BPC January 11 update

VERU +20% Fast Track Designation; Inhibikase IKT +19% Stake

Price and Volume Movers

Veru Inc. (NASDAQ: VERU) shares closed up 20% at $6.41 after attention by CNBC’s Jim Cramer, noting that it had received Fast Track Designation (FTD) for enobosarm for the treatment of AR+ ER+ HER2- metastatic breast cancer.

Inhibikase Therapeutics, Inc. (NASDAQ: IKT) shares closed up 19% at $1.77 after it was disclosed in a 13D filing that FiveT Investment Management has a 6.03% stake in the company.

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced that it received regulatory clearance to start a clinical trial with its lead product candidate, PH-762, to treat melanoma. Phio expects to dose the first patient in the first quarter of 2022. Shares closed up 8% at $1.03.

Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) announced that the FDA cleared an investigational new drug (IND) application for BDTX-1535 to treat glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC). Shares closed up 13% at $5.10.

B. Riley upgraded Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) to Buy from Neutral with a price target of $30, up from $25. Shares closed up 12% at $16.83.

Raymond James maintained Apellis Pharmaceuticals (NASDAQ: APLS) with a Strong Buy and lowered the price target from $116 to $112. Apellis shares closed down 7% at $41.15.

Notable JPM presentations for Wednesday, January 12, 2022: GBIO IMGN EDIT LVTX NTLA MYOV BLUE RPTX

Advancers

CompanyPriceChange
ARDS
Aridis Pharmaceuticals Inc.
$1.60+0.27  +20.30%
CINC
CinCor Pharma Inc.
$18.20+2.13  +13.25%
RVLP
RVL Pharmaceuticals plc
$1.20+0.11  +10.09%
ITCI
Intra-Cellular Therapies Inc.
$42.66+3.79  +9.75%
GMDA
Gamida Cell Ltd.
$3.24+0.28  +9.46%
HILS
Hillstream BioPharma Inc.
$3.36+0.23  +7.35%
KPTI
Karyopharm Therapeutics Inc.
$8.28+0.55  +7.12%
CNTX
Context Therapeutics Inc.
$2.10+0.13  +6.60%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$45.71+2.71  +6.30%
BDSI
BioDelivery Sciences International Inc.
$3.36+0.18  +5.66%

Decliners

CompanyPriceChange
IMMX
Immix Biopharma Inc.
$4.51-0.91  -16.79%
ACXP
Acurx Pharmaceuticals Inc.
$3.64-0.7  -16.13%
CGTX
Cognition Therapeutics Inc.
$3.50-0.64  -15.46%
HOOK
HOOKIPA Pharma Inc.
$1.50-0.26  -14.77%
CVAC
CureVac N.V.
$18.73-3.12  -14.28%
BFRI
Biofrontera Inc.
$3.47-0.53  -13.25%
BSGM
BioSig Technologies Inc.
$1.80-0.27  -13.04%
HCWB
HCW Biologics Inc.
$2.02-0.3  -12.93%
VRPX
Virpax Pharmaceuticals Inc.
$2.30-0.34  -12.88%
APM
Aptorum Group Limited
$1.48-0.21  -12.43%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-503
Non-small cell lung cancer (NSCLC)

$0.13
0.00  -3%
Phase 1/2 Phase 1 Part B data presented at ASCO June 4, 2021. Abstract noted Disease Control Rate (DCR) was 44% (4/9). Phase 1/2 updated data reported a overall response rate (ORR) of 15.4% and DCR of 46%. Two partial responses in part B of the trial, noted January 11, 2022.
$18.9 million

AGTC – Applied Genetic Technologies Corporation
AGTC-501 - SKYLINE
X-linked Retinitis Pigmentosa (XLRP)

$1.57
-0.08  -5%
Phase 1/2 Phase 1/2 data at 12-months post-treatment demonstrated to be well-tolerated at all doses. No SAE related to dosing were reported. All adverse events were Grade 1-2 in centrally treated patients, including those related to the subretinal injection procedure and importantly, immunological assessments did not indicate safety concerns, noted November 12, 2021. Phase 1/2 3-months interim data 2Q 2022.
$67.3 million

