Gainers & Losers Of Mar.27: APOP, IPXL, ZIOP, FOMX...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 27, 2017.

GAINERS

1. Cellect Biotechnology Ltd. (APOP)

Gained 74% to close Monday's (Mar.27) trading at $10.90.

News: The Company's first stem cell transplant procedure has been successfully performed using its ApoGraft technology in its phase I/II clinical trial in a blood cancer patient.

The independent Data and Safety Monitoring Board (DSMB) has given the go-ahead for enrolling additional 2 cancer patients for ApoGraft transplantation treatments.

ApoGraft aims to become a game changer in stem cells transplantations for cancer treatments.

Up to 50 percent of stem cell transplant procedures, such as bone marrow transplants, results in life-threatening rejection disease, known as Graft-versus-Host-Disease.

2. Impax Laboratories Inc. (IPXL)

Gained 37.30% to close Monday's trading at $12.70.

News: The Company has hired Morgan Stanley to explore strategic alternatives, including a possible sale, according to Reuters.

Paul Bisaro has been appointed Impax's President and Chief Executive Officer and a member of the Company's Board, effective March 27, 2017. Bisaro succeeds Kevin Buchi, who has served as Interim President and Chief Executive Officer since December of 2016.

3. Cancer Genetics Inc. (CGIX)

Gained 29.49% to close Monday's trading at $5.05.

News: No news

Recent event: On Mar.23rd, the Company reported record revenue for the fourth quarter and full-year 2016.

Fourth quarter revenues were up 32% year-over-year on strong organic growth to $7.2 million while full-year 2016 revenues were up 50% year-over-year to $27 million.

Net loss improved to $2.8 million or $0.15 per share during the fourth quarter of 2016 compared to a net loss of $5.7 million or $0.48 per share during the fourth quarter of 2015.

During 2017, the Company expects its business to continue high double-digit, durable growth.

4. Regulus Therapeutics Inc. (RGLS)

Gained 21.43% to close Monday's trading at $1.70.

News: No news

Near-term catalysts:

- A phase I multiple ascending dose study of RG-012 in healthy volunteers is underway, with additional pharmacokinetic and safety data expected to be available in the second quarter 2017.

RG-012 is being developed for the treatment of patients with Alport syndrome.

Last September, the Company had initiated a phase II study of RG-012 n patients with Alport syndrome, dubbed HERA. However, with various European regulatory agencies requesting additional information on how the drug works and interacts with the body after repeated injections, Regulus implemented a temporary pause on enrollment in the HERA study in November of 2016.

- The phase II HERA study is expected to resume in the second half of 2017 following completion of the phase I multiple ascending dose study.

The clinical hold imposed by the FDA last July on RG-101, an investigational drug chronic hepatitis C virus infection, continues to be so.

The FDA has requested the final safety and efficacy data from all on-going RG-101 pre-clinical and clinical studies before reconsidering the clinical hold. These data are anticipated to be available in Q4 2017.

5. Catalyst Pharmaceuticals Inc. (CPRX)

Gained 18.24% to close Monday's trading at $2.01.

News: No news

Near-term catalysts:

- The Company's lead product candidate is Firdapse for the symptomatic treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Last February, the Company was issued a "Refusal to File" letter by the FDA in response to its New Drug Application for Firdapse - with the regulatory agency seeking additional supporting information.

A second phase III trial evaluating Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) is underway. NDA submission for Firdapse is expected in second-half 2017.

6. Verastem Inc. (VSTM)

Gained 16.27% to close Monday's trading at $1.93.

News: No news

Recent event: The Company reported Q4 and full-year 2016 financial results on Mar.23rd.

Net loss narrowed to $36.4 million or $0.99 per share in 2016 from $57.9 million or $1.61 per share in 2015. Verastem ended 2016 with cash of $80.9 million, which is believed to be sufficient to support its research and development programs and operations into 2018.

Near-term catalyst:

- Top-line data from its phase III study of Duvelisib in patients with relapsed or refractory Chronic Lymphocytic Leukemia, dubbed DUO, are expected in mid-year 2017.

7. Aevi Genomic Medicine Inc. (GNMX)

Gained 15.62% to close Monday's trading at $1.85, after having been down 5 trading days in a row.

News: No news

Recent event: On Mar. 20th, the Company announced that its Phase 2/3 clinical trial of AEVI-001 (oral non-stimulant) in adolescents with mGluR mutation positive (mGluR+) ADHD, dubbed SAGA, did not meet its endpoint.

Near-term catalyst:

- A phase 1/2 signal finding study of AEVI-002 in severe pediatric onset Crohn's disease is underway, and data are expected in the second half of 2017.

8. ZIOPHARM Oncology Inc. (ZIOP)

Gained 13.78% to close Monday's trading at $6.69.

News: The Company announced successful end-of-phase II meeting with the FDA for Ad-RTS-hIL-12 gene therapy in recurrent glioblastoma.

Based on positive feedback from the FDA, ZIOPHARM is working towards finalization of the optimal pathway for its pivotal study of Ad-RTS-hIL-12-based therapy in patients with recurrent glioblastoma this year.

9. OvaScience Inc. (OVAS)

Gained 11.70% to close Monday's trading at $1.91.

News: No news

Near-term catalysts:

The company is developing three fertility treatments - OvaTure, OvaPrime and AUGMENT.

- OvaTure is under pre-clinical development. The Company expects to fertilize a bovine EggPC cell-derived egg by year-end using this treatment. - Complete enrollment of all 70 patients in the ongoing Canadian study of OvaPrime by the end of the first half of this year and complete biopsies in all patients in the ongoing Canadian study by year-end. - Provide initial read-out, including six months of post-EggPC reintroduction safety data from 20 patients in the OvaPrime study by year-end. - Meet with the FDA to discuss potential market entry of AUGMENT in the first half of this year.

10. Imprimis Pharmaceuticals, Inc. (IMMY)

Gained 11.35% to close Monday's trading at $3.14.

News: No news

Recent event: On Mar.22nd, the Company announced that it had entered into agreements with two accredited investors for a registered direct placement of 1,312,000 shares of common stock at a price of $2.40 per share for aggregate gross proceeds of $3.14 million.

The Company had record growth in the fourth quarter and for the fiscal year 2016 - reporting total revenue of $5.8 million in the fourth quarter of 2016, up 65%, and total revenue of $19.9 million in 2016, up 105% compared to the year-ago periods.

LOSERS

1. Foamix Pharmaceuticals Ltd. (FOMX)

Lost 41.76% to close Monday's trading at $5.30.

News: Only one of the two phase III clinical trials investigating FMX101 in patients with moderate-to-severe acne, dubbed Trial 05, showed significance in both primary endpoints.

The two co-primary endpoints were the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients achieving success at week 12, as defined by an IGA score of "clear" or "almost clear" and at least a two-grade improvement from baseline at week 12.

But the second phase III trial, known as Trial 04, did not meet significance for the IGA score endpoint.

2. Sunshine Heart Inc. (SSH)

Lost 11.22% to close Monday's trading at $1.74.

News: No news

Recent event: The Company reported Q4 and full-year 2016 financial results on Mar.2, 2017.

Net loss in Q4 2016 narrowed to $2.90 million or $4.64 per share on net sales of $746 thousand. This compared with a net loss of $6.60 million or $10.81 per share on nil sales in the year ago quarter.

The Company reduced total costs and expenses by 40% and operating cash utilization by 43% in Q4, 2016 from same quarter last year.