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Regulatory

DJT

Trump Media & Technology Group Corp has filed with the SEC to allow selling securityholders to sell up to 146.1 million shares of common stock from time to time.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:38 pm

ICCM

IceCure Medical announced the final results of its ICE3 breast cancer cryoablation trial, submitting data to the FDA for marketing authorization to treat early-stage breast cancer. The data, presented at the ASBrS Annual Meeting and awarded the Scientific Impact Award, supports the use of cryoablation for early stage T1 invasive breast cancer with adjuvant hormone therapy. The company anticipates enhanced usage upon approval, citing the availability of a reimbursement code for facility expenses and the cost-effectiveness of its ProSense® cryoablation system.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:37 pm

NRXP

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) has developed a new, proprietary formulation of IV Ketamine, HTX-100, with a neutral pH, enabling both IV and subcutaneous administration. This development, based on prior patents by NRx's founder, may lead to patent protection and is expected to be marketed by HOPE Therapeutics, a subsidiary of NRx. The formulation was developed in partnership with Nephron Pharmaceuticals and is aimed at modernizing ketamine's use in medicine, potentially through insulin pump-like devices. NRx plans to submit a New Drug Application for HTX-100 for treating suicidal depression.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:34 pm

RVPH

Reviva Pharmaceuticals announced that it has aligned with the FDA on the clinical trials for Brilaroxazine for NDA in Schizophrenia, with the FDA accepting the 4-week RECOVER-2 Study.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:33 pm

LGVN

Longeveron announced that its Phase 2a clinical trial for Lomecel-B, aimed at treating mild Alzheimer's disease, has been selected for an oral presentation at the 2024 AAIC. This marks a significant milestone for the company as it progresses in its research and development efforts.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:32 pm

MBOT

Microbot Medical Inc. (NASDAQ:MBOT) announced that despite geopolitical tensions in Israel, its regulatory, clinical, operational, and pre-commercial activities remain on track. The company is progressing with its FDA IDE submission for the LIBERTY Endovascular Robotic Surgical System and is preparing for ISO 13485 certification audits for CE approval in Europe. It has also secured sufficient inventory for its pivotal study and is engaging with clinical and strategic partners for future development and commercialization efforts.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:31 pm

DDD

3D Systems has announced that it has received FDA clearance for its VSP PEEK cranial implant, marking a significant milestone for the company in the medical device market.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:31 pm

COGT

MOH

MRNS

NMRA

PSNY

RARE

RDZN

TRMD

Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) shares plummeted 74.2% in pre-market trading after updating on the Phase 3 RAISE Trial and reporting preliminary Q1 2024 financial results with ZTALMY net revenue of $7.4 to $7.6 million. Other stocks also moved lower in pre-market trading: Neumora Therapeutics, Inc. (NASDAQ:NMRA) dropped 17.1% due to an FDA clinical hold, Roadzen, Inc. (NASDAQ:RDZN) fell 14%, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) declined 11.4% after interim Phase 1/2 data, Cogent Biosciences, Inc. (NASDAQ:COGT) decreased 7.7%, Polestar Automotive Holding UK PLC (NASDAQ:PSNY) dropped 7.2%, Molina Healthcare, Inc. (NYSE:MOH) fell 7.1%, and TORM plc (NASDAQ:TRMD) slipped 3.1%.

Portfolio Pulse from Avi Kapoor

April 15, 2024 | 12:19 pm

URGN

UroGen Pharma Ltd. (NASDAQ:URGN) announced FDA acceptance of its IND application for UGN-103, a novel mitomycin-based formulation for treating low-grade intermediate-risk non-muscle invasive bladder cancer. UroGen plans to initiate a Phase 3 study in 2024, with potential advantages including a new 80 mg dosage strength, simplified manufacturing, and extended intellectual property protection until December 2041. UGN-103 utilizes UroGen's RTGel platform technology. Additionally, UroGen is preparing for an NDA submission for UGN-102, another mitomycin formulation, in September 2024.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:11 pm

SATL

Satellogic Inc. (NASDAQ:SATL) announced a $30M strategic investment from Tether Investments Limited through secured convertible notes issued by its subsidiary, Nettar Group, Inc. This investment, which provides Satellogic with additional operating liquidity and financial flexibility, is aimed at advancing the company's U.S. strategy, National Security market focus, and global Space Systems opportunities. The notes, bearing interest at SOFR plus 6.50%, are convertible into Class A ordinary shares at $1.20 each, subject to CFIUS approval, and are secured by the company's assets.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 12:10 pm