Gainers & Losers Of The Day: CYCC, NVCR, STDY, ACOR, OREX...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 3, 2017.

GAINERS

1. Cyclacel Pharmaceuticals Inc. (CYCC)

Gained 74.46% to close Monday's trading at $6.42.

News: The Company presented preclinical data demonstrating the therapeutic potential of its drug candidate CYC065 as a targeted anti-cancer agent.

The data shows that CYC065 substantially inhibited growth, triggered apoptosis, and induced anaphase catastrophe in murine and human lung cancer cells with known high metastatic potential.

CYC065 is in a phase I, first-in-human trial to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The trial is at an expanded sixth dose escalation level with the objective of determining maximum tolerated dose and recommended dosing for phase II.

2. NovoCure Limited (NVCR)

Gained 37.04% to close Monday's trading at $11.10.

News: The Company announced final results from its phase III pivotal trial adding Optune device to standard Temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma.

In the U.S., Optune, also known as the NovoTTF-100A System, was initially approved in 2011 to treat patients with glioblastoma multiforme that had recurred or progressed after treatment. In October 2015, the Optune device was approved for the expanded indication to treat patients with newly-diagnosed glioblastoma multiforme.

Analysis of data from the pivotal trial dubbed EF-14 shows a consistent and maintained improvement in overall survival at two, three, four and five years, says the Company.

The two-year survival rate increased from 30 percent to 43 percent for patients treated with Optune together with Temozolomide versus patients treated with Temozolomide alone. The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with Temozolomide versus patients treated with Temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase III trial to date and represent clinically meaningful increases in landmark survival rate, according to the Company.

Sales of Optune in full-year 2016 were $82.9 million compared with $33.1 million in 2015.

3. SteadyMed Ltd. (STDY)

Gained 29.31% to close Monday's trading at $7.50, continuing its rally for the second trading day.

News: No news

Recent event: On March 31, 2017, the Company received a favorable ruling in the Inter Partes Review (IPR) proceeding against United Therapeutics covering patent No. 8,497,393.

The patent in question, No. 8,497,393, is related to a process to further purify prostacyclin derivatives, such as Treprostinil. Treprostinil is the active pharmaceutical ingredient used in United Therapeutics' Remodulin and SteadyMed's lead drug candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension (PAH). In its ruling, the PTAB found all 22 claims in the '393 patent unpatentable and cancelled them, rendering the patent invalid.

SteadyMed remains on-track to submit a NDA for Trevyent by the end of the second quarter of 2017.

4. BiondVax Pharmaceuticals Ltd. (BVXV)

Gained 17.24% to close Monday's trading at $6.80.

News: No news

Recent event: On Mar.30th, the Company announced that the Israel Investment Center has approved a grant representing 20% of a NIS 20 million budget to be utilized towards the construction of a factory for the production of phase III and commercial batches of BiondVax's universal flu vaccine candidate M-001.

The company reported positive preliminary safety results from its European Phase 2b clinical trial of M-001 last November.

5. Innocoll Holdings plc (INNL)

Gained 14.29% to close Monday's trading at $1.28.

News: No news

Recent event: On Mar.29th, the Company announced that it has clarified from the FDA the data needed to address the questions raised in the Refusal to File Letter issued last December pertaining to the XARACOLL NDA initially submitted on October 31, 2016.

XARACOLL is the Company's product in development for the treatment of postsurgical pain.

Last month, Innocoll confirmed that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

6. BrainStorm Cell Therapeutics Inc. (BCLI)

Gained 13.10% to close Monday's trading at $3.54.

News: No news

Near-term catalysts:

-- A planned phase III clinical trial of NurOwn in patients with Amyotrophic Lateral Sclerosis (Lou Gehrig's disease) to be conducted at multiple sites in the U.S. and in Israel, is expected to begin enrolling patients in the second quarter of 2017. -- The Company's Memorandum of Understanding (MOU) with the Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to explore the possibility of making NurOwn available to ALS patients under the provisions of Hospital Exemption regulation that was signed last month, is expected to be formalized in the first half of 2017.

7. Cellect Biotechnology Ltd. (APOP)

Gained 10.58% to close Monday's trading at $9.51.

News: Cellect receives notice of intention to grant from European Patent Office for patent protecting its technology in multiple indications.

The patent covers a segment of cell-based therapeutics that is separate from ApoGraft, a breakthrough technology for the isolation of stem cells from any given tissue.

Earlier this year, Cellect received a Notice of Allowance from the U.S. Patent & Trademark Office for the same patent.

Read more:

Company Spotlight: Cellect Biotechnology

8. Benitec Biopharma Limited (BNTC)

Gained 10.54% to close Monday's trading at $3.05.

News: The Company announced that key pre-clinical data on oculopharyngeal muscular dystrophy (OPMD) have been published in Nature Communications, an open access scientific journal.

BB-301, the Company's drug candidate for OPMD, is currently in preclinical development and IND-enabling studies are expected to be initiated later this year.

9. Pluristem Therapeutics Inc. (PSTI)

Gained 9.76% to close Monday's trading at $1.35.

News: No news

Recent news: On March 30th, the Company announced it is in advanced discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of PLX-PAD cell therapy product in Japan.

Pluristem and Sosei CVC currently anticipate definitive agreements to be finalized in the coming months.

Near term catalysts:

-- Enrollment in a phase III study of Pluristem's PLX-PAD cells in the treatment of critical limb ischemia in both the U.S. and Europe are expected to begin during the first half of 2017. -- Data from a multinational phase II trial of PLX-PAD in the treatment of intermittent claudication (IC), an early stage of peripheral artery disease, are expected in the first half of 2018.

LOSERS

1. Orexigen Therapeutics Inc. (OREX)

Lost 17.73% to close Monday's trading at $2.83.

News: No news

Recent event: The Company reported Q4 and full-year 2016 financial results on March 28, 2017.

Orexigen reported a net loss of $24.6 million or $1.69 per share on revenue of $13.9 million for the three months ended December 31, 2016. This compared with a net loss of $17.8 million or $1.22 per share and revenue of $4.9 million in the fourth quarter of 2015.

As of December 31, 2016, Orexigen had $182.5 million in cash, restricted cash and investments and an additional $11.5 million in marketable securities, for a total of $194.0 million.

2. TearLab Corporation (TEAR)

Lost 13.73% to close Monday's trading at $2.45.

News: No news

Recent event: On Mar.9th, the Company reported Q4 and full-year 2016 financial results.

The net loss for the fourth quarter of 2016 was $4.3 million or $0.81 per share on revenue of $7.1 million. This compared with a net loss of $8.9 million or $2.64 per share and revenue of $6.8 million in the year-ago quarter.

3. Acorda Therapeutics Inc. (ACOR)

Lost 12.38% to close Monday's trading at $18.40, plunging for the second trading day.

News: No news

Recent event: On Mar.31st, a U.S. District Court invalidated four patents covering Ampyra, the Company's drug indicated to help improve walking in adults with multiple sclerosis.

The invalidated patent Numbers pertaining to Ampyra are 8,663,685 (the '685 patent), 8,007,826 (the '826 patent), 8,440,703 (the '703 patent), and 8,354,437 (the '437 patent)

The Company said it will appeal the ruling on the 4 patents.

Read more:

Who Will Win Ampyra Patent Fight - Acorda Or Kyle Bass?