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Regulatory

PTCT

PTC Therapeutics has paused its 2024 revenue guidance due to uncertainties in forecasting the impact of the continued authorization of Translarna in Europe. The company will update its guidance at a future date.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 11:07 am

TSLA

The NHTSA has closed its year-long investigation into Tesla's Model X seat belt issues after the company issued a recall for nearly 16,000 vehicles. The probe was initiated due to complaints about front seat belts detaching while driving. Tesla's recall included inspections and potential replacements of seat belt components. The NHTSA reserves the right to take future action if necessary.

Portfolio Pulse from Anan Ashraf

May 20, 2024 | 11:04 am

PTCT

PTC Therapeutics, Inc. (NASDAQ:PTCT) announced that the European Commission has returned the CHMP's negative opinion on Translarna's conditional marketing authorization for re-evaluation. Translarna remains available in Europe pending further review.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 11:04 am

DYN

Dyne Therapeutics announced positive clinical data from its Phase 1/2 trials for DYNE-101 in Myotonic Dystrophy Type 1 and DYNE-251 in Duchenne Muscular Dystrophy. Both drugs showed significant improvements in key metrics and favorable safety profiles. The company is pursuing expedited approvals with updates expected by year-end.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 10:33 am

SOBR

SOBR Safe has failed to meet the bid price requirement and is planning to challenge a potential delisting from the stock exchange.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 10:13 am

PEV

SPI

Phoenix Motor Inc. has formed a special committee to investigate allegations against CEO Xiaofeng Denton Peng, including breach of fiduciary duty and unauthorized related party transactions. Peng has been suspended, and former CFO J. Mark Hastings is the interim CEO. The investigation is ongoing.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 10:10 am

BA

China has imposed symbolic sanctions on Boeing Co. and other U.S. defense firms over arms sales to Taiwan. The sanctions are expected to have minimal impact on these companies as they do not conduct significant business in China.

Portfolio Pulse from Benzinga Neuro

May 20, 2024 | 10:09 am

MNOV

MediciNova has received a Notice of Allowance from the US Patent and Trademark Office for its pending patent application covering MN-166 (Ibudilast) for the prevention of metastasis of eye cancer.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 10:04 am

AAPL

Apple Inc. (NASDAQ:AAPL) is set to launch an upgraded version of its AirTag in 2025, featuring an advanced chip for superior location tracking. The delay in launch is due to overstock of the first-generation product. Apple is also addressing concerns about AirTag misuse for stalking by collaborating with Google to enhance unwanted Bluetooth tracking notifications.

Portfolio Pulse from Ananya Gairola

May 20, 2024 | 6:18 am

INVA

ZLAB

Zai Lab and Innoviva Specialty Therapeutics have received approval from China's NMPA for XACDURO (Sulbactam-Durlobactam) to treat hospital-acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. This approval is based on clinical data showing strong activity against carbapenem-resistant strains.

Portfolio Pulse from Benzinga Newsdesk

May 20, 2024 | 4:40 am