BPC October 31 update

BeiGene BGNE shares up 24% after hours on deal with Amgen; ​Agile AGRX +224% on Wednesday's positive panel vote

Price and Volume Movers

Agile Therapeutics, Inc. (NASDAQ:AGRX) shares closed 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 PDUFA date for a final decision by the FDA is November 16, 2019.

BeiGene, Ltd. (NASDAQ:BGNE) shares are trading up 24% after hours to $171.75 following news of a collaboration with Amgen (NASDAQ: AMGN) for the commercialization and development in China of Amgen's Xgeva, Kyprolis and Blincyto and the joint global development of 20 oncology assets in Amgen's pipeline, with BeiGene responsible for development and commercialization in China. Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7b in cash.

Myovant Sciences (NASDAQ: MYOV) shares closed up 17% to $5.46. The company announced that Sumitomo Dainippon Pharma will provide a $350m, five-year term loan facility, with no repayments due until the end of the term.

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 and may be eligible to receive up to an additional $1.47b over time for the achievement of specified development, regulatory and commercial milestones, in addition to royalties based on potential product sales. Shares closed up 5% to $16.49.

Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) shares closed up 80% to $6.09. The company presented data from its Phase 1 trial of ELX-02 for the potential treatment of cystic fibrosis. It noted high bioavailability and an acceptable safety profile without severe or serious drug-related adverse events.

Recro Pharma, Inc. (NASDAQ:REPH) shares rose 14% to $15.77 following its announcement that the FDA has granted its appeal of the Complete Response Letter relating to the New Drug Application (NDA) for intravenous (IV) meloxicam.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Arbutus Biopharma Corporation (ABUS): $1.42; +60%.

EyeGate Pharmaceuticals, Inc. (EYEG): $3.95; +20%.

Galmed Pharmaceuticals Ltd. (GLMD): $4.18; +13%.

Aduro BioTech, Inc. (ADRO): $1.14; +12%.

Correvio Pharma Corp. (CORV): $2.00; +12%.

DECLINERS:

Cyclerion Therapeutics Inc (CYCN): $2.39; -13%.

Kaleido Biosciences Inc (KLDO): $5.86; -11%.

Exelixis, Inc. (EXEL): $15.45; -11%.

Acorda Therapeutics Inc (ACOR): $1.65; -10%.

Nantkwest Inc (NK): $1.05; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Upadacitinib
Atopic Dermatitis

Phase 3 Phase 3 trial met primary and secondary endpoints - October 31, 2019.
$174.9 billion

ALNY – Alnylam Pharmaceuticals Inc.
Lumasiran (ALN-GO1)
Primary Hyperoxaluria Type 1 (PH1)

PDUFA priority review PDUFA date under priority review December 3, 2020.
$17.6 billion

ASLN – ASLAN Pharmaceuticals Limited
Varlitinib - TREETOPP
Biliary tract cancer

Phase 2/3 Phase 3 trial did not meet primary endpoint - November 11, 2019.
$74.8 million

BLUE – bluebird bio Inc.
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma

BLA Filing Refusal-to-file letter received May 13, 2020. BLA to be refiled no later than July 2020.
$3.3 billion

BMY – Bristol-Myers Squibb Company
Ozanimod - TRUE NORTH
Ulcerative Colitis

Phase 3 Phase 3 trial met primary endpoint - June 2, 2020.
$136.6 billion

EIDX – Eidos Therapeutics Inc.
AG10 / BBP-265
ATTR-PN

Phase 2 Phase 3 trial planned for 2H 2020.
$1.9 billion

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystinosis

Phase 2 Phase 2 data released January 14, 2020.
$119.2 million

GRTS – Gritstone Oncology Inc.
SLATE-001
Solid tumors

Phase 1 Phase 1 efficacy data July 13, 2020.
$250 million

IRWD – Ironwood Pharmaceuticals Inc.
MD-7246
Irritable Bowel Syndrome

Phase 2 Phase 2 trial did not meet primary endpoint - May 27, 2020.
$1.7 billion

MNLO – Menlo Therapeutics Inc.
Serlopitant
Chronic pruritus of unknown origin

Phase 2 Phase 2 trial did not meet primary endpoint - February 26, 2020.
$279.1 million

MNTA – Momenta Pharmaceuticals Inc.
Nipocalimab (M281)
generalized myasthenia gravis (gMG)

Phase 2 Phase 2 trial met primary endpoint - June 15, 2020.
$3.9 billion

PRTK – Paratek Pharmaceuticals Inc.
Omadacycline
Complicated urinary tract infections (cUTI) / acute pyelonephritis

Phase 2 Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
$224.7 million

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 MAD data due initially 3Q 2020. Timeline might be delayed due to COVID-19. Update due at later date.
$1.1 billion