BPC January 03 update

Immix IMMX +62% Rare Pediatric Disease designation; Genprex GNPX +167% MRK Fast Track Designation

Price and Volume Movers

The FDA granted Fast Track Designation (FTD) to Genprex, Inc. (NASDAQ: GNPX) for REQORSA in combination with Merck & Co's (NYSE: MRK) Keytruda to treat non-small cell lung cancer (NSCLC). Shares closed up +167% at $3.50.

Applied Therapeutics, Inc. (NASDAQ: APLT) announced that it decided to hold off on submitting a New Drug Application (NDA) for AT-007 for treatment of Galactosemia following discussions with the FDA. Shares closed down 30% at $6.22.

Immix Biopharma, Inc. (NASDAQ: IMMX) announced that the FDA granted Rare Pediatric Disease (RPD) designation for IMX-110 to treat rhabdomyosarcoma, pediatric cancer in children. IMX-110 is currently in a Phase 1b/2a clinical trial. Shares closed up 62% at $5.78.

ImmunityBio Inc. (NASDAQ: IBRX) and Amyris, Inc. (NASDAQ: AMRS) announced the completion of a joint venture agreement to accelerate the commercialization of a leading next-generation COVID-19 vaccine. The companies plan on completing human trials and delivering vaccines in 2022. Shares closed up 24% at $7.53.

Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) announced a public offering of $400 million of shares of common stock. Shares are trading down 10% at $47 during after-hours.

Advancers

CompanyPriceChange
ARDS
Aridis Pharmaceuticals Inc.
$1.60+0.27  +20.30%
CINC
CinCor Pharma Inc.
$18.20+2.13  +13.25%
RVLP
RVL Pharmaceuticals plc
$1.20+0.11  +10.09%
ITCI
Intra-Cellular Therapies Inc.
$42.66+3.79  +9.75%
GMDA
Gamida Cell Ltd.
$3.24+0.28  +9.46%
HILS
Hillstream BioPharma Inc.
$3.36+0.23  +7.35%
KPTI
Karyopharm Therapeutics Inc.
$8.28+0.55  +7.12%
CNTX
Context Therapeutics Inc.
$2.10+0.13  +6.60%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$45.71+2.71  +6.30%
BDSI
BioDelivery Sciences International Inc.
$3.36+0.18  +5.66%

Decliners

CompanyPriceChange
IMMX
Immix Biopharma Inc.
$4.51-0.91  -16.79%
ACXP
Acurx Pharmaceuticals Inc.
$3.64-0.7  -16.13%
CGTX
Cognition Therapeutics Inc.
$3.50-0.64  -15.46%
HOOK
HOOKIPA Pharma Inc.
$1.50-0.26  -14.77%
CVAC
CureVac N.V.
$18.73-3.12  -14.28%
BFRI
Biofrontera Inc.
$3.47-0.53  -13.25%
BSGM
BioSig Technologies Inc.
$1.80-0.27  -13.04%
HCWB
HCW Biologics Inc.
$2.02-0.3  -12.93%
VRPX
Virpax Pharmaceuticals Inc.
$2.30-0.34  -12.88%
APM
Aptorum Group Limited
$1.48-0.21  -12.43%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALT – Altimmune Inc.
Pemvidutide (ALT-801)
Non-alcoholic steatohepatitis (NASH) - Healthy Overweight and Obese Volunteers

$6.99
+0.03  +0%
Phase 2 Phase 1b trial initiated, first patient has been enrolled October 4, 2021. Phase 1b top-line data reported mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with no serious adverse events, noted January 8, 2022. Phase 2 obesity and NASH trials expected to initiate in 1H 2022, with data readouts for obesity 4Q 2022, and for NASH in 2023.
$277.8 million

ANEB – Anebulo Pharmaceuticals Inc.
Anebulo (ANEB-001)
Cannabinoid overdose

$7.00
0.00  0%
Phase 2 Phase 2 trial initiated, noted January 3, 2022. IND expected to be submitted by 1Q 2022 with top-line data due 1H 2022.
$163.4 million

APLT – Applied Therapeutics Inc.
AT-007 - (ACTION-Galactosemia kids)
Galactosemia

$3.17
-0.23  -7%
Phase 1/2 Phase 1/2 trial clinical hold has been lifted - February 1, 2021. Phase 1/2 biomarker data reported a statistically significant reduction in Plasma galactitol of 40%, noted October 2021. Additional data from assessment due in 1Q 2022.
$83.1 million

GNPX – Genprex Inc.
REQORSA (GPX-001) with KEYTRUDA (pembrolizumab) - (Acclaim-2)
Non-Small Cell Lung Cancer (NSCLC)

$1.82
-0.20  -10%
Phase 1/2 Phase 1/2 trial to be initiated in 1Q 2022.
$87 million

HGEN – Humanigen Inc.
Lenzilumab
COVID-19

$2.54
-0.07  -3%
Phase 3 Phase 3 late-breaking results presented at CHEST Annual Meeting 2021 demonstrated an improvement in the likelihood of survival without ventilation by more than 3-fold compared with placebo and mortality was improved by more than 2-fold, noted October 19, 2021. Phase 3 data revealed a 54% relative improvement of survival without invasive mechanical ventilation, noted November 22, 2021. Phase 3 data reported that treated patients had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo, noted January 3, 2022.
$162.1 million

IMMX – Immix Biopharma Inc.
IMX-110
Pediatric rhabdomyosarcoma

$4.51
-0.91  -17%
Phase 1 Rare Pediatric Disease (RPD) designation granted January 3, 2022.
$34.2 million

PFE – Pfizer Inc.
Comirnaty (BNT162b2)
COVID-19 Vaccine (Booster)

$52.79
-1.26  -2%
Approved FDA EUA approval announced for 65 and older, or those 18 and older at high risk September 22, 2021. EUA approval expanded to include all individuals 18 years of age and older, noted November 19, 2021. EUA approval expanded to include adolescents 12 through 15 years of age, noted January 3, 2022.
$296.3 billion

PIRS – Pieris Pharmaceuticals Inc.
PRS-060/AZD1402
Asthma

$3.40
+0.06  +2%
Phase 2a Phase 2a data due 2022. Part 1a sponsor safety review completed and Part 2a and Part 1b enrollment initiated, noted January 3, 2022.
$245 million

RXDX – Prometheus Biosciences Inc.
PR600
Inflammatory bowel disease (IBD)

$32.54
-1.60  -5%
Phase 1 IND expected to be submitted 3Q 2022.
$1.3 billion

SPRO – Spero Therapeutics Inc.
Tebipenem (SPR994)
Complicated urinary tract infections (cUTI)

$11.60
-0.45  -4%
PDUFA priority review PDUFA priority review date June 27, 2022.
$375 million