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5 Top Gainers In Pharma Sector (OTLK, SESN, UROV...)

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

1. Outlook Therapeutics Inc. (OTLK)

Gained 42.86% to close Monday's (May 20) trading at $3.00.

News: No news

Pipeline:

The Company's lead product candidate is ONS-5010, which is under a phase III clinical trial in Australia) for wet age-related macular degeneration, dubbed ONS-5010-001.
Enrollment in this study is nearly complete.

Another phase III clinical trial of ONS-5010 for wet AMD, initiated in the United States, Australia and New Zealand, is expected to begin dosing patients in June 2019.

The Company, which had cash of $0.2 million at March 31, 2019, raised net proceeds of approximately $26.2 million in April of this year.

2. Kaleido BioSciences Inc. (KLDO)

Kaleido Biosciences is a clinical-stage healthcare company developing microbiome metabolic therapies or MMTs, which are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ's existing microbes.

The Company went public on the Nasdaq Global Select Market on February 28, 2019, offering its shares at a price of $15 each.

Gained 22.13% to close Monday's trading at $18.10.

News: No news

Pipeline:

The Company's lead product candidate is KB195 for treatment of hyperammonemia in patients with urea cycle disorders, or UCD. This compound is under a non-IND human clinical study in UCD patients. KB195 is also being explored as a potential treatment for hepatic encephalopathy.

The other investigational drugs include KB174 for the treatment of hepatic encephalopathy, which is under a non-IND human clinical in patients with cirrhosis, and KB109 for the treatment of infections caused by multi-drug resistant bacteria in high-risk patients.

Near-term Catalysts:

-- Initiation of Phase 2 clinical trial of KB195 in patients with UCD in Q2 2019.
-- Data from non-IND clinical study of KB195 in patients with UCD in Q4 2019.
-- Data from non-IND clinical study of KB174 in patients with cirrhosis in Q4 2019.
-- Data from non-IND clinical study of KB174 in healthy subjects to explore dosing in Q4 2019.

3. Sesen Bio Inc. (SESN)

Sesen Bio, formerly Eleven Biotherapeutics Inc., is a late-stage clinical company developing next-generation antibody-drug conjugate therapies for the treatment of cancer.

Gained 21.52% to close Monday's trading at $1.75.

News: No news

Pipeline & Near-term Catalyst:

The lead drug candidate is Vicinium, which is under a phase III trial in patients with high-grade non-muscle invasive bladder cancer, dubbed VISTA.

On May 13, 2019, the Company reported updated, preliminary primary and additional secondary endpoint data from its VISTA trial further supporting the strong benefit-risk profile of Vicinium for the potential treatment in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).

On June 6, 2019, the Company is slated to meet with the FDA to discuss its intended registration strategy for Vicinium for the treatment of high-risk NMIBC.

4. Urovant Sciences Ltd. (UROV)

Urovant is a clinical-stage biopharmaceutical company developing innovative therapies for urologic conditions.

Gained 12.31% to close Monday's trading at $8.30.

News: No news

Clinical Trials:

The Company's lead drug candidate is Vibegron, which is under a phase III trial in adults with symptoms of overactive bladder, dubbed EMPOWUR. Positive topline results from EMPOWUR were reported on March 19, 2019.

A phase IIa clinical trial evaluating Vibegron in patients with abdominal pain due to irritable bowel syndrome is also underway.

A phase III trial to evaluate the safety and efficacy of Vibegron for symptoms of overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH), dubbed COURAGE, was initiated as recently as March of this year.

5. KemPharm Inc. (KMPH)

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions.

Gained 12.03% to close Monday's trading at $1.49.

News: No news

Pipeline:

KemPharm's co-lead clinical development candidates include KP415 and KP484 for the treatment of ADHD. The Company has received FDA approval for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.

Near-term Catalyst:

Submission of New Drug Application for KP415, being developed for the treatment of attention-deficit/hyperactivity disorder, in late second quarter or early third quarter of 2019.

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