BPC December 18 update

Epizyme EPZM positive Advisory Committee vote +10%; Minerva NERV fails depression trial -29% AH

Price and Volume Movers

Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) announced after hours that it has been awarded a 5-year contract by the Biomedical Advanced Research and Development Authority (BARDA) to support the development of Nuzyra (omadacycline) for the treatment of pulmonary anthrax. Initial funding of $59m will be awarded with an additional $226m pending certain milestones. Shares are trading after hours up 78% to $5.25.

Minerva Neurosciences, Inc. (NASDAQ: NERV) announced its Phase 2b trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) failed to meet its primary and key secondary endpoints. Shares are currently trading down 29% to $4.90 after hours.

Epizyme, Inc. (Nasdaq: EPZM) shares closed up 10% to $20.09 following news the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 - 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery. The PDUFA date for a final decision is January 23, 2020.

Syros Pharmaceuticals, Inc. (NASDAQ: SYRS) shares closed up 16% to $5.37 following news of a collaboration with Global Blood Therapeutics, Inc. (NASDAQ: GBT) to develop therapies for sickle cell disease (SCD) and beta thalassemia. Syros receives an upfront payment of $20m and up to $40m in preclinical research.

Axsome Therapeutics, Inc. (NASDAQ:AXSM) announced after hours that it intends to offer and sell shares of its common stock in an underwritten public offering. Shares are currently trading after hours up 6% to $95.00 following the news.

Zafgen, Inc. (Nasdaq:ZFGN) and Chondrial Therapeutics, Inc., announced the two companies will merge to form a new company, Larimar Therapeutics, Inc. Chondrial stockholders are expected to own approximately 60% of the combined company and current Zafgen stockholders will own approximately 40%. Shares of Zafgen closed down 13% to $0.72.

Onconova Therapeutics, Inc. (NASDAQ: ONTX) announced a registered direct offering of 13,878,864 shares and warrants to purchase up to a further 6,939,432 shares, at a combined purchase price of $0.36026 per share and associated warrant, for gross proceeds of approximately $5m. Shares closed down 8% to $0.30

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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:

Mirum Pharmaceuticals, Inc. (MIRM): $23.76; +44%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $4.72; +28%.

HOOKIPA Pharma Inc. (HOOK): $9.96; +24%.

Seelos Therapeutics, Inc. (SEEL): $1.52; +19%.

Galera Therapeutics, Inc. (GRTX): $13.27; +19%.

DECLINERS:

PLx Pharma Inc. (PLXP): $3.36; -29%.

Solid Biosciences Inc. (SLDB): $3.96; -17%.

PDS Biotechnology Corporation (PDSB): $2.12; -15%.

Adamas Pharmaceuticals, Inc. (ADMS): $3.67; -11%.

Intellia Therapeutics, Inc. (NTLA): $15.02; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BMY – Bristol-Myers Squibb Company
liso-cel (JCAR017) - TRANSCEND NHL-001
Relapsed or refractory (R/R) large B-cell lymphoma

PDUFA priority review PDUFA date under priority review August 17, 2020.
$150 billion

BYSI – BeyondSpring Inc.
Plinabulin (Trial 105)
Chemotherapy-induced neutropenia (CIN)

Phase 3 Phase 3 final data due 1H 2020.
$456.7 million

DARE – Dare Bioscience Inc.
DARE-BV1
Bacterial Vaginosis

Phase 3 Phase 3 trial to be initiated in 2020.
$33.6 million

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

PDUFA priority review PDUFA date June 18, 2020 under priority review.
$2.1 billion

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

Approved FDA approval announced January 23, 2020.
$2.1 billion

ETNB – 89bio Inc.
BIO89-100
Nonalcoholic steatohepatitis (NASH)

Phase 1/2 Phase 1b/2 trial top-line data due 2H 2020.
$499.9 million

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

PDUFA PDUFA date May 25, 2020.
$287 million

GSK – GlaxoSmithKline PLC
Benlysta (belimumab)
Lupus Nephritis

BLA Filing Phase 3 trial met primary endpoint - December 18, 2019. BLA filing due 1H 2020.
$105.1 billion

MDGL – Madrigal Pharmaceuticals Inc.
Resmetirom - MAESTRO-NAFLD-1
Non-Alcoholic Fatty Liver Disease

Phase 3 Phase 3 initiation of dosing announced December 18, 2019.
$1.4 billion

NERV – Minerva Neurosciences Inc
MIN-117
Major Depressive Disorder

Phase 2b Phase 2b data failed to meet endpoints - December 18, 2019. Development to be discontinued in MDD.
$350.8 million

PFE – Pfizer Inc.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer

PDUFA priority review PDUFA date under priority review for sNDA April 2020.
$191.9 billion

PFNX – Pfenex Inc.
JZP-458
Acute lymphoblastic leukemia (ALL)

Phase 2/3 Phase 2/3 commencement of enrolment announced December 30, 2019.
$403.2 million

SLDB – Solid Biosciences Inc.
SGT-001
Duchenne Muscular Dystrophy

Phase 1/2 Phase 1/2 trial placed on clinical hold - November 12, 2019. Still in place as of December 18, 2019.
$146.2 million