Gainers & Losers Of May 24: PBYI, INO, NVCR, AKAO, NBIX...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 24, 2017.

GAINERS

1. Puma Biotechnology, Inc. (PBYI)

Gained 29.67% to close Wednesday's (May 24) trading at $74.95.

News: The FDA panel has supported approval of the Company's breast cancer drug Neratinib

The FDA panel voted 12 - 4 to recommend approval of Neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

The U.S. regulatory agency's decision is expected to be announced in the third quarter of 2017.

2. Inovio Pharmaceuticals Inc. (INO)

Gained 21.74% to close Wednesday's trading at $8.68.

News: The Company's HIV vaccine candidate, PENNVAX-GP, produced nearly 100% immune response rates in a clinical study.

In the study, which evaluated a four-dose regimen of PENNVAX-GP DNA vaccine, administered in combination with a DNA encoded immune activator, IL-12 (INO-9012), 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response.

None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study, according to the Company.

3. Spring Bank Pharmaceuticals Inc. (SBPH)

Gained 13.75% to close Wednesday's trading at $13.65.

News: The Company reported encouraging top-line results from the initial 25mg monotherapy dosing cohort of the Phase 2a segment of its ACHIEVE trial.

The first segment of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by Gilead Sciences Inc's Viread 300 mg for an additional 12 weeks.

The primary endpoints for the Phase 2a trial are safety and antiviral activity, as measured by the change in HBV DNA at week 12 from baseline, with multiple exploratory secondary endpoints.

According to the Company, overall, SB 9200 demonstrated a statistically significant reduction in HBV DNA at week 12 compared to placebo.

The Company has begun enrollment in the second cohort (50 mg) of its phase 2a trial, and top-line results are anticipated in the fourth quarter of 2017.

The Phase 2b segment of the ACHIEVE trial is designed to examine the concomitant use of SB 9200 and Viread in approximately 200 HBV patients.

4. Proteostasis Therapeutics Inc. (PTI)

Gained 13.55% to close Wednesday's trading at $4.44.

News: No news

Near-term catalyst:

-- Preliminary phase I data from at least 8 cystic fibrosis subjects from a cohort of stable Orkambi patients dosed with PTI-428 for 7 days followed by a 7-day follow-up period are expected to be reported in this quarter (Q2, 2017). -- Data from the 28-day dosing cohort in phase I clinical trial of PTI-428 are expected in the second half of 2017.

5. NovoCure Limited (NVCR)

Gained 12.50% to close Wednesday's trading at $13.05.

News: Analysts at Wells Fargo & Co have upgraded NovoCure to an "outperform" rating from a "market perform" rating.

Near-term catalysts:

-- Initiate Phase 3 pivotal trial of its proprietary therapy called TTFields in locally advanced pancreatic cancer in the second half of 2017 (TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.) -- Initiate a Phase 3 pivotal trial of TTFields in recurrent ovarian cancer in 2018. -- Data readout from a Phase 2 pilot trial of TTFields (STELLAR trial) in mesothelioma in 2018. -- Data readout from a Phase 3 pivotal trial of TTFields (METIS trial) in brain metastases in 2020 -- Data readout from a Phase 3 pivotal trial of TTFields (LUNAR trial) in non-small cell lung cancer expected in 2021.

6. Pain Therapeutics Inc. (PTIE)

Gained 8.29% to close Wednesday's trading at $4.31.

News: No news

Recent event:

-- A 7-for-1 reverse stock split of the Company's outstanding shares became effective on May 10, 2017. This Reverse Split is intended to increase the per share trading price of the Company's common stock to satisfy the minimum bid price requirement for continued listing on The NASDAQ Global Market.

LOSERS

1. Aeglea Biotherapeutics Inc. (AGLE)

Lost 14.72% to close Wednesday's trading at $4.75, continuing its slide for the second straight day.

News: On May 23rd, the Company announced that dosing in pediatric patients in the ongoing Phase 1/2 trial of AEB1102 in Arginase 1 Deficiency is likely to be delayed.

In March 2017, the Company was informed by the FDA that additional data might be needed to support the inclusion of pediatric patients in the ongoing Phase 1/2 trial of AEB1102 in Arginase 1 Deficiency.

The Company recently received written feedback from the FDA based on supporting data provided in March and a follow-up meeting with the Agency in late April.

Aeglea noted that it is unable to resolve a difference in opinion at this time on the data needed to support inclusion of pediatric patients.

2. Achaogen Inc. (AKAO)

Lost 9.32% to close Wednesday's trading at $23.65.

News: The Company has commenced an underwritten public offering of up to 5 million shares of its common stock.

3. Neurocrine Biosciences Inc. (NBIX)

Lost 8.67% to close Wednesday's trading at $48.89.

News: The Company's phase II study of Ingrezza for treatment of Tourette syndrome in pediatric population failed to meet the endpoint.

The study, dubbed T-Force GREEN, did not meet its primary endpoint of change-from-baseline between the placebo and active groups in the Yale Global Tic Severity Scale (YGTSS) at Week 6 in the intent-to-treat (ITT) in pediatric population with Tourette syndrome.

Tourette syndrome (TS) is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics. (Source: NINDS).

Ingrezza received FDA approval in the treatment of adults with tardive dyskinesia as recently as April of this year. Ingrezza is the first drug approved by the FDA for tardive dyskinesia.

4. Protagonist Therapeutics Inc. (PTGX)

Lost 7.77% to close Wednesday's trading at $9.10.

News: The Company has been awarded $1.34 million SBIR funding for development of biomarkers of IL-23 receptor antagonist activity.

Near-term catalysts:

An interim analysis of an ongoing phase 2b trial of oral alpha-4-beta-7 integrin antagonist PTG-100 in ulcerative colitis patients is expected to be performed in the second half of 2017.

Phase 1 initiation with PTG-300 for iron overload disorders is now expected to begin this quarter (Q2, 2017).

5. Coherus Biosciences Inc. (CHRS)

Lost 6.64% to close Wednesday's trading at $20.40.

News: No news

Recent event:

On May 17, the Company scored a victory in inter partes review - with the Patent Trial and Appeal Board invalidating a key patent covering AbbVie's (ABBV) autoimmune disease drug Humira.

Coherus filed an inter partes review petition against AbbVie's patents related to a 40 mg biweekly dosing regimen for treating rheumatoid arthritis with Humira in November 2015.

Coherus' investigational drug CHS-1420, which is a biosimilar candidate to Humira, successfully completed phase III testing in January of this year.

Near-term catalysts:

-- Anticipate a 351(k) Biologics License Application submission of CHS-1420 in the U.S. at or near the end of second quarter of 2017. -- FDA decision on CHS-1701, a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta, is expected on June 9, 2017.