INNT Soars, CDXS Sees 20% Growth, So Long CGNT, Mark Your Calendar For ASMB

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

1. Innovate Biopharmaceuticals Inc. (INNT)

Gained 27.51% to close Monday's (Mar.12) trading at $19.00.

News: No news

Pipeline:

The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase 2 trials this year.

Near-term Catalyst:

-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.

Upcoming event:

-- The Company will make a presentation at the Cowen Healthcare Conference on Tuesday, March 13, 2018, at 8:40 am.

2. Juniper Pharmaceuticals Inc. (JNP)

Gained 17.20% to close Monday's trading at $10.90.

News: No news

The Company's core businesses include its CRINONE (progesterone gel) franchise and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development and clinical trials manufacturing to clients.

Also in the pipeline are 3 drug candidates based on differentiated intravaginal ring (IVR) technology to address unmet needs in women's health, each of which has demonstrated positive pharmacokinetic data in in vivo animal studies.

-- JNP-0101, an investigational oxybutynin IVR for the treatment of overactive bladder in women. -- JNP-0201, an estrogen plus progesterone IVR for hormone replacement therapy. -- JNP-0301, a natural progesterone IVR in development for the prevention of preterm birth in women with a short cervical length at mid-pregnancy.

Recent events:

-- On January 31, 2018, the Company announced that it is exploring strategic alternatives in order to enhance shareholder value. Advisory firm Rothschild has been engaged as an independent financial advisor to assist Juniper and its Board of Directors in evaluating potential strategic alternatives. This process remains ongoing.

-- On March 8, 2018, the Company reported financial results for the twelve-month period ended December 31, 2017.

The net loss for the year 2017 was $2.1 million or $0.15 per share on total revenue of $50.0 million. This compared with a net income of $6.0 million or $0.55 per share and total revenue of $54.6 million in 2016.

3. Immutep Limited (IMMP)

Gained 17.49% to close Monday's trading at $2.15.

News: The Company announced it has raised A$6.85 million through share institutional placement to drive immuno-oncology development programs.

The capital raise involved placement of 326,192,381 new fully paid ordinary shares in the Company to Australian institutional investors, Platinum Investment Management Limited and Australian Ethical Investment Limited, former Immutep Chairman, Lucy Turnbull AO and U.S. healthcare institutional investors, including Ridgeback Capital Investments at an issue price of A$0.021 per New Share of the Company's ordinary shares.

4. Codexis Inc. (CDXS)

Gained 15.32% to close Monday's trading at $12.80.

News: No news

Recent event:

On Mar.8, 2018, the Company announced financial results for the fourth quarter and full-year ended December 31, 2017.

Net income for the fourth quarter of 2017 was $1.0 million or $0.02 per share on total revenue of $21.7 million. This compared with a net loss of $5.3 million, or $0.13 per share and total revenue of $10.0 million for the fourth quarter of 2016.

Looking ahead to full-year 2018, total revenues are expected to be $60 million to $63 million, a 20% to 26% increase over 2017. Total revenues for 2017 were $50.0 million.

5. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 15.21% to close Monday's trading at $10.53.

Clinical Trials & Near-term Catalysts:

-- A single pivotal study of ZYN002 in Fragile X Syndrome is expected to be initiated mid-year 2018. The trial will enroll approximately 200 pediatric and adolescent patients in the U.S., Australia and New Zealand. -- A phase II study of ZYN002 in Developmental and Epileptic Encephalopathies (DEE) is expected to be initiated in the first half of 2018. -- A double-blind phase IIb trial of ZYN002 in about 300 adult patients with refractory focal epilepsy is expected to be initiated in the second half of 2018. -- A phase I program for ZYN001 in Tourette Syndrome, which is underway, is expected to be completed in the first half of 2018.

6. Cogentix Medical Inc. (CGNT)

Gained 13.35% to close Monday's trading at $3.82.

News: The Company is all set to be acquired by LABORIE Medical Technologies for $3.85 per share in cash, and an enterprise value of $214 million.

The deal is expected to close in the first half of Q2 2018.

7. Alliqua BioMedical Inc. (ALQA)

Gained 12.22% to close Monday's trading at $2.02.

News: No news

Recent events:

-- On January 5, 2018, the Company signed a definitive agreement with Celularity Inc. Celularity agreed to acquire all of the property, assets and rights relating to Alliqua's advanced biologic wound care business, including Biovance amniotic membrane allograft and Interfyl Human Connective Tissue Matrix, UltraMist Therapy System and other therapeutic ultrasound platform products for an aggregate cash consideration of $29.0 million. -- On November 9, 2017, the Company announced financial results for the third quarter ended September 30, 2017.

Non-GAAP net loss from continuing operations for the third quarter of 2017 improved to $3.7 million or $0.79 per share on total revenue of $4.9 million. This compared with a non-GAAP net loss from continuing operations $5.6 million or $1.99 per share and total revenue of $4.4 million in the year-ago quarter.

8. Tetraphase Pharmaceuticals Inc. (TTPH)

Gained 11.38% to close Monday's trading at $3.23.

News: No news

Near-term Catalysts:

-- The NDA for IV Eravacycline in complicated intra-abdominal infections is under FDA review, with a decision expected on August 28, 2018. -- IV Eravacycline for the treatment of patients with cIAI is also under review by the European Medicines Agency. -- Complete phase 1 MAD studies for TP-271, for the treatment of respiratory diseases, and TP-6076, for the treatment of serious and life-threatening bacterial infections, in the second half of 2018. The phase I multiple-ascending dose studies are being conducted in healthy volunteers.

9. Dermira Inc. (DERM)

Gained 10.39% to close Monday's trading at $10.41. The stock is up nearly 18% from its 52-week low of $8.85 recorded on Mar.8, 2018.

News: No news

Recent event:

-- On MAR.5, 2018, the Company announced that its investigational treatment Olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate-to-severe acne vulgaris. This program has been discontinued.

Near-term Catalysts:

-- The New Drug Application for Glycopyrronium tosylate for the treatment of patients with primary axillary hyperhidrosis is under FDA review, with a decision expected by June 30, 2018. -- A Phase 2b dose-ranging study evaluating Lebrikizumab in adult patients with moderate-to-severe atopic dermatitis, the most common form of eczema, is underway. Top line results are expected in the first half of 2019.

10. Assembly Biosciences Inc. (ASMB)

Gained 9.80% to close Monday's trading at $63.84. The stock touched a new 52-week high of $64.28 in intraday trading.

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: The Company announced key additions to its management team and board of directors with the appointments of Graham Cooper and Helen S. Kim.

Cooper has joined Assembly as its new CFO and COO effective March 8, 2018. Kim has been appointed to Assembly's board of directors and will serve as a member of the Science and Technology Committee.

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.