ARGX Soars, SNSS Catches Eyes, BPMC, BLUE Turn Heads, FDA Nod For SNNA

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

1. argenx SE (ARGX)

Gained 78.88% to close Monday's (Dec.11) trading at $54.47.

News: 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.

Myasthenia gravis, which is associated with muscle weakness, affects about 64,000 patients in U.S. Its symptoms include life-threatening choking; muscle dislocation; eyelid fatigue; pain; problems with vision, speech, mobility, and fatigue.

According to the trial results, 75% of ARGX-113 treated patients had a clinically meaningful and statistically significant improvement through at least 6 consecutive study weeks versus 25% of patients on placebo.

After-hours News:

The Company has commenced an underwritten U.S. public offering of $150 million of its American Depositary Shares (ADSs).

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 this stock on November 23, 2017, when it was trading around $25.

2. Sunesis Pharmaceuticals Inc. (SNSS)

Gained 38.71% to close Monday's trading at $3.44.

News: The Company has provided a program update for SNS-062 which is currently being evaluated in an ongoing Phase 1b/2 clinical trial in adults with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

SNS-062 is a potent oral, non-covalent reversible BTK inhibitor.

According to the Company, the first Cohort (25mg BID) in the Phase 1b/2 trial with SNS-062 has enrolled 3 CLL patients. pBTK inhibition is seen in the 2 subjects with evaluable data.

Near-term catalyst:

-- Interim data from the phase 1b/2 trial of SNS-062 is expected in 2Q 2018.

3. Blueprint Medicines Corporation (BPMC)

Gained 22.91% to close Monday's trading at $88.32.

News: The Company reported strong data from its ongoing phase I trial of Avapritinib (BLU-285) in patients with advanced Systemic Mastocytosis.

The overall response rate was 72% and disease control rate was 100% in the trial.

The Company plans to meet up with global regulatory authorities in the first half of 2018 to obtain input on registration pathways for Avapritinib.

If all goes well as planned, a registration-enabling clinical trial of Avapritinib in patients with advanced SM will be initiated in the first half of 2018 and a dose escalation and proof-of-concept clinical trial of Avapritinib in patients with indolent and smoldering SM will be initiated in the second half of 2018.

After-hours News

The Company has commenced an underwritten public offering of $275 million in shares of its common stock.

4. Clearside BioMedical Inc. (CLSD)

Gained 19.69% to close Monday's trading at $7.05.

News: No news

Clinical trials & Near-term catalysts:

-- A pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis, dubbed PEACHTREE, is underway - with preliminary results expected in the first quarter of 2018. -- A phase III clinical trial of suprachoroidal CLS-TA used in combination with intravitreally administered EYLEA in patients with Retinal Vein Occlusion, dubbed SAPPHIRE, is ongoing. Preliminary data from this trial are anticipated in the first quarter of 2019. -- Initiate a second phase III clinical trial of suprachoroidal CLS-TA in combination with an anti-VEGF agent for the treatment of patients with Retinal Vein Occlusion, known as TOPAZ, in the first quarter of 2018. -- A phase II clinical trial of suprachoroidal CLS-TA used in combination with intravitreal Eylea in patients with diabetic macular edema, dubbed TYBEE, is underway. The three-month preliminary data from this study are expected in the first half of 2018.

5. bluebird bio Inc. (BLUE)

Gained 17.91% to close Monday's trading at $201.80.

News: The Company presented encouraging updated data from its trials evaluating LentiGlobin gene therapy product candidate in patients with transfusion-dependent ß-thalassemia (Northstar & Northstar-2 studies), and severe sickle cell disease and transfusion-dependent ß-thalassemia (HGB-205 study) at the 59th Annual Meeting of the American Society of Hematology (ASH).

LentiGlobin is under a phase III study in patients with transfusion-dependent ß-thalassemia (TDT) with the ß0/ß0 genotype, dubbed Northstar-3; a phase III study in patients with TDT and non-ß0/ß0 genotypes, known as Northstar-2; a phase I/II study in patients with TDT and all genotypes, dubbed Northstar; a phase I study in patients with TDT and severe sickle cell disease, dubbed HGB-205, and a phase I study in patients with sickle cell disease, known as HGB-206.

After-hours News:

The Company has commenced an underwritten public offering of $600 million of its common stock.

6. Intersect ENT Inc. (XENT)

Gained 14.51% to close Monday's trading at $32.75.

News: The FDA has approved the Company's New Drug Application for SINUVA Steroid Releasing Sinus Implant, earlier than the original decision date of January 7, 2018.

The implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps that might otherwise warrant a repeat surgical procedure.

7. Sienna Biopharmaceuticals Inc. (SNNA)

Gained 13.42% to close Monday's trading at $22.74.

News: No news

Clinical trials & near-term catalysts:

-- A phase II study of SNA-120 in the treatment of pruritus, or itch, associated with psoriasis and in the treatment of psoriasis itself is underway. -- Pivotal studies of SNA-001 in acne vulgaris, and unwanted light-pigmented hair reduction are ongoing. -- Initiate a phase I/II Proof of Concept study of SNA-125 in atopic dermatitis and pruritus and a phase I/II Proof of Concept study of SNA-125 and psoriasis and pruritus in the first half of 2018.

-- Report top-line data from pivotal trials of SNA-001 for both acne vulgaris and the reduction of unwanted light-pigmented hair in the second half of 2018. -- Report top-line data from the phase II study of SNA-120 in the treatment of pruritus, or itch, associated with psoriasis and in the treatment of psoriasis itself in the first half of 2019.

8. CHF Solutions Inc. (CHFS) Gained 10.79% to close Monday's trading at $3.80.

News: No news

The Company commercializes Aquadex FlexFlow system, indicated for ultrafiltration to reduce fluid overload in patients when diuretics fail. The device is FDA 510(k) market cleared and CE marked.

Recent News:

-- On October 31, 2017, the Company reported third quarter financial results.

Revenue in Q3, 2017 was $957 thousand, up 21% over the comparable year-ago quarter. The company has expanded its sales footprint to 10 territories and has commenced distribution in the United Kingdom. The number of customers continues to increase and is currently at 164.