BPC June 06 update

Key biotech stock catalysts left on the calendar for June; Biotech week in Review

Weekly watchlist

Three trading weeks remain on the calendar before we tick over to the second half of 2019. The period promises to be full of news flow, with various clinical readouts combined with the upcoming EHA (European Hematology Association) and EULAR (European Annual European Congress of Rheumatology) conferences, both set to commence next week.

From last week’s list of catalysts, we have removed InflaRx (Nasdaq: IFRX), which had a rough week on poor data, and added a few others for a list of 15.

First, let's review the week that was.

Amgen (NASDAQ: AMGN) announced at ASCO data from its Phase 1 trial evaluating AMG 510, a KRAS G12C inhibitor, in patients with predominantly Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC). Five out of 10 evaluable patients with NSCLC experienced a partial response (PR) for an overall response rate of 50%. Shares closed Monday up 3.4% to $172.36 on the news. Mirati Therapeutics, Inc. (NASDAQ: MRTX), which is developing its own KRAS G12C inhibitor, MRTX849, saw its shares close the week up 47% to $99.77. Data are due later this year.

La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced Thursday that it met the primary endpoint following interim analysis from its Phase 2 trial of LJPC-401 in patients with hereditary hemochromatosis (HH). Further top-line results are due in 2H 2019. Shares closed the week up 139% to $12.86.

Biohaven Pharmaceutical Holding Company Ltd. (NASDAQ: BHVN) closed Friday up 20% to $67.01 on reports that the company has withdrawn from presenting at next week’s Goldman Sachs Global Healthcare conference, with tradersxers raising the possibility of a buyout as to the reason for the withdrawal.

Motif Bio plc (Nasdaq: MTFB) shares closed Thursday down 43% to $1.13 on news that the FDA has requested additional trials for iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The request follows issuance of a Complete Response Letter (CRL) in February this year.

InflaRx (Nasdaq: IFRX) announced that it failed to meet the primary endpoint in its Phase 2b trial of IFX-1, in patients suffering from moderate to severe Hidradenitis Suppurativa (HS). Shares plunged to close the week down 91% to $3.18. ChemoCentryx, Inc. (NASDAQ: CCXI), which is also developing its own candidate for Hidradenitis Suppurativa (HS), saw its shares also fall, closing the week down 23% to $8.66. Data are due from its Phase 2b trial in 2020.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the FDA has extended the PDUFA date for its New Drug Application (NDA) of Gvoke (ready-to-use glucagon injection) by three months to September 10, 2019. The extension follows submission of an information request from the FDA. Shares closed the week down 22% to $8.51.

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Key biotech stock catalysts left on the calendar for June:

Drug Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
EDSIVO
Vascular Ehlers-Danlos Syndrome

CRL CRL issued June 25, 2019.
$21.1 million

ACHV – Achieve Life Sciences Inc.
Cytisine
Smoking cessation

Phase 2b Phase 2b data met primary endpoint in 3/4 arms - June 11, 2019. Data to be presented at SRNT-E Conference, September 12-14, 2019.
$14.7 million

ACRS – Aclaris Therapeutics Inc.
ATI-502 (ATI-50002-AA-201) - dose ranging
Alopecia areata

Phase 2 Phase 2 data did not meet primary endpoint - June 26, 2019.
$36.1 million

AMAG – AMAG Pharmaceuticals Inc.
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)

Approved FDA approval announced June 21, 2019.
$386.5 million

ARQL – ArQule Inc.
ARQ 531
B-cell malignancies

Phase 1 Phase 1 data at EHA June 14, 2019 noted 66% (4/6) ORR in CLL patients.
$1.1 billion

CBAY – CymaBay Therapeutics Inc.
Seladelpar
Non-alcoholic steatohepatitis (NASH)

Phase 2b Phase 2b further 52-week histology results likely due 2Q 2020.
$399.8 million

DOVA – Dova Pharmaceuticals Inc.
Avatrombopag
Immune Thrombocytopenic Purpura (ITP)

Approved FDA Approval announced June 27, 2019.
$418.2 million

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

NDA Filing NDA filing due 4Q 2019.
$1.2 billion

GBT – Global Blood Therapeutics Inc.
Voxelotor GBT440
Sickle cell disease

NDA Filing NDA to be filed under accelerated approval 2H 2019.
$2.9 billion

ITCI – Intra-Cellular Therapies Inc.
ITI-007 - Monotherapy (Study 401)
Bipolar depression

Phase 3 Phase 3 trial did not meet primary endpoint - July 8, 2019.
$502.1 million

KRYS – Krystal Biotech Inc.
KB103
Epidermolysis Bullosa

Phase 2 Phase 3 trial to commence 4Q 2019.
$738 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant)
Primary insomnia

Phase 2b Phase 2b data June 24, 2019 met primary endpoint.
$264.6 million

SVRA – Savara Inc.
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)

Phase 3 Phase 3 data June 12, 2019 did not meet primary endpoint.
$90.6 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Common warts

Phase 2 Phase 2 data noted 51% of patients noted complete clearance of warts - June 26, 2019.
$236.6 million

XOMA – XOMA Corporation
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing BLA filing due 4Q 2019. Updated data August 8, 2019 noted pooled CR rates of 17%-40%.
$149.4 million