Gainers & Losers Of The Day: EYEG, BLPH, VSAR, MNTA, AMPH...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 21, 2017.

GAINERS

1. EyeGate Pharmaceuticals Inc. (EYEG)

Gained 125.62% to close Tuesday's trading at $3.70.

News: EyeGate has signed a $103 million licensing deal with Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO)

Under the new agreement, Valeant has been granted worldwide commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product candidate for the treatment of post-operative pain and inflammation in ocular surgery patients.

Valeant will pay EyeGate Pharma an upfront payment of $4.0 million and milestone payments totaling up to approximately $99.0 million, upon achievement of certain specified developmental and commercial milestones, and royalties based on a specified percent of net sales of the product.

2. Bellerophon Therapeutics, Inc. (BLPH)

Gained 37.96% to close Tuesday's trading at $1.49.

News: No news

Near-term catalysts:

Bellerophon's phase II trials for INOpulse therapy to treat pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) are underway. The company looks forward to communicating results of each trial during the first quarter of 2017.

Interim analysis of phase III program for INOpulse in Pulmonary Arterial Hypertension (PAH) data monitoring committee is expected to occur by the end of 2017.

3. Galectin Therapeutics Inc. (GALT)

Gained 31.97% to close Tuesday's trading at $1.94.

News: No news

Near-term catalysts:

-- 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.

4. Versartis Inc. (VSAR)

Gained 15.90% to close Tuesday's trading at $18.95.

News: The company has provided an update on its clinical development programs.

Near-term catalysts:

-- Initiate enrollment of Somavaratan "switch" patients in 1H 2017 -- Report top-line data from the pediatric Phase 3 VELOCITY trial in September 2017 -- Complete enrollment of Phase 3 Japan trial in 2H 2017 -- Initiate VITAL Phase 3 trial in adult GHD patients by year end 2017

5. Strongbridge Biopharma plc (SBBP)

Gained 15.38% to close Tuesday's trading at $3.00

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 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. -- Another phase III trial of COR-003 for the treatment of endogenous Cushing's syndrome, dubbed LOGICS, is planned for initiation - with top line data expected to be reported in Q3 2018.

6. Cellect Biotechnology Ltd. (APOP)

Gained 15.27% to close Tuesday's trading at $6.72.

News: The company reported positive final results from its clinical trial of ApoGraft in healthy donors.

The ApoGraft process is designed to prevent Graft-versus-Host Disease (GHz), a common complication associated with stem cell transplant.

Commenting on the results, Cellect CEO said, "In plain words, these positive results bring us one step closer to making stem cell therapies safe, effective and available".

7. Exact Sciences Corp. (EXAS)

Gained 12.56% to close Tuesday's trading at $22.41.

News: The company generated $99.4 million in revenues during 2016, a 152% increase as Cologuard test volume grew 135%.

For the first quarter of 2017, the company expects Cologuard volume of at least 88,000 completed tests. Looking ahead to 2017, the company anticipates revenue of $170-$180 million and Cologuard volume of at least 415,000 completed tests.

LOSERS

1. Trevena Inc. (TRVN)

Lost 40.11% to close Tuesday's trading at $4.27.

News: The company reported top-line results from its two phase III pivotal efficacy studies of Oliceridine - one in moderate-to-severe acute pain following bunionectomy and the other in abdominoplasty.

In the phase III study of Oliceridine in moderate-to-severe acute pain following bunionectomy, dubbed APOLLO-1, all three Oliceridine regimens of 0.1 mg, 0.35 mg, and 0.5 mg, were found to be statistically superior to placebo at 48 hours. But only two dose regimens of Oliceridine - 0.35 mg and 0.5 mg - demonstrated efficacy comparable to morphine at 48 hours.

Similar were the results in the phase III study of Oliceridine in moderate-to-severe acute pain following abdominoplasty, dubbed APOLLO-2. All three Oliceridine regimens of 0.1 mg, 0.35 mg, and 0.5 mg, were found to be statistically superior to placebo. But only two dose regimens of Oliceridine - 0.35 mg and 0.5 mg - demonstrated efficacy comparable to morphine at 24 hours.

The company plans to submit the NDA for Oliceridine in the fourth quarter of this year.

2. Cidara Therapeutics Inc. (CDTX)

Lost 38.46% to close Tuesday's trading at $7.20.

News: The company's phase II trial, dubbed RADIANT, evaluating gel and ointment topical formulations of antifungal CD101 in women with moderate-to-severe acute vulvovaginal candidiasis, failed to show sufficient efficacy to warrant further development.

According to the trial results, the gel and ointment topical formulations of CD101 were similar in efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole, the current standard of care.

Near-term catalyst:

A phase II trial of CD101 IV in candidemia, dubbed STRIVE, is ongoing. This study is comparing the safety and efficacy of CD101 IV to standard-of-care therapy, Caspofungin with an optional step-down to oral fluconazole. The top line data from the STRIVE study are anticipated in the fourth quarter (Q4, 2017).

3. Amphastar Pharmaceuticals Inc. (AMPH)

Lost 22.83% to close Tuesday's trading at $14.20.

News: The FDA has turned down the company's request seeking approval of intranasal Naloxone, proposed for the treatment of opioid addiction or overdose.

In its Complete Response Letter, the FDA has raised certain issues including user human factors study, device evaluation, and other items that need to be addressed before the NDA can be approved.

Amphastar already markets an injectable version of Naloxone, and it recorded sales of $38.3 million in the first nine months of 2016.

4. Momenta Pharmaceuticals Inc. (MNTA)

Lost 15.53% to close Tuesday's trading at $16.05.

News: Pfizer facility, a key part of the supply chain for Momenta's Glatopa products, has received an FDA warning letter.

Glatopa is a generic equivalent of Teva Pharmaceuticals Industries Ltd's (TEVA) blockbuster multiple sclerosis drug Copaxone. Glatopa 20 mg was approved by the FDA in April 2015, and is currently marketed by Sandoz in the United States.

The Glatopa 40 mg ANDA remains under regulatory review. Due to the Pfizer facility compliance issues, Momenta expects that an approval of Glatopa 40 mg in the first quarter of 2017 is not likely to happen.