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Gainers & Losers Of The Day: CEMP, IPCI, OREX, RNVA, ARGS...

Feb24 022417

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 24, 2017.


1. Cempra Inc. (CEMP)

Gained 28.57% to close Friday's (Feb.24, 2017) trading at $4.05.

News: The company's oral Fusidic acid met the primary endpoint in a phase III study of ABSSSI.

The phase III trial demonstrated non-inferiority of oral Fusidic acid compared to oral Linezolid, an approved antibiotic, for early clinical response in patients with acute bacterial skin and skin structure infections (ABSSSI).

The study involved 716 patients. The proportion of patients alive and achievement of a greater than or equal to 20 percent reduction from baseline in lesion size at 48-72 hours after the start of study drug, without receiving rescue antibiotics was set as the primary endpoint, which is also defined as the early clinical response (ECR).

In the study, 87.2 percent of patients receiving oral Fusidic acid demonstrated ECR, compared to 86.6 percent of patients receiving oral Linezolid, demonstrating non-inferiority to Linezolid.

2. Zosano Pharma Corp. (ZSAN)

Gained 18.64% to close Friday's trading at $2.61.

News: No news

Recent event: On Feb.13, 2017, 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.

3. IntelliPharmaCeutics International Inc. (IPCI)

Gained 18.60% to close Friday's trading at $2.55.

News: The company's 500 mg and 750 mg strengths of generic Glucophage XR have won FDA approval.

The branded product Glucophage XR is sold in the United States by Bristol-Myers Squibb, and is indicated for use in the management of type 2 diabetes treatment.

IntelliPharmaCeutics' other 8 ANDA candidates are under review by the FDA and a decision may be announced soon.

4. Bellerophon Therapeutics Inc. (BLPH)

Gained 16.67% to close Friday's trading at $1.40.

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.

5. Aurinia Pharmaceuticals Inc. (AUPH)

Gained 13.41% to close Friday's trading at $3.72.

News: No news

Near-term catalyst:

-- 48-week secondary endpoint durability of renal response data from phase IIb study of Voclosporin in patients with active lupus nephritis, dubbed AURA, is expected this quarter (Q1, 2017).

The AURA trial has already achieved the primary endpoint of statistically significantly greater complete remission, and the primary endpoint result was announced last August.

6. Orexigen Therapeutics Inc. (OREX)

Gained 11.56% to close Friday's trading at $4.44.

News: No news

Anticipated event: The company is slated to report financial results for Q4 and year ended December 31, 2016 on Feb.27, 2017.

7. La Jolla Pharmaceutical Co. (LJPC)

Gained 9.06% to close Friday's trading at $19.87.

News: No news

Near-term catalyst:

-- Top line results from phase III trial of LJPC-501 in Catecholamine-resistant hypotension, dubbed ATHOS, are expected this quarter (Q1, 2017).


1. Diffusion Pharmaceuticals Inc. (DFFN)

Lost 11.63% to close Friday's trading at $3.42.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy.

TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

2. Rennova Health Inc. (RNVA)

Lost 11.21% to close Friday's trading at $1.98.

News: No news

Recent event: A 1 for 30 reverse stock split of the company's common stock came into effect on February 23, 2017. The reverse stock split is intended to increase the per share trading price of the company's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market.

3. Argos Therapeutics Inc. (ARGS)

Lost 9.26% to close Friday's trading at $1.22.

News: No news

Recent event: Argos' shares have been on the decline since the IDMC recommendation to discontinue the pivotal phase III trial of Rocapuldencel-T on Feb.22, 2017.

In the company's pivotal phase III trial, dubbed ADAPT, Rocapuldencel-T in combination with sunitinib/standard-of-care was tested for the treatment of metastatic renal cell carcinoma (mRCC).

Based on an interim data analysis, the Independent Data Monitoring Committee found that the study was unlikely to achieve primary endpoint, and recommended the discontinuation of the study.

Argos shares have lost 72% of their value since the Feb.22 announcement.

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