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BTCUSD

The SEC has reportedly approved the iShares Bitcoin spot ETF, leading to a rise in Bitcoin trading.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 1:35 pm

BTCUSD

The Securities and Exchange Commission (SEC) has approved the iShares Bitcoin Spot ETF, according to Reuters. This marks a significant step in the integration of cryptocurrencies into mainstream financial systems.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 1:33 pm

FBIO

Fortress Biotech's subsidiary, Helocyte, has secured an option agreement with City of Hope for exclusive worldwide rights to use a novel bispecific CMV/HIV CAR T Cell Therapy for HIV-1 treatment. The therapy has shown promising results in preclinical studies, eradicating HIV from latent reservoirs. The California Institute for Regenerative Medicine (CIRM) has granted $11.3 million to fund the Phase 1 clinical trial at City of Hope, which has been accepted by the FDA.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 1:02 pm

BIOC

Biocept's President and CEO, Antonino Morales, has tendered his resignation effective October 13, 2023, according to an SEC filing. The company's assets will be liquidated and any claims paid in accordance with the code.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 1:00 pm

TLRY

Tilray Medical, a division of Tilray Brands, Inc. (NASDAQ:TLRY) (TSX:TLRY), is contributing to a clinical trial researching the efficacy of medical cannabis as a treatment for glioblastoma, a severe form of brain cancer. The trial will be conducted in Spain and will recruit 30 patients from eight specialized neuro-oncology medical sites. Tilray Medical will provide the pharmaceutical-grade medical cannabis for the trial. The trial commenced on September 5, 2023.

Portfolio Pulse from Jelena Martinovic

October 16, 2023 | 12:51 pm

ALDX

Aldeyra Therapeutics Inc's (NASDAQ:ALDX) shares have dropped by 62% following feedback from the U.S. Food and Drug Administration (FDA) on their new drug application for reproxalap, a treatment for dry eye disease. The FDA identified significant issues with the clinical data supporting the drug's effectiveness. Although Aldeyra has responded to these concerns, the FDA has not confirmed the adequacy of the information and indicated that an additional clinical trial may be necessary. This could delay the FDA approval and commercialization of reproxalap, significantly impacting Aldeyra's revenue generation.

Portfolio Pulse from Henry Khederian

October 16, 2023 | 12:49 pm

ALDX

Aldeyra Therapeutics' shares are trading lower after the FDA identified substantive review issues with the New Drug Application (NDA) for reproxalap.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:49 pm

BNTX

CFRX

LQR

PCSA

PCTI

Several stocks are experiencing significant pre-market movements. LQR House Inc. shares surged 109% after delivering an inaugural order to Costco. Processa Pharmaceuticals, Inc. shares rose 84.4% following a 45% jump on Friday. PCTEL, Inc. shares climbed 47.4% after Amphenol Corp agreed to acquire PCTEL for around $139.7 million. ContraFect Corporation shares jumped 30% after the company reported FDA clearance of CF-370 IND application to proceed with Phase 1 clinical study. On the downside, BioNTech SE fell 6% after Pfizer, its partner, cut its COVID-19 vaccine and therapy sales outlook.

Portfolio Pulse from Lisa Levin

October 16, 2023 | 12:47 pm

APRE

Aprea Therapeutics, Inc. (NASDAQ:APRE) presented initial clinical data on ATRN-119 and pre-clinical data on ATRN-1051 at the AACR-NCI-EORTC International Conference. The data includes first-in-human clinical data from the ongoing Phase 1 dose escalation trial of ATRN-119, and pre-clinical data from the WEE1 inhibitor, ATRN-1051. The company plans to submit an IND for ATRN-1051 in Q4 2023. ATRN-119 is in an ongoing Phase 1/2a dose escalation trial in solid tumors, with no hematologic or liver function toxicities observed so far. The company anticipates dose expansion of the trial in Q2 2024.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:45 pm

ETWO

Elliott Investment has expressed its intention to engage in dialogue with E2open Parent Holdings' board and management about strategic opportunities. The firm plans to communicate with E2open's management and board about a broad range of operational matters, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:42 pm