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Regulatory

CFRX

ContraFect has received FDA clearance for its Investigational New Drug (IND) application for CF-370, allowing it to proceed with Phase 1 clinical trials.

Portfolio Pulse from Bill Haddad

October 16, 2023 | 11:31 am

EXAI

Exscientia announced that two abstracts will be presented at the European Society for Medical Oncology Congress 2023. The abstracts demonstrate the preclinical efficacy of LSD1 inhibitor in primary AML samples and the potential of LSD1 inhibitor with AML standard of care therapies. They also show tumor growth inhibition through MALT1 in monotherapy and combination while lowering bilirubin toxicity risk.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:24 am

TRVN

Trevena has reported positive topline safety and tolerability data for the two Phase 1 proof-of-concept studies of TRV045. The results were consistent with prior first-in-human study, with no drug-related adverse events, serious adverse events, lymphopenia, bradycardia, or change in blood pressure reported.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:22 am

FRLN

Freeline Therapeutics will present new clinical data from its ongoing Phase 1/2 GALILEO-1 trial of FLT201 gene therapy candidate for Gaucher Disease Type 1 at the European Society of Gene & Cell Therapy Annual Congress.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:18 am

OLMA

Olema Oncology has announced that the Phase 2 clinical results of Palazestrant for metastatic breast cancer will be presented at the 2023 ESMO Congress.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:14 am

TNXP

Tonix Pharmaceuticals has completed the clinical phase of the Phase 2 UPLIFT1 study of TNX-601 ER, a potential treatment for Major Depressive Disorder. The topline results from the intention-to-treat sample are expected in early November 2023.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:13 am

OMGA

Omega Therapeutics has announced new preclinical data for OTX-2101, a potential treatment for non-small cell lung cancer. The data was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The treatment is being tested in combination with immune checkpoint inhibitors or EGFR inhibitors.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:11 am

BNOX

Bionomics has announced the outcomes of an end-of-phase 2 meeting with the FDA for BNC210, a drug for the acute treatment of social anxiety disorder. The company plans to move into phase 3 studies, with the first patient dosing planned for Q1 FY24.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 10:55 am

MRK

The European Commission has approved Merck's KEYTRUDA as a treatment for adults with non-small cell lung cancer at high risk of recurrence. This follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on results from the Phase 3 KEYNOTE-091 trial.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 10:47 am

AAC

Ares Acquisition (AAC) and X-Energy Reactor Company, LLC have announced the effectiveness of their registration statement and an extraordinary general meeting scheduled for October 31, 2023, to approve their business combination.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 10:33 am