The Daily Biotech Pulse: Pfizer/BioNTech's COVID-19 Booster For Kids, Moderna Starts First African Trial Of mRNA HIV Vaccine, Tonix Extends COVID-19 Antiviral Research Pact

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

Click here to access Benzinga's FDA Calendar

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


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


Calliditas Therapeutics CALT: Before the market open.

Posted In: COVID-19 CoronavirusCOVID-19 VaccineBiotechEarningsLarge CapNewsPenny StocksHealth CareContractsSmall CapFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.