BPC May 03 update

Key biotech earnings next week; May catalysts; Biotech week in review

Weekly watchlist

Next week is setting up to be full of biotech newsflow as we move into the peak of 1Q earnings season. Further down is a selection of companies that are slated to deliver their financial reports.

Looking ahead to the week after, focus will switch to the release of abstracts for next month’s ASCO (American Society of Clinical Oncology) meeting. Abstracts will be released on Wednesday May 15 at 5pm. ASCO is regarded as the premier meeting of the year for oncology professionals, industry representatives, and major media outlets. As a guide, ASCO will publish the official abstracts on its meeting website. The cut-off date for inclusion of data in the abstracts is February 12, 2019. The final conference presentation will include any additional data collected between the abstract submission cutoff and the presentation itself.

Now, for a review of the week that was:

VistaGen Therapeutics (NASDAQ: VTGN) announced that it failed to meet the primary endpoint in a Phase 2 clinical trial of AV-101 in patients with treatment-resistant depression (TRD). Shares closed Thursday down 47% to $0.56.

Nabriva Therapeutics plc (NASDAQ: NBRV) closed the week down 22% to $2.16 on news released late-Tuesday that it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) of Contepo (fosfomycin) for the treatment of complicated urinary tract infections (cUTI). The CRL noted issues related to manufacturing deficiencies at one of its contract manufacturers.

Heron Therapeutics, Inc. (Nasdaq: HRTX) also announced it received a CRL from the FDA regarding its NDA for HTX-011 for the management of postoperative pain. The FDA requested additional chemistry, manufacturing and controls (CMC) and non-clinical information. Shares closed the week down 30% to $17.00.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) shares conversely closed the week up 17% to $46.81, benefiting from the news that hit Heron. Pacira currently markets Exparel, a competitor to Heron’s HTX-011.

-

Selection of 20 companies reporting earnings next week:

M: BHC

T: AGN AMAG CLVS EGRX MNK MYL REGN JAZZ OPK RIGL RGNX SUPN

W: ASRT HZNP ICPT

Th: AKBA ENDP IONS PBYI

-

Listed below are biotech catalysts likely to occur this month. Note that some clinical catalysts are officially slated to read out this quarter and are included below as a best estimate only that the catalyst will occur in May, and not June.

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 data due at ASCO June 3, 2019, 9am CT.
$103.5 billion

DRRX – DURECT Corporation
DUR-928
Alcoholic hepatitis (AH)

Phase 2 Phase 2 preliminary data noted May 8, 2019.
$116.4 million

GWPH – GW Pharmaceuticals Plc
Epidiolex
Tuberous Sclerosis Complex

Phase 3 Phase 3 data released May 6, 2019 met primary endpoint. sNDA due 4Q 2019.
$5.7 billion

INCY – Incyte Corporation
Ruxolitinib
Graft versus host disease

PDUFA priority review PDUFA date under priority review extended by three months to May 24, 2019.
$16.9 billion

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

Phase 3 Phase 3 top-line data due 2Q 2019.
$703 million

KRYS – Krystal Biotech Inc.
KB103
Epidermolysis Bullosa

Phase 2 Phase 2 top-line data due 2Q 2019.
$469 million

KZR – Kezar Life Sciences Inc.
KZR-616
Lupus

Phase 1/2 Initial Phase 1b top-line data due 2Q 2019.
$374.2 million

MDCO – The Medicines Company
Inclisiran - ORION 3
Cardiovascular disease (ASCVD)

Phase 2 Phase 2 open-label data presented May 18, 2019. 51% decrease in LDL-C levels.
$2.5 billion

MRTX – Mirati Therapeutics Inc.
MRTX849
Solid tumors

Phase 1/2 Phase 1/2 update due 2H 2019.
$2.7 billion

MYOV – Myovant Sciences Ltd.
Relugolix - LIBERTY 1 and LIBERTY 2
Menstrual bleeding associated with uterine fibroids

Phase 3 Phase 3 LIBERTY 1 top-line data met primary endpoint - May 14, 2019. LIBERTY 2 data due 3Q 2019.
$905 million

PTCT – PTC Therapeutics Inc.
RG7916 - FIREFISH
Spinal Muscular Atrophy (SMA) Type 1

Phase 2/3 NDA filing due 2H 2019.
$2.3 billion

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

Phase 3 Phase 3 complete response rate 39% after 3 months, 15% after 12 months. Pre-BLA meeting June 6, 2019.
$152.6 million