VYGR Cruises Ahead, APVO On Track, ARDX Continues To Fall, AGRX On Watch

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

GAINERS

1. Voyager Therapeutics Inc. (VYGR)

Gained 11.50% to close Tuesday's (Oct.17) trading at $22.89.

News: The Company presented encouraging new data related to its novel AAV gene therapy capsids in a preclinical model of Friedreich's ataxia.

The Company's novel AAV gene therapy capsids demonstrate widespread gene transfer to the brain and spinal cord of non-human primates after a single intravenous administration. One month after dosing, substantial levels of frataxin-HA were expressed in the Central Nervous System.

Friedreich's ataxia is a severe, inherited neurological disease caused by mutations in the frataxin gene leading to decreased expression of frataxin (FXN), which results in severe sensory impairment, progressive loss of the ability to walk, generalized weakness, loss of sensation, as well as severe and potentially fatal cardiomyopathy.

2. Rigel Pharmaceuticals Inc. (RIGL)

Gained 9.30% to close Tuesday's trading at $4.23.

News: No news

Recent event:

On October 10, 2017, the Company announced the closing of its public offering of 20.81 million shares of its common stock at a price to the public of $3.35 each. The gross proceeds to Rigel from this offering were $69.73 million.

Near-term catalyst:

The Company's New Drug Application for Tavalisse in treating patients with chronic or persistent immune thrombocytopenia is under FDA review - with a decision date set for April 17, 2018.

3. XOMA Corp. (XOMA)

Gained 6.99% to close Tuesday's trading at $23.58.

News: No news

Pipeline:

The Company's lead candidates include XOMA 358, under phase II testing in patients with Hypoglycemia after gastric bypass surgery, and XOMA 213, which recently demonstrated positive results in a phase II proof-of-concept study in physiological hyperprolactinemia.

Recent event:

-- On October 4, 2017, XOMA entered into new non-exclusive license agreements with three different companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma for use of its proprietary phage display libraries for antibody discovery. XOMA's phage display libraries are tools to generate human recombinant antibodies with exquisite specificity and high affinity.

Under these agreements, XOMA is eligible to receive development and regulatory milestone payments plus single-digit royalties on net sales of products. Additionally, the agreement with LakePharma, a U.S.-based biologics services company, enables it to develop its own antibodies using XOMA's library, as well as offer the Company's library to its broad customer base. XOMA is eligible to receive milestone and royalty payments for products developed by LakePharma and as part of its client programs.

4. Foamix Pharmaceuticals Ltd. (FOMX)

Gained 6.36% to close Tuesday's trading at $6.69.

News: No news

Near-term catalysts:

-- Top-line results from third phase III Acne clinical trial for Minocycline Foam FMX101 expected by mid-2018. -- Top-line results from blinded phase of Phase 3 program of topical Minocycline Foam 1.5%, FMX103 for the treatment of moderate-to-severe acne anticipated by mid-2018.

5. Aptevo Therapeutics Inc. (APVO)

Gained 5.70% to close Tuesday's trading at $2.41.

News: The Company's pre-clinical drug candidate APVO210 demonstrated targeted Cytokine delivery for application in various autoimmune and inflammatory diseases. The Company looks forward to advancing APVO210 towards clinical development.

Pipeline:

The Company has two clinical drug candidates - MOR209/ES414 monotherapy in patients with metastatic castration-resistant prostate cancer, under phase I trial, and Otlertuzumab for chronic lymphocytic leukemia, under phase II study.

The Company also has 4 marketed drugs.

6. Agile Therapeutics Inc. (AGRX)

Gained 5.56% to close Tuesday's trading at $5.13.

News: The Company presented additional results from its phase III trial of investigational low-dose combination hormonal contraceptive patch, Twirla, dubbed SECURE, at the 2017 North American Forum on Family Planning.

Near-term catalyst:

-- Agile's New Drug Application for Twirla is under FDA review - with a decision date set for December 26, 2017. Twirla was turned down by the FDA in 2013.

LOSERS

1. Immune Design Corp. (IMDZ)

Lost 18.81% to close Tuesday's trading at $8.20.

News: The Company plans to initiate a pivotal Phase 3 trial to support a Biologics License Application for CMB305, a novel cancer vaccine, in patients with synovial sarcoma in mid-2018.

The study will enroll 248 patients aged twelve and older, and they will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The trial will have progression free survival (PFS) followed by overall survival (OS) as co-primary endpoints. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed.

2. Inotek Pharmaceuticals Corp. (ITEK)

Lost 14.29% to close Tuesday's trading at $2.22.

News: No news

Recent event:

On October 12, 2017, the Company filed a preliminary proxy statement for its previously announced proposed merger with Rocket Pharmaceuticals, a US-based gene therapy company.

The merger is expected to close in the first quarter of 2018.

3. Ardelyx Inc. (ARDX)

Lost 14.06% to close Tuesday's trading at $5.50. This is the second straight day of loss for the stock.

Recent event:

-- On October 11, 2017, the Company reported positive results from T3MPO-2, its second Phase 3 study of Tenapanor for irritable bowel syndrome with constipation (IBS-C). The Company expects to submit a New drug Application for Tenapanor for irritable bowel syndrome with constipation in the second half of 2018.

4. MannKind Corp. (MNKD)

Lost 12.36% to close Tuesday's trading at $4.75.

News: No news

Recent event:

-- On October 11, 2017, the Company announced a registered direct offering of an aggregate of 10.16 million shares of common stock at an offering price of $6.00 per share, for gross proceeds of approximately $61 million. The offering was expected to close on or about October 13, 2017. -- On October 2, 2017, the FDA approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect.

5. Deciphera Pharmaceuticals Inc. (DCPH)

Lost 10.71% to close Tuesday's trading at $21.43.

News: No news

Recent event:

-- On October 3, 2017, the Company closed its initial public offering of 7.5 million shares of its common stock at a public offering price of $17.00 each.

Pipeline:

The Company's lead candidate is DCC-2618, currently in a first-in-human Phase 1 clinical trial. DCC-2618 is in clinical development for the treatment of KIT and/or PDGFRa-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis.

6. Fulgent Genetics Inc. (FLGT)

Lost 9.31% to close Tuesday's trading at $3.80.

News: No news

Upcoming event:

The Company is slated to report financial results for its third quarter ended September 30, 2017 in the first week of November.