BPC August 02 update

GlycoMimetics GLYC shares slide after hours on negative late-stage data

Price and Volume Movers

Pfizer Inc. (NYSE:PFE) and GlycoMimetics, Inc. (NASDAQ: GLYC) announced the Phase 3 trial of rivipansel (GMI-1070) in patients aged six and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids, did not meet its primary or key secondary efficacy endpoints. Shares of GlycoMimetics are trading down 32% to $6.25 after hours.

Acorda Therapeutics, Inc. (NASDAQ: ACOR) shares sold off steadily throughout the morning session, closing the day down 49% to $3.10 following its report of second quarter earnings. Acorda noted Ampyra net revenue of $44.2m had fallen from $150.3m for the same quarter in 2018, while Inbrija revenue was only $3m following its launch in February. In September 2018, Ampyra, which is approved to help improve walking in adults with multiple sclerosis (MS), lost its exclusivity and generics entered the market.

Stemline Therapeutics, Inc. (NASDAQ: STML) shares closed up 14% to $14.86. The company reported in its second quarter earnings release net revenue of Elzonris of $13m, representing a 157% increase over last quarter.

Coherus BioSciences, Inc. (Nasdaq: CHRS) shares closed up 18% to $20.02, also on the back of its release of second quarter earnings. Net income of $23.6m or $0.32 per share, beat estimates of only $0.08. Net product revenue of $83.4m also beat consensus of $75.5m.

Oasmia Pharmaceutical AB (NASDAQ: OASM) announced that it intends to delist its American Depositary Shares (“ADS”) from the Nasdaq Capital Market and to deregister and terminate its reporting obligations with the Securities and Exchange Commission. Oasmia expects the delisting to become effective on or about August 22, 2019.

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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:

DURECT Corporation (DRRX): $1.25; +15%.

22nd Century Group, Inc. (XXII): $1.54; +13%.

Anchiano Therapeutics Ltd (ANCN): $3.19; +13%.

Solid Biosciences Inc. (SLDB): $5.98; +9%.

DelMar Pharmaceuticals, Inc. (DMPI): $1.64; +8%.

DECLINERS:

Intersect ENT, Inc. (XENT): $16.50; -18%.

Correvio Pharma Corp. (CORV): $1.57; -15%.

Adaptimmune Therapeutics plc (ADAP): $2.51; -15%.

Seres Therapeutics, Inc. (MCRB): $2.42; -13%.

Fulcrum Therapeutics, Inc. (FULC): $12.84; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

DCPH – Deciphera Pharmaceuticals Inc.
DCC-3014
Solid tumors or hematological malignancies

Phase 1 Phase 1 initial TGCT data presented at CTOS November 13 2019.
$2.7 billion

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line

NDA Filing NDA filing due 1Q 2020.
$2.7 billion

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and paclitaxel
Solid tumors

Phase 1/2 Phase 1b/2 preliminary data noted 8/43 partial responses - October 28, 2019.
$2.7 billion

GLYC – GlycoMimetics Inc.
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease

Phase 3 Phase 3 data failed to meet endpoints - August 2, 2019.
$259.7 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine
Cancer - ovarian cancer and relapsed endometrial cancer

Phase 3 Phase 3 top-line data released March 1, 2019 did not meet primary endpoint. Further Phase 3 trial to be initiated later in 2019 with data due 1H 2022.
$578.6 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer

Phase 1/2 Phase 1b/2 initial data to be presented mid-2020.
$578.6 million

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

Phase 2 Phase 2 data due 3Q 2020.
$1.8 billion

MNTA – Momenta Pharmaceuticals Inc.
Nipocalimab (M281)
hemolytic disease of the fetus and newborn (HDFN)

Phase 2 Phase 2 data due 2021.
$1.8 billion

MNTA – Momenta Pharmaceuticals Inc.
M254
Immune Thrombocytopenic Purpura (ITP)

Phase 1/2 Phase 1/2 initial data due 1H 2020.
$1.8 billion

MNTA – Momenta Pharmaceuticals Inc.
Nipocalimab (M281)
Warm Autoimmune Hemolytic Anemia (wAIHA)

Phase 2/3 Phase 2 data due 2021.
$1.8 billion

STML – Stemline Therapeutics Inc.
SL-401 (Elzonris)
Myelofibrosis (MF)

Phase 2 Phase 1/2 presentation at ASH December 9, 2019 8:15 AM ET.
$517.1 million

ZYME – Zymeworks Inc.
ZW25
HER2-expressing Gastroesophageal Adenocarcinoma

Phase 2 Phase 1 initial data released October 28, 2019. 5/9 partial responses.
$1.6 billion