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Gainers & Losers Of The Day: ZSAN, EVOK, ARDX, EARS, NEOT...

Feb15 021517

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 15, 2017.

GAINERS

1. Zosano Pharma Corp. (ZSAN)

Stock rallied for the third consecutive day, gaining 41.09% to close Wednesday's trading at $2.85.The stock has gained more than 67% over the last 3 trading days.

News: No news

Recent event: On Feb.13, the company announced that its pivotal phase III efficacy study of M207 in migraine met endpoints.

In the pivotal phase III efficacy study, dubbed ZOTRIP, M207 achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours.

M207 is a zolmitriptan-coated microneedle patch that is designed to rapidly deliver anti-migraine agent zolmitriptan during a migraine attack.

2. Novan Inc. (NOVN)

Gained 34.45% to close Wednesday's trading at $6.44, extending the rally for the second consecutive day.

News: No news

Recent event: On January 27, 2017, the company reported top-line results from its two, replicate phase III pivotal clinical trials for SB204 in the treatment of acne vulgaris.

In one of those trials, dubbed NI-AC302, SB204 demonstrated statistical significance compared to vehicle on all three co-primary endpoints, but in another trial, named NI-AC301, the topical acne product candidate demonstrated statistical significance on only one of three co-primary endpoints. Following the results, the stock shed 74% of its value that day.

The company had its IPO on September 21, 2016, offering its shares at a price of $11.00 each.

3. Evoke Pharma Inc. (EVOK)

Gained 30.27% to close Wednesday's trading at $3.40.

News: The FDA has exempted the company's late stage product, Gimoti from a human factors validation study requirement prior to submission of a New Drug Application.

Gimoti, a nasal formulation of metoclopramide, is under development for symptomatic relief of acute and recurrent diabetic gastroparesis in women. Metoclopramide in oral and IV formulations is approved by the FDA for gastroparesis.

The company reported results from its phase III trial of Gimoti last July. The primary endpoint of symptom improvement in acute and recurrent diabetic gastroparesis in adult women at Week 4 was not met. But statistical significance was demonstrated in patients with moderate to severe gastroparesis symptoms at baseline.

4. AquaBounty Technologies Inc. (AQB)

Gained 18.79% to close Wednesday's trading at $16.75.

News: No news

Shares of AquaBounty underwent a 1-for-30 reverse share split on January 5, 2017 and were uplisted to the Nasdaq on January 19, 2017.

AquaBounty is involved in developing AquAdvantage Salmon, a genetically engineered Atlantic salmon. AquAdvantage Salmon was approved by the FDA in November 2015.

AquaBounty is a majority-owned subsidiary of Intrexon Corp. (XON).

5. XTL Biopharmaceuticals Ltd. (XTLB)

Gained 15.56% to close Wednesday's trading at $3.07.

News: No news

Anticipated event:

The company's lead drug candidate is hCDR1, currently in development for the treatment of systemic lupus erythematosus, or SLE. The compound is set to enter a global phase II trial for SLE.

The company also intends to explore hCDR1 for the treatment of Sjögren's syndrome, a systemic autoimmune disease with some autoantibodies and clinical manifestations similar to those detected in SLE.

6. Novavax Inc. (NVAX)

Gained 14.08% to close Wednesday's trading at $1.62.

News: No news

Last September, the company announced that its phase III trial of respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine), dubbed Resolve, did not meet the pre-specified efficacy objectives.

Near-term catalyst:

A phase II safety and immunogenicity trial of RSV F Vaccine in older adults (60 years of age and older) is underway - with top-line results expected in the third quarter of 2017.

7. Ardelyx Inc. (ARDX)

Gained 13.54% to close Wednesday's trading at $13.00.

News: The company's phase III trial of Tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint.

According to the study results, there was a statistically significant difference in serum phosphorus levels from the end of the eight-week treatment period to the end of the four-week randomized withdrawal period between the Tenapanor-treated group and the placebo-treated group. Tenapanor was also well-tolerated in the trial.

8. INSYS Therapeutics Inc. (INSY)

Gained 12.24% to close Wednesday's trading at $10.82.

News: Insys is making Cannabidiol Oral Solution available on a compassionate use basis to subjects with refractory pediatric epilepsy following completion of 48 weeks of treatment in an ongoing long-term safety study.

A phase 1/phase 2 safety and pharmacokinetic (PK) study of Cannabidiol Oral Solution in pediatric subjects with treatment-resistant epilepsy was successfully completed last May.

9. Zogenix Inc. (ZGNX)

Gained 11.92% to close Wednesday's trading at $10.80.

News: No news

Near-term catalyst: Top-line results from two phase III safety and efficacy clinical trials of ZX008, dubbed Studies 1501 and 1502, for Dravet syndrome are anticipated in Q2 2017.

10. Ignyta Inc. (RXDX)

Gained 11.90% to close Wednesday's trading at $9.40.

News: No news

Near-term catalysts:

The company's lead compound is Entrectinib, under development for solid tumors.

-- An updated data from two phase I clinical trials of Entrectinib - ALKA-372-001 study and the STARTRK-1 - are expected to be presented this quarter.
-- A phase II clinical trial of Entrectinib, dubbed STARTRK-2, is ongoing - with interim data anticipated in Q2, 2017.

LOSERS

1. Auris Medical Holding AG (EARS)

Lost 18.78% to close Wednesday's trading at $0.93.

News: The company priced its previously announced public offering of 10 million common shares and 10 million warrants, each warrant entitling its holder to purchase 0.70 of a common share.

The common shares and warrants are being sold in units comprised of one common share and one warrant at the public offering price of $1.00 per unit. The anticipated gross proceeds amount to $10 million. The offering is expected to close on or about February 21, 2017.

2. Galectin Therapeutics Inc. (GALT)

Lost 18.33% to close Wednesday's trading at $1.47. Pullback after yesterday's gain of over 40%.

News: No news

Near-term catalyst:

-- Top-line data from a phase IIb trial of GR-MD-02 in nonalcoholic steatohepatitis (NASH) patients with advanced fibrosis are anticipated in December of this year.
-- GR-MD-02 is also being explored in severe skin diseases like moderate-to-severe plaque psoriasis and severe atopic dermatitis. Galectin is scouting for a partner to advance the skin disease indications.

3. InspireMD Inc. (NSPR)

Lost 11.99% to close Wednesday's trading at $2.35. The stock has given back most of what it gained (18%) yesterday.

News: No news

The company's CGuard Embolic Prevention System (EPS) is designed to prevent peri-procedural and late embolization. It is CE Marked, but not approved for sale in the U.S. by the FDA.

Anticipated events:
-- Commercial launch of CGuard EPS in Brazil in the first half of 2017.
-- Commercial launch of CGuard EPS in India in the second half of 2017.
-- File an IDE submission for CGuard EPS in the United States this year.

4. Neothetics Inc. (NEOT)

Lost 9.62% to close Wednesday's trading at $1.41.

News: No news

Near-term catalyst: A phase II proof of concept trial of LIPO-202 for the reduction of submental subcutaneous fat is underway. Top-line data from this trial are expected in late second quarter 2017.

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