BPC November 18 update

​Myovant MYOV data due Tuesday; Karuna KRTX shares surge on mid-stage schizophrenia data

Price and Volume Movers

Myovant Sciences (NYSE: MYOV) announced it will hold a conference call at 8:30 a.m. EST Tuesday, November 19, 2019, to discuss results from the Phase 3 HERO trial of oral relugolix in men with advanced prostate cancer.

Karuna Therapeutics, Inc. (Nasdaq: KRTX) announced that its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia, met the primary endpoint, exhibiting a statistically significant 11.6 point mean reduction in total Positive and Negative Syndrome Scale (PANSS) score compared to placebo (p<0.0001) and also demonstrated good overall tolerability. A Phase 3 trial is slated to commence by the end of 2020. Shares closed Monday up 443% to $96.00. After hours, the company announced that it has commenced an underwritten public offering of 2.6m shares.

The Medicines Company (NASDAQ: MDCO) shares closed up 13% to $58.65 following data presented at the AHA meeting from two Phase 3 trials of its cholesterol lowering drug, inclisiran. The company which previously noted that the trials had met their primary endpoints, released detailed data at the meeting. In its ORION-9 trial the company noted reductions of LDL cholesterol of 50% over 18 months compared with placebo, while the ORION-10 trial saw the reductions increase to 58%.

Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA) announced an agreement with Novo Nordisk A/S to develop therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s GalXC RNAi platform technology. Dicerna will receive an upfront payment of $175m while Novo Nordisk will also make a $50m equity investment in Dicerna. Shares closed up 11% to $21.39.

Agile Therapeutics Inc (NASDAQ: AGRX) shares are trading up 21% to $1.66 after hours following a SEC filing which noted Perceptive Advisors has increased its ownership of the company to 18.5%.

Pfizer Inc. (NYSE: PFE) received FDA approval for Abrilada (adalimumab-afzb), as a biosimilar to Humira (adalimumab) for the treatment of various conditions including arthritis, Crohn's disease, ulcerative colitis and plaque psoriasis.

InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) announced a proposed public offering of shares of its common stock. Shares closed down 38% to $0.27.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) shares closed down 27% to $0.14 following the pricing of its public offering of 10m shares at price per share of $0.10, for gross proceeds of $1m .

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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:

Evoke Pharma Inc (EVOK): $1.48; +35%.

CorMedix Inc.(CRMD): $6.74; +21%.

Matinas BioPharma (MTNB): $1.24; +19%.

Agenus Inc (AGEN): $4.40; +18%.

Eidos Therapeutics Inc (EIDX): $55.02; +18%.

DECLINERS:

Sellas Life Sciences Group Inc (SLS): $4.20; -18%.

Anchiano Therapeutics (ANCN): $1.59; -17%.

Therapix Biosciences (TRPX): $1.47; -13%.

Plus Therapeutics Inc (PSTV): $2.38; -12%.

Axcella Health Inc (AXLA): $3.08; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AERI – Aerie Pharmaceuticals Inc.
AVX-012
Dry eye disease

Phase 2b Phase 2b trial to be initiated late-2020.
$920.2 million

ALNY – Alnylam Pharmaceuticals Inc.
Inclisiran - ORION-9
Hypercholesterolemia

Phase 3 Phase 3 data met all endpoints - September 25, 2019. Data November 18, 2019 noted LDL-C reductions of 50%.
$13.8 billion

ALNY – Alnylam Pharmaceuticals Inc.
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)

Phase 3 Phase 3 data met all endpoints - September 25, 2019. Detailed data due at AHA noted 58% LDL-C lowering.
$13.8 billion

BVXV – BiondVax Pharmaceuticals Ltd.
M-001
Universal flu vaccine

Phase 3 Phase 3 data due by the end of 2020.
$58 million

FOMX – Foamix Pharmaceuticals Ltd.
FCD105
Acne

Phase 2 Phase 2 data due 2Q 2020.
$187.4 million

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data presented at AACR November 19, 2019 noted ORR of 20% (RECIST 1.1).
$15.4 million

ITRM – Iterum Therapeutics plc
Sulopenem
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 1Q 2020.
$48.8 million

KRTX – Karuna Therapeutics Inc.
KarXT
Acute psychosis in patients with schizophrenia

Phase 2 Phase 2 top-line data met primary endpoint - November 18, 2019.
$1.6 billion

MOR – MorphoSys AG
Bendamustine + MOR208 - B-MIND
Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL)

Phase 3 Phase 3 futility analysis passed November 18, 2019. Top-line data due 1Q 2022.
$4.2 billion

MRK – Merck & Company Inc. (new)
Vericiguat
Heart Failure

Phase 3 Phase 3 trial met primary endpoint - November 18, 2019.
$226.2 billion

MYOV – Myovant Sciences Ltd.
Relugolix - HERO
Advanced prostate cancer

Phase 3 Phase 3 data meet primary endpoint - November 19, 2019. NDA filing due 2Q 2020.
$1.5 billion

PFE – Pfizer Inc.
ABRILADA (adalimumab-afzb)
Bosimilar to Humira (adalimumab)

Approved FDA Approval announced November 18, 2019.
$211.9 billion

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102)
Fabry disease

BLA Filing BLA filing due April 2019.
$46 million