INFI Turns Heads, ARDX Marches On, VYGR Cruises Ahead, ACRX Disappoints

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 12, 2017.

GAINERS

1. Infinity Pharmaceuticals Inc. (INFI)

Gained 123.35% to close Thursday's (Oct.12) trading at $3.73.

News: The Company will be reporting clinical and translational data from monotherapy dose-escalation component of its ongoing phase 1/1b study of IPI-549 in patients with advanced solid tumors during an oral session at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 10, 2017.

2. Ardelyx Inc. (ARDX)

Gained 44.44% to close Thursday's trading at $7.80.

News: The Company announced positive results from its second phase III study of Tenapanor for irritable bowel syndrome with constipation (IBS-C), dubbed T3MPO-2.

The first of two phase III trials evaluating Tenapanor for the treatment of patients with irritable bowel syndrome with constipation, dubbed T3MPO-1, were reported in May of this year. T3MPO-1 had also met the trial goals.

Based on positive results from two positive Phase 3 trials, Ardelyx is on track to submit a New Drug Application to the FDA for Tenapanor for the treatment of IBS-C in the second half of 2018.

3. Roka Bioscience Inc. (ROKA)

Gained 21.67% to close Thursday's trading at $2.19.

News: No news

Recent event:

On August 17, 2017, the Company agreed to sell its assets to Rokabio Inc., a newly formed, wholly-owned subsidiary of Institute for Environmental Health Inc. for $17.5 million in cash.

4. Codexis Inc. (CDXS)

Gained 17.16% to close Thursday's trading at $7.85.

News: The Company has entered into a strategic collaboration with Nestlé Health Science.

The collaboration includes an option for the global development of Codexis' novel, orally delivered, enzyme, CDX-6114, for the management of phenylketonuria. In addition, Nestlé Health Science has secured strategic access to Codexis' CodeEvolver protein engineering platform for the discovery of biotherapeutics for other metabolic disorders, and for the development of novel enzyme products for Nestlé Health Science's Medical Nutrition and Consumer Care business area.

Codexis will receive an upfront payment of $14 million and is entitled to receive milestones and royalties depending on product success.

5. Zafgen Inc. (ZFGN)

Gained 12.89% to close Thursday's trading at $4.03.

News: No news

Recent event:

On October 10, 2017, the Company announced the appointment of Jeffrey Hatfield as its Chief Executive Officer effective immediately. Thomas Hughes, Zafgen's CEO since 2008, has assumed the newly-created role of Chief Scientific Officer. Both Mr. Hatfield and Dr. Hughes serve on Zafgen's Board of Directors.

Near-term catalyst:

-- Interim data from a phase II trial of ZGN-1061 in patients with type 2 diabetes are expected to be reported in the first half of next year.

6. Foamix Pharmaceuticals Ltd. (FOMX)

Gained 9.95% to close Thursday's trading at $6.79.

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.

7. Adverum Biotechnologies Inc. (ADVM)

Gained 9.72% to close Thursday's trading at $3.95.

News: No news

Near-term catalysts:

-- Begin enrollment in a Phase 1/2 trial of ADVM-043 for treating alpha-1 antitrypsin (A1AT) deficiency in the fourth quarter of 2017. -- File IND applications for ADVM-053 for treating hereditary angioedema and ADVM-022 for wet AMD in 2018.

8. Voyager Therapeutics Inc. (VYGR)

Gained 7.83% to close Thursday's trading at $25.88.

News: No news

Recent event:

-- On September 6, 2017, the Company announced positive results from its ongoing Phase 1b trial of VY-AADC01 in advanced Parkinson's disease.

Near-term catalysts:

-- Initiation of pivotal phase 2-3 program of VY-AADC for advanced Parkinson's disease expected during late 2017. -- Sanofi-Genzyme opt-in decision for VY-AADC for advanced Parkinson's disease to be announced this quarter. -- The lead candidate for Friedreich's ataxia program is expected to be selected this quarter. -- Filing of an investigational new drug application for VY-SOD101 for the treatment of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 gene during late 2017 or early 2018.

