BPC May 13 update

Insys INSY shares plunge on bankruptcy concerns; Myovant MYOV Phase 3 data to be released Tuesday

Price and Volume Movers

INSYS Therapeutics, Inc. (NASDAQ: INSY) shares slumped to close down 74% to $0.95 on news of bankruptcy concerns following the report of first quarter earnings late-Friday. The company noted it has experienced increasing losses from operations due to significant declines in the transmucosal immediate-release fentanyl (TIRF) market and significant legal expenses resulting from the investigation by the U.S. Department of Justice. The company noted in its statement:

“If the company cannot successfully implement its strategic plan for the sale of its assets, and/or reach an agreement with the DOJ, its liquidity, financial condition and business prospects will be materially and adversely affected. Accordingly, it may be necessary for the company to file a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in order to implement a restructuring.”

Myovant Sciences (NYSE:MYOV) announced it will hold a webcast and conference call beginning at 8:30 a.m. EST on Tuesday, May 14, to discuss results from the Phase 3 LIBERTY 1 trial of relugolix in women with uterine fibroids and heavy menstrual bleeding.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the FDA approved Eylea (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness.

Eli Lilly and Company (NYSE: LLY) announced the FDA approved Cyramza (ramucirumab) for the treatment of patients with second-line hepatocellular carcinoma (HCC).

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) shares closed down 15% to $12.23 following news of a lawsuit, filed against it and 19 other companies, for price fixing.

Solid Biosciences Inc. (Nasdaq: SLDB) reported in its first quarter earnings release after hours that one patient in the treatment group of the second cohort of its Phase 1/2 IGNITE DMD trial of SGT-001, was diagnosed with a gastrointestinal infection that was classified as a serious adverse but not related to SGT-001 but also a “transient increase in bilirubin higher than two times the upper limit of normal, which was rapidly resolved with an increase in oral glucocorticoids,” which was recorded as a serious adverse event related to SGT-001. Shares are trading after hours down 6% to $8.35 on the news.

Auris Medical Holding Ltd. (NASDAQ: EARS) shares closed down 20% to $3.93 following its announcement of a public offering of 330,000 shares together with warrants to purchase 330,000 shares and 1,721,280 pre-funded warrants, with each pre-funded warrant exercisable for one common share, together with warrants to purchase 1,721,280 common shares. Gross proceeds are expected to be approximately $8m.

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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:

Novan, Inc. (NOVN): $1.36; +8%.

Pieris Pharmaceuticals, Inc. (PIRS): $3.55; +7%.

Chimerix, Inc. (CMRX): $3.29; +5%.

Regulus Therapeutics Inc. (RGLS): $1.40; +5%.

Palatin Technologies, Inc. (PTN): $1.48; +4%.

DECLINERS:

Endo International plc (ENDP): $6.51; -19%.

Amneal Pharmaceuticals, Inc. (AMRX): $8.91; -14%.

Arcturus Therapeutics Ltd. (ARCT): $5.80; -13%.

Armata Pharmaceuticals, Inc. (ARMP): $4.04; -13%.

Novavax, Inc. (NVAX): $5.76; -12%.

Pipeline updates below

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CAPR – Capricor Therapeutics Inc.
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)

Phase 2 Phase 2 HOPE-2 interim data due early 3Q 2019.
$11.6 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Congenital Myasthenic Syndromes (CMS)

Phase 3 Phase 3 data due 2H 2019.
$395 million

CRNX – Crinetics Pharmaceuticals Inc.
CRN01941
Neuroendocrine tumors

Phase 1 Phase 1 top-line data due late 2019 or early 2020.
$635.3 million

DMAC – DiaMedica Therapeutics Inc.
DM199
Chronic Kidney Disease

Phase 1b Phase 1b data due June 2019.
$34.1 million

EQ – Equillium Inc.
EQ001
Acute graft-versus-host disease

Phase 1/2 Phase 1b top-line data due 1Q 2020.
$134.3 million

FTSV – Forty Seven Inc.
5F9 + Azacitidine
Acute myeloid leukemia (AML)

Phase 1 Phase 1b data to be presented at ASCO June 3, 2019 4:30pm CT.
$393.2 million

GRTS – Gritstone Oncology Inc.
GRANITE-001 (GO-004)
Solid tumors

Phase 1/2 Phase 1/2 initial data due 4Q 2019.
$386.5 million

LLY – Eli Lilly and Company
Ramucirumab REACH-2
Hepatocellular Carcinoma

Approved FDA approval announced May 13, 2019.
$113.2 billion

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant)
Major Depressive Disorder

Phase 2 Phase 2b data May 13, 2019 noted p-value was 0.083.
$226.7 million

NTGN – Neon Therapeutics Inc.
NEO-PV-01 and nivolumab - NT-003
Melanoma

Phase 1b Phase 1b data due 2H 2020.
$143.9 million

REGN – Regeneron Pharmaceuticals Inc.
EYLEA - PANAROMA
Nonproliferative Diabetic Retinopathy

Approved FDA Approval announced May 13, 2019.
$34 billion

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

Phase 1/2 Phase 1/2 negative initial data released February 7, 2019. Update May 12, 2019 noted one drug related serious adverse event.
$215.6 million

TCRR – TCR2 Therapeutics Inc.
TC-210
Mesothelin-positive solid tumors

Phase 1/2 Phase 1/2 update due 2H 2019.
$340.7 million