BPC July 13 update

PLx Pharma PLXP up 27% on Walmart deal, FibroGen FGEN AdCom documents released

Price and Volume Movers

Briefing documents for Thursday’s FDA Cardiovascular and Renal Drugs Advisory Committee were released today, where an expert panel will discuss the regulatory application submitted by FibroGen, Inc. (NASDAQ: FGEN) for roxadustat in patients with anemia. The FDA noted that the drug’s efficacy is not in question with concerns more on safety.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares closed up 10% to $44.60, adding to Monday’s gain of 25%. The company announced late Friday updated data 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.

PLx Pharma Inc. (NASDAQ:PLXP) announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. FDA approved liquid-filled aspirin capsules, will be available in over 4,500 Walmart stores across the United States in mid-August. Stock closed up 27% to $15.81.

scPharmaceuticals Inc. (Nasdaq: SCPH) announced data from its FREEDOM-HF study, evaluating overall and heart failure-related costs of treating congestion in patients with chronic heart failure. Costs associated with patents treated with FUROSCIX were $17,753 lower than the historical comparator group (p<0.0001). Stock price up 7% to $7.01 after hours.

Imara Inc. (NASDAQ:IMRA) announced that it has commenced a proposed underwritten public offering of $50 million of shares of its common stock. Shares currently trading down 16% to $5.98 in the after hours market.

Bicycle Therapeutics plc (NASDAQ:BCYC) announced a licensed agreement with Ionis Pharmaceuticals giving access to Bicycle's macrocyclic peptides to design LIgand Conjugated Antisense (LICA) medicines. Bicycle receives a total of $45 million upfront. Shares closed up 4% to $32.87.

-

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:

Virpax Pharmaceuticals, Inc. (VRPX): $5.65; +26%

Xenetic Biosciences, Inc. (XBIO): $2.46, +21%

Forward Pharma A/S (FWP): $10.01, +17%

Allena Pharmaceuticals, Inc. (ALNA): $1.39, +14%

Atossa Therapeutics, Inc. (ATOS): $6.34, +13%

DECLINERS:

TransCode Therapeutics, Inc. (RNAZ): $4.56, -29%

Aridis Pharmaceuticals, Inc. (ARDS): $6.07, -17%

Ikena Oncology, Inc. (IKNA): $12.72, -16%

Hepion Pharmaceuticals, Inc. (HEPA): $1.72, -15%

Galectin Therapeutics Inc. (GALT): $2.78, -15%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABIO – ARCA biopharma Inc.
rNAPc2 (AB201)
COVID-19

$3.16
-0.25  -7%
Phase 2b Phase 2b top-line data due 4Q 2021.
$45.5 million

CYCC – Cyclacel Pharmaceuticals Inc.
Fadraciclib (CYC065-101)
Advanced cancers

$4.96
-0.13  -3%
Phase 2 Phase 1/2 initiation of dosing announced July 13, 2021.
$45.8 million

GLTO – Galecto Inc.
GB0139 (GALACTIC-1)
Idiopathic pulmonary fibrosis (IPF)

$4.29
-0.07  -2%
Phase 2b Phase 2b resumption of enrollment announced July 13, 2021. Top-line data due by mid-2023.
$108.4 million

GNCA – Genocea Biosciences Inc.
GEN-011 (TITAN study)
Various tumors

$2.02
-0.02  -1%
Phase 1/2 Phase 1/2 initiation of dosing announced July 13, 2021, with initial data due late-4Q 2021 or 1Q 2022.
$110 million

HEPA – Hepion Pharmaceuticals Inc.
CRV431 - AMBITION
Non-alcoholic steatohepatitis

$1.54
0.00  0%
Phase 2a Phase 2a data released July 13, 2021. Primary endpoints met.
$117.4 million

IMMP – Immutep Limited
Eftilagimod Alpha - Active Immunotherapy PAClitaxel (AIPAC)
Metastatic breast cancer (MBC)

$3.42
-0.01  -0%
Phase 2b Phase 2b final overall survival data due 2H 2021.
$221.9 million

IMMP – Immutep Limited
Eftilagimod alpha and KEYTRUDA (pembrolizumab) - TACTI-002
Non-small cell lung cancer; Head and neck cancer

$3.42
-0.01  -0%
Phase 2 Phase 2 further interim data due in 2021 or early 2022.
$221.9 million

IMMP – Immutep Limited
Eftilagimod alpha + chemo+ anti-PD-1 (INSIGHT-003)
Solid tumors

$3.42
-0.01  -0%
Phase 1 Phase 1 enrollment to commence 3Q 2021 with interim data due 2022.
$221.9 million

KALV – KalVista Pharmaceuticals Inc.
KVD900
Hereditary Angioedema (HAE)

$20.14
-0.50  -2%
Phase 2 Phase 2 positive data released February 9, 2021. Significantly reduced use of rescue (p=0.001), with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours. FDA End-of-Phase 2 Meeting scheduled for late-3Q 2021.
$492.2 million

LCTX – Lineage Cell Therapeutics, Inc.
OpRegen
Dry age-related macular degeneration (AMD)

$2.63
+0.08  +3%
Phase 1/2 Phase 1/2a updated data to be presented at Annual Retina Society Meeting September 30, 2021,
$394.5 million

LVTX – LAVA Therapeutics N.V.
LAVA-051
Chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML)

$5.53
-1.96  -26%
Phase 1/2 Phase 1/2 initiation of dosing announced July 13, 2021. Phase 1 dose escalation data due 1H 2022 with Phase 2a data due 2H 2022.
$138.9 million

NRIX – Nurix Therapeutics Inc.
NX-2127
B-cell malignancies

$30.74
-0.06  -0%
Phase 1 Phase 1 initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the dose escalation portion is due by YE 2021.
$1.4 billion

SCPH – scPharmaceuticals Inc.
FUROSCIX (FREEDOM-HF)
Heart Failure

$5.48
0.00  0%
Phase 3 Phase 3 data released July 13 2021, study halted early due to highly statistical reduction in costs of $17,753 (p<0.0001) per study subject
$149.9 million

TFFP – TFF Pharmaceuticals Inc - Ordinary Shares
Tacrolimus Inhalation Powder
Lung transplant (post)

$8.29
-0.47  -5%
Phase 1 Phase 1 safety data due 3Q 2021.
$210.3 million