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26.05.2017 02:43:07

Gainers & Losers Of May 25: AERI, BCRX, NEOT, SNDX, SYRS...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 25, 2017.

GAINERS

1. Aerie Pharmaceuticals Inc. (AERI)

Gained 33.95% to close Thursday's (May 25) trading at $54.25.

News: The Company reported positive phase III top line efficacy results of Roclatan, its drug candidate for glaucoma.

Roclatan is a fixed dose combination of Aerie's most advanced drug candidate Rhopressa, and Latanoprost, a widely prescribed prostaglandin analog for glaucoma.

In the 90-day phase III trial, dubbed Mercury 2, Roclatan dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both Latanoprost and Rhopressa at the primary endpoint range of baseline IOPs from above 20 to below 36 mmHg for each of the nine measured time points.

2. BioCryst Pharmaceuticals Inc. (BCRX)

Gained 31.19% to close Thursday's trading at $6.73.

News: The Company reported positive results from second interim analysis of its Phase 2 trial of BCX7353, dubbed APeX-1, in hereditary angioedema.

APeX-1 is a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in hereditary angioedema (HAE) patients.

The first interim analysis, the results of which were reported in February of this year, evaluated data from 28 of 36 patients in Part 1. The second interim analysis, whose results were reported today, evaluated data from all patients in Parts 1 and 2 of the trial.

According to today's results, a daily dose of 125 mg of BCX7353 results in a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis.

3. Reata Pharmaceuticals Inc. (RETA)

Gained 10.47% to close Thursday's trading at $28.17.

News: No news

The Company's lead product candidates are Bardoxolone methyl and Omaveloxolone.

Near-term catalysts:

-- A phase III trial of Bardoxolone methyl for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, is underway. Data from CATALYST are expected to be available during the first half of 2018. -- Bardoxolone methyl is also being studied in a phase II trial, known as LARIAT, for the treatment of pulmonary hypertension due to interstitial lung disease, or PH-ILD. Data from this trial are expected to be available in the second half of 2017. -- A pivotal phase II/III trial of Bardoxolone methyl, known as CARDINAL, for the treatment of chronic kidney disease, or CKD, caused by Alport syndrome, is also ongoing. The phase II data is expected in the second half of 2017.

Omaveloxolone is under two phase II studies - one in the indication of Friedrich's ataxia, dubbed known as MOXIe, and the other in mitochondrial myopathies, known as MOTOR. Each trial consists of two parts.

-- Data from the first part of MOXIe and MOTOR are expected mid-year 2017 and the second-half of 2017, respectively. -- A phase 1b/2 trial, known as REVEAL, to evaluate Omaveloxolone in combination with existing immunotherapies for the treatment of metastatic melanoma is also ongoing. Data from the 1b dose escalation portion of REVEAL are expected during the second half of 2017.

4. Neothetics Inc. (NEOT)

Gained 8.33% to close Thursday's trading at $2.47.

News: No news

Near-term catalyst

A phase II proof of concept trial of LIPO-202 for reduction of submental fat is underway, and top-line results from this study are expected in June.

LOSERS

1. Vital Therapies Inc. (VTL)

Lost 11.72% to close Thursday's trading at $2.82.

News: No news

Near-term catalysts:

The top line data from a phase III study of ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are anticipated around mid-2018.

2. Syros Pharmaceuticals Inc. (SYRS)

Lost 10.66% to close Thursday's trading at $15.34.

News: No news

The Company has two lead product candidates - SY-1425 for genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) under phase II testing, and SY-1365 for certain solid tumors, under phase I testing.

Near-term catalyst:

Initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 are anticipated in the fall of 2017.

3. Cerus Corp. (CERS)

Lost 10.62% to close Thursday's trading at $2.02.

News: No news

Recent event:

On May 23, 2017, the Company lowered its 2017 product revenue guidance due to expected impact of Platelet Additive Solution supply disruption on INTERCEPT platelet production.

The INTERCEPT Blood System, marketed by Cerus, is designed to reduce the risk of transfusion-transmitted infections.

The U.S. supply shortage of the platelet additive solution (PAS) manufactured and sold by Fresenius Kabi is due to an unanticipated delay in FDA approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi's supplier.

The Company now expects 2017 product revenue to range between $38 million and $46 million compared to the prior range of $43 million to $48 million.

4. Syndax Pharmaceuticals Inc. (SNDX)

Lost 6.98% to close Thursday's trading at $12.92.

News: The Company has offered to sell 3.75 million shares of its common stock to the public at a price of $13.25 per share.

The gross proceeds to Syndax from this offering are expected to be approximately $49.7 million. The offering is expected to close on May 31, 2017.

Syndax has granted the underwriters a 30-day option to purchase up to 562,500 additional shares.

Recent event:

On May 17, 2017, the Company reported results from melanoma cohort of its ongoing phase II trial of Entinostat in combination with Merck's KEYTRUDA. The stock surged over 44% to close that day's trading at $13.58.

The results showed that the addition of Entinostat could result in meaningful responses in patients who have progressed on an anti-PD-1 or anti-PD-1/anti-CTLA-4 regimen like KEYTRUDA, which is an area of very high unmet medical need.

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Aktien in diesem Artikel

BioCryst Pharmaceuticals 7,09 -0,53% BioCryst Pharmaceuticals
Cerus Corp. 1,58 -0,44% Cerus Corp.
Syndax Pharmaceuticals Inc 14,90 1,36% Syndax Pharmaceuticals Inc