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ABEO

Abeona Therapeutics

$2.18

-0.05 (-2.24%)

09:19
10/15/19
10/15
09:19
10/15/19
09:19

Abeona announces publication of long-term data from Phase 1/2a trial of EB-101

Abeona Therapeutics announced long term efficacy and safety results from its Phase 1/2a clinical trial evaluating EB-101, a gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa. Treatment with EB-101 resulted in sustained wound healing with a favorable safety profile at three years post-treatment. These long-term follow-up data in seven RDEB participants with 42 treated wounds were published in the peer-reviewed journal JCI Insight. Key Study findings include: Wounds selected for treatment were present for a mean of 11.2 years. Three years after treatment with EB-101, a majority of RDEB patients had sustained wound healing, with 80% of wounds achieving 50% healing, and 70% achieving greater than or equal to75%. Two years after treatment, only 1 of 6 untreated, prospectively selected control wounds, had greater than or equal to50% healing. 50% or greater wound healing was associated with no pain and no itch at treated sites three years post-treatment, compared with presence of pain in 53% and itch in 61% of wound sites at baseline. EB-101 was associated with long-term molecular expression of type VII collagen protein, which plays an important role in anchoring the dermal and epidermal layers of the skin. No serious treatment-related adverse events were observed during the three-year observation period. No replication competent virus was present at any time point. Researchers from Stanford University School of Medicine conducted the Phase 1/2a single-center, open-label clinical trial to evaluate the long-term wound healing and safety of EB-101 in seven adult patients with severe generalized RDEB and to assess patient-reported outcomes following treatment. Chronic open wounds, defined as wounds present and unhealed for at least 12 weeks, with a total area of at least 100 cm2, were required for enrollment. In the trial, gene-corrected EB-101 skin grafts were transplanted onto six wound sites in each of the seven adult participants and wounds selected for treatment had been present for a mean of 11.2 years. Participants were followed for two to five years after transplantation of EB-101 and received standard of care therapies including iron supplementation and esophageal dilations during the study. Abeona is currently continuing preparations for the pivotal Phase 3 VIITALTM Study evaluating EB-101 for the treatment of RDEB pending the anticipated receipt of Chemical, Manufacturing and Controls clearance from the U.S. Food and Drug Administration expected in Q4 2019.

ABEO Abeona Therapeutics
$2.18

-0.05 (-2.24%)

08/12/19
CANT
08/12/19
DOWNGRADE
Target $2
CANT
Neutral
Cantor Fitzgerald downgrades Abeona, slashes price target to $2 from $29
As previously reported, Cantor Fitzgerald analyst Elemer Piros downgraded Abeona Therapeutics to Neutral from Overweight and slashed his price target on the shares to $2 from $29 following the company's Q2 earnings report. He remains wary of competition for the company's mucopolysaccharidosis IIIA/B and dystrophic epidermolysis bullosa programs and believes Abeona will need to raise money in the next 12 months, Piros tells investors.
08/13/19
RBCM
08/13/19
NO CHANGE
Target $16
RBCM
Outperform
Abeona Therapeutics price target lowered to $16 from $23 at RBC Capital
RBC Capital analyst Kennen MacKay lowered his price target on Abeona Therapeutics to $16 after its Q2 earnings miss, also reflecting the delay in its EB-101 program and changing in his valuation methodology to discounted cash flow model. The analyst is keeping his Outperform rating on the stock longer term however with a positive view of its in-house manufacturing capabilities and the clinical profile of EB-101.
08/15/19
MAXM
08/15/19
DOWNGRADE
MAXM
Hold
Abeona Therapeutics downgraded to Hold from Buy at Maxim
Maxim analyst Jason McCarthy downgraded Abeona Therapeutics to Hold from Buy without a price target. At the current burn rate and the Viital phase 3 study not expected to initiate until Q4, Abeona is likely going to need to raise capital, McCarthy tells investors in a research note. The analyst prefers to wait on the sidelines pending clarity on the RDEB trial and additional larger data sets from the Sanfilippo programs.
08/15/19
08/15/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Evergy (EVRG) downgraded to Market Perform from Outperform at Wells Fargo with analyst Sarah Akers citing valuation. 2. Host Hotels (HST) and Pebblebrook Hotel (PEB) downgraded to Neutral from Buy at BTIG. 3. Toronto-Dominion (TD) downgraded to Neutral from Buy at BofA/Merrill with analyst Ebrahim Poonawala citing the recent outperformance of Canadian banks relative to their global banking peers, the analyst is turning more cautious on the group. 4. Urban Outfitters (URBN) downgraded to Neutral from Buy at B. Riley FBR with analyst Susan Anderson saying on its Q1 earnings call, management said they expected sales will start to improve with new back-to-school product in July and into August. 5. Abeona Therapeutics (ABEO) downgraded to Hold from Buy at Maxim with analyst Jason McCarthy saying at the current burn rate and the Viital phase 3 study not expected to initiate until Q4, Abeona is likely going to need to raise capital. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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