Streetbeat News

Regulatory

INAB

IN8bio, Inc. (NASDAQ:INAB) presented new biological correlative data from the ongoing Phase 1 clinical trial of INB-200 targeting newly diagnosed glioblastoma multiforme (GBM) at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting. The data demonstrated the ability of INB-200, a DeltEx drug-resistant immunotherapy (DRI) gamma-delta T cell therapy, to induce T cell persistence and a sustained immune response. The company will present updated patient, survival and enrollment data from the study at the Society for Neuro-Oncology (SNO) Annual Meeting on November 17, 2023.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:47 pm

CBUS

Cibus, Inc. (NASDAQ:CBUS), an agricultural technology company, has acknowledged the European Parliament's draft report on the proposal for regulation of plants obtained from New Genomic Techniques (NGTs). The proposal supports the introduction of a new regulation on plants obtained by NGTs and identifies a 'Conventional-like' category of NGT products. This would bring EU policy closer to that of trading partners in North and South America, Australia, and Japan. Products from Cibus' gene editing platform, such as disease-resistant canola and oilseed rape, would be considered 'Conventional-like'.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:45 pm

SLNO

Soleno Therapeutics (NASDAQ:SLNO) has published one-year results from the Phase 3 DESTINY PWS study and the open-label extension period of Study C602, evaluating DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS). The study demonstrated significant, sustained reductions in hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients. Soleno anticipates submitting an NDA to the FDA for DCCR in mid-2024.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:44 pm

MBRX

Moleculin Biotech, Inc. (NASDAQ:MBRX) has presented preliminary efficacy findings from its Phase 1B/2 clinical trial of Annamycin for the treatment of soft tissue sarcoma lung metastases. The trial demonstrated a 64% stable disease rate through two cycles of Annamycin. The drug continues to be 100% non-cardiotoxic and has Fast Track Status and Orphan Drug Designation from the FDA. The company's CEO, Walter Klemp, expressed confidence in the potential of Annamycin to be a meaningful treatment option for patients.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:44 pm

NVO

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released research showing that the European Commission's draft Pharmaceutical Legislation could make Europe less innovative than the U.S., China, and Japan. The legislation could decrease the motivation for companies to invest in new medicines by 55% in Europe over the next 15 years. This could result in Europe's share in global research and development declining from 32% to 21% by 2040, leading to €2 billion per year in lost investment. EFPIA President and CEO of Novo Nordisk A/S (NYSE: NVO), Lars Fruergaard Jorgensen, stated that many of Novo's new medicines are being developed in the U.S. due to its more attractive environment.

Portfolio Pulse from Vandana Singh

November 06, 2023 | 1:42 pm

WE

A fake press release circulated among traders on November 3, stating that there was an offer to purchase 51% of WeWork at $9 per share. The related article from Cole Capital has been withdrawn.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:38 pm

MYO

Myomo, Inc. (NYSE:MYO), a wearable medical robotics company, announced that the Centers for Medicare & Medicaid Services (CMS) has posted a proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rate for the MyoPro. The proposed rates for the two HCPCS codes describing the MyoPro are $31,745.42 and $62,457.28. The final rule classifying the MyoPro as a brace will enable reimbursement on a lump sum basis from January 1, 2024.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:32 pm

FEZ

GLD

JD

PDD

The ongoing Israel-Hamas conflict continues to impact the Middle East and global markets. Israeli forces have encircled Gaza City and struck over 450 Hamas targets. U.S. Secretary of State Antony Blinken is undertaking diplomatic efforts in the region. The Israeli shekel strengthened against the dollar, oil prices rose, and gold prices fell. European equities eased slightly, while futures on the S&P 500 and the Nasdaq 100 Indices were up. Chinese-related stocks PDD Holdings Inc. and JD.Com Inc. performed well in premarket trading.

Portfolio Pulse from Piero Cingari

November 06, 2023 | 1:32 pm

BTAI

BioXcel Therapeutics has announced an update on the NIDA-funded trial of BXCL501 for potential treatment of opioid use disorder. The trial, led by Columbia University, is expected to add a fourth site and aims to complete the 4-arm, 160-patient trial in 2024.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:21 pm

RWLK

ReWalk Robotics has announced that the Centers for Medicare & Medicaid Services (CMS) has included its ReWalk Personal Prosthetic Exoskeleton System in the agenda for the upcoming Healthcare Common Procedure Coding System meeting on November 29.

Portfolio Pulse from Benzinga Newsdesk

November 06, 2023 | 1:19 pm