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Regulatory

PFE

VALN

Valneva SE and Pfizer Inc have released positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15. The study showed a robust antibody response in all age groups after a booster dose. The vaccine was well-tolerated with no serious adverse events. Pfizer plans to submit a Biologics License Application to the FDA and a Marketing Authorisation Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

Portfolio Pulse from Vandana Singh

September 07, 2023 | 11:32 am

NVO

Scientists are exploring the potential of obesity drugs to treat conditions like dementia and alcohol addiction. Novo Nordisk's Wegovy weight loss injection has shown to reduce heart failure-related symptoms among high-risk patients. The drug is being tested for its effectiveness in reducing drug and alcohol intake and reducing tau accumulation and brain inflammation in dementia patients. However, concerns about potential adverse effects, including suicidal thoughts, have been raised.

Portfolio Pulse from Vandana Singh

September 07, 2023 | 11:27 am

BTAI

The FDA has scheduled a Type C meeting on November 8 to discuss Bioxcel Therapeutics' BXCL501 Serenity III program for the acute treatment of agitation in schizophrenia and bipolar I and II disorders in the at-home setting.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 11:22 am

CBAY

Cymabay Therapeutics announced that its Phase 3 RESPONSE study of Seladelpar for Primary Biliary Cholangitis has achieved the primary and all key secondary endpoints.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 11:16 am

ALNY

Alnylam Pharmaceuticals has announced that its KARDIA-1 Phase 2 study of Zilebesiran has met its primary endpoint. This suggests that the drug is effective and safe for its intended use.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 11:11 am

DRRX

DURECT Corporation has announced the last patient's last visit in the Phase 2b AHFIRM trial of Larsucosterol for Alcohol-Associated Hepatitis. This marks a significant milestone in the development of the drug.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 11:09 am

TSLA

Mozilla Foundation has criticized the privacy policies of modern cars, including Tesla Inc. (NASDAQ:TSLA), stating that they are a 'privacy nightmare'. The foundation found that all 25 car brands it researched, including Tesla, Audi, Mercedes-Benz, Kia, Lexus, and Toyota, were collecting 'too much' personal data, often for purposes beyond operating the vehicle. Tesla's privacy policy was rated the worst among the 25 car makers reviewed.

Portfolio Pulse from Rounak Jain

September 07, 2023 | 10:57 am

BFLBF

BFLBY

FLR

Fluor Corp (FLR) has agreed to sell its Stork business in Europe and its turbo blading manufacturing operation in the U.S. to Bilfinger SE (BFLBF, BFLBY). The company also settled with the U.S. Securities and Exchange Commission (SEC) for $14.5 million over an investigation into its accounting practices. The sale is part of Fluor's strategy to focus on its core businesses and is expected to be completed in H1 2024.

Portfolio Pulse from Shivani Kumaresan

September 07, 2023 | 10:56 am

MRK

The European Commission has approved an expanded indication for Merck's ERVEBO vaccine, allowing its use for active immunization of individuals 1 year of age or older against Ebola Virus Disease. Previously, the vaccine was approved for use in the European Union for individuals 18 years of age or older.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 10:49 am

EVTV

Envirotech Vehicles has received an extension from the Nasdaq Stock Market to file its delinquent annual and quarterly filings.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 10:33 am