HIIQ In Good Health, BOLD Awaits ASPIRO Data, CELESTIAL Lights Up EXEL

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 16, 2017.

GAINERS

1. Exelixis Inc. (EXEL)

Gained 17.21% to close Monday's (Oct.16) trading at $29.02.

News: The Company's phase III trial of Cabozantinib in patients with advanced hepatocellular carcinoma, dubbed CELESTIAL, met the primary endpoint of overall survival.

The Company plans to submit a supplemental New Drug Application for Cabozantinib in the above indication in the first quarter of 2018.

The supplemental New Drug Application for Cabozantinib as first-line monotherapy for advanced renal cell carcinoma has been granted priority review by the FDA - with a decision date set for February 15, 2018.

Cabozantinib was approved by the FDA for the treatment of patients with advanced renal cell cancer who have received prior anti-angiogenic therapy in April 2016. The drug was approved by the European Commission for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy last September.

2. Mersana Therapeutics Inc. (MRSN)

Gained 12.34% to close Monday's trading at $18.12.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on June 28, 2017 at an offering price of 15.00 per share.

Near-term catalysts:

-- Interim results from phase I trial of lead oncology drug candidate XMT-1522 in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer are expected around the end of this year. -- File the second IND shortly and begin clinical studies in early 2018 for XMT-1536, a potential first-in-class Dolaflexin ADC targeting NaPi2b-expressing tumors.

3. uniQure N.V. (QURE)

Gained 11.86% to close Monday's trading at $11.98.

News: No news

Near-term catalysts:

-- An investigational new drug application for AMT-130 in Huntington's disease is expected to be filed in 2018. -- The Company is planning to meet with U.S. and European regulators in the early fall to further discuss its plans to begin a pivotal program of AMT-060 in hemophilia B in 2018.

4. Health Insurance Innovations Inc. (HIIQ)

Gained 11.64% to close Monday's trading at $21.10.

News: The Company issued certain preliminary results for the third quarter ended September 30, 2017, and also announced a new $50 million share repurchase authorization.

For the three months ended September 30, 2017, the Company expects to report GAAP net income in the range of $5.5 million to $6.0 million, and adjusted net income of $7.3 million to $7.6 million. On a per share basis, GAAP net income is expected in the range of $0.26 to $0.30 and adjusted net income is anticipated to be in the range of $0.44 to $0.46.

Revenue for the third quarter 2017 is expected to be in the range of $62.3 million to $63.3 million, an increase of approximately 35% to 37% over the comparable prior year period.

The Company is expected to report Q3, 2017 financial results on November 1, 2017.

5. bluebird bio Inc. (BLUE)

Gained 8.81% to close Monday's trading at $143.30.

bluebird is a CAR-T player. CAR T-cells are a type of immunotherapy in which a patient's T cells are extracted from their blood and modified in a lab to produce receptors on their surface called chimeric antigen receptors, or CARs. These special receptors allow the T cells to recognize and attach to a specific protein, or antigen, on tumor cells.

The engineered T cells are infused back into the patient where they multiply and with guidance from their engineered receptor, recognize and kill cancer cells. (Source: National cancer Institute).

News: No news

6. NovoCure Limited (NVCR)

Gained 8.28% to close Monday's trading at $17.65.

News: The Company will be making five data presentations at the International Associations for the Study of Lung Cancer (IASLC) 18thWorld Conference on Lung Cancer, October 15 to October 18 in Yokohama, Japan.

Near-term catalysts:

The Company is slated to report financial results for the three and nine months ended September 30, 2017, at 8 a.m. EDT on Thursday, October 26, 2017.

7. Five Prime Therapeutics Inc. (FPRX)

Gained 7.60% to close Monday's trading at $46.74.

News: No news

Near-term catalyst:

-- The Company will be presenting data from its Phase 1a/1b clinical trial evaluating the immunotherapy combination of its Cabiralizumab with Bristol-Myers Squibb's Opdivo n patients with advanced solid tumors on November 11, 2017 at the Society for Immunotherapy of Cancer (SITC).

The presentation at the SITC Annual Meeting will focus on preliminary safety, pharmacokinetic and pharmacodynamic data as well as initial efficacy data from one of the expansion cohorts.

8. Rhythm Pharmaceuticals Inc. (RYTM)

Gained 7.53% to close Monday's trading at $26.26.

The Company is focused on the development and commercialization of peptide therapeutics for treatment of rare genetic deficiencies that result in life-threatening metabolic disorder.

The shares commenced trading on the NASDAQ Global Market on October 5, 2017, at a public offering price of $17.00 per share.

The Company's most advanced product candidate is Setmelanotide, which is currently in Phase 3 development for pro-opiomelanocortin (POMC) deficiency obesity and for LepR deficiency obesity.

LOSERS

1. Tandem Diabetes Care Inc. (TNDM)

Lost 14.38% to close Monday's trading at $2.56.

Recent events:

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

On October 13, 2017, the Company priced an underwritten public offering of (i) 4,630,000 shares of its common stock, (ii) Series A warrants to purchase 4,630,000 shares of its common stock and (iii) Series B warrants to purchase 4,630,000 shares of its common stock, for gross proceeds of approximately $16.2 million, at a public offering price of $3.50 per share and accompanying warrants. The offering is expected to close on or about October 17, 2017.

2. Ardelyx Inc. (ARDX)

Lost 12.03% to close Monday's trading at $6.40. A pullback after having had gained over 34% in the last 3 trading days.

Recent events:

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.

3. Audentes Therapeutics Inc. (BOLD)

Lost 10.95% to close Monday's trading at $24.99.

News: No news

Audentes is a biotechnology company focused on developing and commercializing gene therapy products for patients suffering from serious, life-threatening rare diseases caused by single gene defects.

The Company's drug candidates include AT132 for the treatment of X-Linked Myotubular Myopathy, AT342 for the treatment of Crigler-Najjar Syndrome, AT982 for the treatment of Pompe disease and AT307 for the treatment of the CASQ2 subtype of Catecholaminergic Polymorphic Ventricular Tachycardia.

Near-term catalyst:

-- A phase I/II clinical trial of AT132 for the treatment of X-Linked Myotubular Myopathy, dubbed ASPIRO, is underway - with preliminary data expected to be available in the fourth quarter of 2017.

4. Eiger BioPharmaceuticals Inc. (EIGR)

Lost 10.23% to close Monday's trading at $11.85.

News: No news

Near-term catalysts:

Interim data from a phase II study of Pegylated interferon lambda 1a, for the treatment of hepatitis D virus, dubbed LIMT, are expected to be presented on October 21, 2017.

5. Kala Pharmaceuticals Inc. (KALA)

Lost 7.72% to close Monday's trading at $20.44.

News: No news

Recent events:

-- On July 20, 2017, the Company made its stock debut on The NASDAQ Global Select Market at an offering price of $15.00 per share. -- On May 1, 2017, the Company reported positive results from its confirmatory phase III trial of KPI-121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery.

Near-term catalysts:

-- The two ongoing phase III trials of KPI-121 1% in dry eye disease are expected to complete in late 2017.