Busy Year Awaits INSY, Agile Not So Energetic, FATE Gathers Steam, SRRA On Watch

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

1. Agile Therapeutics Inc. (AGRX)

Gained 17.06% to close Tuesday's (Dec.26) trading at $2.95. Looks like the stock is gaining some of what it lost on December 22, 2017.

On December 22, 2017, the FDA refused to approve the Company's investigational contraceptive patch Twirla, which sent the stock down 47%.

Twirla was rejected by the FDA in 2013 too, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.

Al Altomari, chairman and CEO of Agile Therapeutics, said, "We are clearly disappointed, and we are evaluating the FDA's response. We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible."

2. INSYS Therapeutics Inc. (INSY)

Gained 15.17% to close Tuesday's trading at $8.20.

News: The Company's cannabidiol (CBD) oral solution has secured FDA's Fast Track designation for the treatment of Prader-Willi syndrome.

Prader-Willi syndrome is a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes.

Cannabidiol (CBD) oral solution for Prader-Willi syndrome is under pre-clinical testing, and the Company plans to start the clinical development program in this indication in late first quarter of 2018.

Clinical Trials & Near-term Catalysts:

-- The Company's New Drug Application for Buprenorphine Sublingual Spray for the management of moderate-to-severe acute pain is under FDA review - with a decision expected on July 28, 2018. -- A phase I proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, commenced early this month. Initial results from this study are expected to be available in February. Enrollment in the study is estimated to be complete in the first quarter of 2018. -- On December 19, 2017, the Company announced the initiation of a phase II trial of Cannabidiol (CBD) oral solution for the treatment of refractory childhood absence epilepsy in pediatric patients. This study is expected to be completed in late 2018.

3. Fate Therapeutics Inc. (FATE)

Gained 11.94% to close Tuesday's trading at $6.28.

News: No news

Recent event:

-- On December 15, 2017, the Company closed an underwritten public offering of 10.95 million shares of its common stock and full exercise of the underwriters' option to purchase additional shares at a public offering price of $4.20 per share. Net proceeds from this offering were approximately $42.9 million.

Clinical Trials:

-- The phase II efficacy stage of PROTECT study was initiated earlier this month.

PROTECT is a phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies undergoing matched unrelated donor mobilized peripheral blood HCT. The PROTECT study is intended to evaluate ProTmune to prevent acute graft-versus-host disease (GvHD).

All subjects receiving ProTmune in the PROTECT Phase 1 stage are being followed for a period of two years following HCT. As of a November 29, 2017 data cut-off, all subjects remained relapse-free, and there were no events of graft failure and no serious adverse events related to ProTmune reported by investigators.

-- A phase I study of FATE-NK100, the Company's first-in-class adaptive memory natural killer (NK) cell product candidate for advanced acute myelogenous leukemia, known as VOYAGE, is underway. -- On December 8, 2017, the Company announced the initiation of a phase I trial of FATE-NK100 for the treatment of recurrent ovarian cancer, dubbed APOLLO.

4. Sierra Oncology Inc. (SRRA)

Gained 10.53% to close Tuesday's trading at $3.57.

News: No news

Near-term catalyst:

-- An update on the Company's SRA737 program is expected in February 2018.

SRA737 is under two phase I trials - a phase I trial of SRA737 administered orally in subjects with advanced cancer (Solid Tumors or Non-Hodgkin's Lymphoma), and a phase I trial of oral SRA737 given in combination with Gemcitabine plus Cisplatin or Gemcitabine alone in subjects with advanced cancer (Advanced Solid Tumors).

5. United Therapeutics Corporation (UTHR)

Gained 9.31% to close Tuesday's trading at $150.03.

News: No news

Recent event:

-- On October 25, 2017, the Company reported Q3, 2017 financial results.

On a non GAAP basis, the Company's earnings in the recent third quarter were $206.9 million or $4.69 per share on revenue of $445.5 million. This compared with non GAAP earnings of $195.6 million or $4.23 per share and revenue of $408.2 million in the year-ago quarter.

6. Xenon Pharmaceuticals Inc. (XENE)

Gained 8.91% to close Tuesday's trading at $2.75.

News: No news

Clinical Trials & Near-term Catalysts:

-- File an IND equivalent for XEN901, a selective Nav1.6 inhibitor for the treatment of epilepsy, this month, and, if supported by the data, expects to initiate a phase II clinical trial in late 2018. -- A phase I first-in-human clinical trial of single ascending doses and multiple ascending doses of XEN1101 in healthy subjects is underway. XEN1101 is a next-generation Kv7 potassium channel opener for the potential treatment of epilepsy.

7. Esperion Therapeutics Inc. (ESPR)

Gained 8.46% to close Tuesday's trading at $64.38.

News: No news

Clinical trials & Near-term catalysts:

The Company's lead drug candidate is Bempedoic acid, a once-daily, oral LDL-C lowering drug that significantly reduces elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies.

Bempedoic acid is under a global pivotal phase III program consisting of 4 studies - Studies 1, 2, 3, 4.

-- Top-line results from Studies 1, 3 and 4 are expected in the second quarter of 2018, with top-line results from Study 2 expected in the third quarter of 2018. -- A pivotal phase III study of Bempedoic Acid / Ezetimibe combination pill in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia was initiated last month. Top-line results are expected by the fourth quarter of 2018.