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Regulatory

IONM

Assure Holdings shares are trading higher after the company announced the filing of two Form RWs and requested the withdrawal of offering and business combination filings.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 12:05 pm

COGT

Cogent Biosciences has announced alignment with the FDA on the use of its novel patient-reported outcome measure, MS2D2, in the SUMMIT trial for evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis patients.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 12:05 pm

LGND

Ligand Pharmaceuticals has announced FDA approval for Ohtuvayre, a new COPD treatment. This approval increases their commercial stage portfolio to 11 products. Ligand will receive a $5.8M milestone payment and anticipates an additional $13.8M upon the commercial launch. The company is also entitled to low single-digit royalties on global sales.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 12:04 pm

ALLR

Allarity Therapeutics (NASDAQ:ALLR) has been granted a hearing before a Nasdaq Hearings Panel to present its plan for regaining compliance with NASDAQ listing requirements.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 12:02 pm

SXTP

60 Degrees Pharmaceuticals has enrolled the first patient in a clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine in treating human babesiosis. This is the world's first clinical trial for tafenoquine in babesiosis patients.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 12:00 pm

GSK

MRNA

PFE

The CDC's Advisory Committee on Immunization Practices (ACIP) has recommended RSV vaccines for adults aged 75 and above, and for those aged 60-74 with certain chronic conditions. This decision is seen as negative for GSK, which produces the Arexvy RSV vaccine, as it may lead to lower sales forecasts. The FDA recently expanded approval for Arexvy to adults aged 50-59 at increased risk. Pfizer and Moderna are also involved in the RSV vaccine market.

Portfolio Pulse from Vandana Singh

June 27, 2024 | 11:53 am

BRTX

BioRestorative Therapies has announced a Notice of Allowance for a patent related to its ThermoStem platform, which could enhance its intellectual property portfolio and market position.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 11:41 am

AGEN

Agenus Inc. announced that the Cancer Therapy Evaluation Program (CTEP) is accepting Letters of Intent (LOIs) for clinical studies using botensilimab, an anticancer agent developed in collaboration with Agenus. CTEP will also consider supplying botensilimab for nonclinical studies.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 11:35 am

SLN

Silence Therapeutics reports positive results from the ongoing SANRECO Phase 1 repeat dose study of Divesiran, indicating the drug is well tolerated with no major safety issues. The data supports advancing Divesiran into Phase 2 trials.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 11:32 am

BA

Boeing Co. (NYSE:BA) faces sanctions from the NTSB for unauthorized disclosure of 737 MAX investigation details, straining its relationship with government agencies and risking criminal charges from the DOJ. The FAA also issued a new safety directive for Boeing's 757-200 airplanes.

Portfolio Pulse from Benzinga Neuro

June 27, 2024 | 11:32 am