BPC July 21 update

Cassava SAVA +29% ahead of Alzheimer's data, TRACON TCON -20% offering

Price and Volume Movers

Cassava Sciences, Inc. (NASDAQ:SAVA) shares closed up 29% to $117.60. The company reminded investors today of their upcoming presentation of data at the Alzheimer's Association International Conference (AAIC). Interim 9-month analysis from their Phase 2 open-label trial of simufilam in patients with Alzheimer's disease will be presented on July 29, while the company will also present a poster of SavaDx, its blood-based diagnostic to detect Alzheimer’s disease, on July 26.

Magenta Therapeutics, Inc. (NASDAQ:MGTA) announced the FDA has placed a clinical hold on its Investigational New Drug Application (IND) to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. Shares dropped 9% to $8.07.

Lumos Pharma, Inc. (NASDAQ:LUMO) shares fell 12% to $8.23. The company announced late-Tuesday that the release of data from its Phase 2 OraGrowtH210 trial has been delayed to 2H 2023.

Endo Pharmaceuticals (NASDAQ:ENDP) shares, which closed up 25% Tuesday on reports that the company has made a settlement offer to counties in Tennessee regarding the Baby Doe opioid lawsuit trial, added a further 12% Wednesday to close up at $4.72. The lawsuit seeking over $2 billion in damages was filed on behalf of an infant who was born with Neonatal Abstinence Syndrome.

TRACON Pharmaceuticals (NASDAQ:TCON) announced an offering where H.C. Wainwright & Co. will purchase 2,617,802 shares at a price of $3.82 per share for gross proceeds of $10 million. The stock has declined 20% to $3.94 in after hours trading.

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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:

Forward Pharma A/S (FWP): $15.62; +18%

TransCode Therapeutics, Inc. (RNAZ): $3.31; +15%

Evaxion Biotech A/S (EVAX): $6.19; +14%

Forte Biosciences, Inc. (FBRX): $36.67; +11%

Cellectar Biosciences, Inc. (CLRB): $1.13; +11%

DECLINERS:

NeuroBo Pharmaceuticals, Inc. (NRBO): $3.38, -15%

Ikena Oncology, Inc. (IKNA): $11.62; -13%

Cyteir Therapeutics, Inc. (CYT): $14.57; -12%

Fulcrum Therapeutics, Inc. (FULC): $9.08; -9%

Elevation Oncology Inc. (ELEV): $10.68; -8%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

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

$24.04
-0.04  -0%
Phase 2 Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
$1.9 billion

ALEC – Alector Inc.
AL002 (INVOKE-2)
Alzheimer’s disease

$24.04
-0.04  -0%
Phase 2 Phase 2 trial ongoing. Dosing commenced January 2021.
$1.9 billion

ALNY – Alnylam Pharmaceuticals Inc.
Inclisiran
Hypercholesterolemia

$178.94
-2.89  -2%
PDUFA CRL received December 18, 2020. NDA refiled with new PDUFA date of January 1, 2022.
$21 billion

APRE – Aprea Therapeutics Inc.
Eprenetapopt (APR-246) and Vidaza (azacitidine)
TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) - post transplant

$4.23
-0.11  -3%
Phase 2 Phase 2 data released July 21, 2021. 58% relapse free survival at 1 year post-transplant; 79% overall survival at 1 year post-transplant.
$89.6 million

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

$6.37
+2.26  +55%
BLA Filing BLA filing due 4Q 2021.
$168.2 million

MGTA – Magenta Therapeutics Inc.
MGTA-117
Conditioning for stem cell transplant

$7.12
+0.13  +2%
Phase 1/2 Phase 1/2 trial planned for 4Q 2021. IND filing placed on clinical hold July 21, 2021.
$416.6 million

NVS – Novartis AG
KISQALI (ribociclib) - MONALEESA-2
Breast cancer

$92.39
+0.20  +0%
Phase 3 Phase 3 overall survival data due 2H 2021.
$206.7 billion

NVS – Novartis AG
Canakinumab (ACZ885) - CANOPY-1
Non-small cell lung cancer (NSCLC)

$92.39
+0.20  +0%
Phase 3 Phase 3 data due 2H 2021.
$206.7 billion

NVS – Novartis AG
COSENTYX (secukinumab) - SUNRISE
Hidradenitis Suppurativa (HS)

$92.39
+0.20  +0%
Phase 3 Phase 3 data due 2H 2021.
$206.7 billion

PFE – Pfizer Inc.
Abrocitinib
Atopic Dermatitis

$42.81
+0.02  +0%
PDUFA priority review PDUFA date of 3Q 2021 will not be met, no date provided.
$239.6 billion

PFE – Pfizer Inc.
XELJANZ (tofacitinib)
Ankylosing spondylitis

$42.81
+0.02  +0%
PDUFA PDUFA of 3Q 2021 will not be met, no date has been provided.
$239.6 billion

SAVA – Cassava Sciences Inc.
Simufilam (PTI-125)
Alzheimer’s disease

$69.53
-33.82  -33%
Phase 2 Phase 2b trial did not meet primary endpoint - May 15, 2020. Noted improvements in biomarkers of disease pathology September 14, 2020. Phase 2 open-label data 9-month data released July 29, 2021. Separate Cognition Maintenance Study (CMS) trial ongoing. Phase 3 trial to be initiated Fall 2021.
$2.8 billion

SRNE – Sorrento Therapeutics Inc.
STI-2099 (COVI-DROPS)
COVID-19

$8.21
-0.18  -2%
Phase 2 Phase 2 trial dosing initiated July 21 2021.
$2.4 billion

VIRX – Viracta Therapeutics Inc.
Nanatinostat and valganciclovir and KEYTRUDA (pembrolizumab)
Nasopharyngeal carcinoma and Epstein-Barr Virus-Positive (EBV+) Solid Tumors

$10.52
-0.25  -2%
Phase 1/2 Phase 1b/2 trial to be initiated 2H 2021.
$390.2 million