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An Ear To The Pharma: 10 Stocks To Watch (BHVN, LLY, TOCA, ALDR…)

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The biotech sector witnessed a couple of hurrahs and heartaches this week, and here's some of what happened.

GW Pharmaceuticals plc's (GWPH) cannabis-based drug for epilepsy, Epidiolex, won the unanimous backing of an advisory panel to the FDA on April 19, 2018. The FDA's final decision on Epidiolex is expected by June 27, 2018. If approved, Epidiolex would be the first-ever medicine derived from a marijuana plant to be greenlighted by the FDA.

Argos Therapeutics Inc. (ARGS), which had been hoping to revive its late-stage kidney cancer trial of Rocapuldencel-T all along, finally announced its decision to terminate the study on April 19, 2018, sending the stock down nearly 69% that day.

Now, let's take a look at the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.

1. Biohaven Pharmaceutical Holding Co. Ltd. (BHVN)

Biohaven Pharma is a clinical-stage biopharmaceutical company developing drugs for neurological diseases, including rare disorders.

The Company's lead drug candidate is Rimegepant (BHV-3000) for acute treatment of Migraine, which is under two phase III trials.

On March 26, 2018, Biohaven Pharma announced positive top-line results from its two phase III clinical trials of Rimegepant - with each trial meeting the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom.

Watch out for...

On April 22, 2018, a panel of migraine experts will discuss the potential therapeutic benefits associated with the Rimegepant phase III clinical trial results.

BHVN closed Friday's trading at $27.18, down 0.33%.

2. Eli Lilly and Co. (LLY)

An FDA panel is slated to review the NDA for Baricitinib, proposed for the treatment of patients with moderate-to-severe rheumatoid arthritis, on April 23, 2018.

Baricitinib, a once-daily oral JAK inhibitor, is co-developed by Eli Lilly and Incyte Corp. (INCY).

The FDA's final decision on Baricitinib is expected to be announced in June 2018.

LLY closed Friday's trading at $79.06, down 0.87%.

3. Tocagen Inc. (TOCA)

Tocagen is a cancer-selective gene therapy company developing therapies that are designed to destroy tumors, leaving the healthy tissues unharmed.

Watch out for…

Updated durable response data from a phase I study involving patients with high-grade glioma who received Toca 511 & Toca FC at the time of surgical resection are expected to be presented on April 24, 2018.

You can find more about TOCA in our "This Day That Year" column.

TOCA closed Friday's trading at $10.41, down 0.67%.

4. Argenx (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.

Last December, the Company announced positive top line results from its phase II clinical trial of ARGX-113 in myasthenia gravis patients with confirmed generalized muscle weakness.

Primary endpoint analysis revealed ARGX-113 to be well tolerated in all patients, with most adverse events characterized as mild and deemed unrelated to the study drug. The secondary endpoint measures relating to efficacy showed ARGX-113 treatment resulted in rapid onset of action and strong clinical improvement over placebo during the entire duration of the study.

Watch out for…

Complete data from the phase II clinical trial of ARGX-113 in myasthenia gravis is expected to be presented at the American Academy of Neurology (AAN) Annual Meeting on April 24, 2018.

ARGX closed Friday's trading at $88.90, down 0.29%.

5. NeuroMetrix Inc. (NURO)

NeuroMetrix is a commercial stage, bioelectrical and digital medicine company focused on addressing chronic health conditions including chronic pain and diabetes.

The Company's lead product is Quell, an over-the-counter wearable therapeutic device for chronic pain.

Watch out for…

Data from a pilot study that assessed the accuracy of the sleep monitoring technology in Quell device by comparison to gold standard polysomnography will be presented at the upcoming 2018 American Academy of Neurology Annual Meeting to be held in Los Angeles, CA, April 21-27.

NURO closed Friday's trading at $1.46, down 2.01%. In after-hours, the stock was up 8.22% to $1.58.

6. International Stem Cell Corp. (ISCO.OB)

International Stem Cell is a clinical stage biotechnology company developing stem cell-based therapies and biomedical products.

Last month, the Company completed dosing of the second cohort of its phase I clinical trial of ISC-hpNSC for Parkinson's disease at the Royal Melbourne Hospital in Melbourne, Australia.

ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells.

Watch out for…

Interim clinical results of ISC-hpNSC for Parkinson's disease will be presented on April 24, 2018.

ISCO.OB closed Friday's trading at $1.48, up 2.78%.

7. Acorda Therapeutics Inc. (ACOR)

Acorda Therapeutics is a biopharmaceutical company marketing two approved products namely AMPYRA and QUTENZA, and has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease and multiple sclerosis.

The lead drug candidate in the pipeline is INBRIJA, an investigational treatment for people with Parkinson's living with OFF periods, or the re-emergence of Parkinson's symptoms.

INBRIJA is under FDA review, with a decision expected on October 5, 2018.

Watch out for…

The Company will present new data for INBRIJA at the upcoming American Academy of Neurology Annual Meeting in Los Angeles on April 24, 2018.

ACOR closed Friday's trading at $23.35, down 0.21%.

8. Alder Biopharmaceuticals Inc. (ALDR)

Alder BioPharma is a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine.

The Company's lead drug candidate is Eptinezumab, under two phase III studies to assess its efficacy and safety in migraine prevention, dubbed PROMISE 1 and PROMISE 2.

The primary and secondary endpoint results of PROMISE 2 trial were reported in January of this year. There was a reduction of 8.2 monthly migraine days from baseline following a single Eptinezumab administration compared to 5.6 days for placebo.

Watch out for…

New data from the PROMISE 2 trial will be presented at the 70th Annual American Academy of Neurology Meeting on April 24, 2018.

ALDR closed Friday's trading at $13.75, down 3.17%.

9. Neurocrine Biosciences Inc. (NBIX)

Neurocrine Biosciences is a biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA capsules in the United States for the treatment of adults with tardive dyskinesia.

Tardive dyskinesia (TD) is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.

INGREZZA was approved by the FDA in April 2017. The drug brought home sales of $116.6 million for Neurocrine Biosciences last year.

INGREZZA is also being explored in Tourette syndrome, and a phase IIb trial in this indication is underway. Top-line data from this study is expected in late 2018.

Watch out for…

New data evaluating the efficacy of INGREZZA across body regions in patients with Tardive Dyskinesia is scheduled to be presented at the American Academy of Neurology Annual Meeting on April 25, 2018.

NBIX closed Friday's trading at $79.40, up 1.56%.

10. Mallinckrodt Public Ltd. Co. (MNK)

The FDA is scheduled to announce its decision on Mallinckrodt's supplemental New Drug Application for Amitiza in children 6 to 17 years of age with pediatric functional constipation on April 28, 2018.

Amitiza came under Mallinckrodt's fold following the acquisition of Sucampo Pharmaceuticals last December.

The drug is already approved for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.

The global sales of Amitiza in 2016 were $456 million.

MNK closed Friday's trading at $13.76, down 1.99%. In after-hours, the stock fell another 0.36% to $13.71.

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