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Regulatory

MRSN

Mersana Therapeutics announced that its UPLIFT clinical trial of Upifitamab Rilsodotin did not meet its primary endpoint.

Portfolio Pulse from Bill Haddad

July 27, 2023 | 11:11 am

BHVN

The FDA has informed Biohaven that it will not review the NDA application for troriluzole as the study's primary endpoint was not met. Biohaven may request a Type A meeting within 30 days to address FDA's concerns. Updates regarding the meeting will be provided after the upcoming regulatory interaction.

Portfolio Pulse from Bill Haddad

July 27, 2023 | 11:09 am

CKPT

Checkpoint Therapeutics has announced longer-term data showing increases in complete response rates for its drug, Cosibelimab, in advanced cutaneous squamous cell carcinoma. The drug demonstrated a 55% objective response rate and a 23% complete response rate in locally advanced cSCC, and a 50% objective response rate and a 13% complete response rate in metastatic cSCC. The drug continues to show a favorable safety profile and its Biologics License Application is currently under review by the U.S. FDA, with a PDUFA goal date of January 3, 2024.

Portfolio Pulse from Bill Haddad

July 27, 2023 | 11:05 am

LLY

Eli Lilly has announced the successful results of two Phase 3 studies for Tirzepatide in adults with obesity and weight-related comorbidities, excluding Type 2 diabetes. The studies, SURMOUNT-3 and SURMOUNT-4, met all primary and key secondary objectives compared to placebo.

Portfolio Pulse from Benzinga Newsdesk

July 27, 2023 | 10:51 am

MRK

Merck has announced positive topline results from two Phase 3 trials of V116, an investigational 21-valent pneumococcal conjugate vaccine. The trials demonstrated immune responses in both vaccine-naïve and vaccine-experienced adult patient populations.

Portfolio Pulse from Benzinga Newsdesk

July 27, 2023 | 10:47 am

GOOG

GOOGL

Google, a subsidiary of Alphabet Inc., has updated its Play Store guidelines and ranking algorithms to prioritize apps and games optimized for large screens. Apps not optimized for large screens or with high crash rates will be downranked. This move is likely motivated by Google's focus on tablets and large-screen devices, including the new Pixel Tablet and Pixel Fold.

Portfolio Pulse from Rounak Jain

July 27, 2023 | 10:40 am

TSLA

Indonesia is courting automakers, including Tesla Inc. (NASDAQ:TSLA), with attractive incentives for electric vehicle (EV) production. The country's rich nickel reserves, crucial for battery production, have been a significant part of the negotiations. Indonesia is reportedly planning to offer substantial incentives to companies, including Tesla and BYD, and is willing to benchmark their offers against other countries vying for the same companies.

Portfolio Pulse from Benzinga Neuro

July 27, 2023 | 10:33 am

LQDA

Liquidia has submitted an amendment to add PH-ILD indication to the tentatively approved NDA for YUTREPIA (treprostinil) Inhalation Powder. If approved by the FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH). The FDA can grant final approval after the new clinical investigation exclusivity granted to Tyvaso® expires on March 31, 2024.

Portfolio Pulse from Benzinga Newsdesk

July 27, 2023 | 10:09 am

MSFT

VGK

The European Union (EU) has launched a formal antitrust investigation into Microsoft's Teams software, according to the Wall Street Journal. The investigation will examine whether Microsoft is unfairly promoting its Teams software over rival products.

Portfolio Pulse from Charles Gross

July 27, 2023 | 9:47 am

AZN

AZNCF

AstraZeneca's drug Soliris (Eculizumab) has received approval in the European Union for expanded use to include the treatment of refractory generalized myasthenia gravis in children and adolescents.

Portfolio Pulse from Benzinga Newsdesk

July 27, 2023 | 8:15 am