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Biopulse: High-Flyers With Billion-Dollar Market Cap

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The biotech stocks are known to be notoriously volatile as news related to their trials or regulatory decisions can either reward or punish investors. The iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, is up nearly 13 percent so far this year.

Today we are featuring 5 biotech companies of billion-dollar valuations, whose stocks hit new highs.

1. Cardiovascular Systems Inc. (CSII)

Cardiovascular Systems is a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease.

The Company reported financial results for its fiscal third quarter, ended March 31, 2019, on May 1.

The third-quarter revenues were $63.3 million, an increase of $7.7 million, or 13.9%, from the third quarter of fiscal 2018.

For fiscal 2019 ending June 30, 2019, CSI anticipates revenue of $245 million to $247 million, representing 13% to 14% growth compared to fiscal 2018.

The stock hit a 5-year high of $45.61 in intraday trading yesterday. The Company has a market cap of $1.521 billion.

2. Cortexyme Inc. (CRTX)

Cortexyme is a clinical stage biopharmaceutical company developing therapeutics for Alzheimer's and other degenerative diseases.

The Company went public on the Nasdaq Global Select Market on May 9, 2019, offering its shares at a price of $17 each.

The lead drug candidate is COR388, which is under a phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease dementia, dubbed GAIN.

Near-term Catalyst:

-- The top-line data from the GAIN trial is expected by the end of 2021.

CRTX touched an all-time high of $47.50 in intraday trading yesterday before closing at $42. The Company has a market cap of $1.127 billion.

3. Eidos Therapeutics Inc. (EIDX)

Eidos is a clinical stage biopharmaceutical company focused on developing drugs for diseases caused by transthyretin (TTR) amyloidosis (ATTR).

The Company's lead drug candidate is AG10.

-- AG10 is under a phase III trial in patients with transthyretin (TTR) amyloid cardiomyopathy, dubbed ATTRibute-CM.
-- An open-label extension of a phase II clinical trial of AG10 in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) , is underway, with data expected in the fourth quarter of 2019.
-- A phase III study of AG10 in patients with transthyretin amyloid polyneuropathy (ATTR-PN), is expected to be initiated in the second half of 2019.

Eidos went public on the Nasdaq Global Select Market on June 20, 2018, offering its shares at a price of $17 each.

The stock touched an all-time high of $34.28 in intraday trading yesterday. The Company has a market cap of $1.213 billion.

4. Iovance Biotherapeutics Inc. (IOVA)

Iovance is focused on developing novel cancer immunotherapies based on tumor infiltrating lymphocytes, or TILs in short.

The Company's lead product candidate is LN-145 autologous Tumor Infiltrating Lymphocytes, which is under phase II development in cervical cancer.

Another product candidate of the Company is LN-144 TIL (Lifileucel) for the treatment of advanced melanoma, which is under a pivotal phase II study.

Iovance, formerly known as Lion Biotechnologies, Inc., graduated from the OTC to the Nasdaq Global Market on February 24, 2015.

The stock hit a 5-year high of $22.99 in intraday trading yesterday. The Company has a market cap of $2.767 billion.

5. Voyager Therapeutics Inc. (VYGR)

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

The Company's lead gene therapy product candidate is VY-AADC for Parkinson's disease. A strategic collaboration between Voyager and Neurocrine Biosciences focused on the development and commercialization of two gene therapy programs, VY-AADC for Parkinson's disease and VY-FXN01 for Friedreich's ataxia, as well as two other development programs to be determined, became effective in March of 2019.

The Company's lead clinical program is VY-AADC, a gene therapy product, under a phase II trial for the treatment of Parkinson's disease in patients with motor fluctuations that are refractory to medical management, dubbed RESTORE-1.

The RESTORE-1 study was initially designed to enroll 41 patients. Based on a Type B meeting with the FDA held in December 2018, the Company has decided to increase the target number of patients in the RESTORE-1 study to 75 to 100 patients.

A staggered-parallel phase III trial of VY-AADC, named RESTORE-2, of similar size and design to RESTORE-1, has been planned.

The stock hit a new 52-week high of $28.62 in intraday trading yesterday. The Company has a market cap of $1.027 billion.

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