9. Inotek Pharmaceuticals Corporation (ITEK)

Gained 6.50% to close Thursday's trading at $2.95.

News: The Company has 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.

LOSERS

1. AcelRx Pharmaceuticals Inc. (ACRX)

Lost 59.81% to close Thursday's trading at $2.15.

News: The FDA has issued a Complete Response Letter for its investigational product Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting.

The FDA has sought additional data on at least 50 patients to assess the safety of DSUVIA dosed at the maximum amount described in the proposed labelling and has requested the Company to ensure proper administration of the tablet with the single-dose applicator.

The regulatory agency has also recommended certain changes to the Directions for Use to address use-related errors, including dropped tablets, to be validated through a human factors study.

2. Tandem Diabetes Care Inc. (TNDM)

Lost 17.89% to close Thursday's trading at $4.68.

News: The Company is proposing to offer and sell shares of its common stock, Series A warrants and Series B warrants to purchase shares of its common stock in an underwritten public offering.

Recent event:

-- A 1-for-10 reverse stock split was effected on October 10, 2017.

3. Protagonist Therapeutics Inc. (PTGX)

Lost 15.45% to close Thursday's trading at $16.75.

News: The Company has priced an underwritten public offering of 3.53 million shares of its common stock at a price to the public of $17.00 each.

The gross proceeds to Protagonist from the offering are expected to be $60.01 million.

Near-term catalysts:

-- Interim analysis of phase 2b trial of PTG-100 in ulcerative colitis patients is expected in early 2018 - with top-line results anticipated for the second half of 2018. -- Results from a phase 1 clinical study of PTG-300 in normal healthy volunteers are anticipated in the second half of 2017. PTG-300 is being developed as a potential treatment for patients with chronic iron overload in rare diseases such as beta-thalassemia. -- PTG-200, which is being co-developed by Janssen Biotech, for inflammatory bowel disease is expected to enter Phase 1 clinical testing before the end of 2017.

4. China Biologic Products Holdings Inc. (CBPO)

Lost 14.99% to close Thursday's trading at $82.59.

News: The Company has agreed to acquire 80% equity interest in Tianxinfu (Beijing) Medical Appliance Co., Ltd. from PW Medtech Group Limited, a company listed on The Stock Exchange of Hong Kong Limited.

In exchange for its acquisition of 80% equity interest in TianXinFu from PWM, CBPO will issue 5,521,000 ordinary shares to PWM. Upon the closing of the proposed transaction, PWM is expected to hold approximately 16.66% of the outstanding share capital of CBPO taking into effect the new issuance.

The proposed transaction is expected to close this year.

5. BeiGene Ltd. (BGNE)

Lost 11.09% to close Thursday's trading at $96.07.

News: No news

Pipeline:

The Company's most advanced drug candidate is BGB-3111. A head-to-head phase III trial designed to determine whether the quality of response with BGB-3111 in patients with Waldenström's macroglobulinemia is superior to that of AbbVie's Imbruvica is underway. The other oncology clinical drug candidates are BGB-A317, BGB-283 and BGB-290.

6. KalVista Pharmaceuticals Inc. (KALV)

Lost 9.40% to close Thursday's trading at $9.06.

News: No news

Recent event:

-- On October 6, 2017, KalVista and Merck initiated a collaboration for KVD001, KalVista's intravitreal DME program, as well as future orally delivered plasma kallikrein inhibitors for DME developed by KalVista.

Near-term catalyst:

-- Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

7. Aeglea Biotherapeutics Inc. (AGLE)

Lost 9.20% to close Thursday's trading at $5.43.

News: No news

Pipeline:

-- A phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency, and two phase I trials of AEB1102 in cancer patients with advanced solid tumors and with hematological malignancies are underway.

Near-term catalysts:

-- Top-line results from phase I study of AEB1102 in cancer patients with advanced solid tumors are expected in 4Q2017/1Q2018. -- Top-line results from phase I study of AEB1102 in patients with hematological malignancies are expected in 4Q2017/1Q2018. -- Top-line results from phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency are anticipated in the second half of 2018.