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OTLK

Outlook Therapeutics has received the minutes from a Type A meeting with the FDA regarding ONS-5010, reaffirming its regulatory path forward. The company remains committed to advancing ONS-5010, an investigational ophthalmic formulation of bevacizumab, towards a potential Biologics License Application (BLA) submission.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:07 pm

ICAD

iCAD, Inc. (NASDAQ:ICAD) presented new research at the RSNA annual meeting, showcasing its ProFound Breast Health Suite's ability to predict breast cancer risk and detect heart disease. The AI-powered suite can assess calcium deposits in breast arteries, indicating cardiovascular disease. Studies confirmed the suite's effectiveness in cancer detection and standardizing breast arterial calcifications (BAC) reporting. Dr. Emily Conant and other researchers highlighted the potential of iCAD's 4th generation Breast AI in improving patient outcomes. The company's solutions are at various stages of regulatory approval, with some pending FDA clearance.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:07 pm

ENVB

Enveric Biosciences has announced that a research article detailing the development of their lead therapeutic candidate, EB-373, a novel psilocin prodrug, will be featured on the cover of the Journal of Medicinal Chemistry. This publication could signify a significant milestone for the company's research and development efforts in the field of psychedelic-inspired medicines.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:07 pm

SEEL

Seelos Therapeutics has chosen its SLS-002 (Intranasal Racemic Ketamine) for inclusion in the U.S. Department of Defense's Adaptive Platform Trial, which aims to evaluate potential treatments for Post-traumatic Stress Disorder (PTSD).

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:01 pm

GSK

GSK plc announced positive Phase 3 trial results for belantamab mafodotin, showing significant improvement in progression-free survival for multiple myeloma compared to the standard of care. Despite previous setbacks with FDA and EMA regulatory issues, the encouraging data could signal a potential comeback for the drug, marketed as Blenrep. GSK shares saw minimal change in premarket trading.

Portfolio Pulse from Vandana Singh

November 27, 2023 | 12:57 pm

FSR

LCID

RIVN

TSLA

Needham analyst Chris Pierce reiterated a Buy rating and $25 price target for Rivian (RIVN), keeping it on the firm's 'Conviction List'. He downgraded Lucid (LCID) from Buy to Hold, citing uninspiring Q3 results and tempered expectations for technology licensing to Aston Martin. Pierce also holds Hold ratings on Tesla (TSLA) and Fisker (FSR), expressing concerns over Tesla's margin profile and skepticism about its growth levers. Rivian is seen as an 'underappreciated winner' in the EV transition, being supply-constrained with pricing power and potential for market expansion.

Portfolio Pulse from Shanthi Rexaline

November 27, 2023 | 12:51 pm

ARMN

Aris Mining has announced a significant increase in gold mineral reserves at its Segovia Operations, with a 75% increase to 1.3 million ounces. Additionally, the company plans to expand the Maria Dama processing plant's capacity from 2,000 to 3,000 tonnes per day. The expansion, leveraging an existing unutilized ball mill, is estimated to cost $11.0 million and is expected to be completed by early 2025.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:39 pm

ABEO

Abeona Therapeutics Inc. announced that the FDA has accepted and granted Priority Review for their BLA for pz-cel, a treatment for RDEB. The FDA set a PDUFA target action date of May 25, 2024, and indicated no Advisory Committee meeting is planned for the application.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:32 pm

AUTL

Autolus Therapeutics has submitted a Biologics License Application (BLA) to the FDA for obecabtagene autoleucel, a treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. The company is also planning to submit an application to the European Medicines Agency in the first half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:11 pm

ATEX

Anterix's subsidiary PDV Spectrum has signed an agreement with Tampa Electric to use 900 MHz spectrum. This deal could enhance Tampa Electric's communication capabilities and operational efficiency. The financial terms of the agreement were not disclosed.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:08 pm