logo
Plus   Neg
Share
Email

PRTO On The Move, ARWR Hits A High, WVE Doesn't Wane, Big Events Await CHRS

pharmadaily-011018-lt.jpg

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

1. Proteon Therapeutics Inc. (PRTO)

Gained 26.32% to close Thursday's (Jan.11) trading at $2.40.

News: No news

Pipeline:

The Company's lead drug candidate is Vonapanitase, which is under phase III study in patients with chronic kidney disease undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis, dubbed PATENCY-2. Vonapanitase is also under a phase I clinical trial in patients with peripheral artery disease.

Near-term Catalysts:

-- Complete enrollment of 600 patients in PATENCY-2 in the first quarter of 2018.

2. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 14.55% to close Thursday's trading at $5.04.

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.

The current compounds in the Company's pipeline include 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, ARO-Lung for an undisclosed indication; ARO-HIF2 for renal cell carcinoma; ARO-F12 for Thrombosis/Hereditary Angioedema; ARO-LPA, partnered with Amgen, for cardiovascular disease and ARO-AMG, partnered with Amgen, for cardiovascular disease.

Recent events:

-- The Company made a presentation at the J.P. Morgan Healthcare Conference on January 9, 2018.
-- 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.

3. Coherus Biosciences Inc. (CHRS)

Gained 11.38% to close Thursday's trading at $13.70.

News: No news

Recent event:

-- The Company made a presentation at the J.P. Morgan Healthcare Conference on January 8, 2018.

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. Phase III studies with CHS-0214 in psoriasis and rheumatoid arthritis have been completed. 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.
-- CHS-3351, a biosimilar to Lucentis, is expected to move into clinical testing this year.
-- CHS-1420, a biosimilar to Humira, has completed phase III clinical studies in psoriasis. The Company expects to file a Biologics License Application for CHS-1420 in the first half of 2018.

4. CRISPR Therapeutics AG (CRSP)

Gained 10.36% to close Thursday's trading at $28.44.

CRISPR Therapeutics is a gene-editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 gene-editing platform.

News: No news

Recent event:

-- On December 7, 2017, the Company submitted its first Clinical Trial Application for a CRISPR gene-edited therapy, CTX001 in ß-thalassemia, in Europe.
-- On December 12, 2017, the Company entered into an agreement with Vertex Pharmaceuticals Inc. (VRTX) to co-develop and co-commercialize CTX001.

Near-term Catalysts:

-- A Phase 1/2 trial of CTX001 in adult transfusion dependent ß-thalassemia patients is expected to begin in Europe in 2018.
-- An Investigational New Drug Application for CTX001 to treat sickle cell disease is expected to be filed with the FDA in 2018.

5. WAVE Life Sciences Ltd. (WVE)

Gained 10.18% to close Thursday's trading at $37.35.

News: No news

Clinical Trials:

-- A phase 1b/2a clinical trial evaluating WVE-120101 for Huntington's disease, dubbed PRECISION-HD1.
-- A phase 1b/2a clinical trial evaluating WVE-120102 for Huntington's disease, dubbed PRECISION-HD2.
-- A global phase I trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping.

Near-term Catalysts:

-- Data from the global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping are expected in Q3, 2018.
-- Top line data from PRECISION-HD program, which includes two phase 1b/2a global clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington's disease, are anticipated in 1H 2019.

Related Reading:

Are You Keeping An Eye On EARS And 6 Other Pharma Stocks?

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT