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SNGX Flashes DMC Recommendation, LENS On Watch, IOVA Slumps


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(RTTNews.com) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Soligenix Inc. (SNGX)

Lost 26.21% to close Monday's (Oct.15) trading at $1.07.

News: An independent Data Monitoring Committee has recommended that approximately 40 additional subjects be randomized into the Company's phase III study for SGX301 in the treatment of cutaneous T-cell lymphoma, dubbed FLASH.

The DMC made the recommendation based on the unblinded interim analysis with data from approximately 100 subjects in the FLASH study. The additional enrollment is intended to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint.

2. Presbia PLC (LENS)

Lost 12.86% to close Monday's trading at $1.22.

News: No news

Pipeline:

The Company's lead product is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world, and has also received CE Mark approval in Europe. It is not approved in the U.S. yet.

The final premarket approval (PMA) module related to Presbia Flexivue Microlens was submitted to the FDA in the second quarter of 2018.

Near-term Catalysts:

-- The Company is targeting PMA approval of its Microlens in the fourth quarter of 2018. -- Submit a final report related to Microlens with 36-month data on 300 subjects in the first quarter of 2019.

3. Oragenics Inc. (OGEN)

Lost 11.20% to close Monday's trading at $1.11.

News: No news

The Company is focused on developing antibiotics against infectious diseases and treatments for oral mucositis.

Clinical Trial & Near-term Catalyst:

In August of this year, the Company resumed its phase II clinical trial of AG013, a live biotherapeutic product for the potential treatment of oral mucositis, following a positive review by an independent Data Safety Monitoring Board (DSMB).

The study is expected to be completed next year.

4. vTv Therapeutics Inc. (VTVT)

Lost 10.98% to close Monday's trading at $2.92.

News: No news

Pipeline:

-- A Phase I/II study of TTP399 as an add-on to insulin therapy in patients with type 1 diabetes, dubbed SimplicT-1, is underway. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes. -- In June of this year, the Company announced disappointing results from Part B of STEADFAST Study. The results from Part A of the STEADFAST study, announced in April 2018, were also disappointing.

The STEADFAST is a phase III trial that evaluated Azeliragon in patients with mild Alzheimer's disease. The STEADFAST trial had 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

Cash position:

At June 30, 2018, the Company had cash of $1.2 million.

5. Iovance Biotherapeutics Inc. ( IOVA )

Lost 10.39% to close Monday's trading at $10.69.

News: The Company has offered to sell 22 million shares of its common stock to the public at a price of $9.97 per share.

The gross proceeds from the offering are expected to be $219.3 million. The offering is expected to close on or about October 16, 2018, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to 3.30 million additional shares of common stock.

Near-term Catalysts:

-- Initiate enrollment into Cohort 4 of its phase II study of LN-144 in metastatic melanoma in early 2019. -- Submission of Biologics License Application for LN-144 in metastatic melanoma is expected in the second half of 2020.


Read the original article on RTTNews (http://www.rttnews.com/2943667/sngx-flashes-dmc-recommendation-lens-on-watch-iova-slumps.aspx)


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This article appears in: Stocks
Referenced Symbols: IOVA ,



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