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ATXI Abuzz, CRMD On Watch, AMRN Back In Focus

pharma 012418 11oct18 lt

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

1. Avenue Therapeutics Inc. (ATXI)

Gained 60.95% to close Thursday's (Oct.11) trading at $3.38.

News: No news

Avenue Therapeutics is a specialty pharmaceutical company focused on the development of intravenous Tramadol for the management of moderate to moderately severe postoperative pain.

Upcoming event:

The Company plans to initiate its second phase III trial of IV Tramadol in patients following abdominoplasty surgery this year. Positive data from a phase III trial that evaluated IV Tramadol in patients with post-surgical pain following bunionectomy was reported in May of this year.

Cash position:

As of June 30, 2018, Avenue's cash, cash equivalents and short-term investments totaled $8.9 million.

2. Oragenics Inc. (OGEN)

Gained 28.85% to close Thursday's trading at $1.34.

News: No news

The Company is focused on developing antibiotics against infectious diseases and treatments for oral mucositis.

Clinical Trial & Near-term Catalyst:

In August of this year, the Company resumed its phase II clinical trial of AG013, a live biotherapeutic product for the potential treatment of oral mucositis, following a positive review by an independent Data Safety Monitoring Board (DSMB).

The study is expected to be completed next year.

3. CorMedix Inc. (CRMD)

Gained 23.33% to close Thursday's trading at $1.85.

News: No news

Clinical Trial & Near-term Catalyst:

The lead product Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, is under phase III development for patients undergoing chronic hemodialysis.

The phase III trial of Neutrolin, dubbed LOCK-IT-100, demonstrated efficacy in July of this year.

The Company plans to meet with the FDA regarding the next steps in the Neutrolin development plan in the fourth quarter of 2018.

Recent event:

On August 31, the NYSE Regulation accepted the Company's plan to regain listing compliance.

CorMedix was notified on June 14, 2018, by the Exchange that the Company was not in compliance with Section 1003(a)(i)-(iii) related to insufficient stockholders' equity.

4. argenx SE (ARGX)

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer.

Gained 14.42% to close Thursday's trading at $73.01.

News: No news

Clinical Trials & Near-term Catalysts:

-- Present full data from a phase II proof-of-concept trial of Efgartigimod in adult primary immune thrombocytopenia in December. The Company announced positive topline results from this study in September of this year.
-- A global phase III registration trial in generalized myasthenia gravis and a phase II proof-of-concept trial in pemphigus vulgaris are underway.
-- A phase II proof-of-concept trial of Efgartigimod (IV) in chronic inflammatory demyelinating polyneuropathy is expected to be initiated in the first half of 2019.

5. Amarin Corporation plc (AMRN)

Amarin is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. The Company's first FDA-approved product is Vascepa, an eicosapentaenoic acid (EPA) omega-3 prescription product.

Gained 11.39% to close Thursday's trading at $19.31.

News: No news

Recent event:

On September 24, the Company announced that its cardiovascular outcomes trial evaluating Vascepa, dubbed REDUCE-IT, met its primary endpoint, sending the shares up more than 300% to $12.40 that day.

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