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Gainers & Losers Of Apr.17: CBLI, INFI, PBYI, OMED, INCY...

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 17, 2017.

GAINERS

1. Cleveland BioLabs Inc. (CBLI)

Gained 207.69% to close Monday's (Apr.17) trading at $4.75.

News: The Company has received consent from the FDA for initiation of an in vivo biocomparability study of two formulations of Entolimod - namely the one that is proposed for use under the pre-Emergency Use Authorization and the other drug formulation that was used in previously conducted preclinical and clinical studies.

Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.

The review of Cleveland Bio's pre-Emergency Use Authorization submission for Entolimod will be resumed by the FDA after completion of the in vivo study and discussion of the submitted study results.

2. Infinity Pharmaceuticals Inc. (INFI)

Gained 19.02% to close Monday's trading at $2.19.

News: No news

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

Near-term catalysts:

-- 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 phase evaluating IPI-549 in combination with Opdivo in the second half of 2017
-- Begin enrolling patients with NSCLC, melanoma and SCCHN in expansion cohorts evaluating IPI-549 in combination with Opdivo in the second half of 2017.

3. InVivo Therapeutics Holdings Corp. (NVIV)

Gained 16.90% to close Monday's trading at $4.15.

News: No news

The Company's lead product candidate is Neuro-Spinal Scaffold, an investigational device, currently being evaluated in a pivotal study for the treatment of patients with spinal cord injury, dubbed INSPIRE.

Recent event:

Last month, the Company announced that 7 out of 11 patients in the INSPIRE study have been converted from complete to incomplete spinal cord injury with sensory and motor improvements.

4. Verastem Inc. (VSTM)

Gained 13.51% to close Monday's trading at $2.10.

News: No news

The Company's lead drug candidate is Duvelisib.

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.

5. Bellerophon Therapeutics Inc. (BLPH)

Gained 12.71% to close Monday's trading at $1.33.

News: No news

The Company is developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system. The first is for the treatment of pulmonary arterial hypertension, which is under phase III testing, dubbed INOvation-1.

The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF), both of which are in phase II development.

Near-term catalysts:

-- Results of phase II trials for INOpulse therapy to treat significant unmet needs in pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) are expected to be reported during the middle of 2017.
-- An interim read from the INOvation-1 is expected around the end of 2017, and top line results are targeted in mid-2018.

6. Puma Biotechnology Inc.'s (PBYI)

Gained 11.08% to close Monday's trading at $39.60.

News: The Company's New Drug Application for Neratinib is scheduled to be reviewed by an FDA panel on May 24, 2017.

Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab (Herceptin) containing regimen.

The NDA for Neratinib was accepted for review by the FDA on September 20, 2016. No specific PDUFA (decision) date has been notified. However, the U.S. regulatory agency's decision is expected to be announced in the third quarter of 2017.

7. BrainStorm Cell Therapeutics Inc. (BCLI)

Gained 10.41% to close Monday's trading at $4.03.

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.

8. Repros Therapeutics Inc. (RPRX)

Gained 10.09% to close Monday's trading at $1.20.

News: The Company has been issued a new patent that bolsters its intellectual property relating to its investigational drug Proellex.

Proellex has completed phase II testing in the indications of uterine fibroids and endometriosis.

9. Pulse Biosciences Inc. (PLSE)

Gained 10.06% to close Monday's trading at $25.60.

News: The Company announced it will host its quarterly investor conference call on May 4, 2017.

Recent event:

The Company submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation on March 14th.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS, and it marks Pulse Bio's first FDA 510(k) submission.

Near term catalyst:

-- The Company expects to initiate the first NPS pilot study in immuno-oncology this year.

Pulse Bio featured in our Company Spotlight column on February 17, 2017 when it was trading around $12.30.

LOSERS

1. Apricus Biosciences Inc. (APRI)

Lost 20.62% to close Monday's trading at $1.54.

News: No news

Near-term catalysts:

-- The Company expects to resubmit the NDA for Vitaros, a topical vasodilator cream in development for the treatment of erectile dysfunction, in the third quarter of 2017.

Vitaros was turned down by the FDA in July 2008, with the regulatory agency questioning the results of a transgenic mouse carcinogenicity study, which were completed in 2002.

-- Apricus is also working towards regaining compliance with the minimum $2.5 million shareholder equity requirement as required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2) on or before May 30, 2017.

2. OncoMed Pharmaceuticals Inc. (OMED)

Lost 17.15% to close Monday's trading at $4.01.

News: The Company's phase II trial of Tarextumab in Small Cell Lung Cancer failed to meet the endpoints.

The phase II trial, dubbed PINNACLE, evaluated Tarextumab in combination with etoposide and either cisplatin or carboplatin chemotherapy in previously untreated patients with extensive-stage small cell lung cancer.

The Company noted that results for the combination of Tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival.

3. Akari Therapeutics Plc (AKTX)

Lost 16.92% to close Monday's trading at $13.31.

News: No news

Near-term catalyst:

-- Interim results from the phase II trial evaluating Coversin in patients with PNH who have never received a complement blocking therapy will be released on April 24, 2017.

4. Adeptus Health Inc. (ADPT)

Lost 13.73% to close Monday's trading at $2.01.

News: No news

Recent event:

On April 12, 2017, the Company announced Schedule 13D filing by hedge fund Wexford Capital LLC.

The filing reveals that the hedge fund picked up a stake of 8.54% in the Company on Apr.5, 2017.

By definition, Schedule 13D is a form that must be filed with the SEC when a person or group acquires more than 5% of any class of a company's shares. (Source: Investopedia).

5. DelMar Pharmaceuticals Inc. (DMPI)

Lost 11.51% to close Monday's trading at $2.69.

News: No news

Recent event:

On April 13, 2017, the Company priced its offering of an aggregate of 2.77 million shares of common stock and warrants to purchase an aggregate of 2.08 million shares of common stock at $3.25 per share and related warrant.

The warrants have an exercise price of $3.50 per share, are immediately exercisable and have a term of exercise of five years.

The offering is expected to close on or about April 18, 2017.

6. Incyte Corp. (INCY)

Lost 10.49% to close Monday's trading at $126.07.

News: The FDA has refused to approve Baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis, being co-developed in partnership with Eli Lilly and Co. (LLY).

In its Complete Response Letter handed down to the companies, the FDA indicated that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.

The companies disagree with the agency's conclusions. The timing of resubmission of the New Drug Application for Baricitinib will be based on further discussions with the FDA.

Baricitinib was approved in the European Union, under trade name Olumiant, as recently as February of this year for the treatment of moderate-to-severe active rheumatoid arthritis.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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