Gainers & Losers Of Feb.28: KITE, PBMD, LIFE, VRX, PRGO...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 28, 2017.

GAINERS

1. Kite Pharma Inc. (KITE)

Gained 24.34% to close Tuesday's trading at $70.66.

News: The primary analysis of pivotal phase II study of Axicabtagene ciloleucel (previously referred to as KTE-C19), in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL) demonstrated encouraging results.

The study, dubbed ZUMA-1, met the primary endpoint of objective response rate with 82%. At month 6, 41% of treated patients achieved a response, including 36 percent in Complete Response.

Last September, the company reported positive top line results from a pre-planned interim analysis of the ZUMA-1 trial.

Kite intends to complete its rolling submission of the Biologics License Application, seeking k regulatory approval of Axicabtagene ciloleucel in aggressive NHL, by the end of the first quarter of 2017.

2. Prima Biomed Ltd. (PBMD)

Gained 22.59% to close Tuesday's trading at $2.93.

News: The United States Patent Office has granted patent to the company's lead product candidate IMP321, which is currently in a phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer. Interim-data of safety run-in from the phase IIb study, dubbed AIPAC, is expected in mid of 2017.

A phase I study of IMP321 in combination with pembrolizumab, known as TACTI-mel , for the treatment of melanoma is also underway.

3. CRISPR Therapeutics AG (CRSP)

Gained 18.95% to close Tuesday's trading at $23.73.

News: Jon Terrett has been appointed as the company's Head of Immuno-Oncology Research and Translation.

Prior to joining CRISPR Therapeutics, Terrett was the Vice President of oncology discovery for CytomX, a U.S.-based biotechnology company focused on developing drugs to treat different types of cancer. In addition, Terrett has held various R&D leadership roles in biopharma, including serving as the Chief Scientific Officer at Oxford Biotherapeutics, and as a director at various biotechnology companies including Medarex, CellTech and Oxford Glycosciences.

CRISPR Therapeutics has a global license agreement for CRISPR technology with UC Berkeley. CRISPR, which stands for "clustered regularly interspaced short palindromic repeats," is an advanced genetic engineering technique.

4. aTyr Pharma, Inc. (LIFE)

Gained 15.94% to close Tuesday's trading at $4.00.

News: The company's drug candidate Resolaris has been granted Orphan Drug Designation by the FDA for the treatment of limb girdle muscular dystrophy (LGMD) patients.

Resolaris is under a phase 1b/2 clinical study in LGMD2B, a sub-type of limb girdle muscular dystrophy.

5. InspireMD Inc. (NSPR)

Gained 15.38% to close Tuesday's trading at $2.40.

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:

-- Launch CGuard EPS in several leading German medical centers in the first half of 2017. -- Commence sales of CGuard EPS in Russia in the first half of this year. -- Regulatory approvals of CGuard EPS in India and Mexico where the company plans to to launch sales initiatives in the second half of this year.

6. Infinity Pharmaceuticals Inc. (INFI)

Gained 13.47% to close Tuesday's trading at $2.78.

News: No news

The key drug candidate in the pipeline is IPI-549, an oral immuno-oncology compound.

Anticipated event: The company is scheduled to report Q4 and Full-year 2016 financial results on March 14, 2017.

Near-term catalysts:

- Present additional data from a Phase 1 study of IPI-549 in patients with advanced solid tumors later this year - Report Phase 1 data from the monotherapy dose-escalation phase as well as the IPI-549 plus Opdivo dose-escalation phase in 2017 - Complete the dose-escalation phase evaluating IPI-549 monotherapy in the first half of 2017 - Begin enrolling patients with advanced solid tumors in the monotherapy expansion cohort during the second half of 2017 - Complete the dose-escalation combination phase evaluating IPI-549 plus Opdivo in the second half of 2017 - Begin enrolling patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) in combination expansion cohorts evaluating IPI-549 plus Opdivo in the second half of 2017.

7. Idera Pharmaceuticals Inc. (IDRA)

Gained 13.33% to close Tuesday's trading at $1.87.

