BPC November 19 update

Moderna MRNA Booster EUA; Gracell GRCL Orphan Drug Designation

Pre-Market Updates

Moderna, Inc. (NASDAQ: MRNA) announced that the FDA has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. This booster is for all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced that the FDA granted Orphan Drug Designation for GC012F, Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma.

Voyager Therapeutics, Inc. (NASDAQ: VYGR) reported findings from its preclinical analysis of a proprietary TRACER AAV vector, noting that it achieved widespread transduction of brain tissue and efficacious levels of HER2-directed antibodies for extended periods.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced an underwritten public offering of American Depositary Shares (ADSs). Each ADS represents ten ordinary shares.

Connect Biopharma Holdings Limited (NASDAQ: CNTB) reported top-line results from its Phase 2 trial of CBP-201 to treat atopic dermatitis (AD). The data showed that the trial met its primary efficacy endpoint with a low reported incidence of injection site reactions (1.8%) and conjunctivitis (3.5%).

Longeveron Inc. (NASDAQ: LGVN) is maintaining a rally in the pre-market after the FDA gave rare pediatric disease designation to its drug, Lomecel-B to treat Hypoplastic Left Heart Syndrome (HLHS).

Pre-Market Advancers

CompanyPriceChange
PTN
Palatin Technologies Inc.
$0.79+0.2324  +41.68%
STSA
Satsuma Pharmaceuticals Inc.
$5.96+0.71  +13.52%
BYSI
BeyondSpring Inc.
$16.25+1.9  +13.24%
ACHL
Achilles Therapeutics plc
$5.39+0.55  +11.36%
OGEN
Oragenics Inc.
$0.60+0.0488  +8.87%
DRMA
Dermata Therapeutics Inc.
$2.93+0.23  +8.52%
UNCY
Unicycive Therapeutics Inc.
$3.16+0.24  +8.22%
WDNA
WisdomTree BioRevolution Fund
$26.00+1.8493  +7.66%
LOGC
LogicBio Therapeutics Inc.
$3.15+0.21  +7.14%
URGN
UroGen Pharma Ltd.
$13.00+0.86  +7.08%

Pre-Market Decliners

CompanyPriceChange
NAVB
Navidea Biopharmaceuticals Inc.
$1.15-0.15  -11.54%
IKT
Inhibikase Therapeutics Inc.
$1.91-0.15  -7.28%
PSTI
Pluristem Therapeutics Inc.
$2.52-0.17  -6.32%
BPTS
Biophytis SA
$5.40-0.36  -6.25%
APVO
Aptevo Therapeutics Inc.
$12.26-0.81  -6.20%
ANGN
Angion Biomedica Corp.
$3.54-0.2099  -5.60%
PBLA
Panbela Therapeutics Inc.
$1.86-0.11  -5.58%
VLON
Vallon Pharmaceuticals Inc.
$5.05-0.26  -4.90%
RVPH
Reviva Pharmaceuticals Holdings Inc.
$3.60-0.18  -4.76%
CRNX
Crinetics Pharmaceuticals Inc.
$23.25-1.15  -4.71%