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Regulatory

WAVE

Eco Wave Power has officially connected to the Israeli electrical grid, supplying the country's power supply with its first wave energy. The news was confirmed through an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:10 pm

SHPH

Shuttle Pharmaceuticals has provided a Q2 2023 corporate update, highlighting its progress in the development of Ropidoxuridine, a drug candidate for brain cancer treatment. The company is on track to commence Phase II clinical study in Q4 2023. It has completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine and received approval for a Type B pre-IND meeting with the FDA. The company's Q2 2023 operating expenses totaled $1.5 million and its cash balance was $8.4 million as of June 30, 2023.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:07 pm

TLSA

Tiziana Life Sciences announced that the FDA has cleared its Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. This news has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:06 pm

ACLX

The FDA has lifted the partial clinical hold on Arcellx Inc's iMMagine-1 Phase 2 Clinical Program. The decision comes after modifications were made to the trial protocol to better manage the risk of adverse events. Arcellx has retrained clinical sites and expanded treatment options for therapies that patients can receive. Preliminary data from the study is expected in the second half of 2024. Arcellx's shares are down 0.09% at $33.66 premarket.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

DSGN

Design Therapeutics Inc (NASDAQ:DSGN) reported initial results from its Phase 1 clinical trial of DT-216 in patients with Friedrich ataxia (FA). The results showed that DT-216 was generally well-tolerated and achieved a significant increase in frataxin (FXN) mRNA levels. However, injection site reactions were observed, leading the company to plan a reformulation of the drug. A new Phase 1 study is planned for the second half of 2024. DSGN shares are down 45.7% in premarket trading.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

FXLV

F45 announced its intention to voluntarily delist and deregister its securities, leading to a drop in its share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:03 pm

RNA

Avidity Biosciences has received FDA Orphan Drug Designation for AOC 1044, a treatment for Duchenne Muscular Dystrophy (DMD) in people with mutations amenable to exon 44 skipping. AOC 1044 is currently in Phase 1/2 EXPLORE44™ clinical trial. Results from the healthy volunteer portion of the trial are expected in Q4 2023. AOC 1044 received FDA Fast Track designation in April 2023.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:01 pm

PHG

Koninklijke Philips N.V. (NYSE:PHG) is recalling several ventilators due to dust and dirt detected in the air path of some devices. The FDA has classified this as its most serious type of recall, as the use of these devices could cause serious injuries or death. Philips has started the recall process on March 29 and has recalled 73,000 devices in the U.S. The company has received 542 reports about this issue, with two reported injuries and one death attributable to the issue.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 12:57 pm

PFE

The FDA has granted accelerated approval to Pfizer's Elrexfio, a therapy for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The approval is based on Phase 2 trial results and is contingent upon verification of clinical benefit in confirmatory trials. Pfizer expects the therapy to generate more than $4 billion in potential peak revenue. Pfizer's shares are down 0.42% in premarket trading.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 12:56 pm

DCTH

Delcath Systems has received FDA approval for its HEPZATO KIT, a treatment for adult patients with unresectable hepatic-dominant metastatic uveal melanoma. This news has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 12:56 pm