BPC December 06 update

Biotech catalysts to watch for the remaining weeks of 2018; Biotech Week in Review

Weekly watchlist

With the annual ASH conference complete it is now time to focus on catalysts slated for the remaining last few weeks of 2018 with a considerable number of catalysts still left on the BioPharmCatalyst FDA Calendar. From this week, watch lists will focus on such events, with completed events replaced each week by other catalysts to watch. 

First, let’s review the week that was post-ASH.

TESARO Inc (NASDAQ: TSRO) shares surged to close Monday up 58% to $73.50 following news that it will be acquired by GlaxoSmithKline plc (NYSE: GSK) for approximately $5.1b (£4b).

Global Blood Therapeutics, Inc. (Nasdaq: GBT) shares rallied to close Monday up 48% to $46.62 following news the FDA will allow an accelerated approval pathway for voxelotor for the treatment of sickle cell disease (SCD), which will allow a faster potential approval of voxelotor.

Biohaven Pharmaceuticals (NYSE: BHVN) closed Monday up 25% to $42.62 following news its Phase 3 clinical trial evaluating its Zydis orally dissolving tablet (ODT) formulation of rimegepant for the acute treatment of migraine, met both of its co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours using a single dose.

Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) announced that its Phase 2 trial of tradipitant in patients with idiopathic and diabetic gastroparesis, met its primary endpoint. Shares closed Monday up 26%.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) shares slid to close down 57% to $1.94 on Thursday following news released when markets were closed Wednesday that top-line results from its Phase 2b ENCORE-PH trial for the treatment of NASH cirrhosis did not meet its primary endpoint. 

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) shares closed Thursday down 12% and a further 10% Friday to $36.53 following the release of data from two of its Phase 3 trials of SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD) in children. While both trials met their primary endpoints, shares sold off due to concerns that the effect sizes, measuring the efficacy of SPN-812, would be challenging to match generic versions of currently approved Strattera.

Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA) shares closed the week down 47% to $5.33 following news that it failed to reach the primary endpoint in its Phase 2b trial of SNA-120 for the treatment of mild-to-moderate psoriasis.

AbbVie (NYSE: ABBV) announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC), due to lack of efficacy.

Moderna, Inc. (Nasdaq: MRNA) listed on Nasdaq on Friday in the largest biotech initial public offering (IPO) in history. The company rasied $604m after selling shares at $23 per share before closing the session down 15% to $18.60. Upcoming healthcare IPOs and past performance can can be viewed in the BioPharmCatalyst IPO Calendar.

Biotech stock catalysts to watch for the remaining 15 trading days of 2018:

Drug Stage Catalyst Market Cap

ACHN – Achillion Pharmaceuticals Inc.
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 2 Phase 2 final data presented at EHA June 15, 2019.
$414.8 million

ADMA – ADMA Biologics Inc
BIVIGAM
Primary humoral immunodeficiency

CRL Response to Complete Response Letter submitted January 7, 2019.
$215.3 million

CELG – Celgene Corporation
REVLIMID - ROBUST
First-line ABC Diffuse large B-cell lymphoma (DLBCL)

Phase 3 Phase 3 data released April 25, 2019 did not meet primary endpoint.
$69 billion

CFRX – ContraFect Corporation
CF-301
Serious infections caused byStaph aureus including MRSA

Phase 2 Phase 2 trial noted clinically meaningful data but not statistically significant. Phase 3 trial planned.
$37.5 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

NDA Filing Phase 3 data released December 17, 2018. Primary endpoint met. NDA to be refiled 2H 2019.
$306.8 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

NDA Filing Phase 3 MACE safety data released May 9, 2019. Non-inferior in non-dialysis, no worse risk than placebo. NDA filing due September/October 2019.
$3.8 billion

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 additional data due 4Q 2019.
$25.6 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod + ipilimumab - ILLUMINATE 204
Cancer - melanoma

Phase 2 Phase 2 final data due 4Q 2019.
$80.1 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Magnolia
Postpartum depression

Phase 2 Data due first half of 3Q 2019.
$215.5 million

NBIX – Neurocrine Biosciences Inc.
INGREZZA - T-Force GOLD
Tourette syndrome - juvenile

Phase 2b Phase 2 top-line data released December 12, 2018 did not meet primary endpoint.
$7.8 billion

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

BLA Filing Rolling BLA filing to commence 4Q 2019.
$119.5 million

SNNA – Sienna Biopharmaceuticals Inc.
SNA-001
Acne

Phase 3 Phase 3 data released July 30, 2018 did not meet primary endpoint.
$33 million