BPC January 13 update

Covid-19 Vaccine makers drop after SCOTUS block: NVAX -14% MRNA -6% BNTX -8% PFE -2%

Price and Volume Movers

COVID-19 vaccine makers, including Moderna, Inc. (NASDAQ: MRNA), BioNTech (NASDAQ: BNTX), Pfizer, Inc. (NYSE: PFE), and Novavax, Inc. (NASDAQ: NVAX) traded lower after the US Supreme Court today blocked President Biden's workplace vaccine-or-test mandate for larger employers. Moderna shares closed down 6% at $210.17. BioNTech shares closed down 8% at $202.99. Pfizer shares closed down 2% at $55.54. Novavax shares closed down 14% at $112.38.

Denali Therapeutics Inc. (NASDAQ: DNLI) announced that the FDA placed a clinical hold on its DNL919 Investigational New Drug (IND) application. The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. Shares closed down 12% at $33.86.

Rockwell Medical Inc. (NASDAQ: RMTI) partner, Jeil Pharmaceutical Co Ltd, received regulatory approval in South Korea for Triferic Injection for iron supplementation therapy and maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Shares closed up 18% at $0.47.

ChemoCentryx (NASDAQ: CCXI) shares closed up 3% at $33.31 after Raymond James noted more than 100 unique prescribers for Tavneos to treat ANCA vasculitis in Q4 2021.

Biogen (NASDAQ: BIIB) shares closed up 5% at $236.67 after analysts weighed in on merger and acquisition prospects for the company following a conference call with its management.

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

ACHL – Achilles Therapeutics plc
ATL001 - (THETIS)
Melanoma

$4.03
+0.01  +0%
Phase 1/2 Phase 1/2a update reported stable disease in 63% (5 of 8) in the initial, low-dose cohort noted November 12, 2021. Phase 1/2a data due in 2H 2022.
$163.6 million

ACHL – Achilles Therapeutics plc
ATL001 - (CHIRON)
Non Small Cell Lung Cancer

$4.03
+0.01  +0%
Phase 1/2 Phase 1/2a update reported stable disease in 63% (5 of 8) in this initial, low-dose cohort, noted November 12, 2021. Phase 1/2a data due in 2H 2022.
$163.6 million

ADAG – Adagene Inc.
ADG106 combined w/ Nivolumab
Non-small cell lung cancer

$7.47
-0.02  0%
Phase 1/2 Phase 1b/2 trial first patient dosed, January 13, 2022.
$406.9 million

ADGI – Adagio Therapeutics Inc.
ADG20 - (EVADE)
COVID-19 (prevention)

$6.29
-0.15  -2%
Phase 2/3 Phase 2/3 trial data suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months, noted September 29, 2021. EUA submission due in 3Q 2022. Pediatric trial to be initiated in mid-2022. Phase 2/3 trial enrollment paused pending alignment with FDA, noted January 13, 2022.
$699.8 million

AZN – AstraZeneca PLC
IMFINZI (Durvalumab) + tremelimumab - (HIMALAYA)
Hepatocellular carcinoma (HCC)

$59.10
-1.07  -2%
Phase 3 Phase 3 trial met primary endpoint of overall survival with a single priming dose every four weeks vs. sorafenib, noted October 15, 2021. Additional Phase 3 trial showed that a single priming dose demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment, noted January 18, 2022.
$183.1 billion

AZN – AstraZeneca PLC
IMFINZI (Durvalumab) - (TOPAZ-1)
Biliary-tract cancer

$59.10
-1.07  -2%
Phase 3 Phase 3 interim analysis reported trial met primary endpoint of improvement in OS versus standard of care. The trial also met key secondary endpoints, noted October 25, 2021. Phase 3 trial demonstrated a statistically significant and clinically meaningful improvement in of 58% overall survival (OS) and 81% progression-free survival (PFS) versus 66% OS and 86% PFS with chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC), noted January 22, 2022
$183.1 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson - (COMFORT)
Psoriasis

$1.21
-0.08  -6%
Phase 3 Phase 3 top-line data due 1Q 2022. Enrollment completed September 2, 2021.
$32.9 million

CGEM – Cullinan Oncology Inc.
CLN-049 - (Florentine)
Acute myeloid leukemia (AML)

$12.36
-0.16  -1%
Phase 1 Phase 1 trial first patient dosed, noted January 13, 2022.
$539.9 million

GRTS – Gritstone bio Inc.
GRANITE-001 (GO-004)
Colorectal Cancer / Gastric Cancer

$5.00
-0.20  -4%
Phase 2/3 Phase 2/3 trial initiated, noted January 13, 2021. Phase 2 data expected in mid-2023.
$339.9 million

GRTS – Gritstone bio Inc.
GRANITE in combination with nivolumab and ipilimumab
1L Microsatellite-Stable Colorectal Cancer (MSS-CRC)

$5.00
-0.20  -4%
Phase 1/2 Phase 1/2 data demonstrated that patients who experienced a molecular response, continue to have an OS advantage compared to those patients who did not have a molecular response. All patients alive at the time of the ESMO 2021 data presentation remain alive after an additional 22 weeks of follow-up, noted January 13, 2021.
$339.9 million

GSK – GlaxoSmithKline PLC
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-TAIL)
COVID-19

$45.10
+0.22  +0%
Phase 3 Phase 3 data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations, noted November 12, 2021. EUA application submitted, noted January 13, 2022.
$113.5 billion

RDHL – Redhill Biopharma Ltd.
YELIVA (Opaganib)
COVID-19

$2.61
-0.29  -10%
Phase 2/3 Phase 2/3 preliminary top-line data results did not meet its primary endpoint September 14, 2021. Phase 2/3 data showed 62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients, noted October 4, 2021. Phase 2/3 study showed that in all patients with positive PCR at screening, the drug improved the median time to viral RNA clearance by at least 4 days; Median of 10 days for viral clearance in the dosed arm vs. clearance median not reached by end of 14-day treatment in placebo arm, noted January 13, 2022.
$134.2 million

RUBY – Rubius Therapeutics Inc.
RTX-224
Solid tumors

$7.30
-0.40  -5%
Phase 1/2 Phase 1/2 trial first patient dosed January 13, 2022.
$656 million

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide - (SWITCH)
Obesity due to biallelic POMC, PCSK1, LEPR deficiency or BBS

$7.30
-0.29  -4%
Phase 3 Phase 3 trial initiated, noted January 13, 2022.
$367 million