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ARWR Hits A High, URGN Begins 2018 In Style, ARNA To Report Data In Q1

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The following are some of today's top gainers in the pharma/biotech sector.

1. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 24.73% to close Wednesday's (Jan.3) trading at $4.64. The stock hit a new intraday high of $4.88.

News: No news

Pipeline:

In 2016, Arrowhead had to discontinue development of prior generation drugs, ARC-520, ARC-521, and ARC-AAT, which moved the Company from a clinical-stage company with two Phase 2 candidates and one Phase 1 candidate, to a preclinical-stage company overnight.

ARO-AAT for the treatment of alpha-1 antitrypsin deficiency liver disease; ARO-HBV for the treatment of chronic hepatitis B virus infection, and ARO-APOC3, ARO-ANG3 for the treatment of hypertriglyceridemia are the current compounds in the Company's pipeline.

Recent events:

-- On December 22, 2017, the Company made a regulatory submission to the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to begin a Phase 1/2 study of ARO-HBV.
-- On December 20, 2017, a regulatory submission was made to the MEDSAFE to begin a phase I study of ARO-AAT.

2. Coherus Biosciences Inc. (CHRS)

Gained 19.37% to close Wednesday's trading at $11.40.

News: No news

Near-term Catalysts:

-- Resubmit BLA for CHS-1701 to the FDA in mid-first quarter 2018. CHS-1701, a biosimilar candidate for Amgen Inc's blockbuster treatment, Neulasta, was turned down by the FDA last June.

CHS-1701 is under review by the European Medicines Agency, and an opinion is anticipated in the first half of 2018.

Another product in the pipeline is CHS-0214, a biosimilar candidate for Amgen's Enbrel. Coherus has filed petitions for Inter Partes Review ("IPR") in the United States Patent and Trademark Office seeking invalidation of 2 patents related to Enbrel.

-- The PTAB is expected to enter decisions on whether to institute these two IPRs by March 13, 2018 and by March 26, 2018.

3. Adverum Biotechnologies Inc. (ADVM)

Gained 17.81% to close Wednesday's trading at $4.30.

News: No news

Clinical Trials & Near-term Catalysts:

-- The first patient in a phase 1/2 clinical trial of ADVM-043 for alpha-1 antitrypsin (A1AT) deficiency, dubbed ADVANCE, was dosed as recently as December 28, 2017. Preliminary data from this study are expected in the second half of 2018.
-- File two INDs with the FDA in the second half of 2018, for ADVM-022 in wet AMD and ADVM-053 in hereditary angioedema.

4. INSYS Therapeutics Inc. (INSY)

Gained 16.05% to close Wednesday's trading at $13.38. This is the second straight of double-digit gain for the stock.

News: No news

Recent event:

-- On December 26, 2017, the Company's cannabidiol (CBD) oral solution secured FDA's Fast Track designation for the treatment of Prader-Willi syndrome.

Prader-Willi syndrome is a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes.

Cannabidiol (CBD) oral solution for Prader-Willi syndrome is under pre-clinical testing, and the Company plans to start the clinical development program in this indication in late first quarter of 2018.

Clinical Trials & Near-term Catalysts:

-- The Company's New Drug Application for Buprenorphine Sublingual Spray for the management of moderate-to-severe acute pain is under FDA review - with a decision expected on July 28, 2018.
-- A phase I proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, commenced early December. Initial results from this study are expected to be available in February 2018. Enrollment in the study is estimated to be complete in the first quarter of 2018.
-- On December 19, 2017, the Company announced the initiation of a phase II trial of Cannabidiol (CBD) oral solution for the treatment of refractory childhood absence epilepsy in pediatric patients. This study is expected to be completed in late 2018.

5. Urogen Pharma Ltd. (URGN)

Gained 15.37% to close Wednesday's trading at $44.58. The stock touched a new intraday high of $46.68.

News: The Company will make a presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 11, 2018 at 9:00 a.m. PST.

Clinical Trials & Near-term Catalysts:

-- The Company's lead drug candidate is MitoGel, which is in a phase III trial for the treatment of low-grade upper tract urothelial carcinoma, dubbed OLYMPUS. Topline data from this trial are expected to be available in the second quarter of 2018.

The other clinical programs are:

-- VesiGel, for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC), which has completed phase IIa study. A phase IIb study of VesiGel is planned for the first half of 2018.
-- Vesimune, for the treatment of Carcinoma In-Situ (CIS), a high-grade form of NMIBC, which has completed phase Ib study. A phase II study of Vesimune is planned for the first half of 2018.
-- Botugel, a novel intravesical sustained release formulation of botulinum toxin for Overactive Bladder (OAB) and Interstitial Cystitis (IC). In October 2016, the Company licensed the BotuGel program to Allergan for further development.

6. Cellular Biomedicine Group Inc. (CBMG)

Gained 14.40% to close Wednesday's trading at $14.30.

News: No news

Cellular Biomedicine is a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases.

Pipeline:

The Company currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL), CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), and a phase I trial in China for AlloJoin (CBMG's "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis.

Near-term Catalysts:

-- Top line data readout from phase I clinical trials for CARD-1 and CALL-1 Chimeric Antigen Receptor (CAR) T-cell treatment for Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL) in the first half of 2018.
-- Final data readout from AlloJoin phase I clinical trial for off-the-shelf Knee Osteoarthritis (KOA) therapy in China in the first half of 2018.

7. Trevena Inc. (TRVN)

Gained 11.67% to close Wednesday's trading at $2.01.

News: The Company's New Drug Application for OLINVO for the management of moderate to severe acute pain has been accepted for review by the FDA, with a decision expected in the fourth quarter of 2018.

Pipeline:

Apart from OLINVO, the other investigational drugs of the Company are TRV734, which has completed Phase 1 studies for the oral treatment of acute and chronic pain and TRV250, which is in Phase 1 development for the treatment of migraines.

A Phase 2b study of TRV027 for the treatment of acute heart failure, dubbed BLAST-AHF, failed to meet the trial goals in May 2016.

8. Arena Pharmaceuticals Inc. (ARNA)

Gained 10.94% to close Wednesday's trading at $40.17.

News: No news

Pipeline:

The advanced clinical programs are Ralinepag, which has completed a Phase 2 trial for pulmonary arterial hypertension (PAH), Etrasimod in Phase 2 evaluation for multiple autoimmune indications, and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn's disease. The Company is also collaborating with Axovant Sciences Ltd. (AXON) for the development of Nelotanserin, which is under phase II testing for Visual hallucinations in Lewy body dementia and REM sleep behavior disorder in subjects with Lewy body dementia.

Near-term Catalysts:

-- Data readout from a phase II study of Etrasimod in ulcerative colitis is expected in Q1, 2018.
-- Phase 2 data of Nelotanserin for visual hallucinations in Lewy body dementia expected in Q1 2018.
-- Phase 2 data of Nelotanserin REM sleep behavior disorder in subjects with Lewy body dementia expected in Q2, 2018.

9. Apellis Pharmaceuticals Inc. (APLS)

Gained 8.95% to close Wednesday's trading at $22.64.

News: No news

Recent event:

The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.

Clinical Trials & Near-term Catalysts:

APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris.

A phase III program of APL-2 for the treatment of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) is planned to begin in the second half of 2018.

by RTTNews Staff Writer

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