APVO Walks The Talk, Eleven Bio Gains Over 13%, PADDOCK Data Boosts APLS

pharmaup 041618

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

1. Aptevo Therapeutics Inc. (APVO)

Gained 17.99% to close Monday's (Apr.16) trading at $4.46.

News: New preclinical data of APVO436 demonstrate potent T-cell cytotoxicity of tumors expressing CD123 with limited cytokine release and suggest that APVO436 has the potential for increased clinical benefit and a favorable safety profile.

Near-term Catalysts:

-- File an IND for APVO436 in the upcoming weeks.
-- Commence a phase I clinical trial of APVO436 later this year in acute myeloid leukemia and myelodysplastic syndrome.
-- Complete enrollment of Phase 1 dosing cohorts in APVO414 clinical trial in metastatic castration resistant prostate cancer in Q3 2018.
-- Report preliminary data from phase II trial of Otlertuzumab in peripheral T-cell lymphoma in Q4 2018.
-- Submit an IND for APVO210 in Autoimmune/Inflammatory Diseases in Q4 2018.
-- Report preliminary APVO414 phase I dose escalation clinical data in Q4 2018.

You can find more about APVO in our premium stock report. Our premium subscribers were alerted to the stock on November 6, 2017, when it was trading around $2.83. The stock had touched a high of $4.85 on January 3, 2018.

2. Eleven Biotherapeutics Inc. (EBIO)

Gained 13.67% to close Monday's trading at $1.58.

News: The Company presented preclinical data from its novel, next-generation ADC (antibody-drug conjugate) program using an innovative deBouganin cytotoxic protein payload.

deBouganin exhibits certain advantages over first-generation ADCs, which use more conventional small molecule cytotoxins, with respect to cell killing power, including the ability to kill cancer stem cells, circumvent multi-drug resistance and avoid cross-resistance mechanisms," according to Gregory P. Adams, chief scientific officer of Eleven Biotherapeutics.

Near-term Catalyst:

-- The first, topline data from its phase III trial of Vicinium in patients with high grade non-muscle invasive bladder cancer, dubbed VISTA, are expected to be presented on May 21, 2018, at this year's American Urological Association Annual Meeting being held in San Francisco.

3. Apellis Pharmaceuticals Inc. (APLS)

Gained 12.23% to close Monday's trading at $30.00.

News: The Company presented interim data from its ongoing phase Ib trial evaluating APL-2 in subcutaneous formulation as a monotherapy in paroxysmal nocturnal hemoglobinuria, dubbed PADDOCK.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, life-threatening blood disease characterized by severe anemia, severe abdominal pain, severe headaches, back pain, excessive weakness, fatigue, and recurrent infections.

The interim analysis was based on 8 patients who were treated with a 270 mg/day dose of APL-2.

At baseline (prior to the start of the treatment), the patients' average hemoglobin level was 7.9 g/dL, and they had a mean LDH of 11.6x the upper limit of normal (ULN), which is 250 U/L.

Within the first 12 weeks of the treatment period, the patient's average hemoglobin level increased to 12.2 g/dL. Except for two patients each of whom received a single transfusion within the first two weeks of treatment, no other transfusions have been reported in this study for any patients during the treatment period with APL-2, according o the Company.

At Day 28, the mean LDH of the eight patients was reduced to 0.9x ULN. Seven of the eight patients (88%) had LDH levels below the upper limit of normal at day 28, noted the Company.

Near-term Catalysts:

-- Report further updates to the ongoing PADDOCK trial in June.
-- Initiate a phase III clinical trial in approximately 70 patients with PNH comparing treatment with APL-2 monotherapy to treatment with Soliris the second half of 2018.

You can find more about AVLS in our Company Spotlight column.

4. Viveve Medical Inc. (VIVE)

Gained 11.63% to close Monday's trading at $3.36.

News: No news

The Company has one marketed product Geneveve, a non-invasive solution for vaginal laxity. There are 3 major components in Geneveve - the Viveve System (a radio frequency generator housed in a table-top console), a reusable handpiece and a single-use treatment tip, as well as several other consumable accessories.

Near-term Catalysts:

-- Begin the VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve System for the improvement of sexual function in women following vaginal childbirth in Q2, 2018.

You can find more about VIVE in our premium stock report titled "Only For Her…", posted on Feb.12, 2018.

5. Sorrento Therapeutics Inc. (SRNE)

Gained 11.11% to close Monday's trading at $6.50.

News: No news

Recent event:

On Feb.28, 2018, the FDA approved the Company's ZTlido, a next-generation non-opioid, lidocaine patch proposed for the relief of pain associated with post-herpetic neuralgia. The product will be commercially available to patients sometime this year.


Gained 9.83% to close Monday's trading at $38.00.

News: No news

Clinical Trials & Near-term Catalysts:

-- Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD.
-- Continuing dosing of second cohort in RGX-501 Phase I/II clinical trial for Homozygous Familial Hypercholesterolemia (HoFH).
-- Present topline data from RGX-314 and RGX-501 clinical trials in late 2018.
-- Initiate dosing in clinical trials for RGX-111 for MPS I and RGX-121 for MPS II in mid-2018.

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