BPC October 19 update

Biotech stock events slated for the next two weeks; Biotech week in Review

Weekly watchlist

The latest week, pre-ESMO, saw just a few major clinical updates with most eyes on this weekend’s ESMO conference.

This week we review key catalysts slated for the next two weeks, with much attention focused on Phase 2 gout data due next week from Selecta Biosciences Inc (SELB).

Firstly, our brief review of five clinical and regulatory events to make headlines this week.

EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) announced Monday the early approval from the FDA of Yutiq for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Shares closed up 7% to $3.45.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NYSE: SNY) announced Friday the FDA has approved Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older.

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) shares slipped Friday 22% to $4.01 following news its Phase 2 SHERLOC trial of MM-121 in combination with docetaxel in patients with heregulin positive non-small-cell lung cancer (NSCLC), will be terminated due to futility. 

Endocyte, Inc. (Nasdaq:ECYT) shares surged Thursday to close up 50% to $23.40 following news that it will be acquired by Novartis for $24 per share, or approximately $2.1b in cash. 

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) shares closed Friday down 18% to $22.26 following the presentation of updated preliminary results from its ongoing Phase 1 trial of DCC-2618 in patients with gastrointestinal stromal tumors (GIST). While the data were still impressive, the combined Objective Response Rate (ORR) for 21% for 2nd and 3rd line patients dropped slightly compared with 24% reported earlier in the year.


Remaining key biotech stock events slated over the next two weeks:

Drug Stage Catalyst Market Cap

ACRX – AcelRx Pharmaceuticals Inc.
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure

Approved FDA Approval announced November 2, 2018.
$233.6 million

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

CRL CRL announced February 1, 2019.
$3.9 billion

BIIB – Biogen Inc.
BAN2401
Alzheimer’s disease

Phase 3 Phase 3 initiation announced March 22. 2019.
$45.2 billion

CHRS – Coherus BioSciences Inc.
CHS-1701
Pegfilgrastim biosimilar

Approved FDA approval announced November 2, 2018.
$1.4 billion

FOMX – Foamix Pharmaceuticals Ltd.
FMX103
Papulopustular rosacea

NDA Filing NDA filing due mid-2019.
$145.3 million

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Development to be suspended - noted December 21, 2018.
$16.8 million

SELB – Selecta Biosciences Inc.
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout

Phase 2 Phase 2 interim data due 4Q 2019 and full data 1Q 2020. Phase 3 trial to be initiated 4Q 2019.
$106.1 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

CRL CRL issued November 2, 2018. Additional QT interval data required - trial to commence June, 2019.
$121 million

TXMD – TherapeuticsMD Inc.
TX-001HR: BIJUVA
Moderate to severe vasomotor symptoms (VMS)

PDUFA FDA approval announced October 29, 2018.
$786.4 million