:APRE) presented initial clinical data on ATRN-119 and pre-clinical data on ATRN-1051 at the AACR-NCI-EORTC International Conference. The data includes first-in-human clinical data from the ongoing Phase 1 dose escalation trial of ATRN-119, and pre-clinical data from the WEE1 inhibitor, ATRN-1051. The company plans to submit an IND for ATRN-1051 in Q4 2023. ATRN-119 is in an ongoing Phase 1/2a dose escalation trial in solid tumors, with no hematologic or liver function toxicities observed so far. The company anticipates dose expansion of the trial in Q2 2024.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:45 pm

ETWO

Elliott Investment has expressed its intention to engage in dialogue with E2open Parent Holdings' board and management about strategic opportunities. The firm plans to communicate with E2open's management and board about a broad range of operational matters, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:42 pm

TOPS

TOP Ships Inc., an international owner and operator of modern, fuel efficient 'ECO' tanker vessels, has regained compliance with the NASDAQ minimum bid price requirement for the Nasdaq Capital Market, as per Nasdaq Listing Rule 5550(a)(2).

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:38 pm

CRL

Charles River Laboratories International, Inc. (NYSE:CRL) has announced its ability to conduct preclinical cancer research using ITCC-P4's collection of 400 annotated pediatric cancer models. This comes as regulatory guidelines necessitate testing for pediatric indications in oncology research and development. Charles River is offering clients access to this collection, which is critical for research due to the FDA's RACE for Children Act requiring all oncology drugs to be tested for pediatric indications before approval.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:34 pm

ACRV

Acrivon Therapeutics (NASDAQ:ACRV) presented data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, demonstrating the capabilities of its AP3 platform and ACR-368 OncoSignature assay for patient responder identification. The data supports the use of the ACR-368 OncoSignature assay in ongoing Phase 2 clinical trials for patients with ovarian, endometrial, or bladder cancer. The company's AP3 platform is designed to measure the activity state of drug-regulated proteins and drug-induced resistance mechanisms to match with drug mechanism-of-action.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:33 pm

AAPL

AXP

GS

Goldman Sachs is reportedly reconsidering its venture into consumer lending, including the Apple credit card and General Motors card, due to operational and financial challenges. The bank is selling GreenSky at a significant loss and has offloaded most of its portfolio of personal loans. The Consumer Financial Protection Bureau is investigating Goldman's credit card account management practices. The bank's partnership with Apple is under review, with options including allowing Apple to assume a more significant role or offloading the consumer products to American Express.

Portfolio Pulse from Anusuya Lahiri

October 16, 2023 | 12:32 pm

MDAI

Spectral AI, Inc. (NASDAQ:MDAI) has announced the addition of seven clinical sites to support the development of its diabetic foot ulcer (DFU) application for the DeepView® Wound Imaging System. The technology combines multi-spectral imaging and AI to provide immediate healing assessments of DFUs. The data collected from these sites will be used to develop the DFU healing prediction algorithm and support applications for FDA, UKCA, and CE mark approval for DeepView®'s DFU indication.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:31 pm

SCYX

SCYNEXIS, Inc. (NASDAQ:SCYX) announced the presentation of preclinical data on its second generation antifungal compound, SCY-247, at the 11th Congress on Trends in Medical Mycology. SCY-247 has demonstrated broad-spectrum antifungal activity and SCYNEXIS anticipates that the FDA may grant it Qualified Infectious Disease Product and Fast Track designations. Clinical studies are planned to begin in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:27 pm