BPC November 01 update

Biotech stock catalysts for the week ahead; Biotech week in Review

Weekly watchlist

This week’s watch list looks at potential catalysts slated for the upcoming week, with much focus on the Society for Immunotherapy of Cancer's (SITC) Annual Meeting from November 7-10. Full regular and late-breaking abstracts will be released to the public on November 5 at 8am EST.

First, let’s review a selection of price-moving events from the week that was.

Agile Therapeutics, Inc. (NASDAQ:AGRX) shares closed Thursday up 224% to $1.20 following Wednesday’s FDA Advisory Committee meeting which delivered a 14 to 1 vote (1 abstention) supporting approval of the New Drug Application (NDA) for its contraceptive patch, Twirla. The surge reversed the move earlier in the week, where shares slumped following the release of briefing documents on Monday for the meeting, falling 67% from $1.11 to $0.37 in the two days leading up to the panel. The PDUFA date for a final decision by the FDA is November 16, 2019.

BeiGene, Ltd. (NASDAQ:BGNE) shares closed Friday up 37% to $189.56 following news released late-Thursday of a collaboration with Amgen (NASDAQ: AMGN) for the commercialization and development in China of Amgen's oncology drugs. Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7b in cash.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) shares closed the week down 19% to $9.94 following a negative vote from an Advisory Committee reviewing its marketed treatment Makena for pre-term births. The panel voted 9-7 in favor of recommending the withdrawal of Makena from the market, following a post-approval trial that showed the treatment not to be effective. Makena was originally approved in 2011.

Mirati Therapeutics, Inc. (NASDAQ: MRTX) shares closed the week up 23% to $100.04 following data released Monday from its Phase 1/2 trial evaluating its KRAS inhibitor, MRTX849, in patients with solid tumors expressing KRAS G12C mutations. Across all dose levels, three of six patients with non-small cell lung cancer (NSCLC) and one of four patients with colorectal cancer (CRC) achieved a partial response.

Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) shares slumped to close the week down 78% to $2.45 following news that it did not meet the primary endpoints in two Phase 2 trials, of praliciguat, in heart failure with preserved ejection fraction (HFpEF) and in diabetic nephropathy, respectively.

Iveric bio, Inc. (NASDAQ: ISEE) shares closed the week up 309% to $3.80. The company announce its Phase 2b trial of Zimura met the primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD).

Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX) announced that its Phase 3 CMS-001 trial evaluating amifampridine phosphate for the symptomatic treatment of genetically confirmed Congenital Myasthenic Syndromes (CMS), did not meet its primary endpoint. Shares closed the week down 14% to $4.81.

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) announced a research collaboration and licensing agreement with Roche (OTCQX: RHHBY) to develop therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s RNAi platform technology. Dicerna will receive $200m in an initial upfront payment. Shares closed Thursday up 5% to $16.49. Arbutus Biopharma Corporation (Nasdaq: ABUS) saw its shares climb 60% to $1.42 in sympathy to the move, with the company also targeting HBV using RNA.

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Selection of 15 top revenue earning companies reporting 3Q earnings during the week of November 4:

Mon: BHC NBIX

Tue: ACOR AGN ENDP JAZZ MNK MYL REGN

Wed: AMRX EBS HZNP IONS

Thur: SRPT TEVA

Other biotech events to watch over next week:

Drug Stage Catalyst Market Cap

AGEN – Agenus Inc.
AGEN2034 (anti-PD-1)
Cervical cancer

Phase 1/2 Subset analysis of Phase I dose escalation trial presented at SITC November 8, 2019.
$563.2 million

ALKS – Alkermes plc
ALKS 4230 ARTISTRY-1
Solid tumors

Phase 1 Phase 1/2 data at SITC November 2019 - 8/14 SD for monotherapy, 12/18 for combo (incl. 2 PRs).
$3.2 billion

ASMB – Assembly Biosciences Inc.
ABI-H0731
Hepatitis B virus (HBV)

Phase 2a Phase 2a data presented at AASLD November 11, 2019.
$363.4 million

CRVS – Corvus Pharmaceuticals Inc.
CPI-006
Solid tumors

Phase 1b Phase 1/1b updated at SITC November 8, 2019 noted tumor regression in 4/9 patients receiving 6 mg/kg or higher.
$82.3 million

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystinosis

Phase 2 Phase 2 data due 4Q 2019.
$184 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

NDA Filing NDA filing due 4Q 2019.
$3.3 billion

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

Phase 2 Phase 2 pivotal cohort enrolment to be completed 1Q 2020. Cohort 2 data noted 41% ORR in patients refractory to anti-PD1/L1 - November 21, 2019.
$2.8 billion

NXTC – NextCure Inc.
NC318
Solid tumors

Phase 1/2 Phase 2 part to be completed 4Q 2020.
$825.5 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-343
HER2-positive solid tumors

Phase 1/2 Phase 1 data at SITC November 9, 2019 noted 2/18 response rate.
$177.3 million

SURF – Surface Oncology Inc.
SRF231
Hematologic malignancies, solid tumors

Phase 1 Phase 1 data presented at SITC meeting November 9, 2019.
$58.8 million

THOR – Synthorx Inc.
THOR-707 (HAMMER)
Soild tumors

Phase 1/2 Phase 1/2 data presented at SITC November 9, 2019.
$561.1 million