Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

FDA Gives Green Signal To Pfizer/BioNTech's COVID-19 Booster For Kids 5-11 Years

The FDA has authorized a booster shot of Pfizer Inc PFE and BioNTech SE's BNTX COVID-19 vaccine for children aged 5 to 11. Kids will be eligible for the booster at least five months after completing a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

The move makes everyone in the U.S over the age of 5 eligible for a third shot or a booster.

Aquestive Therapeutics Announces CEO Transition

Aquestive Therapeutics Inc AQST CEO, president and board member, Keith Kendall, is leaving the company. 

The board has appointed Daniel Barber, the current Chief Operating Officer, as the president & CEO, effective immediately. Kendall will assist in the transition of the role of CEO and the execution of the company's business strategy and operations until the end of the year.

IAVI, Moderna Launch First African Trial Of mRNA HIV Vaccine

The nonprofit scientific research organization IAVI and Moderna, Inc MRNA will soon start participant screening for the Phase 1 trial of an mRNA HIV vaccine antigen (mRNA-1644) in Rwanda and South Africa.

Recent findings from the Phase 1 trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein safely induced the targeted immune responses in 97% of recipients. 

IAVI G003 will test the hypothesis that vaccination with eOD-GT8 60mer, delivered via Moderna's mRNA platform, can induce similar immune responses in African populations as was seen for IAVI G001.

Tonix Pharma Extends Research Pact For Antiviral Drugs Against COVID-19

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Tonix Pharmaceuticals Holding Corp TNXP has entered into a license agreement and extended a research collaboration with the University of Alberta, focused on identifying and testing broad-spectrum antiviral drugs against future SARS-CoV-2 variants and other emerging viruses.

The research collaboration is focused on developing and testing of Wnt/β-Catenin signaling pathway inhibitors as broad-spectrum antivirals. 

Keros Therapeutics Posts Preliminary Data Early-Stage KER-012 Trial

Keros Therapeutics Inc KROS announced preliminary topline results from Part 1 of its Phase 1 trial evaluating single and multiple ascending doses of KER-012 in healthy postmenopausal volunteers.

KER-012 was generally well tolerated in Part 1 at dose levels up to 5 mg/kg, the highest dose level tested when administered as a single dose. 

No serious adverse events were reported. Additionally, most of the adverse events observed in Part 1 of this trial were mild in severity.

Seelos Receives Additional Patent For SLS-007

Seelos Therapeutics Inc SEEL has received a Notice of Allowance for the U.S. patent for SLS-007.

The patent covers the method of treating several neurodegenerative diseases through contacting alpha-synuclein (α-synuclein) protofilaments with an effective amount of SLS-007.

Acasti Pharma's IV Hemorrhage Drug Compares Favorably With Oral Nimodipine

Acasti Pharma Inc's ACST pharmacokinetic bridging study with IV GTX-104, its lead drug candidate for Subarachnoid Hemorrhage, met all its planned study endpoints. 

All three endpoints indicated that statistically, there was no difference in exposures between IV GTX-104 and oral nimodipine over the defined periods for maximum and total exposure. 

Clinical Readouts/Presentations

American Society for Gene & Cell Therapy (ASGCT) 25th Annual Meeting

Homology Medicines Inc FIXX: Detailing the optimization and mechanism of action of its HMI-103 nuclease-free gene editing candidate for phenylketonuria.

4th Annual Treg Directed Therapies Summit

NightHawk Biosciences NHWK: Data on PTX-35 Treg immunomodulator with utility in both oncology and auto/inflammation

Offerings

Baudax Bio Inc BXRX announced a registered direct offering of 1.65 million shares at $1.215 per share, for gross proceeds of $2 million.

Concurrently, the company also agreed to issue a private placement of warrants to purchase up to 1.65 million shares.

Celularity Inc CELU has announced a private placement of 4.1 million shares at $7.40 per share and warrants to purchase 4.1 million shares at an exercise price of $8.25 per share, resulting in gross proceeds of approximately $30 million.

On The Radar

Earnings

Calliditas Therapeutics CALT: Before the market open.