Streetbeat News

Regulatory

PTPI

Petros Pharmaceuticals has partnered with Idea Evolver, the sole provider to have successfully completed an Actual Use Trial for FDA review, which is necessary for Rx-to-OTC switch approval. This partnership is related to the over-the-counter (OTC) switch technology for the blockbuster cholesterol drug Crestor.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:17 pm

VLD

Velo3D, Inc. (VLD) announced its Sapphire family of 3D printers are the first to achieve the U.S. Department of Defense's Green-level STIG Compliance, allowing connection to DoD's SIPRNet and NIPRNet. This certification ensures the printers are protected against cyberattacks, simplifies the management process, and makes it easier for defense contractors and agencies to purchase the printers. Velo3D's printers, including Sapphire, Sapphire 1MZ, Sapphire XC, and Sapphire XC 1MZ, exceeded the DoD's security threshold with an average score of 97% on tests.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:12 pm

SAGE

Sage Therapeutics announced that its investigational drug SAGE-718 has been granted the nonproprietary name 'Dalzanemdor'. This is a key step in the drug development process, indicating progress towards potential commercialization. The new name will be used in clinical trials and future marketing.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:10 pm

CDTX

Melinta Therapeutics and Cidara Therapeutics (NASDAQ:CDTX) announced the publication of pooled data from the ReSTORE Phase 3 and STRIVE Phase 2 trials of REZZAYO in The Lancet ID, demonstrating its efficacy and safety for treating candidemia and invasive candidiasis. REZZAYO, a once-weekly echinocandin, was approved by the FDA on March 22, 2023, for adults with limited treatment options and received a CMS J-Code and NTAP. Melinta acquired U.S. commercial rights from Cidara, who retains rights in Japan and licensed rights elsewhere to Melinta and Mundipharma. The EMA is reviewing the MAA for rezafungin.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:08 pm

PG

Procter & Gamble has announced in an SEC 8K filing that it anticipates incurring additional restructuring charges ranging from $1 billion to $1.5 billion after tax.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:06 pm

KTRA

Kintara Therapeutics, Inc. (NASDAQ:KTRA) has been granted an extension by Nasdaq to regain compliance with the stockholders' equity continued listing requirement. The company must meet certain milestones by March 18, 2024, to avoid potential delisting. Failure to comply by the end of the quarter on March 31, 2024, may result in delisting, although the company can appeal to a Nasdaq Hearings Panel.

Portfolio Pulse from Benzinga Newsdesk

December 05, 2023 | 2:06 pm

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