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FDA Nod For AMDA, Check Out CKPT, TOPAZ, SAPPHIRE Make CLSD Shine, SLS Abuzz


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

1. Clearside BioMedical Inc. (CLSD)

Gained 25.36% to close Tuesday's (Mar.6) trading at $12.95. This is the second straight day of double digit gain for the stock.

News: The Company provided an update on two phase III clinical trials of CLS-TA in Retinal Vein Occlusion, dubbed TOPAZ and SAPPHIRE.

SAPPHIRE, the Company's first phase III Retinal Vein Occlusion study, is evaluating suprachoroidal CLS-TA in combination with intravitreal Eylea. Preliminary data from this trial are now expected in the fourth quarter of 2018 instead of the first quarter of 2019.

TOPAZ, the second phase III Retinal Vein Occlusion study, is evaluating suprachoroidal CLS-TA in combination with one of two intravitreal anti-VEGF agents, Lucentis or Avastin. The first patient has been enrolled in the trial. Clearside anticipates total enrollment of approximately 460 patients in the TOPAZ study.

Recent event:

-- On Mar.5, 2018, the Company announced positive topline results from its pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis, dubbed PEACHTREE.

2. Zosano Pharma Corp. (ZSAN)

Gained 24.56% to close Tuesday's trading at $9.28.

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. Checkpoint Therapeutics Inc. (CKPT)

Gained 19.15% to close Tuesday's trading at $5.60.

News: No news

Checkpoint is focused on developing novel, non-chemotherapy, immune-enhanced combination treatments for patients with solid tumor cancers.


The Company has 3 compounds in phase I testing - CK-301 for the treatment of lung and other solid tumors; CK-101 for EGFR mutant lung cancer, and CK-102 for multiple solid tumors.

Also in pipeline are 3 compounds in pre-clinical phase - CK-302 and CK-103 for multiple solid tumors, and Anti-CAIX for renal cell carcinoma.

4. Amedica Corp. (AMDA)

Gained 16.50% to close Tuesday's trading at $2.33.

News: The FDA has given market clearance for the Company's spinal fusion implant Valeo C+CsC with Lumen Interbody Fusion Device. This device is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients.

The Valeo C+CsC device is already used in Europe, and the Valeo C+CsC with Lumen is the introduction of this porous technology in the USA.

5. Veru Inc. (VERU)

Gained 13.99% to close Tuesday's trading at $1.63.

News: The Company announced that it has completed a $10 million "synthetic" royalty financing on FC2 Female Condom product sales with SWK Holdings.

Under the terms of the deal, Veru received $10 million at closing and may receive an additional $2 million upon potential signing of tenders for FC2 Female Condom product with two large international customers, subject to minimum units ordered.

FC2 Female Condom is one of the two products marketed by Veru, and the other being PREBOOST medicated individual wipe, a male genital desensitizing drug product for the prevention of premature ejaculation.


TAMSULOSIN DRS for the Treatment of BPH, VERU-944 for the treatment of hot flashes caused by prostate cancer hormonal therapies in men with advanced prostate cancer, VERU-111, a novel oral chemotherapy, for metastatic prostate cancer as well as for other forms of metastatic cancers, VERU-722 for the treatment of male infertility, and VERU-112 for the treatment of Gout and Familial Mediterranean Fever are the Company's investigational drugs.

The Company utilizes FDA's 505(b)(2) regulatory approval pathway to develop and commercialize drug candidates. This pathway allows for potentially expedited regulatory approval based on a previously established safety and efficacy profile of the product.

6. SELLAS Life Sciences Group Inc. (SLS)

Gained 13.85% to close Tuesday's trading at $6.00.

News: No news

Pipeline & Near-term Catalysts:

The Company's lead product candidate is GALINPEPIMUT-S.

-- Phase III trials of the compound in the indications of Acute Myeloid Leukemia and Mesothelioma are planned.
-- A Phase 2 Study of GALINPEPIMUT-S in Multiple Myeloma and a Phase 1/2 Study in Ovarian Cancer are ongoing.
-- A Phase 2a proof of concept study of GALINPEPIMUT-S as immune combo is planned for the first half of this year.

Also in the pipeline are:

-- NEUVAX for breast cancer, which is under phase II testing.

Interim analysis from a phase II study of NEUVAX in combination with Roche's Herceptin in HER2 1+/2+ breast cancers is expected this month.

-- ANAGRELIDE CR for essential Thrombocythemia, which is a phase III-ready compound.

7. OncoMed Pharmaceuticals Inc. (OMED)

Gained 13.73% to close Tuesday's trading at $2.90.

News: No news

Recent events:

-- On January 4, 2018, the Company announced that a phase 1a/b clinical program of Rosmantuzumab that included five patients harboring a RSPO3 gene fusion failed to provide compelling evidence of clinical benefit.
-- The same day, i.e., on January 4th, the Company announced that its Chairman, President and Chief Executive Officer Paul J. Hastings had resigned to pursue new career opportunities, effective January 1st, 2018.

Upcoming event:

-- On March 8, 2018, the Company will report fourth quarter and full year 2017 financial results and operational highlights.

8. Anavex Life Sciences Corp. (AVXL)

Gained 11.83% to close Tuesday's trading at $2.93.

News: No news


The lead drug candidate is ANAVEX2-73, which recently completed a successful a Phase 2a clinical trial for Alzheimer's disease.

Near-term Catalyst:

-- The Company plans to submit an IND to the FDA within the first half of this year for the planned Alzheimer's Phase 2/3 study of ANAVEX2-73. This study will be conducted in Australia and North America.

9. Endocyte Inc. (ECYT)

Gained 11.22% to close Tuesday's trading at $7.04.

News: No news

Recent event:

-- On Mar.2, 2018, the Company closed its underwritten registered public offering of 20.54 million shares of its common stock, including full exercise of the underwriters' option to purchase additional shares of common stock, at a public offering price of $4.20 each. The aggregate net proceeds from the offering were approximately $80.6 million.

Clinical Trials & Near-term Catalysts:

The lead program is a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, whose phase III trial design has been finalized.

-- Enrollment in the trial, dubbed VISION, is expected to begin in the second quarter of 2018 and is expected to be completed in 18-24 months. The first interim assessment of overall survival could occur as early as the second half of 2019.
-- Updated results from Peter MacCallum Cancer Center-sponsored 177Lu-PSMA-617 trial in metastatic castration-resistant prostate cancer (mCRPC) patients are expected in the second half of 2018.

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