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Regulatory

CTMX

CytomX Therapeutics, Inc. (NASDAQ:CTMX) announced that it will present preclinical data for its conditionally activated cytokine program, CX-801, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The company anticipates filing an IND for CX-801 by the end of 2023.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:15 pm

FDMT

4D Molecular Therapeutics (NASDAQ:FDMT) has gained alignment with the FDA on a plan to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310 for Fabry disease cardiomyopathy. The company has initiated a single non-human primate safety study evaluating intravenous 4D-310 combined with rituximab/sirolimus immunosuppressive regimen. The INGLAXA protocol has been amended to minimize the risk of atypical hemolytic uremic syndrome associated with intravenous AAV dosing. Interim clinical data from INGLAXA is expected to be presented in Q1 2024.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:13 pm

AMTX

Aemetis, Inc. (NASDAQ:AMTX) has been selected by India's three government-controlled oil marketing companies (OMCs) to supply an estimated $150 million of biodiesel under cost-plus purchase contracts for approximately 40 million gallons of biodiesel during the one year period starting October 2023. This comes as part of India's National Policy on Biofuels which targets a 5% minimum blend on direct sale of biodiesel by 2030. Aemetis plans to continue to expand capacity to meet growing demand under the OMC cost-plus contract structure.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:12 pm

PHAT

The FDA has approved Phathom Pharmaceuticals' reformulated Vonoprazan tablets for Voquezna Triple Pak and Voquezna Dual Pak for H. Pylori infection in adults. This approval could potentially increase the company's market share and revenues.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:11 pm

META

VGK

Meta Platforms Inc. (formerly Facebook) has announced plans to offer a subscription-based, ad-free version of Facebook and Instagram in the EU, EEA, and Switzerland. The subscription will cost €9.99/month on the web or €12.99/month on iOS and Android. This move is in response to evolving European regulations and is aimed at giving users more choice while complying with the EU's General Data Protection Regulation (GDPR). The company has stated that this new subscription model has been factored into their most recent business outlook and guidance.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:10 pm

N/A

The FDA has issued an approvable letter for SeaStar Medical's Selective Cytopheretic Device for pediatric patients. This device is designed to treat patients in the ICU.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:06 pm

ICCM

IceCure Medical Ltd. (NASDAQ:ICCM) announced its participation in the 10th Annual Conference of the Breast Imaging Society of India (BISICON 2023) where its ProSense® System was featured. The system, a minimally-invasive cryoablation technology that destroys tumors by freezing, was used to perform India's first breast cryoablation procedure in June 2023. The ICE3 trial results of ProSense® showed a 96.91% recurrence free rate, 100% safety, and 100% doctor and patient satisfaction. The trial is expected to be finalized in Q1 2024.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:06 pm

DAWN

Day One Biopharmaceuticals has announced that the FDA has accepted its New Drug Application (NDA) and granted priority review for Tovorafenib, a treatment for relapsed or progressive pediatric low-grade glioma (pLGG).

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 12:06 pm

EAR

Trading of Eargo's shares has been temporarily halted, pending further news.

Portfolio Pulse from Charles Gross

October 30, 2023 | 11:43 am

AUVI

Applied UV has been granted a US patent for its Airo Vortex product. The company also received a publication notice for its Fighter Flex LED.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 11:32 am