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5 Top Gainers In Pharma Sector (CVM, ALNA, SOLY...)

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

1. CEL-SCI Corporation (CVM)

Gained 26.26% to close Tuesday's (June 4) trading at $4.76.

News: The Company made a presentation at the 9th annual LD Micro Invitational on June 4, 2019.

Pipeline:

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.

On 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.

2. Guardion Health Sciences Inc. (GHSI)

Guardion Health is an ocular health sciences and technologies company.

Gained 24.84% to close Tuesday's trading at $1.96.

News: The Company has launched a second ocular health formula GlaucoCetin.

In an IRB-approved trial conducted at the New York Eye and Ear Infirmary, the parent compound of GlaucoCetin, GlaucoHealth, designed by Robert Ritch, successfully reversed mitochondrial dysfunction in patients with glaucoma.

3. Allena Pharmaceuticals Inc. (ALNA)

Gained 24.38% to close Tuesday's trading at $5.00.

News: The Company announced positive interim data from its phase II basket clinical trial of Reloxaliase, an orally-administered, recombinant oxalate-degrading enzyme, in adult and pediatric patients suffering from the progression of primary hyperoxaluria (PH) or enteric hyperoxaluria (EH) with advanced chronic kidney disease.

According to the trial results, substantial treatment effect was observed in patients with enteric hyperoxaluria, including robust reductions in both urine and plasma oxalate.

Near-term Catalyst:

-- A phase III program of Reloxaliase in patients with enteric hyperoxaluria, dubbed URIROX, is underway.

The URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2.

The URIROX-1 study is designed to enroll 124 patients for a four-week treatment period. Allena expects to report topline data from URIROX-1 in the second half of 2019.

The URIROX-2 study is designed to enroll 400 patients over a minimum treatment period of two years. This study was initiated in the fourth quarter of 2018.

4. Soliton Inc. (SOLY)

Soliton is a medical device company, which recently received FDA clearance to market its Rapid Acoustic Pulse ("RAP") device for tattoo removal. The potential of the RAP device is also being explored to reduce cellulite and enhance existing fat removal technologies.

Gained 22.05% to close Tuesday's trading at $18.49.

News: The Company announced results of preclinical studies of the use of a new version of its acoustic pulse technology demonstrating that its RAP device is capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite.

Recent event:

On May 29, 2019, the Company announced positive data from its proof of concept clinical trial of Rapid Acoustic Pulse (RAP) device in cellulite.

The proof of concept clinical trial involved a study of five patients with moderate to severe cellulite, each treated on their thighs, with a new higher-powered version of Soliton's RAP device. This new higher-powered version of RAP device is not yet approved by the FDA.

Near-term Catalyst:

Following the positive proof of concept clinical trial, the Company has decided to undertake a pivotal cellulite study, which will involve between 45 and 60 patients. The study is expected to begin within the next three months.

5. HOOKIPA Pharma Inc. (HOOK)

Gained 21.67% to close Tuesday's trading at $9.77.

News: No news

Recent event:

The Company went public on the Nasdaq Global Select Market on April 18, 2019, offering its shares at a price of $14.00 each.

Pipeline & Near-term Catalyst:

-- A phase II clinical trial of HB-101, a prophylactic vaccine for Cytomegalovirus, is underway. The safety and immunogenicity data from the first cohorts enrolled in this trial are expected in the first half of 2020, with preliminary efficacy data to follow in the second half of 2020.
-- A phase I/II clinical trial for HB-201 in patients with treatment-refractory HPV16+ cancers is expected to be initiated in the second half of 2019.
-- A phase I/II trial combining HB-201 and HB-202, both with and without a checkpoint inhibitor, in patients with treatment-refractory HPV16+ cancers is anticipated to be initiated in the second half of 2020.

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