BPC June 09 update

Bluejay BJDX FDA De Novo support; Sonnet SONN Preclinical oncology data

Pre-Market Updates

Yesterday's BIOrdle ticker was RLMD. Relmada Therapeutics, Inc. (NASDAQ: RLMD) is a late-stage company developing treatments for diseases of the central nervous system (CNS). Relmada will be releasing Phase 3 data from its RELIANCE I trial to treat depression in the third quarter this year. Shares closed yesterday down 6% at $18.45.

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Bluejay Diagnostics, Inc. (NASDAQ: BJDX) announced that the FDA has agreed to consider its plan to pursue a De Novo submission for the Symphony IL-6 Test, a near-patient testing system that provides quantitative measurements of specific biomarkers.

Sonnet BioTherapeutics (NASDAQ: SONN) released data from a preclinical combination study of SON-1010 with an anti-PD1 compound. Data noted that the combination increased the survival rate and demonstrated efficacy in a B16F10 mouse melanoma model.

Novavax, Inc. (NASDAQ: NVAX) shares are trading down after the FDA said it needs to review changes to Novavax’s manufacturing before deciding whether to authorize its Covid-19 vaccine in the U.S. Novavax notified the FDA of the change of manufacturing on June 3.

bluebird bio, Inc. (NASDAQ: BLUE) shares will be halted today and tomorrow due to the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meeting to discuss the biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).

Caladrius Biosciences, Inc. (NASDAQ: CLBS) reported that its merger partner, Cend Therapeutics, Inc. announced that the first patient has been treated in the Phase 2b ASCEND study of CEND-1 in combination with gemcitabine and nab-paclitaxel to treat metastatic pancreatic ductal adenocarcinoma.

Seelos Therapeutics, Inc. (NASDAQ: SEEL) announced data from an in vitro study of its gene-therapy, SLS-004, to treat dementia with Lewy bodies (DLB). Data demonstrating a statistically significant 19% down regulation of mRNA and a ~40% reduction of alpha synuclein (α-synuclein).

Pre-Market Advancers

CompanyPriceChange
TALS
Talaris Therapeutics Inc.
$1.01 +1.01  +100%
AKUS
Akouos Inc.
$1.01 +1.01  +100%
QNRX
Quoin Pharmaceuticals Ltd.
$1.01 +1.01  +100%
BBI
Brickell Biotech, Inc.
$1.01 +1.01  +100%
AKBA
Akebia Therapeutics Inc.
$1.01 +1.01  +100%
ALNA
Allena Pharmaceuticals Inc.
$1.01 +1.01  +100%
PRVB
Provention Bio Inc.
$1.01 +1.01  +100%
IVC
Invacare Corporation
$1.01 +1.01  +100%
ENSC
Ensysce Biosciences Inc.
$1.01 +1.01  +100%
BNTC
Benitec Biopharma Inc.
$1.01 +1.01  +100%

Pre-Market Decliners

CompanyPriceChange
CADL
Candel Therapeutics Inc.
$1.01 -1.01  -100%
CLVS
Clovis Oncology Inc.
$1.01 -1.01  -100%
ENDP
Endo International plc
$1.01 -1.01  -100%
TYRA
Tyra Biosciences Inc.
$1.01 -1.01  -100%
CTKB
Cytek Biosciences Inc.
$1.01 -1.01  -100%
BLTE
Belite Bio Inc
$1.01 -1.01  -100%
MREO
Mereo BioPharma Group plc
$1.01 -1.01  -100%
CRTX
Cortexyme Inc.
$1.01 -1.01  -100%
PULM
Pulmatrix Inc.
$1.01 -1.01  -100%
RXST
RxSight Inc.
$1.01 -1.01  -100%