Streetbeat News

Regulatory

GMDA

Gamida Cell Ltd. (NASDAQ:GMDA) has published a sub-study of the Phase 3 clinical trial for Omisirge, its allogeneic stem cell transplant therapy. The study found that Omisirge facilitates faster immune reconstitution and a decreased rate of post-transplant viral infection compared to umbilical cord blood. Omisirge recipients demonstrated a significant advantage in median cell counts and received a higher median dose of CD34+ stem cells. The rate of infections in the first year were significantly lower with Omisirge.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:19 pm

DARE

Daré Bioscience has announced additional data from the exploratory Phase 2B Respond study evaluating topical Sildenafil Cream, 3.6% for Female Sexual Arousal Disorder. The Sildenafil Cream demonstrated statistically significant improvement in sexual desire, an exploratory endpoint. Improvements in arousal lubrication, orgasm, and sexual desire seen in the Sildenafil Cream group persisted through the end of the study.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:12 pm

BYRN

FB

Byrna has withdrawn its guidance for fiscal year 2023 due to the ban on advertising of its products on all Meta platforms. Despite this, Byrna still expects to improve its top- and bottom-line performance in fiscal 2023.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:11 pm

INMB

INmune Bio has announced that analysis of MRI scans from participants in its Phase 1B study shows that a novel gray matter biomarker improved after three months of treatment with XPro1595.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:09 pm

INTC

SNPS

Synopsys, Inc. (NASDAQ:SNPS) has announced its digital and custom design flows, powered by the Synopsys.ai™ full-stack AI-driven EDA suite, are certified for the Intel Foundry Services (IFS) Intel 16 process. The collaboration optimizes power, performance, and area for advanced chips targeting RF, storage, consumer, military, aerospace, and government applications. The collaboration also supports the U.S. Department of Defense's implementation of the Microelectronics Commons, a national network established under the CHIPS Act.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:08 pm

OCEA

Ocean Biomedical is developing a multivalent mRNA-based malaria vaccine that could target several stages in the malaria cycle. The company has also discovered a new therapeutic approach that could lead to a new class of anti-malarials. Ocean Biomedical holds multiple U.S. and global patents for both the vaccine and therapeutic approaches.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:06 pm

AKTX

Akari Therapeutics has chosen the version of long-acting PAS-Nomacopan that it will advance into clinical trials. The company is on schedule for an IND submission in the first half of 2024 and the start of clinical trials in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:05 pm

MAIA

MAIA Biotechnology, Inc. (NYSE:MAIA) has announced updates on disease control data for its ongoing THIO-101 phase 2 trial for advanced Non-Small Cell Lung Cancer (NSCLC). Of the first 11 patients enrolled, 9 (82%) met the primary endpoint of disease control. All patients have previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor and platinum-based chemotherapy for advanced NSCLC.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:03 pm

CING

Biopharmaceutical company Cingulate Inc. (NASDAQ:CING) has announced positive top-line results from its Phase 3 adult trial of lead candidate CTx-1301 (dexmethylphenidate), a treatment for attention deficit/hyperactivity disorder (ADHD). The drug is being developed as a once-daily stimulant medication, pending approval from the U.S. Food and Drug Administration (FDA).

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:02 pm

F

The U.S. has opened a probe into 346,071 Ford Escape SUVs due to a potential issue where the vehicle door may inadvertently open while driving, according to Reuters.

Portfolio Pulse from Charles Gross

July 11, 2023 | 11:47 am