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MYNZ

Mainz Biomed N.V. (NASDAQ:MYNZ) announced positive topline results from its U.S. eAArly DETECT study for colorectal cancer (CRC) screening. The study showed a sensitivity of 97% and specificity of 97% for CRC, and 82% sensitivity for advanced adenoma. These results surpass the European ColoFuture study and support the inclusion of novel mRNA biomarkers in the upcoming FDA PMA clinical trial, ReconAAsense, set to begin in mid-2024. The company aims to enhance its ColoAlert® test, making it a leading at-home CRC diagnostic tool.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:03 pm

NURO

NeuroMetrix has announced that its Phase 2 clinical trial results, which show that Quell, its wearable pain relief device, improves symptoms of chemotherapy-induced peripheral neuropathy (CIPN), have been published in a peer-reviewed journal. This publication could potentially boost the credibility of Quell and NeuroMetrix's standing in the medical community.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:01 pm

REPL

Replimune Group Inc (NASDAQ:REPL) reported that its CERPASS trial of RP1 with cemiplimab for cutaneous squamous cell carcinoma did not meet primary endpoints. While RP1 increased the complete response rate, it fell short of statistical significance. The company also presented initial data from the IGNYTE Cohort for anti-PD1 failed melanoma, showing consistent activity. A BLA submission is planned for 2H 2024, and a Type C meeting with the FDA has been conducted. Replimune's cash reserves are expected to last until early 2026. REPL shares dropped 45.20% in premarket trading.

Portfolio Pulse from Vandana Singh

December 05, 2023 | 1:49 pm

HOTH

Hoth Therapeutics has announced the successful completion of manufacturing its cancer treatment HT-KIT for IND-enabling studies, which is a critical step towards initiating clinical trials.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:34 pm

CKPT

Checkpoint Therapeutics has received a new US patent from the USPTO for a method of treating various cancers, including cutaneous squamous cell carcinoma (cSCC), with the administration of cosibelimab.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:31 pm

BBIO

BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for Acoramidis, intended for the treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:21 pm

LLY

Lilly will present the final overall survival analysis from the MONARCH 3 study of Verzenio at the 2023 San Antonio Breast Cancer Symposium. The study shows a numerical improvement in overall survival for women with HR+, HER2- metastatic breast cancer treated with Verzenio plus an aromatase inhibitor, but the results were not statistically significant. Additional analyses of Verzenio and imlunestrant in combination with Verzenio will also be presented.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:18 pm

PENN

PENN Entertainment, Inc. has announced a strategic partnership with Quail Hollow Club for market access in North Carolina for its online sports wagering platform, ESPN BET. This partnership includes ESPN BET becoming the exclusive official betting operator of the Wells Fargo Championship at Quail Hollow Club. The agreement is subject to regulatory approvals and will involve marketing integrations and fan activations during the tournament. ESPN BET, operated by PENN, launched on November 14 in 17 states, leveraging ESPN's brand and PENN's technology and expertise.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:13 pm

HYMC

Hycroft Mining Holding Corporation (NASDAQ:HYMC), also known as Hycroft, has received notification from Nasdaq that it now complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. As a result, Hycroft's common stock will maintain its listing status, meeting all applicable listing standards.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:12 pm

NEO

NeoGenomics, Inc. (NASDAQ:NEO) will present new data on its RaDaR assay for minimal residual disease (MRD) at the San Antonio Breast Cancer Symposium. The data includes an updated analysis of the TRACER study, which evaluates the use of RaDaR in early-stage breast cancer for therapy response monitoring and post-operative recurrence. The company also announced the receipt of the first samples from the SURVIVE clinical trial, which uses RaDaR for recurrence monitoring. RaDaR is a highly sensitive, tumor-informed assay that has received Breakthrough Device Designation by the US FDA and the CE mark.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 1:05 pm