AKCA ON The Move, MNLO Makes A Mark, OBSV Looks Ahead With Hope, ARGX Soars

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

GAINERS

1. Akcea Therapeutics Inc. (AKCA)

The Company is an affiliate of Ionis Pharmaceuticals Inc. (IONS)

Gained 17.51% to close Monday's (Jan.29) trading at $22.82.

News: No news

Pipeline:

-- The Company's marketing applications for Volanesorsen have been accepted for review in the U.S., EU and Canada for the treatment of patients with familial chylomicronemia syndrome (FCS). -- A phase 2b trial of AKCEA-APO(a)-LRx in patients with high lipoprotein(a), also known as Lp, is ongoing. -- A phase 2b clinical study of AKCEA-APOCIII-LRx in patients with hypertriglyceridemia and established cardiovascular disease was initiated early this month. -- A phase 2 program of AKCEA-ANGPTL3-LRx in patients with hypertriglyceridemia, type 2 diabetes mellitus and nonalcoholic fatty liver disease, initiated last month, is underway. -- An exploratory phase 2 program of AKCEA-ANGPTL3-LRx in patients with rare hyperlipidemias, initiated last November, is ongoing.

Near-term Catalysts:

-- Report top line results from the phase 2b trial of AKCEA-APO(a)-LRx in patients with high lipoprotein in 2018. -- The FDA decision on Volanesorsen for the treatment of patients with familial chylomicronemia syndrome is expected on August 30, 2018.

2. Menlo Therapeutics Inc. (MNLO)

Gained 17.12% to close Monday's trading at $33.39.

News: The Company announced the closing of its IPO of 8.05 million shares of common stock at a public offering price of $17.00 each, including the full exercise of underwriters' option to purchase additional shares.

Pipeline:

The Company's lead drug candidate is Serlopitant, and phase III trials for the treatment of pruritus associated with prurigo nodularis are expected to be initiated in the first half of 2018.

Serlopitant is also under phase II studies for the treatment of pruritus associated with atopic dermatitis, pruritus associated with psoriasis, and refractory chronic cough.

3. Geron Corp. (GERN)

Gained 16.34% to close Monday's trading at $2.35.

News: No news

Pipeline:

The Company's lead drug candidate is Imetelstat, which is being developed for the potential treatment of hematologic myeloid malignancies.

A phase 2/3 clinical trial of Imetelstat, dubbed IMerge, in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, is underway.

4. ObsEva SA (OBSV)

Gained 15.09% to close Monday's trading at $12.43.

News: No news

Pipeline:

-- The Company's most advanced investigational drug is OBE2109, under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM), dubbed EDELWEISS, is also underway. -- Also in the pipeline are Nolasiban to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) for low fertility, and OBE022 for the treatment of preterm labor.

Nolasiban advanced to phase III testing last March. The phase III trial, known as IMPLANT2, is expected to enroll about 760 women who have undergone assisted reproduction technology (ART).

OBE022 for the potential treatment of preterm labor to delay or prevent preterm birth is under a phase 2a Proof-of-Concept clinical trial, called PROLONG.

Near-term Catalysts:

-- Top line data from the IMPLANT2 trial is expected in the first quarter of 2018. Data from the EDELWEISS trial is expected in mid-2018. -- Top line data from the PROLONG trial are expected around year end 2018.

5. Editas Medicine Inc. (EDIT)

Gained 13.18% to close Monday's trading at $40.70. The stock touched an all-time high of $41.60 in intra-day trading.

News: No news

You can find more about Editas in our premium stock report. EDIT was trading around $20 when we alerted our subscribers to this stock last May.

6. Protagonist Therapeutics Inc. (PTGX)

Gained 13.10% to close Monday's trading at $21.75.

News: No news

Pipeline:

The Company's lead oral product candidates are PTG-100 for ulcerative colitis, which is under phase 2b trial, and PTG-200 for Crohn's disease, which is under phase I testing.

Also in the pipeline is PTG-300, an injectable hepcidin mimetic peptide for potential treatment of chronic iron overload in rare diseases such as beta-thalassemia, which recently completed phase I testing. The Company plans to initiate Phase 2 trials of PTG-300 in patients with beta-thalassemia and myelodysplastic syndrome during 2018.

Protagonist retains worldwide commercial rights to the PTG-100 and PTG-300 programs. PTG-200 is partnered with Janssen Biotech.

7. Ablynx NV (ABLX)

Gained 12.59% to close Monday's trading at $53.65.

News: Sanofi SA (SNY) is acquiring Ablynx NV for 3.9 billion euros ($4.8 billion), trumping Novo Nordisk's offer of 2.6 billion euros ($3.1 billion).

The transaction has been unanimously approved by both the Sanofi and Ablynx Boards of Directors.

Ablynx's most-advanced product in development is Caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). The product is already filed in the European Union and expected to be filed in the U.S. during the first half of this year. Caplacizumab, if approved, would be the first-in-class treatment for this acute, life-threatening disease.

8. CRISPR Therapeutics AG (CRSP)

Gained 12.52% to close Monday's trading at $44.39.

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.

9. Proteon Therapeutics Inc. (PRTO)

Gained 11.36% to close Monday's trading at $2.45.

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.

10. argenx SE (ARGX)

Gained 9.82% to close Monday's trading at $82.83. The stock touched an intraday high of $85.31.

News: No news

Recent events:

-- On December 18, 2017, the Company announced the closing of U.S. public offering for gross proceeds of approximately $266 million. -- On December 11, 2017, the Company reported positive top-line results from its phase II proof-of-concept clinical trial of ARGX-113 in myasthenia gravis (MG) patients with confirmed generalized muscle weakness.

Clinical Trials & Near-term Catalysts:

-- Two phase II trials with ARGX-113 are underway - one in patients with primary immune thrombocytopenia and another in patients with pemphigus vulgaris. -- Topline data for the immune thrombocytopenia trial and interim data from the pemphigus vulgaris trial are both expected in the second half of 2018.

We had alerted our premium subscribers to ARGX on November 23, 2017, when it was trading around $25.