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.
$172.1 million

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

PDUFA PDUFA date of January 31, 2019. Advisory Committee Meeting November 1, 2018 voted 2-21 against recommending approval.
$5.1 billion

BIIB – Biogen Inc.
BAN2401 (Aβ mAb)
Alzheimer’s disease

Phase 2 Phase 2 mixed data released July 25, 2018. High dose exhibited statistical improvement. Low doses missed.
$63.4 billion

CHRS – Coherus BioSciences Inc.
CHS-1701
Pegfilgrastim biosimilar

Approved FDA approval announced November 2, 2018.
$661.9 million

ESPR – Esperion Therapeutics Inc.
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-047
Hypercholesterolemia

Phase 3 Phase 3 data released October 28, 2018. 18% LDL-C Lowering, no difference in adverse events vs placebo. NDA filings due 1Q 2019.
$1.3 billion

FOMX – Foamix Pharmaceuticals Ltd.
FMX103
Papulopustular rosacea

Phase 3 Phase 3 top-line data released November 7, 2018. Primary endpoints met. Safety data due 1H 2019.
$216 million

GLPG – Galapagos NV
GLPG 2451+2222+2737 - FALCON open label
Cystic fibrosis - homozygous F508del patients

Phase 1/2 Phase 1b data released October 24, 2018 noted drug was well tolerated. Safety data due 1Q 2019.
$5.7 billion

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
$34 million

SELB – Selecta Biosciences Inc.
SEL-212
Tophaceous gout

Phase 3 Phase 3 trial to be initiated 1Q 2019 with with interim data likely 3Q and 4Q 2019 and full data 1Q 2020.
$105.9 million

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

CRL CRL issued November 2, 2018.
$47.8 million

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

PDUFA FDA approval announced October 29, 2018.
$920.6 million