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Regulatory

NXTC

NextCure, Inc. (NASDAQ:NXTC) has announced the presentation of Phase 2 clinical data demonstrating clinical benefit in patients with advanced, PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC) treated with a combination regimen of NC318, a Siglec-15 (S15) monoclonal antibody (mAb), and pembrolizumab, an anti-PD-1 antibody.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 12:07 pm

BOLT

Bolt Biotherapeutics has announced the issuance of a US patent covering Dectin-2-targeting agonist antibodies, including BDC-3042. This patent strengthens the company's intellectual property position.

Portfolio Pulse from Bill Haddad

September 12, 2023 | 12:07 pm

PRCT

Procept Biorobotics has received an Investigational Device Exemption approval from the FDA to investigate the safety and efficacy of Aquablation therapy for prostate cancer.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 12:03 pm

MNMD

MindMed has completed the enrollment for its Phase 2b trial of MM-120, a drug aimed at treating Generalized Anxiety Disorder (GAD).

Portfolio Pulse from Bill Haddad

September 12, 2023 | 11:37 am

ARQT

Arcutis has submitted a Supplemental New Drug Application to the FDA for its Roflumilast Cream 0.15% for the treatment of atopic dermatitis in adults and children aged 6 years and older.

Portfolio Pulse from Bill Haddad

September 12, 2023 | 11:33 am

BTCUSD

Nassim Nicholas Taleb, author of 'Black Swan', criticized artificial market manipulation, particularly in the Bitcoin market. He highlighted the impact of decreasing trading volumes, stating that it facilitates market manipulation and warned that manipulators would eventually look to exit.

Portfolio Pulse from Benzinga Neuro

September 12, 2023 | 11:30 am

MSFT

VGK

EU antitrust regulators are seeking views on Microsoft's remedies to UK watchdog. This comes after Microsoft's proposed acquisition of Nuance Communications, which raised competition concerns.

Portfolio Pulse from Charles Gross

September 12, 2023 | 11:29 am

AVTX

Avalo Therapeutics is selling its AVTX-801, AVTX-802, and AVTX-803 to AUG Therapeutics for an upfront payment of $150,000. Additionally, AUG will make a contingent milestone payment of $15,000,000 for each compound if the first FDA approval is for an indication other than a Rare Pediatric Disease, potentially aggregating to $45 million. AUG will also pay up to 20% of certain payments if any priority review voucher is granted by the FDA and sold.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 11:13 am

BTAI

Bioxcel Therapeutics has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to the use of sublingual dexmedetomidine for the treatment of agitation. The company plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations for IGALMI. The patent is expected to expire no earlier than December 29, 2037.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 11:10 am

TSLA

A video showing a wheel cap of Tesla's Cybertruck detaching on the freeway has raised safety concerns. The incident occurred near Fremont, California. The Cybertruck's delivery event is scheduled for later this year, and Tesla may need to address this issue promptly. Earlier, a German newspaper reported design flaws in the Cybertruck, including issues with suspension, body sealing, noise levels, handling, and braking.

Portfolio Pulse from Anan Ashraf

September 12, 2023 | 11:06 am