BPC June 14 update

Outset OM Shipment hold; Soleno SLNO Long term PWS data

Pre-Market Updates

Yesterday's BIOrdle ticker was SGMO. Sangamo Therapeutics, Inc. (NASDAQ:SGMO) is a genomic medicine company. Sangamo will read out data from two Phase ½ trials in the second half of this year, one for SAR445136 to treat sickle cell disease and another for ST-920 to treat fabry disease. Shares closed yesterday down 13% at $3.28.

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Soleno Therapeutics, Inc. (NASDAQ: SLNO) continues to trade up in the pre-market after it presented clinical data of diazoxide choline extended-release (DCCR) to treat Prader-Willi syndrome (PWS) from a Phase 3 and open-label trial. The long term data reported that DCCR showed metabolic and body composition improvements.

Outset Medical, Inc. (NASDAQ: OM) announced it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use, pending the FDA’s review and clearance of a 510(k) application submitted for changes made since the device's original March 2020 clearance.

Stealth BioTherapeutics Corp (NASDAQ: MITO) announced that a Type B meeting is scheduled with FDA's Division of Cardiology and Nephrology to discuss new data for its new drug application (NDA) submission regarding elamipretide for the treatment of Barth Syndrome. Stealth previously received a refusal to file letter due to issues with its Phase 2 and open label trial data.

Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) commenced a public offering of $125 million of shares of its stock.

Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that it expects to re-submit its Biologics License Application (BLA) by September 2022 following receipt of additional correspondence from the FDA.

Cogent Biosciences, Inc. (NASDAQ: COGT) priced its public offering of 15,169,698 shares of stock at $8.25 per share. Cogent is also offering pre-funded warrants to purchase 3,030,302 shares of its stock at $8.24 per pre-funded warrant. The gross proceeds are to be approximately $150 million.

Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the FDA approved OLUMIANT (baricitinib) as a treatment for adults with severe alopecia areata (AA).

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced that the FDA approved AMVUTTRA (vutrisiran) to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

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%