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6 Top Gainers In Healthcare Sector (ACRS, NSPR, AVDL…)

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

1. Aclaris Therapeutics Inc. (ACRS)

Aclaris Therapeutics is a biopharmaceutical company focused on immuno-inflammatory and dermatological diseases.

Gained 63.64% to close Tuesday's (Sep.17) trading at $1.80.

News: The Company announced positive results from a phase III trial of A-101 45% Topical Solution for the treatment of common warts.

The trial, dubbed THWART-2, met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts.

Another phase III pivotal clinical trial investigating A-101 45% Topical Solution for the treatment of common warts, dubbed THWART-1, is also ongoing, and results are expected in the coming months.

There are no FDA approved prescription treatments for common warts, and if approved, A-101 45% Topical Solution would be the first FDA approved prescription treatment for common warts.

2. BioCardia Inc. (BCDA)

BioCardia is focused on developing regenerative biologic therapies to treat cardiovascular disease.

Gained 24.75% to close Tuesday's trading at $6.30.

News: An independent Data Safety Monitoring Board (DSMB) has recommended that the Company's Phase III pivotal CardiAMP Heart Failure Trial continue, as planned, as there were no safety concerns.

CardiAMP cell therapy uses a patient's own (autologous) bone marrow cells delivered to the heart in a minimally-invasive, catheter-based procedure to potentially stimulate the body's natural healing response. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of a stem cell therapy to prospectively screen for stem cell therapeutic potency in order to improve patient outcomes.

Recent event:

In May of this year, the Company received FDA clearance for its AVANCE device, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.

3. Bicycle Therapeutics plc (BCYC)

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a brand new class of small, chemically synthesized medicines called Bicycles.

Gained 16.14% to close Tuesday's trading at $11.80.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead asset is BT1718, under phase I/IIa trial in patients with advanced solid tumors.

Recent event:

The Company went public on the Nasdaq Global Select Market on May 23, 2019, offering its American Depositary Shares at a price of $14.00 per ADS.

4. Avadel Pharmaceuticals plc (AVDL)

Avadel is a branded specialty pharmaceutical company, generating revenue primarily from the sale of pharmaceutical products, previously sold in the U.S. without FDA approval ("Unapproved Marketed Products" or "UMDs").

Gained 15.45% to close Tuesday's trading at $2.84.

News: No news

Pipeline:

The lead drug candidate FT218 for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy is under phase III testing. The study, dubbed REST-ON trial, is expected to complete enrollment in the second half of 2020.

Near-term Catalysts:

-- The Company's fourth hospital product is under FDA review, with a decision expected on December 15, 2019.

5. InspireMD Inc. (NSPR)

InspireMD is a commercial-stage medical device company marketing CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, and MGuard Prime EPS in patients with coronary artery disease.

Gained 13.89% to close Tuesday's trading at $3.28.

News: No news

Recent event:

On August 6, 2019, the Company reported financial results for the second quarter ended June 30, 2019.

Revenue for the second quarter of 2019 was $1.35 million representing an increase of 35.0% from the comparable period in 2018.

6. Cyclerion Therapeutics, Inc. (CYCN)

Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on the development of soluble guanylate cyclase (sGC) stimulators for the treatment of serious and orphan diseases.

Gained 13.01% to close Tuesday's trading at $13.90.

News: No news

Clinical Trials & Near-term Catalysts:

** The Company's lead asset is Praliciguat, which is under two phase II studies for diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF). The topline results from both the trials are expected in Q4 2019.
** A phase II study of Olinciguat in patients with sickle cell disease, dubbed STRONG SCD, is underway, with data readout anticipated in mid-2020.
** A phase I study of IW-6463, a central nervous system (CNS) penetrant sGC stimulator in development for serious neurodegenerative diseases, is ongoing, with data readout expected in Q4 2019.

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