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Gainers & Losers Of Apr.19: SNGX, IMGN, CBLI, SSH, AKTX...

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 19, 2017.

GAINERS

1. Cleveland BioLabs Inc. (CBLI)

Gained 46.13% to close Wednesday's (Apr.19) trading at $5.10.

News: No news

Recent event: On April 17th, the Company announced that it received consent from the FDA for initiation of an in vivo biocomparability study of two formulations of Entolimod - namely the one that is proposed for use under the pre-Emergency Use Authorization and the other drug formulation that was used in previously conducted preclinical and clinical studies.

Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.

2. Soligenix Inc. (SNGX)

Gained 43.58% to close Wednesday's trading at $3.69.

News: Investigation of immune correlates of protection in sera of animals vaccinated with RiVax has produced encouraging results. The findings will be presented at the 20th Annual Conference on Vaccine Research on April 25, 2017.

RiVax is the Company's proprietary vaccine candidate for the prevention of exposure to ricin toxin. It has completed phase I testing.

3. NewLink Genetics Corp. (NLNK)

Gained 18.88% to close Wednesday's trading at $19.02.

News: No news

Recent event: On April 4th, the Company reported interim phase II results of its drug candidate Indoximod in combination with Merck's FDA-approved Keytruda in patients with advanced melanoma. The news sent the stock down 9% that day.

According to the trial results, patients who received the combination of Indoximod plus Keytruda demonstrated a 52% objective response rate (ORR) and a 73% disease control rate (DRR).

While the Company said that results are robust, investors are of the view that it was not a meaningful benefit compared to Incyte's (INCY) investigational melanoma drug Epacadostat.

In a phase I trial, which evaluated the safety and efficacy of Incyte's Epacadostat in combination with Keytruda in advanced melanoma patients, the objective response rate was 58% and disease control rate was 74%.

Near-term catalyst:

-- The Company is slated to release its first quarter 2017 financial results on Thursday, May 4, 2017.

4. Skyline Medical Inc. (SKLN)

Gained 16.13% to close Wednesday's trading at $2.52.

News: No news

Recent event: On March 15th, the Company reported Q4 and full year 2016 financial results.

Net loss available to common shareholders for the fourth quarter of 2016 was $0.73 million or $0.16 per share on revenue of $0.14 million. This compared with a net loss available to common shareholders of $2.26 million or $10.87 per share and revenue of $0.18 million in the year-ago quarter.

Revenue was derived from the sale of four STREAMWAY Systems and disposable products during each of these periods.

STREAMWAY system is an FDA-cleared direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures.

5. Strongbridge Biopharma PLC (SBBP)

Gained 15.07% to close Wednesday's trading at $4.20.

News: No news

Near-term catalysts:

-- Launch Keveyis in April 2017. Keveyis was approved by the FDA in August 2015 to treat all forms of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. Strongbridge acquired the U.S. rights to Keveyis from a subsidiary of Taro Pharmaceutical Industries Ltd. as recently as December 23, 2016.
-- Enrollment in a phase III trial of RECORLEV (COR-003) for the treatment of endogenous Cushing's syndrome, dubbed SONICS, is expected to be completed by end of Q2 2017, and top-line data is anticipated in Q1 2018.
-- A phase III trial, dubbed LOGICS, which will supplement the long-term efficacy and safety data from SONICS, is anticipated to begin in mid-2017 and top-line data are expected in the third quarter of 2018.

6. ImmunoGen (IMGN)

Gained 10.49% to close Wednesday's trading at $3.58.

News: Analysts at Leerink Partners upgraded their rating on the Company's stock to Outperform from Market Perform.

Near-term catalysts:

-- Initial data from phase 1b/2 trial of Mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in ovarian cancer, dubbed FORWARD II, are expected in Q2, 2017.
-- Pooled data from over 100 ovarian cancer patients treated in multiple Mirvetuximab soravtansine phase 1 cohorts and data from phase I steroid eye drop expansion cohort are anticipated in Q2, 2017.
-- Initial phase I data for IMGN779 for the treatment of acute myeloid leukemia are expected in mid-2017.

7. Albireo Pharma Inc. (ALBO)

Gained 9.82% to close Wednesday's trading at $22.14.

News: No news

Near-term catalyst:

-- A phase III trial of A4250 in patients with progressive familial intrahepatic cholestasis (PFIC) is planned for initiation in the second half of 2017.

LOSERS

1. Sunshine Heart Inc. (SSH)

Lost 32.59% to close Wednesday's trading at $0.91.

News: The Company has priced an underwritten public offering of units for gross proceeds of $8.0 million.

The offering is comprised of Class A Units and Class B Units. The Class A Units are priced at a public offering price of $1.00 per unit, with each unit consisting of one share of common stock and one five-year warrant (each, a "warrant") to purchase one share of common stock with an exercise price of $1.10 per share.

The Class B Units are priced at a public offering price of $1,000 per unit, with each unit comprised of one share of preferred stock, which is convertible into 1,000 shares of common stock, and warrants to purchase 1,000 shares of common stock, also with an exercise price of $1.10 per share.

The offering is expected to close on or about April 24, 2017.

2. Nivalis Therapeutics Inc. (NVLS)

Lost 10.23% to close Wednesday's trading at $2.37.

News: No news

Recent event: On April 18, Nivalis and privately-held Alpine Immune Sciences, Inc entered into a merger agreement under which Alpine will merge with a wholly-owned subsidiary of Nivalis in an all-stock transaction.

The merger is expected to close in the third quarter of 2017.

3. Proteostasis Therapeutics Inc. (PTI)

Lost 9.34% to close Wednesday's trading at $6.21.

News: No news

Near-term catalyst:

-- Preliminary data from at least 8 cystic fibrosis subjects from a cohort of stable Orkambi patients dosed with PTI-428 for 7 days followed by a 7-day follow-up period are expected to be reported in this quarter (Q2, 2017).
-- Data from the 28-day dosing cohort in phase I clinical trial of PTI-428 are expected in the second half of 2017.

4. CRISPR Therapeutics AG (CRSP)

Lost 8.35% to close Wednesday's trading at $17.57.

News: No news

Recent event: On April 13th, the University of California, Berkeley, and the University of Vienna appealed the decision by the Patent Trial and Appeal Board in the case concerning CRISPR technology.

CRISPR Therapeutics has a global license agreement for CRISPR technology with University of California, Berkeley.

CRISPR, which stands for "clustered regularly interspaced short palindromic repeats," is an advanced genetic engineering technique.

On February 15, 2017, the Patent Trial and Appeal Board declared that the patents granted to Broad Institute, MIT and Harvard concerning CRISPR do not interfere with patent claims filed by University of California, Berkeley and the University of Vienna.

The Broad Institute and University of California, Berkeley have been claiming that they were the first to invent the CRISPR technology and applied for a patent in March of 2013, and October of 2013, respectively. The Broad's patent was issued on April 15, 2014. But the University of California is yet to be issued one.

As mentioned earlier, on April 13th, the University of California, Berkeley and the University of Vienna appealed to the U.S. Court of Appeals for the Federal Circuit seeking review and reversal of the Patent Trial and Appeals Board's decision which terminated the interference without determining which inventors actually invented the use of the CRISPR/Cas9 genome editing technology in eukaryotic cells.

5. Akari Therapeutics Plc (AKTX)

Lost 7.88% to close Wednesday's trading at $13.79.

News: No news

Near-term catalyst:

-- Interim results from the phase II trial evaluating Coversin in patients with Paroxysmal nocturnal haemoglobinuria (PNH) who have never received a complement blocking therapy will be released on April 24, 2017.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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