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CBAY

The FDA has granted a revised Breakthrough Therapy Designation to Seladelpar, a drug developed by CymaBay Therapeutics (CBAY), for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 12:18 pm

PDSB

PDS Biotechnology Corporation (NASDAQ:PDSB) announced preliminary results from a subset of patients in a Phase 2 clinical trial (VERSATILE-002) evaluating the safety and efficacy of PDS0101 in combination with Merck's KEYTRUDA® in patients with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma. The data suggests that the combination of PDS0101 and KEYTRUDA® may promote a TH1 predominant cytokine profile associated with improved killer T cell activity and anti-tumor activity.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:16 pm

GLTO

Galecto, Inc. (NASDAQ:GLTO) presented encouraging clinical data from its Phase 1b/2a GALLANT-1 trial at the ESMO Congress 2023. The trial studies the combination of atezolizumab and GB1211 in treating non-small cell lung cancer. The company reported a 60% response rate in patients who received GB1211 for at least three weeks, compared to a 22-38% response rate with atezolizumab monotherapy. Galecto has decided not to initiate Part B of the GALLANT-1 trial and will instead focus on severe liver diseases. The company will continue to supply GB1211 for an upcoming Phase 2 trial.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:14 pm

ENPH

Enphase Energy, Inc. (ENPH) has entered the Greek solar market with the launch of its IQ8 Microinverters and IQ Batteries. This comes as the Greece Ministry of Environment and Energy has launched a subsidy program to expand solar-plus-battery storage systems and reach its goal of building two gigawatts of residential solar capacity by 2030. The program covers up to 65% of solar system costs and approximately 90% of battery costs.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:11 pm

AMAM

Ambrx Biopharma, Inc. (NASDAQ:AMAM) has announced promising results from the Phase 1 portion of the ongoing APEX-01 trial for ARX517, a PSMA-targeted ADC. The trial demonstrated a 52% PSA50 reduction and a highly differentiated safety and PK profile in patients with mCRPC, who had progressed on multiple FDA-approved treatments. The data also showed a strong and highly differentiated safety profile across 65 patients at all dose levels with no treatment-related SAEs or DLTs.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:10 pm

ARDX

Ardelyx, Inc. (NASDAQ:ARDX) will present positive data on IBSRELA, a treatment for irritable bowel syndrome with constipation (IBS-C), at the American College of Gastroenterology (ACG) annual meeting. The data includes findings from phase 2b and phase 3 T3MPO studies, which show that patients experience a quick onset of symptom relief under tenapanor treatment and that weekly response rates increase with treatment duration. The company will also host a product theater at the event.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:08 pm

TARA

Protara Therapeutics has announced the dosing of the first patient in its Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with lymphatic malformations. This marks a significant step in the company's clinical development program.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 12:06 pm

IMMP

MRK

Immutep Limited (NASDAQ:IMMP) has announced promising clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (efti) in combination with Merck & Co., Inc.'s (NYSE:MRK) anti-PD-1 therapy KEYTRUDA as a first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC). The data shows promising overall survival, overall response rate, progression free survival, and duration of response across all PD-L1 subgroups. Immutep plans to launch a Phase III trial next year.

Portfolio Pulse from Happy Mohamed

October 23, 2023 | 12:06 pm

ACST

Acasti Pharma has announced the dosing of the first patient in its GTX-104 STRIVE-ON trial. This marks a significant milestone in the company's clinical development program.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 12:05 pm

MDT

Medtronic has received FDA approval for its extravascular defibrillator, a device designed to treat abnormal heart rhythms and sudden cardiac arrest. This approval could potentially boost the company's market share in the cardiac devices sector.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 12:03 pm