BPC July 22 update

Seres MCRB -62% misses mid-stage trial goals; Arvinas ARVN +9% deal with Pfizer

Price and Volume Movers

Seres Therapeutics, Inc. (NASDAQ:MCRB) announced that its Phase 2b ECO-RESET trial of SER-287 in patients with mild-to-moderate ulcerative colitis (UC), did not meet its primary endpoint of improving clinical remission rates compared to placebo. Shares fell 62% to $7.95. Finch Therapeutics Group, Inc. (NASDAQ:FNCH), which is due to initiate a Phase 1 trial next year also for UC, fell 17% to $13.31.

Arvinas, Inc. (NASDAQ:ARVN) announced a collaboration with Pfizer Inc. (NYSE: PFE) to develop and commercialize ARV-471, which is currently in a Phase 2 trial for the treatment of patients with ER+/HER2- breast cancer. Arvinas receives $650 million upfront in addition to a $350 million equity investment by Pfizer, representing an equity ownership stake by Pfizer of approximately 7%. Shares rallied to close up 9% to $84.51.

Endo International plc (NASDAQ:ENDP) announced that it will pay $35m to settle an opioid-related case involving counties and cities in Tennessee, and one individual infant who was allegedly born with Neonatal Abstinence Syndrome. The lawsuit which sought over $2 billion in damages was due to commence within the next few days and was filed following the abuse effects of its painkiller Opana ER, which was withdrawn from the market four years ago. Shares closed up 4% for a 3-day cumulative gain of 46%, with a close price of $4.89.

ERYTECH Pharma S.A. (NASDAQ:ERYP) shares closed up 17% to $5.10. The company confirmed Wednesday that it is on track to submit its Biologics License Application (BLA) next quarter for Eryaspase for the treatment of Acute lymphoblastic leukemia (ALL)

Cyclerion Therapeutics, Inc. (NASDAQ:CYCN) was trading up 16% in after hours with a price of $4.20 following an announcement that they will be presenting the Phase 2a clinical trial design for CY6463 for the treatment of Alzheimer’s disease at the upcoming Alzheimer’s Association International Conference from July 26-30 2021.

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Other major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

PainReform Ltd. (PRFX): $4.08; +30%

Aridis Pharmaceuticals, Inc. (ARDS): $5.85; +15%

BiondVax Pharmaceuticals Ltd. (BVXV): $3.05; +11%

Kadmon Holdings, Inc. (KDMN): $4.32; +10%

PLx Pharma Inc. (PLXP): $21.28; +8%

DECLINERS:

TRACON Pharmaceuticals, Inc. (TCON): $3.72; -25%

Evelo Biosciences, Inc. (EVLO): $9.97; -23%

Kaleido Biosciences, Inc. (KLDO): $6.19; -15%

Selecta Biosciences, Inc. (SELB): $3.36; -12%

Harpoon Therapeutics, Inc. (HARP): $11.12; -12%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADAG – Adagene Inc.
ADG126 combined with KEYTRUDA (pembrolizumab) - (ADG126-P001; KEYNOTE-C98)
Solid tumors

$15.22
+0.71  +5%
Phase 1 Phase 1 trial to be initiated in 2022.
$829 million

ADVM – Adverum Biotechnologies Inc.
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)

$2.31
+0.08  +4%
Phase 1 Phase 1 data to be presented in Fall 2021.
$226.7 million

ADVM – Adverum Biotechnologies Inc.
ADVM-022 - INFINITY
Diabetic macular edema

$2.31
+0.08  +4%
Phase 2 Phase 2 data to be presented 2H 2021, however intends not to further develop.
$226.7 million

CBIO – Catalyst Biosciences Inc.
CB 4332
CFI deficiency

$5.18
+0.19  +4%
Phase 1/2 Phase 1/2 trial to commence 2022.
$159.5 million

GBT – Global Blood Therapeutics Inc.
OXBRYTA (Voxelotor)
Sickle cell disease - children age 4-11

$28.03
+1.68  +6%
PDUFA priority review PDUFA date under priority review December 25, 2021.
$1.7 billion

IONS – Ionis Pharmaceuticals Inc.
Tofersen (VALOR study)
Amyotrophic lateral sclerosis (ALS)

$37.21
+0.78  +2%
Phase 3 Phase 3 data due by fall of 2021.
$5.3 billion

LABP – Landos Biopharma Inc.
Omilancor (BT-11)
Ulcerative Colitis

$15.54
+0.27  +2%
Phase 2 Phase 2 data to be presented at the United European Gastroenterology Week (UEGW) meeting October 3-5, 2021. Phase 3 trial planned.
$623.4 million

MCRB – Seres Therapeutics Inc.
SER-287
Mild-to-Moderate Ulcerative Colitis

$7.12
+0.61  +9%
Phase 2b Phase 2b trial did not meet primary endpoint - July 22, 2021. Microbiome analyses due 2H 2021.
$653 million

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab) and LENVIMA (lenvatinib)
Endometrial Cancer

$71.68
-0.29  -0%
Approved FDA approval announced July 22, 2021.
$181.4 billion

NGM – NGM Biopharmaceuticals Inc.
NGM621 (CATALINA)
Geographic atrophy

$23.03
-0.81  -3%
Phase 2 Phase 2 topline data to be released 2H 2022.
$1.8 billion

PSTV – PLUS THERAPEUTICS Inc.
Rhenium-186 NanoLiposome ( 186 RNL) - (ReSPECT)
Glioblastoma

$1.97
+0.09  +5%
Phase 2/3 Phase 2/3 study to be initiated mid-2022. Phase 1 data presented August 21, 2021. Treatment was well tolerated, with no dose-limiting toxicity or serious adverse events observed.
$23.8 million

RDUS – Radius Health Inc.
RAD011 (SCOUT)
Prader-Willi syndrome

$12.80
+0.62  +5%
Phase 2/3 Phase 2/3 trial planned for late-2021 / early-1Q 2022 with data due 2H 2024.
$605 million

RHHBY – Roche Holding AG ADR
TECENTRIQ (atezolizumab) - (IMvoke010)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

$46.07
-0.75  -2%
Phase 3 Phase 3 data due 2022.
$314.8 billion

RHHBY – Roche Holding AG ADR
Polivy (polatuzumab vedotin) - POLARIX
Diffuse Large B-Cell Lymphoma

$46.07
-0.75  -2%
Phase 3 Phase 3 trial met primary endpoint - August 9, 2021.
$314.8 billion