BPC November 22 update

Provention PRVB +15% Type A meeting; Qualigen QLGN +26% Price Target Increase

Price and Volume Movers

Provention Bio, Inc. (NASDAQ: PRVB) released an update on the Type A meeting with the FDA regarding the Complete Response Letter (CRL) it received for its type 1 diabetes treatment teplizumab. The FDA approved the proceeding to populate a popPK model with data from a pharmacokinetic/pharmacodynamic (PK/PD) substudy of the ongoing PROTECT Phase 3 trial. Shares closed up 15% at $7.18.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) shares closed up 26% at $1.25 following a Zach’s Small Cap report noting a $9 price target for the company.

Aurinia Pharmaceuticals (NASDAQ: AUPH) has filed a FORM S-3ASR with the SEC for a mixed shelf offering to offer and sell up to $250 million of securities such as common shares, debt, and warrants either individually or in any combination. Shares closed down 31% at $19.65

BioNTech SE (NASDAQ: BNTX) and Pfizer Inc (NYSE: PFE) released top-line results from a longer-term analysis of its Phase 3 trial of its COVID-19 vaccine in children aged 12-15. The vaccine was reported to be 100% effective against COVID-19. BioNTech shares closed up 11% at $321.71.

Kamada Ltd (NASDAQ: KMDA) acquired four FDA-approved commercial products from Saol Therapeutics for $95 million upfront and an additional $50 million in sales milestones during 2022-2034. Shares closed up 8% at $6.02.

Advancers

CompanyPriceChange
BFRI
Biofrontera Inc.
$7.90+2.68  +51.34%
NRXP
NRX Pharmaceuticals Inc.
$6.75+2.25  +50.00%
ADGI
Adagio Therapeutics Inc.
$25.12+6.39  +34.12%
ATNF
180 Life Sciences Corp.
$5.41+0.95  +21.30%
GOVX
GeoVax Labs Inc.
$4.69+0.81  +20.88%
MRNA
Moderna Inc.
$329.63+56.24  +20.57%
ICVX
Icosavax Inc.
$27.55+4.51  +19.57%
VALN
Valneva SE
$59.60+9.7  +19.44%
TYRA
Tyra Biosciences Inc.
$23.87+3.66  +18.11%
PTPI
Petros Pharmaceuticals Inc.
$2.09+0.26  +14.21%

Decliners

CompanyPriceChange
LGVN
Longeveron Inc.
$30.67-11.63  -27.49%
AMTI
Applied Molecular Transport Inc.
$16.33-2.66  -14.01%
NEXI
NexImmune Inc.
$7.94-1.06  -11.78%
IGMS
IGM Biosciences Inc.
$49.63-6.58  -11.71%
CRNX
Crinetics Pharmaceuticals Inc.
$24.40-3.08  -11.21%
AVRO
AVROBIO Inc.
$4.08-0.51  -11.11%
ELYM
Eliem Therapeutics Inc
$13.76-1.72  -11.11%
MRSN
Mersana Therapeutics Inc.
$6.95-0.82  -10.55%
MNOV
MediciNova Inc.
$3.22-0.35  -9.80%
TARS
Tarsus Pharmaceuticals Inc.
$25.00-2.7  -9.75%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-2820 (emetine)
COVID-19

$2.20
-0.06  -3%
Phase 2/3 Phase 2/3 trial initiation is dependent on the ability to raise non-dilutive capital, noted November 22, 2021.
$31.5 million

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

$2.20
-0.06  -3%
PDUFA PDUFA date June 5, 2022.
$31.5 million

AFMD – Affimed N.V.
AFM13 + NK cells (AFM13-104)
CD30-positive lymphomas

$6.97
-0.10  -1%
Phase 1/2 Phase 1/2 interim data showed a 100% objective response rate with a 42% complete response rate in 12 patients. No cases of serious adverse events such as cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease were observed, noted November 22, 2021. Updated results to be discussed on December 9, 2021.
$835 million

BLUE – bluebird bio Inc.
Betibeglogene autotemcel (beti-cel) (LentiGlobin)
β-Thalassemia

$10.50
-0.26  -2%
PDUFA priority review PDUFA priority review date May 20, 2022.
$736.1 million

ENLV – Enlivex Therapeutics Ltd.
Allocetra
COVID-19

$7.57
+0.48  +7%
Phase 2b Phase 2b enrollment slower than anticipated, noted November 22, 2021. Phase 2b top-line data due late 2022 or 1Q 2023.
$101.9 million

EXEL – Exelixis Inc.
CABOMETYX (cabozantinib) + TECENTRIQ (atezolizumab) - (COSMIC-312)
Hepatocellular Carcinoma

$17.06
-0.42  -2%
Phase 3 Phase 3 top-line data released June 28, 2021. Progression-free survival (PFS) primary endpoint met. Overall survival (OS) primary endpoint not met, noted November 20, 2021. Final data due early 2022. sNDA to be filed following final data in early 2022.
$5.4 billion

HGEN – Humanigen Inc.
Lenzilumab
COVID-19

$6.11
-0.32  -5%
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. Requested and was granted a Type B meeting with FDA, noted November 12, 2021. Phase 3 data to be presented in abstracts at the British Thoracic Society Winter 2021 Meeting November 24-26, 2021.
$389.9 million

IMRA – IMARA Inc.
Tovinontrine (IMR-687) - (Ardent)
Sickle cell disease (SCD)

$3.28
-0.14  -4%
Phase 2b Phase 2b completion of enrollment announced August 5, 2021. Phase 2b interim analysis due 4Q 2021. Primary endpoint readout due 1Q 2022. Final data analysis on-track 2H 2022.
$86.2 million

LIXT – Lixte Biotechnology Holdings Inc.
LB-100
Glioblastoma Multiforme

$1.66
+0.03  +2%
Phase 2 Phase 2 trial resumed enrollment, noted November 22, 2021.
$22.8 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - (Violet)
PCDH19-related epilepsy

$11.29
-0.54  -5%
Phase 2 Phase 2 trial showed a median 61.5% reduction in seizure frequency for ganaxolone compared to 24.0% for placebo, noted March 9, 2021. Phase 2 data to be presented in a poster at AES December 6, 2021.
$415.1 million

NVCR – NovoCure Limited
Tumor Treating Fields (TTFields) LUNAR
Non-small cell lung cancer (NSCLC)

$97.01
-2.72  -3%
Phase 3 Phase 3 last patient enrolled, November 22, 2021 with final data expected by year-end 2022.
$10.1 billion

OBSV – ObsEva SA
Linzagolix (OBE2109) - (PRIMROSE 1)
Uterine fibroids

$2.24
0.00  0%
PDUFA PDUFA date September 13, 2022.
$174.7 million

OLMA – Olema Pharmaceuticals Inc.
OP-1250
HR+, HER2- Breast Cancer

$20.87
-1.30  -6%
Phase 1 Phase 1 initial data due at the upcoming San Antonio Breast Cancer Symposium (SABCS) December 8, 2021. Phase 2 trial to be initiated in 1Q 2022.
$840.8 million

ZEAL – Zealand Pharma A/S
Dapiglutide (ZP7570)
Short bowel syndrome (SBS)

$21.36
+0.07  +0%
Phase 1b Phase 1b data reported that treatment with dapiglutide was associated with higher rates of gastrointestinal symptoms at the highest doses, with side effects being in line with what was observed in Phase 1a, noted November 22, 2021.
$930.9 million