BPC October 01 update

​Merck MRK +9% Oral Covid-19 Data; Omeros OMER -38% FDA response to BLA

Price and Volume Movers

Merck (NYSE: MRK) released interim data from its Phase 3 MOVe-OUT trial of oral molnupiravir to treat non-hospitalized adult patients with mild-to-moderate COVID-19. Data showed a reduced risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died (28/385), compared with 14.1% of placebo-treated patients (53/377). Shares closed up 9% at $81.40.

Price action of other companies involved in COVID-19 vaccine and treatment development:

Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) +20%

BioNTech SE (NASDAQ: BNTX) -7%

Moderna, Inc. (NASDAQ: MRNA) -11%

Novavax, Inc. (NASDAQ: NVAX) -12%

Dynavax Technologies Corporation (NASDAQ: DVAX) -12%

AbCellera Biologics, Inc. (NASDAQ: ABCL) -14%

CureVac BV (NASDAQ: CVAC) -15%

Immunome, Inc. (NASDAQ: IMNM) -17%

Vir Biotechnology, Inc. (NASDAQ: VIR) -21%

Neurobo Pharmaceuticals, Inc. (NASDAQ: NRBO) -33%

Adagio Therapeutics, Inc. (NASDAQ: ADGI) -34%


Omeros Corporation (NASDAQ: OMER) announced the FDA identified deficiencies in its submitted Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros does not expect resolution to occur before its set PDUFA date of October 17, 2021. Shares closed down -38% at $8.54.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$3.09+0.59  +23.60%
CNTX
Context Therapeutics Inc.
$6.98+0.81  +13.21%
ATHA
Athira Pharma Inc.
$10.69+1.06  +11.01%
RPTX
Repare Therapeutics Inc.
$24.66+1.9  +8.35%
KALA
Kala Pharmaceuticals Inc.
$2.04+0.14  +7.11%
CMPS
COMPASS Pathways Plc
$37.78+2.47  +7.00%
EYEN
Eyenovia Inc.
$6.34+0.37  +6.20%
TYRA
Tyra Biosciences Inc.
$22.75+1.28  +5.96%
MRTX
Mirati Therapeutics Inc.
$187.66+10.36  +5.84%
PTPI
Petros Pharmaceuticals Inc.
$1.80+0.1  +5.69%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.65-2.18  -56.92%
OCUL
Ocular Therapeutix Inc.
$6.84-3.98  -36.80%
AGEN
Agenus Inc.
$3.90-1.24  -24.07%
SIOX
Sio Gene Therapies Inc.
$2.03-0.33  -13.98%
STAB
Statera Biopharma Inc.
$3.35-0.52  -13.44%
JANX
Janux Therapeutics Inc.
$22.03-2.99  -11.95%
RNLX
Renalytix AI plc
$24.14-3.26  -11.90%
APLT
Applied Therapeutics Inc.
$13.84-1.85  -11.82%
GRCL
Gracell Biotechnologies Inc.
$10.38-1.34  -11.43%
XFOR
X4 Pharmaceuticals Inc.
$4.42-0.54  -10.81%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALXO – ALX Oncology Holdings Inc.
ALX148 and KEYTRUDA (pembrolizumab) - ASPEN-04
Head and Neck Squamous Cell Carcinoma

$53.16
-0.67  -1%
Phase 2 Phase 2 clinical data to be presented at the SITC 36th Annual Meeting from November 10 –14, 2021.
$2.1 billion

BNTX – BioNTech SE
BNT112 - PRO-MERIT
Prostate cancer

$276.36
-10.00  -3%
Phase 1/2 Phase 1/2 trial initiated December 2019. Phase 1/2 data to be presented November 12, 2021.
$67 billion

CHRS – Coherus BioSciences Inc.
CHS-201 (Lucentis Biosimilar)
Wet age-related macular degeneration (wAMD), among others

$16.69
+0.01  +0%
PDUFA Biosimilar User Fee Act action date for August 2, 2022.
$1.3 billion

IMMP – Immutep Limited
Eftilagimod alpha (IMP321) and KEYTRUDA (pembrolizumab) - TACTI-003
Head and neck squamous cell carcinoma (HNSCC)

$4.23
-0.13  -3%
Phase 2b Phase 2b enrollment to be initiated 3Q 2021. Phase 2b data will be presented at the Society for Immunotherapy of Cancer (SITC) November 12-13, 2021.
$316.5 million

IMV – IMV Inc.
Maveropepimut-S (DPX-Survivac) and epacadostat (DeCidE1)
Ovarian cancer

$1.51
-0.03  -2%
Phase 2 Phase 2 final data released August 10, 2021. Median overall survival was 19.9 months, and overall survival rate was 44.9% at 23.8 months. Translational data obtained in the study to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12, 2021.
$124.4 million

IOVA – Iovance Biotherapeutics Inc.
LN-145 (IOV-COM-202)
Non-small cell lung cancer (NSCLC)

$25.45
-0.57  -2%
Phase 2 Phase 2 data to be presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) November 12-14, 2021.
$3.9 billion

LLY – Eli Lilly and Company
Mirikizumab
Ulcerative Colitis (Maintenance data)

$242.91
+1.74  +1%
Phase 3 Phase 2 week 104 data showed 75.6% of patients (59/78) maintained symptomatic remission, noted October 1, 2021.
$232.4 billion

MNKD – MannKind Corporation
TYVASO (treprostinil) DPI
Pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease (PH-ILD) (WHO Group 3)

$4.60
+0.19  +4%
CRL CRL issued October 15, 2021. Resubmission planned with approval expected in summer 2022.
$1.1 billion

MRK – Merck & Company Inc.
Molnupiravir (MOVe-OUT)
COVID-19

$81.05
-0.12  0%
Phase 3 Phase 3 interim analysis showed risk reduction of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo - noted October 1, 2021. Emergency Use Authorization (EUA), submitted October 11, 2021.
$205.2 billion

NXTC – NextCure Inc.
NC318
Solid tumors

$8.25
-0.24  -3%
Phase 2 Phase 2 trial data will be presented at the Society for Immunotherapy of Cancer (SITC) November 13, 2021.
$227.8 million

OMER – Omeros Corporation
Narsoplimab
Hematopoietic stem cell-associated TMA (HSCT-TMA)

$6.38
-0.08  -1%
CRL CRL announced October 18, 2021.
$398.7 million

RARE – Ultragenyx Pharmaceutical Inc.
UX143 (setrusumab)
Osteogenesis Imperfecta

$77.86
-0.54  -1%
Phase 2b Phase 2b presented secondary endpoint data on UX143 (setrusumab) ASTEROID study for the Treatment of Osteogenesis Imperfecta (OI). Data were presented at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting. noted October 1, 2021.
$5.3 billion

REPL – Replimune Group Inc.
RP1 (vusolimogene oderparepvec) and LIBTAYO (cemiplimab) - CERPASS
Cutaneous squamous cell carcinoma (CSCC)

$28.76
-0.18  -1%
Phase 2 Phase 2 data due late-2022.
$1.3 billion

RGNX – REGENXBIO Inc.
RGX-314 (AAVIATE)
Wet AMD using suprachoroidal delivery

$35.75
+0.72  +2%
Phase 2 Phase 2 safety results reported at Retina Society 54th Annual Scientific Meeting showed that it was well tolerated by 50 patients in the first 3 cohorts - noted October 4, 2021.
$1.5 billion