BPC May 28 update

​Amgen AMGN receives approval for KRAS inhibitor; ETON issued Complete Response Letter

Price and Volume Movers

Amgen (NASDAQ: AMGN) announced that the FDA approved LUMAKRAS (sotorasib), a KRAS inhibitor, for the first treatment of non-small cell lung cancer (NSCLC) in patients with gene mutation KRAS G12C. The decision came well ahead of its assigned PDUFA date scheduled for August this year. Shares closed up 1% to $237.94.

Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) shares fell 4% to $11.26 following news the FDA has extended the PDUFA date by three months to September 23, 2021 for the review of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum. The extension allows the FDA time to review new information, including its training program and distribution model.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) received a Complete Response Letter (CRL) from FDA for its NDA for dehydrated alcohol injection for the treatment of methanol poisoning. The company noted a Pre-Approval Inspection (PAI) of its European contract manufacturer by the FDA is pending due to COVID-related travel restrictions. Shares fell 17% to $7.06.

Liminal BioSciences Inc. (NASDAQ:LMNL) announced that it will no longer initiate a Phase 2 trial of fezagepras in patients with Idiopathic Pulmonary Fibrosis and a Phase 1a/2b trial for Hypertriglyceridemia. The decision follows its review of pharmacokinetic (PK) data from its multiple ascending dose (MAD) trial.

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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:

Iterum Therapeutics plc (ITRM): $1.54; +18%.

Prometheus Biosciences, Inc. (RXDX): $23.29; +16%.

Freeline Therapeutics Holdings plc (FRLN): $11.00; +12%.

Adagene Inc. (ADAG): $14.18; +12%.

SELLAS Life Sciences Group, Inc. (SLS): $11.96; +12%.

DECLINERS:

Provention Bio, Inc. (PRVB): $7.61; -29%.

CytomX Therapeutics, Inc. (CTMX): $7.16; -13%.

Vallon Pharmaceuticals, Inc. (VLON): $4.00; -11%.

Humanigen, Inc. (HGEN): $20.23; -11%.

Scopus BioPharma Inc. (SCPS): $7.08; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AMGN – Amgen Inc.
LUMAKRAS (Sotorasib)
Non-small cell lung cancer (NSCLC)

$239.91
-0.33  -0%
Approved FDA approval announced May 28, 2021.
$137.8 billion

CVAC – CureVac N.V.
CVnCoV
COVID-19 vaccine

$58.10
-1.57  -3%
Phase 2/3 Phase 2b/3 trial did not meet prespecified statistical success criteria - June 16, 2021.
$10.8 billion

ETON – Eton Pharmaceuticals Inc.
Dehydrated alcohol injection (DS-100)
Methanol poisoning

$5.71
-0.25  -4%
CRL CRL announced May 28, 2021.
$139.9 million

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss

$6.97
+0.34  +5%
PDUFA CRL announced August 10, 2020. NDA resubmitted with new PDUFA date of November 27, 2021.
$176.7 million

HGEN – Humanigen Inc.
Lenzilumab
COVID-19

$18.46
-0.54  -3%
Phase 3 Phase 3 trial met primary endpoint - March 29, 2021. EUA filing announced May 28, 2021.
$1.1 billion

LMNL – Liminal BioSciences Inc.
Fezagepras
Idiopathic pulmonary fibrosis (IPF)

$4.09
+0.05  +1%
Phase 1 Phase 2 trial will no longer be initiated - May 28, 2021.
$122.5 million

LMNL – Liminal BioSciences Inc.
Fezagepras
Hypertriglyceridemia

$4.09
+0.05  +1%
Phase 1/2 Phase 1b/2a trial will not longer be initiated - noted May 28, 2021.
$122.5 million

MDNA – Medicenna Therapeutics Corp.
MDNA11
Cancer Immunotherapies

$3.73
-0.01  -0%
Phase 1/2 Phase 1/2 trial to be initiated 3Q 2021 with top-line safety, PK/PD and biomarker data due end of 2021.
$182 million

MORF – Morphic Holding Inc.
MORF-057
Healthy volunteers

$60.37
-2.47  -4%
Phase 1 Phase 1 full data due at ECCO Virtual Congress in July 9, 2021.
$2.2 billion

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

$11.62
+0.04  +0%
PDUFA CRL announced July 14, 2020. NDA resubmitted. Initial PDUFA date extended by three months to September 23, 2021.
$318.5 million