Streetbeat News

Regulatory

RLMD

Relmada Therapeutics, Inc. (NASDAQ:RLMD) announced positive efficacy and safety results from the Phase 3 long-term study of REL-1017 in patients with Major Depressive Disorder (MDD). The study showed that patients treated with REL-1017 experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment. The drug was well-tolerated with low rates of adverse events and discontinuations due to adverse events. No new safety signals were detected.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:31 pm

SILO

Silo Pharma, Inc. (NASDAQ:SILO) has announced positive pre-clinical data for SPC-15, a targeted intranasal prophylactic for the treatment and prevention of anxiety, PTSD, and other stress-related disorders. The company is working with Kymanox to prepare a pre-Investigational New Drug (IND) package and meeting request with the FDA, with submission targeted for Q1 2024. Kymanox will provide regulatory affairs support, including the development of a clinical pharmacology and biopharmaceutics strategy and program.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:29 pm

AVGR

BRDS

ELUT

EXAI

FRTX

SPRY

Shares of several companies including TransCode Therapeutics, Fresh Tracks Therapeutics, EBET, Exscientia, Histogen, Rail Vision, Avinger, Inhibikase Therapeutics, Microbot Medical, and Cheche Group are trading higher in pre-market. Fresh Tracks Therapeutics and Histogen announced plans of liquidation and dissolution. Exscientia and Merck announced collaboration on AI-driven drug discovery. Avinger announced the commercial launch of its Tigereye ST image-guided CTO crossing device. On the other hand, shares of ARS Pharmaceuticals, Connexa Sports Technologies, Bird Global, TD Holdings, AgileThought, Elutia, Digital Transformation Opportunities Corp., Cybin, and Revance Therapeutics are trading lower. ARS Pharmaceuticals received a Complete Response Letter from the FDA for its neffy® Epinephrine nasal spray. Bird Global announced its purchase of micromobility operator Skinny Labs for $19 million. Elutia announced a $26 million private placement of shares.

Portfolio Pulse from Lisa Levin

September 20, 2023 | 12:19 pm

ATVI

MSFT

VGK

The UK's Competition and Markets Authority (CMA) is expected to issue a preliminary decision on Microsoft's Activision Blizzard deal next week. This follows Microsoft restructuring its deal to transfer cloud gaming rights for current and new Activision Blizzard games to Ubisoft. The final decision is due by October 18th.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:15 pm

PDSB

PDS Biotechnology Corporation (NASDAQ:PDSB) announced that its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses in preclinical studies. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets. The data were presented at the 9th European Scientific Working Group on Influenza (ESWI) Conference. PDS0202 combines PDS Biotech's Infectimune® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:08 pm

TAK

The FDA has accepted Takeda's resubmission of its New Drug Application for TAK-721 (Budesonide Oral Suspension) for the short-term treatment of Eosinophilic Esophagitis.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:07 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has been granted a new U.S. patent for its EVM301 Series of drug candidates, which are carboxylated psilocybin derivatives aimed at treating mental health disorders. The patent covers novel compositions and pharmaceutical drug formulations, and is expected to strengthen and add value to Enveric's EVM301 Series. The company's CEO believes this could greatly enhance the commercial opportunity of EVM301 Series-based therapies.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:06 pm

AAPL

AMZN

GOOG

During a federal antitrust trial, Google's VP for advertising products, Jerry Dischler, expressed concerns about Google's decreasing market share in the advertising industry. He highlighted the increasing competition from companies like Amazon and TikTok. The trial also discussed Google's control over ad pricing and changes in auction dynamics. The outcome of this trial could reshape the digital advertising industry.

Portfolio Pulse from Anusuya Lahiri

September 20, 2023 | 12:06 pm

VIR

Vir Biotechnology has initiated a Phase 1 trial of VIR-1388, a novel T cell vaccine for the prevention of HIV. The first participant has been dosed and initial data from the trial is expected in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 12:04 pm

SPRY

ARS Pharma's shares are trading lower following the FDA's Complete Response Letter for the company's neffy epinephrine nasal spray, requesting additional study.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 11:51 am