BPC November 12 update

​Amarin AMRN shares rally on release of Adcom briefing notes; Solid Biosciences SLDB clinical hold sends shares down 74%

Price and Volume Movers

Amarin Corporation plc (NASDAQ:AMRN) shares closed up 24% to $20.94 following the release of briefing documents for Thursday’s Advisory Committee meeting which will review Vascepa and data from its REDUCE-IT trial. In the summary of the documents the FDA noted "the benefit-risk assessment favors the use of Vascepa for cardiovascular disease risk reduction in the intended population with caution regarding a potential increase in risk of atrial fibrillation."

Acasti Pharma Inc. (NASDAQ: ACST) saw its shares climb 16% to $2.13 in reaction to the positive move by Amarin. The company is due to release data in December and January from its two Phase 3 trials in patients with severe hypertriglyceridemia.

Kadmon Holdings, Inc. (NYSE: KDMN) shares closed up 23% to $3.69 following data released Monday after hours from its ROCKstar trial of KD025 in patients with chronic graft-versus-host disease (cGVHD), which met the primary endpoint of Overall Response Rate (ORR).

Solid Biosciences Inc. (Nasdaq: SLDB) shares slumped to close down 74% to $2.82 following news its Phase 1/2 trial of SGT-001 for the treatment of Duchenne muscular dystrophy (DMD), has been placed on clinical hold by the FDA due to a patient experiencing a serious adverse event (SAE) that saw a decrease in red blood cell count, acute kidney injury, and cardio-pulmonary insufficiency.

Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) shares closed after hours' trading down 11% to $4.35 following its report of 3Q earnings. The company noted revenues of $30.9m compared with estimates of $33.2m.

Melinta Therapeutics, Inc. (NASDAQ: MLNT) announced in its third quarter earnings (10Q) that it "has been managing its liquidity position and, while we continue to evaluate potential strategic and other alternatives, including a sale of all or substantially all of the Company’s assets, it will likely be necessary for us to commence proceedings under Chapter 11 of the U.S. Bankruptcy Code." Shares closed down 40% after hours to $1.20.

Jaguar Health, Inc. (NASDAQ:JAGX) announced that it will provide an update on November 14 regarding the interim analysis of the third-party, investigator-initiated Phase 2 HALT-D trial evaluating Mytesi (crofelemer) for the prevention and prophylaxis of diarrhea in breast cancer patients. Shares closed up 26% to $0.99.

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) announced after hours its intention to offer and sell 2m shares in an underwritten public offering. Shares, which closed the normal trading session down 14% to $182.83, closed flat after hours.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced a public offering of $55m shares. Shares closed down 7% after hours to $1.66, adding to its 6% loss during the normal trading session.

Halozyme Therapeutics, Inc. (NASDAQ:HALO) shares closed down 5% after hours to $16.00 following news that it intends to offer $400m aggregate principal amount of convertible senior notes.

Replimune Group, Inc. (NASDAQ:REPL) also announced a public offering of up to 5m shares of its common stock. Shares closed down 2.5% after hours to $16.29.

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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:

DiaMedica Therapeutics Inc. (DMAC): $3.66; +22%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.96; +17%.

UroGen Pharma Ltd. (URGN): $27.51; +14%.

Forty Seven, Inc. (FTSV): $9.65; +13%.

RAPT Therapeutics, Inc. (RAPT): $21.75; +11%.

DECLINERS:

Prevail Therapeutics Inc. (PRVL): $11.07; -18%.

Galectin Therapeutics, Inc. (GALT): $3.59; -17%.

Cabaletta Bio, Inc. (CABA): $11.77; -15%.

Cellectar Biosciences, Inc. (CLRB): $1.08; -15%.

Alpine Immune Sciences, Inc. (ALPN): $2.45; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKBA – Akebia Therapeutics Inc.
Vadadustat - INNO2VATE
Anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)

Phase 3 Phase 3 data met primary endpoints - May 5, 2020.
$1.5 billion

APTX – Aptinyx Inc.
NYX-2925
Fibromyalgia

Phase 2 Phase 2 enrolment has been suspended due to COVID-19.
$187.6 million

APTX – Aptinyx Inc.
NYX-2925
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Phase 2 Phase 2 enrolment has been suspended due to COVID-19.
$187.6 million

ARAV – Aravive Inc.
AVB-500 and Durvalumab
Ovarian cancer

Phase 1/2 Phase 1/2 trial initiation announced November 12, 2019.
$96.5 million

DRRX – DURECT Corporation
DUR-928
Alcoholic hepatitis (AH)

Phase 2b Phase 2b trial to commence 2H 2020.
$463.3 million

EDIT – Editas Medicine Inc.
AGN-151587 (EDIT-101)
Leber Congenital Amaurosis type 10 (LCA10).

Phase 1/2 Phase 1/2 commencement of dosing announced March 4, 2020.
$2.2 billion

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss

PDUFA priority review PDUFA date under priority review August 10, 2020.
$248 million

GILD – Gilead Sciences Inc.
Magrolimab + rituximab
Diffuse Large B-Cell Lymphoma

Phase 3 Registration-enabling trial initiated 1Q 2020 with interim data due 2H 2020.
$85.6 billion

JAGX – Jaguar Health Inc.
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)

Phase 2 Phase 2 trial to enrol through to completion - November 14, 2019.
$24.7 million

MYOV – Myovant Sciences Ltd.
Relugolix
Menstrual bleeding associated with uterine fibroids

NDA Filing NDA filing announced June 1, 2020.
$1.4 billion

PFE – Pfizer Inc.
Tofacitinib
Juvenile idiopathic arthritis (JIA)

Phase 3 Phase 3 trial met primary endpoint.
$213.2 billion

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

Phase 1/2 Phase 1/2 trial remains on clinical hold - noted July 24, 2020.
$124 million

TGTX – TG Therapeutics Inc.
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)

Phase 3 Phase 3 PFS primary endpoint met. Trial to be stopped due to superior efficacy - May 5, 2020. Full data to be presented 2H 2020.
$2.2 billion