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Famous Five: These Biotech Stocks Notched Triple-digit Gains

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The biotech sector got off to a good start in 2019, and the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has so far gained 17 percent.

Listed below are the biotech stocks that scored a triple-digit gain.

1. PhaseBio Pharmaceuticals Inc. (PHAS): 373% YTD

PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary disorders.

The Company's pipeline includes PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, for the treatment of patients on ticagrelor who are experiencing a major bleeding event or those who require urgent surgery, and PB1046, a once-weekly novel treatment for pulmonary arterial hypertension.

Near-term Catalysts:

-- Initiate a Phase 2a trial of PB2452 in the first half of 2019.
-- Data readout from Phase 2a trial of PB2452 in the first half of 2019.
-- Initiate Phase 2b trial of PB2452 in the second half of 2019.
-- A Phase 2b clinical trial of PB1046 in patients with Pulmonary Arterial Hypertension is underway, with results expected in the first half of 2020.

PhaseBio made its debut on the Nasdaq Global Market on October 18, 2018, offering its shares at a price of $5.00 each.

PHAS closed Tuesday's trading at $16.23, and that represents a gain of nearly 373% year-to-date.

2. EDAP TMS S.A. (EDAP): 180% YTD

EDAP TMS is a French medical device company which develops and distributes worldwide minimally invasive medical devices for urology using ultrasound technology.

2018 marked the fifth consecutive year of growth for the Company.

The total revenue in 2018 was €39.2 million. (USD 46.2 million) an increase of 9.6% compared to €35.7 million (USD 40.7 million) for the year ended December 31, 2017.
Full-year net loss narrowed to €0.3 million (USD 0.4 million), or a loss of €0.01 per share from €0.7 million (USD 0.8 million) or a loss of €0.02 per share in 2017.
The Company ended the year 2018 with cash and cash equivalents of €19.5 million (USD 22.3 million).

EDAP debuted on Nasdaq National Market under the symbol "EDAPY" and on the European Association of Securities Dealers Automated Quotation System under the symbol "EDAP" in August 1997, offering its American Depositary Shares at a price of $9.00 each. The company changed its NASDAQ ticker symbol to "EDAP" in December 2001.

EDAP closed Tuesday's trading at $5.19, which represents a year-to-date gain of 180%.

3. Soliton Inc. (SOLY): 142% YTD

Soliton is a medical device company whose investigational product - Rapid Acoustic Pulse ("RAP") device - uses rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos.

Near-term Catalysts:

-- The Company's 510(k) application for premarket clearance of Rapid Acoustic Pulse tattoo removal device was accepted for review by the FDA as recently as March 27, 2019.

The potential of the RAP device is also being explored to reduce cellulite and enhance existing fat removal technologies.

-- Early in April, the Company initiated a clinical trial evaluating a higher-energy version of its acoustic shockwave technology to affect the factors contributing to the formation of cellulite.

Soliton went public on the Nasdaq Capital Market on February 19, 2019, offering its shares at a price of $5.00 each. The stock closed Tuesday's trading at $ 11.80, and that marks a gain of 142%.

4. Insmed Incorporated (INSM): 141% YTD

Insmed is a global biopharmaceutical company developing treatments for rare lung diseases.

The Company has 1 commercial product ARIKAYCE, which was granted accelerated approval by the FDA last September for the treatment of Mycobacterium avium complex (MAC) lung disease.

Insmed expects total net product sales of ARIKAYCE to be approximately $21.9 million for the quarter ended March 31, 2019. For the full-year 2019 revenues for ARIKAYCE are expected to be in the range of $80 million to $90 million.

INSM closed Tuesday's trading at $31.62, and that represents a gain of 141% year-to-date.

5. CEL-SCI Corporation (CVM): 118% YTD

CEL-SCI is a biotechnology company involved in the research and development of immunotherapy products for the treatment of cancer, autoimmune and infectious diseases.

The Company's lead clinical program is Multikine, an immunotherapeutic agent that is being developed as a potential first-line neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, and potentially, as a treatment for cervical dysplasia or peri-anal warts in HIV/HPV co-infected patients.

A phase III study of Multikine in head and neck cancer is underway, and it is the largest in the world.

As recently as March 29, 2019, an Independent Data Monitoring Committee (IDMC), which reviewed the data from the Company's pivotal phase III head and neck cancer study of Multikine, recommended that the trial be continued until the appropriate number of events have occurred.

CVM closed Tuesday's trading at $6.27, and that reflects a gain of $118% year-to-date.

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