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GKOS Gains On Rival's Loss, TRPX Turns Heads, ZYNE Back On Track, SPHS On Watch


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(RTTNews.com) - The following are some of today's top gainers in the pharma/biotech sector.

1. Glaukos Corp (GKOS)

Gained 40.41% to close Wednesday's (Aug.29) trading at $62.86.

News: The Company's major competitor, Novartis AG's (NVS) Alcon eye-care division, is withdrawing its CyPass Micro-Stent from the global market based on an analysis of five-year post-surgery data from a long-term safety study.

Novartis' CyPass Micro-Stent received FDA approval in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma. Glaukos also has a device by the name iStent inject Trabecular Micro-Bypass System, which was approved by the FDA in June of this year, for the same indication.

2. Opiant Pharmaceuticals Inc. (OPNT)

Gained 36.82% to close Wednesday's trading at $21.43.

News: The Company's commercial partner Adapt Pharma is all set to be acquired by Emergent BioSolutions Inc. (EBS) for a total consideration of up to $735 million.

Adapt Pharma Ltd developed Narcan Nasal Spray, an FDA-approved nasal form of naloxone for the emergency treatment of a known or suspected opioid overdose, in partnership with Opiant Pharmaceuticals.

In the second quarter ended June 30, 2018, Opiant recognized $3.1 million of royalty revenue from the license agreement between Opiant and Adapt for the sale of NARCAN Nasal Spray, which is a sequential growth of over 70% in royalty revenue.

3. Sophiris Bio Inc. (SPHS)

Gained 24.61% to close Wednesday's trading at $3.19.

News: The investigation into the previously reported death of a patient in the Company's Phase 2b trial of Topsalysin for the treatment of localized prostate cancer has concluded, revealing that the patient death is unlikely to be related to either Topsalysin or the procedure.

Near-term Catalyst:

The complete efficacy and safety data from the Phase 2b study of Topsalysin for the treatment of localized prostate cancer are expected to be reported by the end of the year.

4. Aileron Therapeutics Inc. ( ALRN )

Gained 24.03% to close Wednesday's trading at $2.89.

News: No news

Pipeline:

The Company's lead product candidate is ALRN-6924.

Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

Near-term Catalysts:


-- Additional interim data from the Phase 2a trial of ALRN-6924 for the treatment of patients with peripheral T-cell lymphoma are expected to be reported in the fourth quarter of 2018.
-- Interim data from Phase 1 and 1b open-label, multi-center clinical trials of ALRN-6924 as a monotherapy and in combination with cytosine arabinoside (Ara-C) for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are expected in the fourth quarter of this year.
-- John Longenecker was named interim Chief Executive Officer on May 15, 2018. Aileron is actively engaged in a process to appoint a new CEO.

5. Tilray Inc. (TLRY)

Gained 20.64% to close Wednesday's trading at $62.13.

News: The Company announced financial results for second quarter and six months ended June 30, 2018.

Net loss for the recent second quarter was $12.8 million compared to $2.4 million for the second quarter of 2017. Revenue increased to $9.7 (C$12.7) million, up 95.2% compared to the second quarter of last year. The increase in revenue was driven by increased patient demand in Canada, sales to other Licensed Producers and international sales.

Recent event:

The Company made its debut on the Nasdaq Global Select Market on July 19, 2018 whereby 10.350 million shares of Class 2 Common Stock were sold at an initial price to the public of $17.00 per share.

6. Evofem Biosciences Inc. (EVFM)

Gained 20.27% to close Wednesday's trading at $3.15.

News: The data recently released by the Centers for Disease Control and Prevention on the increasing rates of sexually transmitted diseases in the United States support the continued need for and clinical development of the Company's Amphora vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhea in women.

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.

Data from the phase III clinical trial of Amphora for the prevention of pregnancy are now expected in late 2018, ahead of its earlier guidance of Q1, 2019. If all goes well as planned, resubmit Amphora NDA for contraception in the first half of 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.

7. Therapix Biosciences Ltd. (TRPX)

Gained 19.73% to close Wednesday's trading at $4.43.

News: No news

Clinical Trials & Near-term Catalysts:

The first patient in a phase IIb, placebo-controlled 12-week clinical trial for THX-110 in Tourette syndrome, which will be conducted in Germany, is expected to be enrolled by the end of the third quarter. Top line results are expected in the first half of 2020.

A phase IIa sponsor-initiated trial with THX-110 in Obstructive Sleep Apnea is underway, with top line results expected in the first half of 2019.

The other ongoing studies are a phase IIa investigator-initiated trial with THX-110 for the treatment of chronic pain, and a pre-clinical study evaluating THX-130 in a rodent model for cognitive impairment related to traumatic brain injury. Results from the pre-clinical study are expected by the second half of this year.

8. Galectin Therapeutics Inc. (GALT)

Gained 17.72% to close Wednesday's trading at $5.38.

News: No news

Pipeline:

The lead drug candidate is GR-MD-02 in NASH cirrhosis.

Clinical Trials & Near-term Catalysts:

The Company is proceeding with plans for a phase III trial GR-MD-02 in NASH Cirrhosis. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA.

Back Bay Life Science Advisors, a Boston-based, internationally focused integrated strategy and transaction advisory organization, has been engaged to support the Company's exploration of strategic alternatives.

9. Evolus Inc. (EOLS)

Gained 17.65% to close Wednesday's trading at $23.80.

News: The Company's resubmitted Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450) has been accepted for review by the FDA, with a decision date set for February 2, 2019.

PrabotulinumtoxinA is being developed for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan's (AGN) Botox.

In May of this year, the FDA rejected the Company's Biologics License Application for prabotulinumtoxinA citing the deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes. The deficiencies were not related to clinical or non-clinical matters.

10. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 17.65% to close Wednesday's trading at $8.00.

News: No news

Clinical Trials & Near-term Catalysts:

-- A pivotal trial of ZYN002 in Fragile X Syndrome, dubbed CONNECT-FX, is underway, with topline results expected in the second half of 2019. -- A phase II clinical trial evaluating the efficacy and safety of ZYN002 in approximately 50 children and adolescents with Developmental and Epileptic Encephalopathies, dubbed BELIEVE 1, is ongoing, with topline results expected in 2019. -- A phase IIb study of ZYN002 in Focal Epilepsy is expected to be initiated in the second half of 2018.


Read the original article on RTTNews (http://www.rttnews.com/2930523/gkos-gains-on-rival-s-loss-trpx-turns-heads-zyne-back-on-track-sphs-on-watch.aspx)


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This article appears in: Stocks , World Markets , Banking and Loans
Referenced Symbols: ALRN ,



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