BPC July 09 update

Sigilon SGTX Mid-Stage Clinical Hold -25%; Celldex CLDX updated data +43%

Price and Volume Movers

Sigilon Therapeutics, Inc. (NASDAQ:SGTX) announced the FDA placed a clinical hold on its Phase 1/2 trial of SIG-001 in patients with severe or moderately severe hemophilia A. The clinical hold was initiated following a serious adverse event (SAE). One of the three patients on the high dose developed inhibitors to Factor VIII (FVIII). Shares dropped 25% to $6.90.

Galectin Therapeutics Inc. (NASDAQ:GALT) shares closed up 25% to $3.45. The company announced data from their Phase 1b trial of Belapectin (GR-MD-02), in combination with KEYTRUDA (pembrolizumab) in patients with metastatic melanoma and head and neck cancer. While the company noted the disease control rates were positive, just one out of 14 (7%) partial responses were recorded.

ASLAN Pharmaceuticals Limited (NASDAQ:ASLN) shares closed up 8% to $3.41. Analysts at Jefferies initiated coverage of the stock with a Buy rating and a price target of $8.00.

Novan, Inc. (NASDAQ:NOVN) also saw its shares rally on the back of analyst coverage, with Cantor Fitzgerald initiating coverage with an Overweight rating and a price target of $30.00. Shares closed up 8% to $9.81.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares are trading up 43% to $46.33 following the release of updated data from its open label Phase 1b clinical 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.

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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): $15.67; +49%.

INmune Bio, Inc. (INMB): $22.97; +14%.

Taysha Gene Therapies, Inc. (TSHA): $21.31; +12%.

89bio, Inc. (ETNB): $17.89; +12%.

ChemoCentryx, Inc. (CCXI): $16.77; +11%.

DECLINERS:

Alterity Therapeutics Limited (ATHE): $1.68; -17%.

TransCode Therapeutics, Inc. Common Stock (RNAZ): $5.29; -12%.

Aerpio Pharmaceuticals, Inc. (ARPO): $2.50; -10%.

Cassava Sciences, Inc. (SAVA): $95.34; -10%.

OncoSec Medical Incorporated (ONCS): $2.88; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AIM – AIM ImmunoTech Inc.
Ampligen
human Rhinovirus hRV

$2.09
+0.01  +0%
Phase 2a Phase 2a trial to commence 4Q 2021.
$83 million

CLDX – Celldex Therapeutics Inc.
CDX-0159
Chronic Inducible Urticaria

$43.75
-0.41  -1%
Phase 1b Phase 1b data released March 29, 2021. 8/10 complete responses; 1/10 partial responses. Update July 9, 2021 noted 18/19 (95%) complete responses and 1/19 (5%) partial responses.
$2 billion

GALT – Galectin Therapeutics Inc.
GR-MD-02 and KEYTRUDA (pembrolizumab)
Melanoma

$2.75
+0.13  +5%
Phase 1b Phase 1b data released July 9, 2021. 1/9 partial responses in melanoma patients. 2/5 head and neck cancer patients displayed stable disease.
$159.8 million

MDWD – MediWound Ltd.
EscharEx
Venous leg ulcers (VLU’s)

$3.80
-0.28  -7%
Phase 2 Phase 2 trial to continue as planned as per Independent Data Monitoring Committee’s (IDMC) recommendation - July 28, 2021. Data due 1H 2022.
$103.5 million

MORF – Morphic Holding Inc.
MORF-057
Healthy volunteers

$57.62
-1.98  -3%
Phase 1 Phase 1 full data released July 9, 2021 - well tolerated in all cohorts and no safety signals were identified.
$2.1 billion

MTEM – Molecular Templates Inc.
MT-6402
Solid tumors

$7.00
-0.30  -4%
Phase 1 Phase 1 commencement of dosing announced July 9, 2021. Update due by end of 2021.
$392.7 million

SGEN – Seagen Inc.
PADCEV (enfortumab vedotin) - EV-301
Urothelial cancer

$153.39
+6.44  +4%
Approved FDA approval announced July 9, 2021.
$27.8 billion

SGTX – Sigilon Therapeutics Inc.
SIG-001
Hemophilia A

$5.04
-0.25  -5%
Phase 1/2 Phase 1/2 clinical hold announced July 9, 2021.
$158.9 million