BPC June 17 update

MREO AZN Bid rumors; Kazia KZIA Orphan Drug Designation

Pre-Market Updates

Yesterday's BIOrdle ticker was INFI. Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) is a clinical-stage biotechnology company immuno-oncology treatments. Infinity has two catalysts upcoming in the second half of the year for its MARIO-275 and MARIO-3 late stage cancer trials. Shares closed yesterday down 7% at $0.68.

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Mereo BioPharma Group plc (NASDAQ: MREO) shares are trading up the pre-market after the UK journal, The Times reported that AstraZeneca (NASDAQ: AZN) may be considering a bid for the company. The speculative claims were made without attribution.

Kazia Therapeutics Limited (NASDAQ:KZIA) announced that the FDA granted Orphan Drug Designation (ODD) to paxalisib to treat atypical rhabdoid / teratoid tumors (AT/RT), a childhood brain cancer.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares will be halted for trading today, ahead of the FDA’s Advisory Committee meeting to review its resubmitted NUPLAZID (pimavanserin) supplemental New Drug Application(sNDA) for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.

Cytokinetics, Incorporated (NASDAQ: CYTK) announced that the FDA has extended the review period for its New Drug Application regarding omecamtiv mecarbil to treat heart failure with reduced ejection fraction (HFrEF) by three months to February 28, 2023. The extension is due to the submission of additional data that constitutes a major amendment to the application.

Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) announced the FDA’s decision regarding its supplementary New Drug Application (sNDA) for IMCIVREE (setmelanotide), noting that for Bardet-Biedl syndrome it was approved, but for Alström syndrome it was not approved. During the after-hours yesterday Rhythm also announced a $100 million financing agreement.

ObsEva SA (NASDAQ: OBSV) announced that the European Commission granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the treatment of uterine fibroids.

Sierra Oncology, Inc. (NASDAQ: SRRA) submitted a New Drug Application (NDA) to the FDA regarding momelotinib to treat myelofibrosis. The company expects the FDA to respond as to whether this submission is accepted within 60 days.

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%