WVE Makes A Splash, Mark Your Calendar For ANAB, For Now All's Well With DBVT

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

1. DBV Technologies S.A. (DBVT)

Gained 25.74% to close Wednesday's (Feb.14) trading at $26.23.

News: The FDA has agreed that the available efficacy and safety data for Viaskin Peanut supports the submission of a Biologics License Application for the treatment of peanut allergy in children four to 11 years of age.

Last November, the Company reported positive top-line safety results from its phase III trial of Viaskin Peanut for the treatment of peanut-allergic patients, dubbed REALISE. On October 23, 2017, the Company had announced that its phase III trial which evaluated the safety and efficacy of Viaskin Peanut in children four to 11 years of age, dubbed PEPITES, did not meet the primary endpoint, sending the stock down 53% that day.

Near-term Catalyst:

Submission of BLA for Viaskin Peanut in the second half of 2018.

2. Zosano Pharma Corporation (ZSAN)

Gained 22.80% to close Wednesday's trading at $4.47.

News: No news

Recent event:

-- A 1-for-20 reverse stock split was implemented on January 26, 2018.

Clinical Trials & Near-term Catalysts:

The lead drug candidate is M207 for the treatment of migraine. A long-term safety study of M207 is underway.

-- The Company expects to enroll 100 patients by the end of Q1, 2018, and 250 patients by Q2, 2018. -- 6-month safety data from the trial is expected in Q4, 2018. -- 12-month safety data from the trial is expected in Q1, 2019. -- NDA filing for M207 for the treatment of migraine is expected by the end of 2019.

3. Cerecor Inc. (CERC)

Gained 16.52% to close Wednesday's trading at $3.95.

News: No news

Recent events:

-- On Feb.12, 2018, the Company agreed to acquire Avadel Pharmaceuticals' pediatric products including Karbinal ER, AcipHex Sprinkle, Cefaclor for Oral Suspension, and Flexichamber. The transaction, which is slated to close before February 28, 2018, is expected to be immediately accretive to revenue and earnings. -- Last November, the Company acquired TRx Pharmaceuticals, LLC, including subsidiary Zylera Pharmaceuticals LLC and its franchise of commercial medications led by Poly-Vi-Flor and Tri-Vi-Flor.

4. Odonate Therapeutics Inc. (ODT)

Gained 16.28% to close Wednesday's trading at $21.00.

News: No news

Recent events:

-- The Company went public on the NASDAQ Global Select Market on December 7, 2017, offering its shares at a price of $24.00 each. -- On January 2, 2018, Jefferies initiated coverage on Odonate with a Buy rating and a price target of $40. -- The Company announced financial results for the three and twelve months ended December 31, 2017, on Feb.14, 2018.

As of December 31, 2017, Odonate had $198.1 million in cash.

Clinical Trial:

A phase III study of Tesetaxel in patients with locally advanced or metastatic breast cancer, dubbed CONTESSA, was initiated as recently as December 28, 2017.

5. InspireMD Inc. (NSPR)

Gained 16.01% to close Wednesday's trading at $5.58.

News: The Company announced encouraging financial results for the fourth quarter and year-ending December 31, 2017.

Net loss for the quarter ended December 31, 2017 narrowed to $1.50 million or $7.38 per share from $2.26 million or $30.59 per share in the same period in 2016. Revenue for the recent fourth quarter increased to $833,000 from $322,000 during the same period in 2016, primarily due to an increase in sales of CGuard EPS.

The CGuard Embolic Prevention System (EPS) is designed to prevent peri-procedural and late embolization. It is CE Marked and not approved for sale in the U.S. by the FDA.

6. Nuvectra Corporation (NVTR)

Gained 15.15% to close Wednesday's trading at $10.26.

News: No news

Recent events:

-- On Feb.5, 2018, the Company announced the closing of follow-on stock offering at a price to the public of $8.00 per share, and full exercise of underwriters' option to purchase additional shares. The gross proceeds from the offering were roughly $26.0 million. -- On Jan.8, 2018, the Company announced preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2017.

Preliminary unaudited fourth quarter consolidated revenue for 2017 is expected to be in a range of $11.5 million to $12.0 million, compared to $4.2 million in the fourth quarter of 2016.

