BPC November 22 update

Aurinia AUPH Mixed shelf offering; Affimed AFMD Phase 1/2 data

Pre-Market Updates

Aurinia Pharmaceuticals (NASDAQ: AUPH) has filed a FORM S-3ASR with the SEC for a mixed shelf offering. The filing indicates that Aurinia may, from time to time, offer and sell up to $250 million of securities such as common shares, debt, and warrants either individually or in any combination.

Provention Bio, Inc. (NASDAQ: PRVB) provided an update from a Type A meeting held on November 18, 2021, following a Complete Response Letter (CRL) regarding teplizumab. The FDA approved the proceeding to populate a popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic (PK/PD) substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes (T1D) patients.

Affimed N.V. (NASDAQ: AFMD) announced interim clinical results from the Phase 1/2 study of cbNK cells with AFM13 to treat relapsed or refractory Hodgkin and non-Hodgkin lymphomas. Results reported a 100% objective response rate with a 42% complete response rate in 12 patients.

Amryt Pharma plc (NASDAQ: AMYT) announced its intention to cancel the admission of its ordinary shares of nominal value £0.06 each to trading on AIM, effective on January 11, 2022. Amryt will retain its listing on the Nasdaq Global Select Market.

Mirati Therapeutics, Inc. (NASDAQ: MRTX) and Verastem Oncology (NASDAQ: VSTM) announced a non-exclusive clinical collaboration agreement to evaluate the combination of Mirati's investigational KRASG12C inhibitor adagrasib with Verastem Oncology's investigational RAF/MEK inhibitor VS-6766 in a Phase 1/2 trial to treat KRASG12C-mutant non-small cell lung cancer (NSCLC).

Bluebird bio, Inc. (NASDAQ: BLUE) announced that the FDA accepted its Biologics License Application (BLA) for betibeglogene autotemcel (beti-cel) for priority review with a PDUFA date of May 20, 2022.

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%