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ECYT On A Roll, MannKind Delighted, DRRX Gains On Patent Deal, PTCT Slumps

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

GAINERS

1. Endocyte Inc.(ECYT)

Gained 61.98% to close Tuesday's (Oct.3) trading at $5.88. This is the second straight day of gain for the stock.

News: No news

Recent event:

-- On October 2, 2017, the Company announced a deal with ABX GmbH, in-licensing its proprietary ligand PSMA-617. The transaction provides Endocyte with 177Lu-PSMA-617, a phase III-ready prostate cancer drug.

Endocyte plans to seek regulatory approval to initiate a phase III registration trial of 177Lu-PSMA-617 in early 2018. If all goes well as planned, the Company expects to complete the trial as early as 2020.

2. Endologix Inc. (ELGX)

Gained 20.62% to close Tuesday's trading at $5.85.

News: No news

Recent events:

-- On September 21, 2017, the Company announced the CE Mark approval for its Nellix EndoVascular Aneurysm Sealing System with the refined Indications for Use (IFU).
-- On August 17, 2017, the Company announced positive interim results from its head-to-head study comparing currently available endovascular abdominal aortic stent grafts trial, dubbed LEOPARD. The trial directly compared the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.

The primary endpoint of the study - freedom from Aneurysm Related Complications ("ARC"), such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions - with AFX/AFX2 was 84.7%, compared to 82.0% with the other devices, according to the trial results.

3. MannKind Corp. (MNKD)

Gained 20.51% to close Tuesday's trading at $2.82.

News: The FDA has approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect.

Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute.

Commenting on the updated label, Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) - University of Colorado, said, "These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels."

4. CareDx Inc (CDNA)

Gained 13.82% to close Tuesday's trading at $4.53.

News: No news

Near-term catalyst:

-- AlloSure, the Company's proprietary next-generation sequencing test for measuring the percentage of donor-derived cell-free DNA (dd-cfDNA) in solid organ transplant recipients, is expected to be launched this month.

The Company estimates that AlloSure could bring home revenue of $200 million per year.

The Medicare reimbursement rate for AlloSure has been pegged at $2,840.75, and will be reimbursed for kidney transplant patients covered by Medicare across the United States starting October 9, 2017.

5. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 12.54% to close Tuesday's trading at $9.78.

News: No News

Recent event:

-- On September 28, 2017, the Company reported positive top line results from its phase II trial of ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome.

Near-term catalyst:

-- The Company is planning to meet with the FDA in the first half of 2018 with the goal of moving ZYN002 cannabidiol (CBD) gel quickly into a pivotal phase II/III program in pediatric and adolescent patients with FXS in 2018.

6. DURECT Corp. (DRRX)

Gained 12.30% to close Tuesday's trading at $2.10.

News: The Company has signed a patent purchase agreement with Indivior UK Limited, an affiliate of Indivior PLC.

The agreement relates to intellectual property for RBP-7000, Indivior's investigational once-monthly injectable Risperidone product for Schizophrenia.

Indivior has submitted a New Drug Application for RBP-7000 to the FDA.

Under the terms of the agreement, Indivior has made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based on a regulatory milestone, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the patent rights, including RBP-7000. The patent rights include granted patents extending through at least 2026.

7. Intellia Therapeutics Inc. (NTLA)

Intellia is a genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system.

Gained 11.67% to close Tuesday's trading at $30.52.

News: No news

Upcoming events:

The Company is scheduled to make a presentation on:

-- Tuesday, October 10, 2017, Chardan Gene Therapy Conference
-- Thursday, October 12, 2017, Jefferies Gene Therapy and Editing Summit.

8. Marinus Pharmaceuticals Inc. (MRNS)

Gained 10.11% to close Wednesday's trading at $6.86.

Near-term catalysts:

-- Initiate a phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis, later this year.
-- Initiate a phase II study of Ganaxolone IV in patients with status epilepticus later this year.

LOSERS

1. Aralez Pharmaceuticals Inc. (ARLZ)

Lost 12.26% to close Tuesday's trading at $2.29.

News: No news

Recent event:

-- On August 9, 2017, the Company reported financial results for the second quarter and first half of 2017.

Net loss in the second quarter of 2017 widened to $27.5 million or $0.42 per share from $17.5 million or $0.27 per share in the year-ago quarter. Total revenues for the recent second quarter were $27.6 million compared to $12.6 million in the year-ago period.

At June 30, 2017, the Company had cash and cash equivalents of approximately $55.8 million.

2. PTC Therapeutics Inc. (PTCT)

Lost 10.87% to close Tuesday's trading at $18.62.

News: No news

Recent event:

-- On September 28, 2017, an FDA panel voted 10-1 that the data provided by the Company was inconclusive to recommend approval of its Duchenne muscular dystrophy drug Translarna. The FDA's final decision will be announced by October 24, 2017.

3. Sucampo Pharmaceuticals Inc. (SCMP)

Lost 10.87% to close Tuesday's trading at $18.62.

News: No news

Recent event:

-- On September 28, 2017, the Company announced that its supplemental New Drug Application for AMITIZA in children aged 6 to 17 years with pediatric functional constipation has been granted priority review - with a decision slated for January 28, 2018.

AMITIZA is already indicated for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.

Net sales of AMITIZA, reported by Takeda for royalty calculation purposes, were $416.5 million in full year 2016 compared to $380.4 million in 2015.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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