Gainers & Losers Of Mar.1: DVAX, SKLN, FOLD, IPXL, QASM...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 1, 2017.

GAINERS

1. Dynavax Technologies Corp. (DVAX)

Gained 53.33% to close Wednesday's (March 1st) trading at $6.90.

News: The company's resubmitted NDA for HEPLISAV-B, an experimental vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older, has been accepted for review by the FDA.

The U.S. regulatory agency's decision on HEPLISAV-B is expected on August 10, 2017. This is HEPLISAV-B's third go-around with the FDA.

Last November, the FDA refused to approve HEPLISAV-B, seeking information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments.

In February 2013 too, the FDA had rejected HEPLISAV-B, and requested additional data before it could be approved.

2. Skyline Medical Inc. (SKLN)

Gained 33.33% to close Wednesday's trading at $2.56.

News: The company has been awarded an Innovative Technology contract from Vizient Inc. for STREAMWAY System.

The FDA-approved STREAMWAY System is a direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures.

As of September 30, 2016, Skyline Medical customers have installed 96 STREAMWAY systems in 50 facilities across 19 states.

3. Calithera Biosciences Inc. (CALA)

Gained 28.89% to close Wednesday's trading at $11.60.

News: Calithera is slated to make a presentation at the Cowen and Company 37th Annual Health Care Conference 2017 on Wednesday, March 8, 2017.

Recent event:

On January 30, 2017, Calithera signed a deal with Incyte Corp. (INCY) to develop CB-1158, a phase I drug candidate. As per the deal terms, Calithera stands to earn as much as $483 million from Incyte.

4. NeuroDerm Ltd. (NDRM)

Gained 26.57% to close Wednesday's trading at $29.30.

News: The company's phase II trial of ND0612H for advanced Parkinson's disease, dubbed Trial 006, has successfully met its primary, key secondary and additional secondary endpoints.

The trial demonstrated a statistically significant and clinically meaningful reduction in OFF-time and increase in proportion of patients "ON" by 8:00 am (primary and key secondary endpoints). The study also showed statistically significant reduction in troublesome dyskinesia and a complete reduction of OFF-time to zero hours in 66% of responders.

5. Amicus Therapeutics Inc. (FOLD)

Gained 17.10% to close Wednesday's trading at $7.60.

News: The company says it is seeing growing momentum for Galafold in the EU, approved as a monotherapy for Fabry disease in patients with amenable mutation.

A target of 300 patients has been set to be treated with reimbursed Galafold by year-end 2017. There were 75 patients on reimbursed Galafold as of February 28, 2017, according to the company.

During his first address to a joint session of Congress, President Trump reiterated the need for a speedier FDA approval process. Highlighting the story of rare disease survivor, Megan Crowley, in his speech, Trump said, "Megan's story is about the unbounded power of a father's love for a daughter. But our slow and burdensome approval process at the FDA keeps too many advances, like the one that saved Megan's life, from reaching those in need. If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles just like Megan".

Megan Crowley's father is John Crowley, the chairman and CEO of Amicus Therapeutics. In 1999, John Crowley co-founded Novazyme Pharmaceuticals, primarily focused on enzyme-replacement treatment for Pompe disease.

The enzyme replacement treatment for Pompe disease, which was later to be known as Myozyme, came under Genzyme Corp.'s fold when it acquired Novazyme in August 2001. Myozyme was approved by the FDA for Pompe disease in April 2006. Genzyme was itself bought out by Sanofi in February 2011.

6. Rigel Pharmaceuticals Inc. (RIGL)

Gained 16.33% to close Wednesday's trading at $2.85.

News: No news

Anticipated event:

-- Report fourth quarter and year end 2016 financial results after market close on Tuesday, March 7, 2017.

Near-term catalyst:

-- Submit NDA for Fostamatinib to the FDA for chronic immune thrombocytopenic purpura in the first quarter of this year.

7. Esperion Therapeutics Inc. (ESPR)

Gained 16.32% to close Wednesday's trading at $30.44. The shares have gained 139% in just 19 trading days.

News: No news

Esperion's shares have been on the rise ever since Amgen Inc. (AMGN) announced on February 3rd, 2017 that its cholesterol lowering approved drug Repatha met the primary and secondary key endpoints in a landmark cardiovascular outcomes study, dubbed FOURIER.

Esperion is also developing a cholesterol lowering drug, which goes by the name Bempedoic acid.

Bempedoic acid is an inhibitor of ATP Citrate Lyase, and is under phase III testing. A global cardiovascular outcomes trial for Bempedoic acid, known as CLEAR Outcomes CVOT, was initiated by the company as recently as last month.

The top line results from one of the phase III studies of Bempedoic acid are expected by Q2 2018.

8. Stemline Therapeutics Inc. (STML)

Gained 14.29% to close Wednesday's trading at $8.00.

News: No news

Near-term catalysts:

-- Enrollment in final cohort (Stage 3) of phase II pivotal trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm is expected to be completed this quarter. -- A phase I dose escalation study of SL-801 is underway, and further trial updates are expected later this year. -- A phase II trial of SL-701 in adult patients with second-line glioblastoma has been completed, and patients are being followed to assess survival. Further updates are expected later this year.

9. Leap Therapeutics Inc. (LPTX)

Gained 14.01% to close Wednesday's trading at $8.14.

News: No news

Near-term catalysts:

Leap Therapeutics' lead clinical candidate is DKN-01, which is under phase I/II trials in esophageal cancer and cholangiocarcinoma, a form of bile duct cancer. Another clinical candidate of the company is TRX518, currently in phase I clinical trials in solid tumor malignancies.

-- The company is scheduled to make preclinical and clinical data presentations during the 2017 American Association for Cancer Research (AACR) Annual Meeting, being held April 1 - 5, 2017, in Washington, D.C.

10. Kite Pharma Inc. (KITE)

Gained 12.51% to close Wednesday's trading at $79.62, continuing its rally for the second straight day.

News: No news

Recent event: On February 28, 2017, the company reported positive topline primary results from its pivotal phase II study of Axicabtagene Ciloleucel in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma, dubbed ZUMA-1.

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 regulatory approval of Axicabtagene ciloleucel in aggressive NHL, by the end of the first quarter of 2017.

Kite shares have gained 40% since the Feb.28th announcement.

LOSERS

1. Impax Laboratories Inc. (IPXL)

Lost 34.74% to close Wednesday's trading at $9.30.

News: Q4 and full-year 2016 revenue and profitability badly hit.

Adjusted earnings per share for the fourth quarter of 2016 were $0.16 compared to $0.62 in the fourth quarter of 2015. Total revenues in the fourth quarter of 2016 decreased 29.7% to $198.4 million compared to $282.1 million in the fourth quarter of 2015.

Looking ahead to 2017, the company expects the headwinds of aggressive competition and pricing pressure to persist and weigh on its results through the year.

2. Oasmia Pharmaceutical AB (OASM)

Lost 19.31% to close Wednesday's trading at $1.88.

News: The company's Chairman Anders Lönner has announced his withdrawal from the board of directors.

Lönner was elected chairman of the board at an extraordinary general meeting on November 21st 2016.

3. Prima Biomed Ltd. (PBMD)

Lost 15.36% to close Wednesday's trading at $2.48. It's a pullback after a gain of more than 22% on Feb.28th.

News: No news

Recent event: On Feb.28th, the United States Patent Office 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.