BPC June 09 update

Wednesday's biotech price movers and pipeline updates

Price and Volume Movers

Lyra Therapeutics, Inc. (NASDAQ: LYRA) shares closed up 18% to $9.28 on the back of news reported late-yesterday that the FDA has agreed on key elements of its end-of-year Phase 3 trial of LYR-210, its pipeline candidate for the treatment of chronic rhinosinusitis (CRS).

Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) shares closed up 19% to $3.17. Analysts at Chardan initiated coverage of the company with a Buy rating and a price target of $18.00.

CEL-SCI Corporation (NYSE:CVM) announced after Tuesday’s close that it increased its previously announced offering from $22.6 million to $31.7 million. Shares closed down 12% to $21.08.

Clovis Oncology, Inc. (NASDAQ:CLVS) shares closed up 11% to $6.31, while shares of Inovio Pharmaceuticals, Inc. (NASDAQ:INO) rallied to close 17% higher to $10.03. No news was released by the respective companies, with the move appearing to be based on traders targeting high levels of short interest in the respective stocks (31% and 27%).

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced the FDA has accepted for review its resubmitted New Drug Application (NDA) for ZIMHI, for the treatment of opioid overdose. The PDUFA date is November 12, 2021.

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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:

Aeterna Zentaris Inc. (AEZS): $1.12; +22%.

Jaguar Health, Inc. (JAGX): $2.19; +20%.

Connect Biopharma Holdings Limited (CNTB): $18.00; +14%.

Progenity, Inc. (PROG): $2.68; +14%.

BriaCell Therapeutics Corp. (BCTX): $5.84; +13%.

DECLINERS:

Atossa Therapeutics, Inc. (ATOS): $4.40; -28%.

Vaccinex, Inc. (VCNX): $2.61; -11%.

180 Life Sciences Corp. (ATNF): $10.20; -9%.

Enochian Biosciences, Inc. (ENOB): $4.30; -9%.

ESSA Pharma Inc. (EPIX): $28.82; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
ZIMHI (naloxone HCI Injection)
Opioid overdose

$1.03
-0.03  -3%
PDUFA CRL announced November 16, 2020. NDA resubmitted with new PDUFA date November 12, 2021.
$153.4 million

ATOS – Atossa Therapeutics Inc.
Endoxifen
Breast cancer

$7.02
+1.13  +19%
Phase 2 Phase 2 final data presented June 9, 2021. Primary endpoint met.
$848.2 million

DRRX – DURECT Corporation
DUR-928
Nonalcoholic steatohepatitis (NASH)

$1.69
-0.02  -1%
Phase 1b Phase 1b top-line data released May 26, 2020. Additional data to be presented at EASL meeting June 24-26, 2021.
$384.3 million

IPHA – Innate Pharma S.A.
IPH4102 - TELLOMAK
Mycosis Fungoides and Sézary syndrome

$3.50
-0.22  -6%
Phase 2 Phase 2 mycosis fungoides data presented at ICML meeting June 22, 2021. 1/17 complete responses; 3/17 partial responses and 2 unconfirmed partial responses.
$276.5 million

IVA – Inventiva S.A.
Lanifibranor
Nonalcoholic steatohepatitis (NASH)

$13.95
-0.06  -0%
Phase 2b Phase 3 trial to be initiated 1H 2021. Phase 2b subgroup analysis to be presented at EASL meeting June 25, 2021.
$538.7 million

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

$4.77
+0.04  +1%
Phase 2 Phase 2 interim assessment due by the end of July 2021.
$130 million

OMER – Omeros Corporation
OMS906
MASP-3 inhibitor

$15.46
+0.14  +1%
Phase 1 Phase 1 data released June 9, 2021 - well tolerated with no apparent safety signals.
$963.6 million

PFE – Pfizer Inc.
PREVNAR 20
Pneumococcal conjugate vaccine (18 yrs +)

$39.61
+0.19  +0%
Approved FDA approval announced June 8, 2021.
$221.7 billion

SIOX – Sio Gene Therapies Inc.
AXO-AAV-GM1
GM1 gangliosidosis

$2.66
-0.04  -1%
Phase 1/2 Phase 1/2 12-month data from low-dose cohort due 2H 2021. 12-month topline data from the first two patients dosed in the high-dose cohort due 1Q 2022.
$185 million

VRTX – Vertex Pharmaceuticals Incorporated
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
Children (6-11 years old) who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive

$188.87
+1.17  +1%
Approved FDA approval announced June 9, 2021.
$48.9 billion