BPC July 12 update

Celldex CLDX offering following positive late-Friday data +25%; FibroGen FGEN briefing documents likely Tuesday

Price and Volume Movers

Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares closed up 25% to $40.67 following the release of updated data late-Friday from its Phase 1b trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response. The company took advantage of the favourable price action when it announced after hours today it intends to sell $175 million of shares of its common stock in an underwritten public offering.

IVERIC bio, Inc. (NASDAQ:ISEE) also announced after hours that it is commencing an underwritten public offering of shares of its common stock. Shares are trading down 5% to $8.57 after hours following a drop of 6% during normal trading hours.

FibroGen, Inc. (NASDAQ:FGEN) shares closed down 4% to $25.39 ahead of its FDA Advisory Committee meeting on July 15, 2021 which will discuss the regulatory application for Roxadustat. Briefing documents for the meeting should be released tomorrow (Tuesday).

Prothena Corporation plc (NASDAQ:PRTA) announced that Novo Nordisk A/S (Nasdaq: NOVO) will acquire its antibody PRX004 and broader ATTR amyloidosis programme, which has completed Phase 1 trials. Prothena is eligible to receive development and sales milestone payments totalling up to $1.2 billion, including $100 million in upfront and near-term clinical milestone payments. Shares initially rose in pre-market trading on the news, only to close the session down 8% to $54.39.

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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:

Tempest Therapeutics Inc. (TPST): $24.19; +54%.

Ayala Pharmaceuticals, Inc. (AYLA): $10.60; +29%.

TransCode Therapeutics, Inc. (RNAZ): $6.45; +22%.

Clene Inc. (CLNN): $13.04; +21%.

Sierra Oncology, Inc. (SRRA): $22.49; +13%.

DECLINERS:

Sensei Biotherapeutics, Inc. (SNSE): $8.12; -9%.

ASLAN Pharmaceuticals Limited (ASLN): $3.11; -9%.

Generation Bio Co. (GBIO): $23.87; -8%.

Abeona Therapeutics Inc. (ABEO): $1.42; -8%.

Alterity Therapeutics Limited (ATHE): $1.55; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALNA – Allena Pharmaceuticals Inc.
Reloxaliase (ALLN-177) - (URIROX-2)
Enteric Hyperoxaluria

$0.94
-0.01  -1%
Phase 3 Phase 3 interim analysis due 1Q 2022.
$70.8 million

ALNA – Allena Pharmaceuticals Inc.
ALLN-346
Hyperuricemia

$0.94
-0.01  -1%
Phase 2a Phase 1b initial data due 4Q 2021.
$70.8 million

ARDS – Aridis Pharmaceuticals Inc.
AR-712
COVID-19

$4.99
+0.04  +1%
Phase 1 Phase 1/2/3 trial to be initiated 2H 2021.
$56.1 million

ARQT – Arcutis Biotherapeutics Inc.
Roflumilast foam (ARQ-154) - (STRATUM)
Seborrheic dermatitis

$23.33
-0.32  -1%
Phase 3 Phase 3 top-line data due 2Q / 3Q 2022.
$1.2 billion

ARTL – Artelo Biosciences Inc.
ART27.13 (CAReS)
Cancer-Related Anorexia and Weight Loss

$1.00
-0.03  -3%
Phase 1/2 Phase 1/2 initial safety data due 2H 2021. Full data due 1H 2022.
$24.5 million

EQ – Equillium Inc.
Itolizumab (EQ001)
Acute graft-versus-host disease

$5.42
-0.13  -2%
Phase 3 Phase 3 trial to be initiated 4Q 2021.
$157.4 million

GLYC – GlycoMimetics Inc.
Uproleselan with VENCLEXTA (Venetoclax) and VIDAZA (Azacitidine)
Acute myeloid leukemia (AML)

$2.02
-0.04  -2%
Phase 1/2 Phase 1/2 trial initiation announced July 12, 2021. Interim data due 2022.
$104.1 million

HALO – Halozyme Therapeutics Inc.
DARZALEX (Daratumumab) in combination with Pomalyst (pomalidomide) and dexamethasone
Multiple myeloma

$41.33
+0.26  +1%
Approved FDA approval announced July 12, 2021.
$5.9 billion