BPC July 29 update

Annovis ANVS -66%, Alector ALEC -21%, Cassava SAVA -23% Alzheimer's; Atreca BCEL -40% early data

Price and Volume Movers

Annovis Bio, Inc. (NASDAQ:ANVS) shares fell 66% to $43.50 following the release of updated data from its trial of Posiphen in patients with Alzheimer's and Parkinson’s disease. The data showed that patients on the placebo saw improved cognitive impairment compared with Posiphen. Other stocks that presented data at the Alzheimer's Association International Conference also sold off on their presentations; Alector Inc, (NASADAQ:ALEC) fell 21% to $24.07, and Cassava Sciences, Inc. (NASDAQ:SAVA) fell 23% to $103.35.

Ardelyx, Inc. (NASDAQ:ARDX) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. The FDA had already identified deficiencies that precluded discussion of labeling and post-marketing requirements/commitments, so a CRL was expected. Shares are currently trading up 6% with a price of $1.81.

ERYTECH Pharma (NASDAQ:ERYP) announced today that the FDA has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia. Shares are currently trading up 125% with a price of $9.25.

Atreca, Inc. (NASDAQ:BCEL) announced initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types. Only eight of the 20 participants (40%) experienced stable disease, which was their best response. The stock decreased by 40% to $4.91 on the news.

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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:

Xenetic Biosciences, Inc. (XBIO): $5.30; +65%

Intec Pharma Ltd (NTEC): $13.55; +48%

PainReform Ltd. (PRFX): $3.46; +20%

Acer Therapeutics Inc. (ACER): $2.80; +15%

Vallon Pharmaceuticals, Inc. (VLON): $4.59; +11%

DECLINERS:

Forward Pharma A/S (FWP): $9.99; -30%

Anavex Life Sciences Corp. (AVXL): $18.29; -14%

Synaptogenix, Inc. (SNPX): $7.80; -14%

Cleveland BioLabs, Inc. (CBLI): $4.36; -13%

Cyclerion Therapeutics, Inc. (CYCN): $2.93; -13%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABBV – AbbVie Inc.
BOTOX
Upper Limb Spasticity

$107.73
-0.35  -0%
Approved FDA approval announced July 29, 2021.
$190.4 billion

ALEC – Alector Inc.
AL001 (INFRONT-2)
Frontotemporal Dementia

$26.81
+1.35  +5%
Phase 2 Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
$2.2 billion

ALNY – Alnylam Pharmaceuticals Inc.
OXLUMO (lumasiran) - ILLUMINATE-C
Impaired renal function

$190.34
+0.14  +0%
Phase 3 Phase 3 top-line data released July 29, 2021.
$22.6 billion

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

$33.50
+2.26  +7%
Phase 2a Phase 2a completion of dosing announced August 11, 2021 full data due early Fall 2021. Phase 3 trial to be initiated 1Q 2022.
$271.4 million

ARDX – Ardelyx Inc.
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis

$1.31
-0.03  -2%
CRL FDA issued CRL on July 29 2021.
$135.1 million

ARWR – Arrowhead Pharmaceuticals Inc.
ARO-AAT (SEQUOIA)
Alpha-1 Liver Disease

$64.93
+1.27  +2%
Phase 2/3 Phase 2/3 completion of enrollment announced July 29, 2021.
$6.8 billion

BCEL – Atreca Inc.
ATRC-101
Solid tumors

$6.29
+0.18  +3%
Phase 1b Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.
$232.1 million

CYCN – Cyclerion Therapeutics Inc.
CY6463
Alzheimer's disease with vascular features (ADv)

$3.12
+0.02  +1%
Phase 2 Phase 2 trial has been initiated.
$135 million

ERYP – Erytech Pharma S.A.
GRASPA (Eryaspase)
Acute lymphoblastic leukemia (ALL)

$5.92
+0.33  +6%
BLA Filing BLA filing due 4Q 2021.
$164.1 million

GSK – GlaxoSmithKline PLC
NUCALA (Mepolizumab)
Chronic rhinosinusitis with nasal polyps

$38.93
-0.18  -0%
Approved FDA approval announced July 29, 2021.
$97.9 billion

IONS – Ionis Pharmaceuticals Inc.
AKCEA-TTR-LRx (NEURO-TTRansform)
hATTR Amyloidosis

$37.21
+0.78  +2%
Phase 3 Phase 3 completion of enrollment announced July 29, 2021 with interim analysis due mid-2022.
$5.3 billion

MRK – Merck & Company Inc.
Gefapixant
Chronic cough

$71.68
-0.29  -0%
PDUFA PDUFA date extended by three months to March 21, 2022. Advisory Committee meeting planned.
$181.4 billion

OCUL – Ocular Therapeutix Inc.
OTX-TKI
Wet Age-related Macular Degeneration (AMD)

$10.55
+0.23  +2%
Phase 1 Phase 1 initiation of dosing (U.S. trial) announced July 29, 2021.
$807.9 million

PALI – Palisade Bio Inc.
LB1148 - (China trial)
Gastrointestinal (GI) surgery

$2.74
-0.03  -1%
Phase 2 Phase 2 data released July 29, 2021- statistically significant (p=0.0008) effect in accelerating the return of bowel function.
$35.4 million