Streetbeat News

Regulatory

BIOC

Biocept's President and CEO, Antonino Morales, has tendered his resignation effective October 13, 2023, according to an SEC filing. The company's assets will be liquidated and any claims paid in accordance with the code.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 1:00 pm

TLRY

Tilray Medical, a division of Tilray Brands, Inc. (NASDAQ:TLRY) (TSX:TLRY), is contributing to a clinical trial researching the efficacy of medical cannabis as a treatment for glioblastoma, a severe form of brain cancer. The trial will be conducted in Spain and will recruit 30 patients from eight specialized neuro-oncology medical sites. Tilray Medical will provide the pharmaceutical-grade medical cannabis for the trial. The trial commenced on September 5, 2023.

Portfolio Pulse from Jelena Martinovic

October 16, 2023 | 12:51 pm

ALDX

Aldeyra Therapeutics Inc's (NASDAQ:ALDX) shares have dropped by 62% following feedback from the U.S. Food and Drug Administration (FDA) on their new drug application for reproxalap, a treatment for dry eye disease. The FDA identified significant issues with the clinical data supporting the drug's effectiveness. Although Aldeyra has responded to these concerns, the FDA has not confirmed the adequacy of the information and indicated that an additional clinical trial may be necessary. This could delay the FDA approval and commercialization of reproxalap, significantly impacting Aldeyra's revenue generation.

Portfolio Pulse from Henry Khederian

October 16, 2023 | 12:49 pm

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