5 Top Gainers In Healthcare Sector (HEPA, ARDX, PTI...)

(RTTNews) - The following are some of today's top gainers in the healthcare sector.

1. BioCardia Inc. (BCDA)

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

The Company markets the Helix transendocardial delivery system, the Morph steerable guide and sheath catheter portfolio, and the new AVANCE steerable introducer family of products. The biotherapeutic product candidates in clinical development include CardiAMP and CardiALLO cell therapies.

Gained 33.52% to close Tuesday's (Nov.26) trading at $4.70.

News: No news

Near-term Catalysts:

-- The Company expects to gain FDA clearance for its Morph DNA Catheter System in Q4, 2019. The Morph DNA Catheter System is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. -- FDA acceptance of the IND application for CardiALLO cell therapy is expected in the second quarter of 2020. -- A pivotal phase III CardiAMP Heart Failure Trial is underway. Data Safety Monitoring Board Review of all patients enrolled in the CardiAMP Heart Failure Trial, including 60 patients at primary one-year follow-up endpoint, is expected to occur in the fourth quarter of 2020. 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.

2. Hepion Pharmaceuticals Inc. (HEPA)

Hepion Pharma, formerly ContraVir Pharmaceuticals, is a clinical-stage biopharmaceutical company developing targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The lead drug candidate is CRV431 for NASH and HBV and HCV, in early stage of clinical development.

Gained 28.69% to close Tuesday's trading at $4.62.

News: No news

Clinical Trials & Near-term Catalysts:

-- A 28-day multiple ascending dose phase I clinical trial of CRV431 in HBV patients is underway. Data from this trial is expected in the first half of 2020. -- A phase II biomarker pilot study of CRV431 in NASH is expected to be initiated in the first half of 2020, with data expected in the second half of the year.

3. Proteostasis Therapeutics Inc. (PTI)

Proteostasis Therapeutics is a clinical-stage biopharmaceutical company with the main focus on developing therapies to treat cystic fibrosis.

Gained 26.98% to close Tuesday's trading at $2.40.

News: No news

Near-term Catalyst:

-- A placebo-controlled, 28-day, phase II study evaluating its proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulator combinations of PTI-808, PTI-801, and PTI-428 in F508del homozygous and heterozygous cystic fibrosis subjects is underway, with top-line data expected later in the fourth quarter of 2019.

4. Neoleukin Therapeutics Inc. (NLTX)

Neoleukin is a biopharmaceutical company creating next-generation immunotherapies using de novo protein design technology. The Company is the result of the reverse merger between Aquinox Pharmaceuticals and Neoleukin Therapeutics.

Gained 21.23% to close Tuesday's trading at $5.14.

News: No news

Cash position:

As of September 30, 2019, the Company had cash of $66.3 million.

Upcoming Event:

The Company is slated to make a presentation at the Piper Jaffray 31st Annual Healthcare Conference on Thursday, December 5, 2019, at 2:50 p.m. EST in New York.

5. Ardelyx Inc. (ARDX)

Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases.

Gained 18.18% to close Tuesday's trading at $7.54.

News: The Company expanded its partnership with Japan-based Kyowa Kirin by signing two new agreements.

Ardelyx and Kyowa Kirin have established research collaboration with associated options to license any resulting development candidates with the potential for up to $500 million in development and sales milestones for Ardelyx.

In addition, Kyowa Kirin has made a $20 million equity investment in Ardelyx at $6.96 for 2,873,563 shares.

Recent event:

On September 12, 2019, Ardelyx received FDA approval for IBSRELA (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The Company is seeking a commercial collaboration partner for IBSRELA.

Near-term Catalysts:

-- A phase III monotherapy study of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis and peritoneal dialysis, dubbed PHREEDOM, is underway, with results expected in the fourth quarter of this year. -- If all goes well as planned, the Company expects to file NDA for Tenapanor in the treatment of hyperphosphatemia in 2020.