BPC November 19 update

Dermata DRMA Phase 1b data -30%; Covid-19 Vaccine Booster EUAs

Price and Volume Movers

Dermata Therapeutics, Inc. (NASDAQ: DRMA) announced efficacy and safety data from its Phase 1b study of DMT410 to treat multiple aesthetic skin conditions. Data reported an improvement in overall GAI at week 4 in 70% of patients, 80% of patients at week 8, and 60% of patients at week 12. The mean improvement in GAI score was 0.8 at week 8. Shares closed down 30% at $3.31.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares for gross proceeds of $15.5 million. Shares closed down 27% at $20.83.

Enanta Pharmaceuticals (NASDAQ: ENTA) shares closed down 19% at $75.33. JMP Securities lowered their price target from $121 to $111. RBC also cut their price target to $72 from $74. The decrease follows an announcement by Enanta regarding the halt of development of EDP-721 due to safety signals that were displayed.

Moderna, Inc. (NASDAQ: MRNA) announced that the FDA has extended the emergency use authorization of a booster dose of their COVID-19 vaccine to all adults aged 18 and older. Shares closed up 5% at $263.78.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced that the FDA has expanded the emergency use authorization (EUA) of a booster dose of their COVID-19 vaccine to include individuals 18 years of age and older.

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

ALLK – Allakos Inc.
Lirentelimab - (ENIGMA 2)
Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD)

$80.09
-1.13  -1%
Phase 3 Phase 3 top-line data due 4Q 2021 or 1Q 2022. Phase 3 study showed 45% (181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the histologic criteria for eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) noted October 25, 2021.
$4.3 billion

ALNY – Alnylam Pharmaceuticals Inc.
ONPATTRO (patisiran) - APOLLO-B
Wild-type ATTR amyloidosis patients with cardiomyopathy

$188.53
-0.27  0%
Phase 3 Phase 3 completion of enrollment announced June 1, 2021. Phase 3 top-line data due mid-2022. NDA filing due in late 2022.
$22.5 billion

ALNY – Alnylam Pharmaceuticals Inc.
Zilebesiran (ALN-AGT) - (KARDIA-1)
Hypertension

$188.53
-0.27  0%
Phase 2 Phase 2 initiation announced June 30, 2021. Phase 2 enrollment expected to be complete by mid-2022, with top-line data due in late 2022.
$22.5 billion

ARNA – Arena Pharmaceuticals Inc.
Etrasimod - (CULTIVATE)
Crohn's disease

$57.42
-1.54  -3%
Phase 2/3 Phase 2/3 Study A reached target enrollment November 19, 2021. Phase 2/3 top-line data on track for 2Q 2022.
$3.5 billion

BMRN – BioMarin Pharmaceutical Inc.
VOXZOGO (Vosoritide)
Achondroplasia

$87.58
-1.99  -2%
Approved Approved November 19, 2021.
$16.1 billion

BMY – Bristol-Myers Squibb Company
Mavacamten (MYK-461)
Hypertrophic cardiomyopathy (HCM)

$56.53
-0.28  0%
PDUFA PDUFA date extended to April 28, 2022.
$125.5 billion

CNTX – Context Therapeutics Inc.
Onapristone (ONA-XR) - (ONAWA)
Breast Cancer

$5.10
+0.14  +3%
Phase 1 Early Phase 1 results to be presented at SABCS December 8, 2021.
$55.9 million

INCY – Incyte Corporation
Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.

$68.38
+1.64  +2%
Phase 2 Phase 2 poster to be presented at SABCS December 9, 2021.
$15.1 billion

JAGX – Jaguar Health Inc.
Mytesi (crofelemer) - (HALT-D)
Cancer related diarrhea (CRD)

$1.38
-0.05  -4%
Phase 2 Phase 2 results to be presented at San Antonio Breast Cancer Symposium December 10, 2021. Abstract reported that the primary endpoint - the incidence of having diarrhea for two or more days - was not statistically different for the two groups since about 70% of patients had this outcome regardless of cycle or CID treatment group, noted November 19, 2021. Phase 3 trial ongoing.
$63.6 million

PBYI – Puma Biotechnology Inc
NERLYNX (Neratinib) - SUMMIT
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

$3.23
-0.26  -7%
Phase 2 Phase 2 data update to be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) December 7-10, 2021.
$131.9 million

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

$54.00
+3.11  +6%
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.
$303.1 billion

STOK – Stoke Therapeutics Inc.
STK-001 - (MONARCH)
Dravet syndrome

$25.11
-2.53  -9%
Phase 1/2 Phase 1/2 data study demonstrated that single doses of STK-001 up to 30mg and multiple doses of 20mg were well-tolerated with no safety concerns. FDA will allow the evaluation of an additional higher dose level (45mg) September 21, 2021. Additional Phase 1/2a interim data to be presented at AES 2021 December 5, 2021.
$923.8 million

XCUR – Exicure Inc.
Cavrotolimod
Merkel cell carcinoma / Cutaneous squamous cell carcinoma

$0.50
-0.05  -9%
Phase 1/2 Phase 1b/2 interim data noted overall response rate (ORR) of 21% in all evaluable MCC patients - August 5, 2021. Top-line ORR data due 2H 2022.
$43.7 million

ZYME – Zymeworks Inc.
Zanidatamab
HER2-positive breast cancer

$19.50
-0.16  -1%
Phase 1 Phase 1 initiation of dosing announced July 28, 2021. Phase 1 data from abstract reported a confirmed objective response rate of 37.5% and the disease control rate of 81.3% in 16 response-evaluable patients, noted November 19, 2021. Presentation at SABCS on December 8, 2021.
$907.8 million