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004 (Eblasakimab) - (TREK-AD)
Atopic dermatitis

$0.91
-0.01  -1%
Phase 1b Phase 2b trial initiated January 20, 2022. Phase 2b top-line data due in 1H 2023.
$63.2 million

BLUE – bluebird bio Inc.
Betibeglogene autotemcel (beti-cel) - (LentiGlobin)
β-Thalassemia

$7.24
+0.31  +4%
PDUFA priority review AdCom meeting scheduled for March 9, 2022. PDUFA priority review date extended by 3 months to August 19, 2022.
$507.6 million

BLUE – bluebird bio Inc.
bb21217 (CRB-402)
Multiple Myeloma

$7.24
+0.31  +4%
Phase 1 Development will be discontinued, noted January 11, 2022.
$507.6 million

CHMA – Chiasma Inc.
MYCAPSSA (octreotide)
Maintenance treatment of adult acromegaly

$0.00
0.00  0%
Phase 3 Phase 3 trial met primary non-inferiority endpoint - November 18, 2020. Phase 3 long-term data reported that 47% of patients had very good or excellent symptomatic control at the end of the Randomized Control Treatment (RCT) phase when treated with iSRLs, increasing to 79% at the end of the OLE when treated with Mycapssa, noted January 11, 2022.
$

ONCY – Oncolytics Biotech Inc.
Pelareorep and TECENTRIQ (atezolizumab) - (GOBLET)
Colorectal and advanced anal cancers

$1.91
-0.06  -3%
Phase 1/2 Phase 1/2 first patient dosed November 3, 2021.
$105.1 million

PLRX – Pliant Therapeutics Inc.
PLN-74809 - (INTEGRIS-IPF)
Idiopathic Pulmonary Fibrosis (IPF)

$10.73
-0.47  -4%
Phase 2a Phase 2a enrollment completed December 2021, top line data due by mid-2022.
$386.7 million

RCKT – Rocket Pharmaceuticals Inc.
RP-L201
Leukocyte Adhesion Deficiency-I (LAD-I)

$15.69
-0.65  -4%
Phase 1/2 Additional Phase 1/2 data reported that all eight patients demonstrated durable neutrophil CD18 expression that exceeded the 4-10% threshold associated with survival into adulthood and consistent with reversal of the severe LAD-I phenotype, noted December 13, 2021. Phase 2 topline data expected 2Q 2022.
$1 billion

RVMD – Revolution Medicines Inc - Ordinary Shares
RMC-5552
Solid tumors

$22.71
-0.55  -2%
Phase 1 Phase 1/1b commencement of dosing announced April 21, 2021. Phase 1/1b data reported one patient exhibiting a confirmed partial response with a 63% reduction from baseline and the other three with stable disease, noted January 11, 2022.
$1.7 billion

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-2100
Skin test for COVID-19

$0.23
-0.02  -7%
Phase 1 Phase 1 trial to be initiated January 11, 2022. Phase 1 top-line data due in 1H 2022.
$116.1 million

VSTM – Verastem Inc.
VS-6766 and defactinib (RAMP 201)
Low-grade serous ovarian cancer (LGSOC)

$1.48
-0.05  -3%
Phase 2 Phase 2 part B is currently ongoing, noted January 11, 2022. Part A top-line data due 2Q 2022.
$269.6 million

XNCR – Xencor Inc.
Plamotamab (XmAb13676)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, DLBCL

$34.26
-0.57  -2%
Phase 1/2 Phase 1 data showed to be generally well tolerated and demonstrated encouraging clinical activity as a monotherapy, noted December 12, 2021. Phase 2 trial to be initiated in 2022. Phase 1 data due in 2H 2022.
$2 billion

XNCR – Xencor Inc.
Vudalimab (XmAb717)
Solid tumors

$34.26
-0.57  -2%
Phase 1/2 Phase 1 updated clinical results showed that dosing was generally well-tolerated; objective responses observed across multiple tumor types. Confirmed partial responses observed in two of four evaluable castration. Additional complete response observed in patient, noted November 12, 2021. Phase 2 study to be initiated in 2022 with data from mCRPC cohort due in 2H 2022.
$2 billion