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AMRN Heartens Investors, AKCA On Watch, ACRX Faces FDA Panel In Oct.


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

1. Amarin Corporation plc (AMRN)

Gained 314.72% to close Monday's (Sep.24) trading at $12.40.

News: The Company's cardiovascular outcomes trial evaluating Vascepa, dubbed REDUCE-IT, met its primary endpoint.

The trial demonstrated an approximately 25% relative risk reduction in major adverse cardiovascular events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo. MACE includes cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

Vascepa, an eicosapentaenoic acid (EPA) omega-3 prescription product, was approved by the FDA in July 2012.

2. Intrexon Corp. (XON)

Gained 31.52% to close Monday's trading at $19.07.

News: The Company announced advances in the development of its microbial platform to produce cannabinoids for medical uses.

Through its proprietary technologies, the Company has engineered a yeast strain to produce low-cost, robust and consistent cannabinoid outputs via fermentation.

3. Akcea Therapeutics Inc. (AKCA)

Gained 18.23% to close Monday's trading at $33.08.

News: Akcea and Ionis Pharmaceuticals Inc. (IONS) announced positive topline results from a phase II clinical study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease and elevated levels of lipoprotein(a), or Lp(a).

The study demonstrated significant Lp(a) reduction, favorable safety and tolerability profile.

Near-term Catalysts:

-- The Company's antisense drug Tegsedi, designed to reduce the production of transthyretin, or TTR protein, proposed for the treatment of hereditary transthyretin amyloidosis (hATTR), awaits the FDA decision on October 6, 2018. Tegsedi was approved in the European Union on July 11, 2018.
-- Additional data from the phase II study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease and elevated levels of lipoprotein(a) will be presented as a late-breaking clinical trial presentation at the American Heart Association Scientific Sessions in Chicago November 10-12, 2018.

4. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 16.46% to close Monday's trading at $4.60.

News: No news

Near-term Catalysts:

The Company's New Drug Application for DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings in adult patients is scheduled to be reviewed by an FDA panel on October 12, 2018. The regulatory agency's final decision on DSUVIA is set for November 3, 2018.

5. Achieve Life Sciences Inc. (ACHV)

Achieve Life Sciences is a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation.

Gained 15.66% to close Monday's trading at $2.88.

News: No news

Recent events:

-- On July 12, the Company announced it is planning to conduct a Phase 2b optimization trial of Cytisine in approximately 250 smokers in the U.S.
-- On June 19, the Company closed an underwritten public offering of units for gross proceeds of $13.8 million, which included the full exercise of the underwriter's over-allotment option.
-- On May 23, the Company effected a reverse stock split of its shares of common stock at a ratio of 1-for-10.

6. Novavax Inc. (NVAX)

Gained 15.62% to close Monday's trading at $1.85.

News: No news

Near-term Catalysts:

-- Final efficacy results from phase III trial of ResVax to protect infants from respiratory syncytial virus disease, dubbed Prepare, are expected to be reported in the first quarter of 2019.
-- Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019. The FDA has already acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.

7. Innovate Biopharmaceuticals Inc. (INNT)

Gained 14.70% to close Monday's trading at $7.96.

News: No news


-- INN-202 entering Phase 3 for the treatment of celiac disease (CeD) with Fast Track designation
-- INN-217 entering Phase 1/2 for nonalcoholic steatohepatitis (NASH) alone and/or in combination with other agents
-- INN-289 entering Phase 1 for a subset of Crohn's disease (CD)
-- INN-108 entering Phase 2 for inflammatory bowel disorders, mild to moderate ulcerative colitis (UC), and a GI orphan disease in a convenient liquid formulation
-- INN-329 entering Phase 3 for magnetic resonance cholangiopancreatograph.

8. Conatus Pharmaceuticals Inc. (CNAT)

Gained 13.66% to close Monday's trading at $6.49.

News: No news

Clinical Trials & Near-term Catalysts:

-- The Company will host an invitation-only symposium on portal hypertension for institutional investors and research analysts on Thursday, September 27, 2018, from 4:30 p.m. to 6:00 p.m. ET in New York.
-- Top-line results from a phase IIb clinical trial of Emricasan in patients with NASH Cirrhosis and severe portal hypertension, dubbed ENCORE-PH, are expected in the fourth quarter of 2018.
-- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF, is ongoing. Top line results are expected in the first half of 2019.
-- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF, is underway. Top-line results are expected in the second half of 2019.

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