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An Ear To The Pharma: 8 Stocks To Watch (VYGR, BOLD, RXII, CYAD…)

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It's been an action-packed week with announcements of a number of FDA approvals, a couple of Big Pharma names failing in late-stage trials, and two acquisitions.

On May 11th, the FDA expanded the approval of Novartis' (NVS) Gilenya to treat multiple sclerosis in pediatric patients. Gilenya becomes the first drug approved to treat multiple sclerosis in ages 10 and older. It was first approved in the U.S. in 2010 to treat adults with relapsing multiple sclerosis.

Akcea Therapeutics Inc.'s (AKCA) WAYLIVRA winning the FDA panel support on May 10th for the treatment of a rare lipid disorder called familial chylomicronemia syndrome, rejection of Lipocine Inc.'s (LPCN) oral testosterone product candidate TLANDO on May 9th, FDA approval of Johnson & Johnson's Darzalex on May 8th for first-line multiple myeloma patients, and Astellas Pharma's Myrbetriq/VESIcare combo approval on May 7th for overactive bladder are some of the other regulatory news that made headlines.

The Big Pharma names that were disappointed with their late-stage trials this week were Roche, which announced the IMblaze370 advanced colorectal cancer study results on May 10th, and AstraZeneca, which reported its GALATHEA chronic obstructive pulmonary disease study results on May 11th.

Although a Takeda-Shire deal has been in the news for quite some time, it was officially confirmed on May 8, with Japan's Takeda agreeing to acquire Irish drugmaker Shire for 45.3 billion pounds ($62 billion).

Just two days after Takeda clinched the mega deal, Eli Lilly and Co. (LLY), on May 10th, snapped up ARMO BioSciences Inc. (ARMO) for $50 per share, or approximately $1.6 billion, in an all-cash transaction.

Let's take a look at the pharma stocks and upcoming events to keep an ear out for in the coming week.

1. Xenon Pharmaceuticals Inc (XENE)

Xenon Pharma is a clinical-stage biopharmaceutical company with a neurology-focused pipeline.

A phase I first-in-human clinical trial of single ascending doses and multiple ascending doses of XEN1101 in healthy subjects along with transcranial magnetic stimulation (TMS) study is underway. XEN1101 is a next-generation Kv7 potassium channel opener for the potential treatment of epilepsy.

Watch out for…

Interim results from the phase I study of XEN1101 in healthy subjects are scheduled for presentation at the 14th EILAT Conference on New Antiepileptic Drugs and Devices to be held in Madrid, Spain on May 15, 2018.

The presentation will also include a read-out from the completed Phase 1a transcranial magnetic stimulation (TMS) study.

According to the Company, the transcranial magnetic stimulation can help answer the following key questions at an early stage in the clinic:

-- Does XEN1101 get into the brain?
-- Does XEN1101 act at the intended target?

XENE closed Friday's trading at $5.85, down 0.85%.

2. Voyager Therapeutics Inc. (VYGR)

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases.

VY-AADC is the Company's drug candidate for advanced Parkinson's disease. Dosing of the first patient in a pivotal phase II/III program of VY-AADC for advanced Parkinson's disease is expected to begin during the second quarter of this year.

Watch out for…

The already reported interim results of a phase 1b trial of VY-AADC in advanced Parkinson's disease will be presented at the American Society of Gene and Cell Therapy (ASGCT) on May 16, 2018.

VYGR closed Friday's trading at $18.21, up 8.65%.

3. Audentes Therapeutics Inc. (BOLD)

Audentes is a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases.

The Company has 4 gene therapy products in development - AT132 under phase I/II trial for X-Linked Myotubular Myopathy; AT342 under phase I/II trial for Crigler-Najjar Syndrome; AT982 for Pompe disease and AT307 for the treatment of CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia, both of which are under IND enabling stage.

Watch out for…

Additional interim data from the phase I/II trial of AT132 for X-Linked Myotubular Myopathy, dubbed ASPIRO, is expected to be presented during an oral presentation at the American Society of Gene and Cell Therapy (ASGCT) on May 16, 2018.

BOLD closed Friday's trading at $34.20, up 1.63%.

4. Amgen Inc. (AMGN)

Amgen will know whether or not its experimental migraine therapy Aimovig gets the FDA nod on May 17, 2018.

Aimovig is an injectable human monoclonal antibody that works by blocking the CGRP receptor, which is associated with migraine activation.

Amgen and Novartis will co-commercialize Aimovig in the U.S.

If approved, the drug is expected to notch up sales of $115 million in 2018, $361 million in 2019, $685 million in 2020, $941 million in 2021, and $1.170 billion in 2022. (Source: Clarivate Analytics).

AMGN closed Friday's trading at $173.89, up 1.83%.

5. RXi Pharmaceuticals Corp. (RXII)

RXi Pharmaceuticals Corp. is a biotechnology company developing immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform.

Watch out for…

An update on the Company's phase II study with RXI-109 for the reduction of hypertrophic scars is scheduled for presentation at the International Investigative Dermatology (IID) Conference on May 17, 2018.

Updates on a phase II study with Samcyprone for the treatment of cutaneous warts, and the consumer testing program with its cosmetic product RXI-231 to improve the appearance of skin pigmentation are expected to be presented on May 18, 2018.

RXII closed Friday's trading at $2.38, up 6.25%.

6. GTx Inc. (GTXI)

GTx is a biopharmaceutical company focused on developing medicines to treat serious and/or significant unmet medical conditions, including stress urinary incontinence and prostate cancer.

The Company's lead drug candidate is Enobosarm, which is under phase II Proof-of-Concept trial, and phase II trial, dubbed ASTRID, in post-menopausal women with stress urinary incontinence.

Watch out for…

The Company will be presenting updated results from its phase II proof-of-concept clinical trial evaluating Enobosarm 3 mg in postmenopausal women with stress urinary incontinence at the 2018 American Urological Association (AUA) meeting on May 18, 2018.

The presentation will include a summary of previously reported results, plus present additional data demonstrating duration of response following completion of treatment from women who have now reached seven months post-treatment.

GTXI closed Friday's trading at $17.33, up 0.76.

7. Rocket Pharmaceuticals Inc. (RCKT)

Rocket Pharma is a gene therapy company. The most advanced product candidate in the pipeline is LVV-based gene therapy for Fanconi Anemia (FA), under phase I/II development.

Fanconi Anemia is a rare genetic disease. Individuals with Fanconi anemia have an increased risk of developing a cancer of blood-forming cells in the bone marrow called acute myeloid leukemia (AML) or tumors of the head, neck, skin, gastrointestinal system, or genital tract. (Source: Genetics Home Reference).

Watch out for…

Updated data of the ongoing phase I/II trial in Fanconi Anemia is scheduled for presentation at the American Society of Gene & Cell Therapy (ASGCT) 2018 Annual Meeting on May 18, 2018.

RCKT closed Friday's trading at $17.97, up 0.96%.

8. Celyad SA (CYAD)

Celyad is a clinical-stage biopharmaceutical company focused on the development of CART-cell therapies.

A phase I study of CYAD-01 in seven refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma), dubbed THINK, and a phase I study of multiple doses of CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer, dubbed SHRINK, are ongoing.

Watch out for…

Updated data of the ongoing THINK Phase 1 trial with the case report of a CYAD-01 associated complete response in one relapsed/refractory AML patient will be presented at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 19, 2018.

CYAD closed Friday's trading at $33.90, down 7.38%

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