BPC January 24 update

Biotech earnings season kicks off; Biotech week in Review

Weekly watchlist

The upcoming week sees the first major week of 4Q earnings season, with predominantly large-cap companies reporting. We list key earnings dates to key an eye on and also note some upcoming events slated for the next 2-3 weeks.

Note, the list of events does not include catalysts without a specific date. For general first quarter regulatory and clinical catalysts, we suggest you refer to the Phase 1/2, Phase 3, and PDUFA lists which have been highlighted over the past three weeks. Most remain in play and will be the focus for the quarter.

Key news from the week:

Influenza-related stocks saw speculative activity following the coronavirus outbreak in China. Much of this was just that, speculation. Head of the pack was Novavax, Inc. (NASDAQ: NVAX), which closed the week up 36% to $7.80, while Vaccinex, Inc. (NASDAQ: VCNX) shares closed Friday up 32% to $6.90 despite being a cancer/autoimmune vaccine (not influenza vaccine) company.

Horizon Therapeutics plc (Nasdaq: HZNP) announced Tuesday that the FDA approved Tepezza (teprotumumab) for the treatment of Thyroid Eye Disease (TED). The decision came ahead of its assigned PDUFA date of March 08, 2020.

Epizyme, Inc. (NASDAQ:EPZM) announced Thursday that the FDA granted accelerated approval of Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma. The approval was expected given its positive Advisory Committee meeting vote late last year. Despite the good news, the stock closed the week down 16% to $22.40, a common sell-on-the-news reaction post-approval for companies where FDA approval was largely anticipated.

Baudax Bio, Inc. (NASDAQ:BXRX) announced that the FDA has set a PDUFA goal date of February 20, 2020 for the New Drug Application (NDA) for intravenous (IV) meloxicam for the management of moderate to severe pain. The assignment of the PDUFA date follows its 2019 complete response letter (CRL) and appeal filing. Such a short timeframe between NDA acceptance and the PDUFA date is almost unheard of and this saw shares close the week up 13% to $8.31.

EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) shares closed the week up 14% to $1.93. The company reported preliminary net product revenues for the fourth quarter of 2019, estimated to be between $6.9 and $7.6m, a significant improvement from net product revenues of $1m reported for the third quarter of 2019.

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Key earnings dates for the upcoming week:

T: PFE

W: NVS

Th: ALXN AMGN BIIB LLY VRTX

Upcoming catalysts with definitive dates of mid-February or earlier:

Drug Stage Catalyst Market Cap

ACST – Acasti Pharma Inc.
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia

Phase 3 Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data due 3Q 2020.
$47.7 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$212.9 million

AIMT – Aimmune Therapeutics Inc.
PALFORZIA - AR101
Peanut Allergy

Approved FDA approval announced January 31, 2020.
$1.7 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Rimegepant
Migraine - preventative

Phase 3 Phase 3 top-line data due 1Q 2020.
$2.5 billion

FTSV – Forty Seven Inc.
Magrolimab + Avelumab
Ovarian cancer

Phase 1 Phase 1b due at ASCO-SITC February 6, 2020 - 0% ORR in 18 ovarian cancer patients.
$2.3 billion

MGEN – Miragen Therapeutics Inc.
Cobomarsen MRG-106
Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-Cell Lymphoma (DLBCL); Cutaneous T-cell Lymphoma (CTCL); Adult T-Cell Leukemia/Lymphoma (ATLL)

Phase 1 Phase 1 data noted median survival time of 26 months compared with 7.4 months in historical cohort and PFS of 12.5 months compared with 5.4 months in historical cohort - January 30, 2020.
$27.7 million

TROV – TrovaGene Inc.
Onvansertib (PCM-075) and Zytiga
Prostate cancer

Phase 2 Phase 2 biomarker data to be presented at AACR April 24-29, 2020.
$12.1 million

XXII – 22nd Century Group Inc.
VLN cigarettes
MRTP application

NDA Filing FDA Tobacco Products Scientific Advisory Committee (TPSAC) to met February 14, 2020, regarding MRTP application.
$128.2 million