BPC January 26 update

Immunocore IMCR Approval; TYME Discontinuation of SM-88

Pre-Market Updates

Immunocore Holdings plc (NASDAQ: IMCR) announced the approval of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Cortexyme, Inc. (NASDAQ: CRTX) announced that the FDA is placing a full clinical hold on atuzaginstat's (COR388) Investigational New Drug application (IND).

Vaccinex, Inc. (NASDAQ: VCNX) reported interim response data from the Phase 1b segment of the KEYNOTE-B84 study of pepinemab with KEYTRUDA (pembrolizumab) to treat head and neck squamous cell carcinoma (R/M HNSCC). Of the first three patients, two have reported complete responses (CR).

NRx Pharmaceuticals (NASDAQ: NRXP) received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI (Aviptadil) to patients with COVID-19 respiratory failure. Data reported that of the first 19 patients treated, three had died, 16 (84%) were reported to be alive by Jan. 22, 2021, 14 of these 16 patients had been discharged to a rehabilitation center or home and two remained in the hospital. No Serious Adverse Events (SAEs) related to ZYESAMI were reported.

TYME Technologies, Inc. (NASDAQ: TYME) announced the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) due to futility. The overall survival for the monotherapy was lower compared to standard of care chemotherapies.

MediciNova, Inc. (NASDAQ: MNOV) announced that it received a Notice of Intention to Grant from the European Patent Office for a patent application that covers MN-001 (tipelukast) and MN-002 for hepatic ballooning.

Gilead Sciences Inc. (NASDAQ: GILD) announced that the FDA placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms.

Pre-Market Advancers

CompanyPriceChange
ENDP
Endo International plc
$1.01 +1.01  +100%
ATHX
Athersys Inc.
$1.01 +1.01  +100%
FREQ
Frequency Therapeutics Inc.
$1.01 +1.01  +100%
EVFM
Evofem Biosciences Inc.
$1.01 +1.01  +100%
PTE
PolarityTE Inc.
$1.01 +1.01  +100%
ACRX
AcelRx Pharmaceuticals Inc.
$1.01 +1.01  +100%
IMMX
Immix Biopharma Inc.
$1.01 +1.01  +100%
HLVX
HilleVax Inc.
$1.01 +1.01  +100%
ATNF
180 Life Sciences Corp.
$1.01 +1.01  +100%
NVCT
Nuvectis Pharma Inc.
$1.01 +1.01  +100%

Pre-Market Decliners

CompanyPriceChange
GOVX
GeoVax Labs Inc.
$1.01 -1.01  -100%
FHTX
Foghorn Therapeutics Inc.
$1.01 -1.01  -100%
SIGA
SIGA Technologies Inc.
$1.01 -1.01  -100%
TXMD
TherapeuticsMD Inc.
$1.01 -1.01  -100%
NNVC
NanoViricides Inc.
$1.01 -1.01  -100%
TNYA
Tenaya Therapeutics Inc.
$1.01 -1.01  -100%
AEMD
Aethlon Medical Inc.
$1.01 -1.01  -100%
TPST
Tempest Therapeutics Inc.
$1.01 -1.01  -100%
IBIO
iBio Inc.
$1.01 -1.01  -100%
TNXP
Tonix Pharmaceuticals Holding Corp.
$1.01 -1.01  -100%