BPC June 13 update

Day One DAWN Phase 2 glioma data; Bluebird BLUE Double AdCom success

Pre-Market Updates

Friday’'s BIOrdle ticker was CHNA. Loncar China BioPharma ETF (NASDAQ: CHNA) is an exchange traded fund that offers exposure to a number of companies powering China's biopharmaceutical industry. Its top holdings include Simcere Pharmaceutical and Hansoh Pharmaceutical. Shares closed Friday down 1% at $18.46.

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Bluebird Bio, Inc. (NASDAQ: BLUE) shares are trading up in the pre-market after an FDA Advisory Committee voted in favor of two biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).

LENSAR, Inc. (NASDAQ: LNSR) announced that the FDA granted 510(k) clearance for its next-generation ALLY Adaptive Cataract Treatment System.

Day One Biopharmaceuticals (NASDAQ: DAWN) announced initial data from its Phase 2 FIREFLY-1 trial of tovorafenib to treat low-grade glioma. Data show an overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in the first 22 evaluable patients treated.

Hillstream BioPharma, Inc. (NASDAQ: HILS) announced that its Board of Directors has authorized a share repurchase program to acquire up to $1 million of the Company's common stock.

Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced updated clinical data from a Phase 1 trial of GC012F to treat relapsed/refractory multiple myeloma (RRMM), noting that the response rate at different dose levels was 100% (2/2) in DL1, 80% (8/10) in DL2, and 100% (17/17) in DL3. All patients achieved minimal residual disease (MRD) negativity.

Valneva SE (NASDAQ: VALN) announced that it proposed a remediation plan after the European Commission sent a notice of intent to terminate the advance purchase agreement for its inactivated COVID-19 vaccine candidate.

Optinose (NASDAQ: OPTN) announced data from its Phase 3 ReOpen2 trial of XHANCE to treat chronic sinusitis. Data showed statistically significant benefits for both the symptoms co-primary endpoint and the CT scan co-primary endpoint.

Cogent Biosciences, Inc. (NASDAQ: COGT) announced that it has commenced an underwritten public offering of $125 million of shares of its stock.

HC Wainwright & Co. maintained Fulcrum Therapeutics (NASDAQ: FULC) with a Buy rating and lowered the price target from $40 to $20.

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%