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Regulatory

MDNA

Medicenna Therapeutics Corp. (NASDAQ:MDNA) has announced a clinical update on the monotherapy dose escalation portion of the Phase 1/2 ABILITY Study for its drug candidate MDNA11. The drug has shown durable single-agent activity in patients with advanced, treatment-refractory cancer, with a manageable safety profile. The company is now initiating the dose expansion phase of the study, with the recommended dose for expansion set at 90g/kg. Initial results from the monotherapy dose expansion are expected in Q4 2023.

Portfolio Pulse from Happy Mohamed

August 09, 2023 | 11:39 am

PGEN

Precigen has received confirmation from the FDA that its ongoing Phase 1/2 study of PRGN-2012 AdenoVerse Immunotherapy will serve as a pivotal study to support accelerated approval. The FDA also confirmed that no additional randomized, placebo-controlled trial will be required to support the submission of a biologics license application (BLA). Precigen plans to initiate a confirmatory study prior to the BLA submission.

Portfolio Pulse from Benzinga Newsdesk

August 09, 2023 | 11:06 am

NVS

Novartis has announced that its Remibrutinib Phase 3 trials met their primary endpoints and demonstrated rapid symptom control in chronic spontaneous urticaria. This positive outcome could potentially lead to a new treatment option for patients.

Portfolio Pulse from Benzinga Newsdesk

August 09, 2023 | 9:39 am

NNDM

Nano Dimension Ltd. (NNDM) has highlighted that Murchinson Ltd. paid its director nominees $50,000 each, a total of $250,000, for agreeing to stand for election to Nano's Board of Directors. This payment makes the nominees beholden to Murchinson and they cannot be considered independent.

Portfolio Pulse from Charles Gross

August 09, 2023 | 9:04 am

IMRN

Immuron Limited, an Australian biopharmaceutical company, has received GMP Clearance from the Therapeutic Goods Administration (TGA) for its packaging supplier. This allows its product, Travelan, to be released for sale in Australia to retail pharmacy wholesalers and other customers.

Portfolio Pulse from Charles Gross

August 09, 2023 | 8:51 am

PHAR

Pharming Group has enrolled its first patient in a Phase III clinical trial of Leniolisib for the treatment of Activated PI3K Delta Syndrome (APDS) in Japan. The trial is expected to provide further evidence of the drug's efficacy and safety.

Portfolio Pulse from Benzinga Newsdesk

August 09, 2023 | 6:33 am

DOGEUSD

Elon Musk's attorneys have filed a motion to dismiss a lawsuit brought by a group of Dogecoin investors, arguing that the litigation has dragged on for too long. The lawsuit, which initially sought $258 billion in damages, accuses Musk of market manipulation, insider trading, and deliberate actions related to Dogecoin. Musk's support for Dogecoin has been well-documented, particularly since his acquisition of Twitter.

Portfolio Pulse from Mehab Qureshi

August 09, 2023 | 4:45 am

BTCUSD

DOGEUSD

ETHUSD

Major cryptocurrencies including Bitcoin, Ethereum, and Dogecoin saw significant gains on Tuesday amid optimism about the prospects of a spot Bitcoin ETF being approved by the SEC. Ark Invest CEO Cathie Wood and Galaxy Digital CEO Mike Novogratz expressed their optimism about the ETF. PayPal is set to launch a stablecoin tied to the U.S. dollar. The global crypto market capitalization stands at $1.19 trillion, a 2.11% increase in the last day. Stocks declined on Tuesday as the banking sector received a downgrade from Moody's.

Portfolio Pulse from Mehab Qureshi

August 09, 2023 | 2:40 am

ICVX

Icosavax has reported positive 12-month durability data for its VLP vaccine candidate IVX-121. The data from the Phase 1b extension trial in older adults showed persistent GMTs against RSV through day 365. The company also reported a robust immune response against RSV-A in trial participants who were revaccinated with IVX-121 twelve months after the initial dose. The vaccine was generally well tolerated with no additional safety concerns. The company's IVX-A12, a combination of IVX-121 for RSV and IVX-241 for hMPV, is currently in a Phase 2 trial with interim data expected by end 2023.

Portfolio Pulse from Benzinga Newsdesk

August 08, 2023 | 9:56 pm

TERN

Terns Pharmaceuticals, Inc. (NASDAQ:TERN) reported positive top-line results from the Phase 2a DUET clinical trial of TERN-501, a treatment for non-alcoholic steatohepatitis (NASH). The trial achieved its primary endpoint with significant reductions in liver fat content. TERN-501 also demonstrated improvements in plasma lipid parameters and was well-tolerated with no gastrointestinal and no cardiovascular safety signals. The combination of TERN-501 and TERN-101 also showed promising results.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 9:42 pm