News: No news

The company's lead product candidate is IMO-2125, which is under phase I/2 study in refractory melanoma.

Near-term catalysts:

-- All the objectives in the phase 1 portion of the phase I/2 study of IMO-2125 in refractory melanoma trial have been achieved, and the phase 2 portion of the trial is planned to be taken up by the end of Q2, 2017. -- Initiate phase I monotherapy trial of IMO-2125 in multiple refractory solid tumors in Q1, 2017.

8. BioCryst Pharmaceuticals Inc. (BCRX)

Gained 13.33% to close Tuesday's trading at $1.87.

News: No news

Recent event:

On Feb.27, 2017, the company reported encouraging interim results from its phase II trial of BCX7353 in hereditary angioedema.

In the trial, dubbed APeX-1, 28 subjects were randomized equally to receive BCX7353 350 mg QD or placebo for 28 days. According to the interim analysis, there was a reduction of 63% in overall attack rate in HAE patients with severe disease.

A pre-planned analysis of peripheral and abdominal attacks showed reductions of 88% and 24%, respectively, for BCX7353 compared with placebo, according to the company.

9. Kura Oncology Inc. (KURA)

Gained another 9.87% to close Tuesday's trading at $8.35, adding to yesterday's gain.

News: No news

Near-term catalysts:

--The company will be presenting preliminary evidence of clinical activity with Tipifarnib in squamous cell carcinomas of the head & neck (SCCHN) with HRAS mutations at the 15th International Congress on Targeted Anticancer Therapies on March 6, 2017. -- Additional data from phase II study of Tipifarnib in HRAS mutant squamous cell carcinomas of the head & neck expected in the first half of this year. -- Data from phase II study of Tipifarnib in peripheral T-cell lymphoma (PTCL) are also expected in the first half of this year.

LOSERS

1. Ophthotech Corp. (OPHT)

Lost 21.66% to close Tuesday's trading at $3.58.

News: The company reported wider-than-expected loss for the fourth quarter ended December 31, 2016.

Net loss for Q4, 2016 widened to $66.3 million or $1.86 per share from $35.6 million or $1.02 per share for the same period in 2015. Analysts polled by Thomson Reuters expected the company to incur a loss of $1.69 per share.

The company's shares have been hard-hit after its two phase III clinical trials of Fovista anti-PDGF therapy in combination with Lucentis failed to meet their primary endpoints last December. The drug was being developed as a treatment for wet age-related macular degeneration.

OPHT has lost over 90% of its share value since the announcement of the trial results on December 12, 2016.

2. Cempra Inc. (CEMP)

Lost 19.05% to close Tuesday's trading at $3.40.

News: During a meeting to discuss the complete response letter for oral and intravenous Solithromycin for the treatment of CABP in adults, the FDA has reiterated its request for additional clinical safety data prior to approval. Solithromycin was issued complete response letter on December 29, 2016.

Cempra also announced that it has recently initiated company wide cost and personnel reductions. Accordingly, the workforce has been reduced from 136 to 45 employees, i.e. by 67%, and significant reductions in external spending related to commercial preparedness and non-essential activities.

3. Valeant Pharmaceuticals International Inc. (VRX)

Lost 13.94% to close Tuesday's trading at $14.38.

News: Q4 revenue declined by 13%.

Valeant's total revenues in the fourth quarter of 2016 were $2.40 billion compared to $2.76 billion in the fourth quarter of 2015, reflecting a 13% drop. Analysts polled by Thomson Reuters expected the company to report revenue of only $2.34 billion. The decrease was primarily due to reduced product sales, negative impact of foreign currency exchange and drop in realized pricing.

4. Perrigo Company plc (PRGO)

Lost 11.70% to close Tuesday's trading at $74.77.

News: The company's Chief Financial Officer Judy Brown has resigned, and Ron Winowiecki has been appointed as acting CFO. Perrigo has also stated that it won't be able to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 by the due date of March 1, 2017.