BPC July 15 update

​FibroGen FGEN delivered negative vote by FDA Advisory Committee - shares remain halted

Price and Volume Movers

FibroGen (NASDAQ:FGEN) shares were halted for trading today while an FDA Advisory Committee discussed the company’s regulatory application for roxadustat for the treatment of anemia of chronic kidney disease. The committee voted 12-2 against recommending approval in patients on dialysis and 13-1 against approval for patients not on dialysis. Shares remain halted as of 6:30pm EST.

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) announced that it has discontinued its Phase 3 study of mupadolimab for COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering hospitalizations. The company noted that the discontinuation was not related to any safety or efficacy issues observed in study patients. Shares are currently trading down 8% after hours to $2.15.

IMV Inc. (NASDAQ:IMV) shares fell 29% to $1.48 following the pricing of its previously-announced public offering of 14,285,714 units at a price of $1.75 per unit, for gross proceeds of approximately US$25 million. Each unit consisted of one common share and three-quarters of one common share purchase warrant.

Immunic, Inc. (NASDAQ:IMUX) shares fell 21% to $9.34 also following its announcement of the pricing of its public offering of 4.5 million shares at a price of $10 per share for gross proceeds of approximately $45 million.

Galapagos NV (NASDAQ:GLPG) shares closed down 13% to $57.23 following the release of negative data from two of three readouts late-Wednesday of its pipeline candidate GLPG3970. While promising signs were noted from its trial in patients with psoriasis, both rheumatoid arthritis and ulcerative colitis patients saw no differentiation from placebo in their respective trials.

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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:

BioLineRx Ltd. (BLRX): $3.34; +10%.

Calithera Biosciences, Inc. (CALA): $2.03; +9%.

MediWound Ltd. (MDWD): $4.63; +9%.

Prelude Therapeutics Incorporated (PRLD): $28.02; +9%.

Anixa Biosciences, Inc. (ANIX): $4.07; +9%.

DECLINERS:

Virpax Pharmaceuticals, Inc. (VRPX): $5.64; -24%.

Ambrx Biopharma Inc. (AMAM): $9.34; -21%.

Cassava Sciences, Inc. (SAVA): $82.43; -15%.

Brooklyn ImmunoTherapeutics, Inc. (BTX): $10.31; -14%.

Tempest Therapeutics Inc. (TPST): $19.43; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-504
Prostate Cancer

$0.41
0.00  -0%
Phase 1 Phase 1 trial initiation announced July 15, 2021 with initial data due 1H 2022.
$59.7 million

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz)
Generalized myasthenia gravis (gMG)

$182.50
0.00  0%
Phase 3 Phase 3 top-line data met primary endpoint - July 15, 2021.
$40.3 billion

BCRX – BioCryst Pharmaceuticals Inc.
BCX9930 (REDEEM-1)
Paroxysmal nocturnal hemoglobinuria (PNH)

$16.10
-0.66  -4%
Phase 3 Pivotal trials to commence 2H 2021.
$2.9 billion

CGEN – Compugen Ltd.
COM902
Advanced cancer

$6.79
-0.09  -1%
Phase 1 Phase 1 COM902 monotherapy data due 4Q 2021. Initiation of combination arm of COM902 with COM701 announced July 15, 2021.
$569.8 million

CRVS – Corvus Pharmaceuticals Inc.
Mupadolimab (CPI-006)
COVID-19 (Mild to Moderate)

$2.09
-0.07  -3%
Phase 3 Phase 3 trial to be discontinued with company citing positive trends exhibited by COVID-19 vaccines in lowering hospitalizations.
$80.1 million

DNLI – Denali Therapeutics Inc.
DNL310
Hunter syndrome MPS II

$51.03
+0.04  +0%
Phase 1/2 Phase 1/2 24-week data presented July 25, 2021. 12-month data likely due early-2022. Phase 2/3 trial to be initiated 1H 2022.
$6.2 billion

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

$13.00
+0.16  +1%
PDUFA Advisory Committee meeting July 15, 2021 voted 12-2 against recommending approval in patients on dialysis and 13-1 against approval for patients not on dialysis.
$1.2 billion

NAVB – Navidea Biopharmaceuticals Inc.
NAV3-32 (TC99m-tilmanocept)
Rheumatoid arthritis

$1.68
-0.03  -2%
Phase 2b Phase 2b commencement of US site enrollment announced February 8, 2021. End of Phase 2b (NAV3-31 trial) meeting with FDA scheduled for September 1, 2021. Phase 3 trial planned.
$48.8 million

NLSP – NLS Pharmaceutics Ltd.
Quilience
Narcolepsy

$2.60
-0.04  -2%
Phase 2 Phase 2 trial to commence August 2021.
$31.4 million

SYBX – Synlogic Inc.
SYNB1618 (SynPheny-1)
Phenylketonuria (PKU)

$3.16
-0.04  -1%
Phase 2 Phase 2 data due 2H 2021.
$165.5 million

SYBX – Synlogic Inc.
SYNB1934
Phenylketonuria (PKU)

$3.16
-0.04  -1%
Phase 1 Phase 1 trial initiation announced July 15, 2021. Data due by the end of 2021.
$165.5 million

VIR – Vir Biotechnology Inc.
VIR-2218 and VIR-3434 (MARCH)
Hepatitis B

$35.65
-0.74  -2%
Phase 2 Phase 2 initiation announced July 15, 2021.
$4.6 billion