Nuvectra's preliminary unaudited full year 2017 consolidated revenue is expected to be in the range of $31.5 to $32.0 million, compared to $12.5 million for full year 2016.

Upcoming Event:

-- The Company plans to release its fourth quarter and full year 2017 financial results in early March 2018.

7. WAVE Life Sciences Ltd. (WVE)

Gained 14.30% to close Wednesday's trading at $48.35. The stock touched an all-time high of $48.80 in intraday trading.

News: No news

Clinical Trials:

-- A phase 1b/2a clinical trial evaluating WVE-120101 for Huntington's disease, dubbed PRECISION-HD1. -- A phase 1b/2a clinical trial evaluating WVE-120102 for Huntington's disease, dubbed PRECISION-HD2. -- A global phase I trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping.

Near-term Catalysts:

-- Data from the global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping are expected in Q3, 2018. -- Top line data from PRECISION-HD program, which includes two phase 1b/2a global clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington's disease, are anticipated in 1H 2019.

8. Assembly Biosciences Inc. (ASMB)

Gained 13.96% to close Wednesday's trading at $54.61.

Assembly Biosciences is a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral live biotherapeutics for disorders associated with the microbiome.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is ABI-H0731, under phase 1b trial in patients with chronic hepatitis B infections.

-- Interim top line phase 1b data are anticipated this quarter (Q1, 2018). -- Full results from the phase 1b trial of ABI-H0731 are expected in the first half of 2018. -- Initiate Phase 2a trial of ABI-H0731 (POC study) in patients with chronic hepatitis B infections in the first half of 2018. -- Initial POC HBV clinical data are expected in the second half of 2018. -- Select next indications (non-GI) in microbiome in year-end 2018. -- Advancements with collaboration partners in microbiome by the end of this year.

9. AnaptysBio Inc. (ANAB)

Gained 9.29% to close Wednesday's trading at $124.77. The stock touched an all-time high of $132.46 in intraday trading.

News: No news

Near-term Catalysts:

-- Additional efficacy and safety data from the Company's phase 2a trial of ANB020 in adult patients with moderate-to-severe atopic dermatitis will be presented during an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting on Saturday, Feb. 17, 2018.

The Company announced positive proof-of-concept data from its phase 2a clinical trial of ANB020 in adult patients with moderate-to-severe atopic dermatitis on October 10, 2017, sending the stock up more than 100% that day to $70.41.

-- Top line data from phase 2a study of ANB020 in adults with severe peanut allergy are expected in the first quarter of 2018. -- Top line data from phase 2a study of ANB020 in adults with severe eosinophilic asthma are expected in the second quarter of 2018. -- Initiate a phase 2b study in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate multi-dose subcutaneous administration of ANB020 during the first half of 2018, with data expected in 2019. -- Advance ANB019 into phase II studies for generalized pustular psoriasis and palmo-plantar pustular psoriasis during 2018.

10. Ascendis Pharma A/S (ASND)

Gained 9.01% to close Wednesday's trading at $56.00.

News: No news

Clinical Trials & Near-term Catalysts:

The phase III trial of TransCon Growth Hormone for pediatric growth hormone deficiency, dubbed heiGHt, has randomized over 160 subjects, exceeding its target enrollment.

Top-line results from the heiGHt study are anticipated to be available in the first quarter of 2019.

Ascendis Pharma is also conducting the fliGHt Trial to evaluate TransCon Growth Hormone in patients who have previously been treated with daily growth hormone therapy as part of the pivotal TransCon Growth Hormone phase III program. Enrollment in the fliGHt Trial is expected to be completed during the third quarter of 2018.

The other investigational products in the pipeline are TransCon PTH, a long-acting prodrug of parathyroid hormone for hypoparathyroidism currently in a phase 1 trial, and TransCon CNP, a long-acting prodrug of C-type Natriuretic Peptide for achondroplasia.

The Company presented encouraging pharmacokinetic data from an ongoing phase 1 trial of TransCon PTH in healthy volunteers last month. TransCon PTH may be moved directly into phase 3 development in the first quarter of 2019.

The Company recently initiated the regulatory process in Australia to enable its first-in-human phase 1 trial for TransCon CNP. Dosing in the phase 1 trial in healthy volunteers is expected to begin in the second quarter of 2018, with top-line data to be announced in the fourth quarter of 2018.