AMDA Grows A Spine, OGEN To Report Data In Q2, SCPH Faces FDA In June

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

1. Amedica Corp. (AMDA)

Gained 181.98% to close Tuesday's (May 8) trading at $3.13.

News: The Company provided an update on its clinical study activities related to silicon nitride spinal implants.

The spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America.

A clinical study comparing silicon nitride spinal implants to allograft spacers in cervical fusion showed faster and more effective outcomes with silicon nitride. Significantly earlier and more effective bone fusion was observed with silicon nitride than allograft spacers at 3- 6-, and 12-month time points after surgery, all the way to 24 months.

In another study, which was a retrospective survey of over 2,000 silicon nitride spinal implants implanted in more than 1,000 patients over the last eight years, the preliminary data was consistent with other clinical studies - with the outcomes corroborating the basic science understanding of the surface chemistry of the material, the key strength of silicon nitride.

A 24-month double-blinded multicenter randomized controlled human trial for lumbar fusion comparing intervertebral cages from either silicon nitride or polyetheretherketone, dubbed SNAP, appears to confirm the study's hypothesis of silicon nitride's non-inferiority, according to the Company.

An interbody fusion study using a goat model comparing silicon nitride to polyetheretherketone (PEEK), has demonstrated improved fusion and greater bone volume using silicon nitride implants versus PEEK at the study's six-month end-point.

2. ProPhase Labs Inc. (PRPH)

Gained 54.56% to close Tuesday's trading at $4.47.

ProPhase is a marketer and distributor of a diversified range of over-the-counter ("OTC") dietary supplements.

News: The Company has declared a special cash dividend in the amount of $1.00 per share on its common stock, payable on June 5, 2018 to stockholders of record as of May 21, 2018.

Near-term Catalyst:

The Company is slated to report financial results for the first quarter ended March 31, 2018, in the second week of May.

3. Oragenics Inc. (OGEN)

Gained 27.02% to close Tuesday's trading at $1.59.

News: No news

Recent events:

On April 6, 2018, the Company entered into a securities purchase agreement with certain new institutional investors providing for the purchase and sale of 900,000 shares of common stock at a price of $2.00 per share in a registered direct offering. The total gross proceeds from the registered direct offering are expected to be roughly $1.8 million. The closing of the sale of the securities is expected to take place on or about April 10, 2018.

Near-term Catalysts:

Preliminary data on initial 20 enrolled patients in the Company's phase II clinical trial of AG013 for the treatment of oral mucositis is anticipated during the second quarter of 2018 - with top-line results of the trial expected in 2019. Approximately 200 subjects will be enrolled in the study.

4. Stellar Biotechnologies Inc. (SBOT)

Gained 19.05% to close Tuesday's trading at $6.50.

The Company is a manufacturer of Keyhole Limpet Hemocyanin (KLH), a molecule used in immunotherapy development.

News: No news

Recent events:

-- On May 7, 2018, the Company reported financial results for the second quarter ended March 31, 2018.

Stellar's net loss widened to $1.35 million or $0.90 per share on revenue of $0.06 million in the second quarter of fiscal year 2018. This compared with a net loss of $1.10 million or $0.76 per share and revenue of $0.06 million for the second quarter of the prior year.

-- A one-for-seven reverse share split of the Company's common shares came into effect at the market open on May 7, 2018.

Near-term Catalyst:

A number of therapeutic vaccines that utilize the Company's KLH protein as a carrier molecule are currently in clinical studies by third parties. Results from the first of these trials are anticipated to be announced during the summer of 2018.

5. scPharmaceuticals Inc. (SCPH)

Gained 18.55% to close Tuesday's trading at $15.40.

News: The Company announced financial results for the first quarter ended March 31, 2018, and provided a business update.

The Company reported a net loss of $8.7 million in the first quarter of 2018 compared to $4.9 million for the first quarter period of 2017.

Recent event:

-- The Company went public on the Nasdaq Global Select Market on November 17, 2017, offering its shares at a price of $14 each.

Near-term Catalysts:

-- The Company's 505(b)(2) New Drug Application for Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting is under FDA review - with a decision expected on June 23, 2018.

-- The Company continues to expect initiating enrollment in the FREEDOM-HF (FUROSCIX Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure) study in the second quarter of 2018. This study will evaluate the economic impact of FUROSCIX administered in an outpatient setting compared with intravenous (IV) furosemide administered in the hospital.

6. Second Sight Medical Products Inc. (EYES)

Gained 18.30% to close Tuesday's trading at $1.81.

News: No news

Recent event:

On May 7, 2018, the Company completed a $10 million private placement of common stock with Gregg Williams, Chairman of the Board of Directors.

Near-term Catalyst:

The Company is slated to release its 2018 first quarter financial results on Thursday, May 10, 2018, after the close of the U.S. financial markets.

7. SunLink Health Systems Inc. (SSY)

Gained 17.27% to close Tuesday's trading at $1.63.

News: No news

Recent event:

On February 14, 2018, the Company announced financial results for the fiscal 2018 second quarter ended December 31, 2017.

Net earnings for the quarter ended December 31, 2017, were $726,000, or $0.08 per share compared to net earnings of $3.09 million or $0.33 per share for the quarter ended December 31, 2016.

Consolidated net revenues from continuing operations for the quarter ended December 31, 2017 decreased to $13.88 million from $14.25 million in the year-ago quarter.

Near-term Catalyst:

The Company is slated to report financial results for the fiscal 2018 third quarter ended March 31, 2018 next week.