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NBY To Sell Lash Spray On Amazon, PRVB Proves Mettle, CVM Catches Eyes

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

1. NovaBay Pharmaceuticals Inc. (NBY)

NovaBay is a biopharmaceutical company focusing on commercializing prescription Avenova for the domestic eye care market.

Gained 874.84% to close Monday's (June 10) trading at $3.10.

News: The Company announced that Avenova Direct is available at affordable pricing and without a prescription on Amazon.com through the Company's new direct-to-consumer online channel.

Avenova is a lid and lash spray that is designed for the removal of bacteria and debris on and around the eyelid margin that contribute to bacterial eye infections.
A 20ml size of Avenova Direct is available from Amazon in the U.S. at a price of $29.99.

Recent event:

On May 9, 2019, the Company announced financial results for the first quarter ended March 31, 2019.

The net loss for the first quarter of 2019 widened to $4.8 million or $0.28 per share from $2.2 million or $0.13 per share in the year-ago quarter. Net sales for the first quarter of 2019 declined to $1.5 million from $2.9 million for the first quarter of 2018, with the decrease due to lower unit sales and lower gross-to-net pricing of Avenova.

As of March 31, 2019, the Company had cash of $2.9 million.

2. Provention Bio Inc. (PRVB)

Provention Bio is a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases.

Gained 217.01% to close Monday's trading at $13.79.

News: The NIH-Sponsored "At-Risk" study has demonstrated that a single 14-day course of the Company's investigational drug PRV-031 (Teplizumab) can delay Type 1 Diabetes onset in high-risk individuals by at least two years.

The "At Risk" Study enrolled 76 participants ages 8 to 49 who were "At-Risk" because they had two or more T1D autoantibodies and abnormal glucose metabolism (dysglycemia).

Based on the promising results, the Company is evaluating a regulatory path forward for PRV-031 in at-risk individuals.

A phase III clinical trial of PRV-031 in patients with recent-onset type 1 diabetes, dubbed PROTECT, is underway.

The global PROTECT trial is designed to enroll approximately 300 patients ages 8-17 with recent-onset type 1 diabetes at approximately 80 centers worldwide. Enrollment in the trial is expected to be completed by the end of 2020.

3. CEL-SCI Corporation (CVM)

Gained 21.96% to close Monday's trading at $5.72.

News: The Company is all set to join the broad-market Russell 3000 Index at the conclusion of the 2019 Russell indexes annual reconstitution, effective after the US market opens on July 1, 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 has occurred.

4. CorMedix Inc. (CRMD)

CorMedix is a biopharmaceutical company developing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.

Gained 16.54% to close Monday's trading at $7.40.

News: No news

Product pipeline:

The lead product candidate is Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters for patients undergoing chronic hemodialysis.

The phase III trial of Neutrolin, dubbed LOCK-IT-100, demonstrated efficacy last July. The topline results of the full data set of LOCK-IT-100 were announced on January 30, 2019.

The Company is continuing its discussions with the FDA and looks forward to completing the clinical study report, which is required to demonstrate the safety and efficacy of Neutrolin as a catheter-lock solution for hemodialysis patients.

5. Pulse Biosciences Inc. (PLSE)

Pulse Biosciences is a clinical stage electroceutical company pursuing multiple clinical applications of its proprietary Nano-Pulse Stimulation.

Gained 15.23% to close Monday's trading at $12.86.

News: No news

Recent events:

In February of this year, the Company filed a 510(k) with the FDA for use of its CellFX System in dermatologic procedures to remove general benign lesions including sebaceous hyperplasia (SH), a common but difficult to treat facial lesion, and seborrheic keratosis (SK), the most common benign raised pigmented lesion.

On April 30, 2019, the Company received an additional information letter from the FDA, which among other things, questioned the adequacy of the predicate device provided in the 510-K.

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