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ABEO

Abeona Therapeutics

$2.54

-0.075 (-2.87%)

09:19
01/13/20
01/13
09:19
01/13/20
09:19

Abeona Therapeutics initiates Phase 3 trial evaluating EB-101

Abeona Therapeutics announced that it has received Institutional Review Board (IRB) approval from Stanford University to commence the VIITAL study, the Company's pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa. The majority of patients targeted for enrollment have completed the pre-screening process at Stanford, and the Company expects the first patient in the VIITAL(TM) study to be treated in the first quarter of 2020. The VIITAL Phase 3 study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total. The primary study endpoint is the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient's global impression of change from baseline in pain as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function. Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL study, with additional study sites expected to be added in the coming months. Additional information about the trial is available at abeonatherapeutics.com/clinical-trials/rdeb. Abeona will produce EB-101 for the pivotal VIITAL study at the Elisa Linton Center for Rare Disease Therapies, its fully-functional gene and cell therapy manufacturing facility, centrally-located in Cleveland, OH. The center is a 26,000 ft2 facility housing large-scale cGMP capacity and state-of-the-art laboratories to support CMC development for process and analytics, all of which is validated and governed by comprehensive quality systems and overseen by experienced staff. The facility is also capable of clinical production of the Company's AAV gene therapies.

ABEO Abeona Therapeutics
$2.54

-0.075 (-2.87%)

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.
12/10/19
CANT
12/10/19
INITIATION
Target $4
CANT
Neutral
Abeona Therapeutics assumed with a Neutral at Cantor Fitzgerald
Cantor Fitzgerald analyst Kristen Kluska assumed coverage of Abeona Therapeutics with a Neutral rating with a price target of $4, up from $2. While the analyst remains bullish on gene therapy and believes Abeona could form a partnership with earlier-stage programs, she remains on the sidelines due to concerns about the company's lead programs and its current financial status.
12/20/19
CANT
12/20/19
NO CHANGE
Target $4
CANT
Neutral
Abeona financing to lessen takeover chartter, says Cantor Fitzgerald
Cantor Fitzgerald analyst Kristen Kluska believes Abeona Therapeutics' plans to sell common shares will lessen the takeover chatter in the name for the time being. The analyst expects the shares to be down on last night's financing news, as she thinks investors will assume that an acquisition is less likely to happen at this time. Kluska is bullish on gene therapy, but given the "significant late-stage competition" for Abeona's lead programs, her thesis is that a partnership from the earlier-stage pipeline is more likely to happen. With that said, the analyst does not believe a proposed offering necessarily means a takeover is off the table. She views the financing as instrumental for Abeona and keeps a Neutral rating on the shares with a $4 price target.
12/30/19
HCWC
12/30/19
NO CHANGE
Target $11
HCWC
Buy
Abeona Therapeutics price target lowered to $11 from $15 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Abeona Therapeutics to $11 from $15 to account for the company's recent sale of common stock and pre-funded warrants, telling investors that he believes the funds raised should extend the company's operational runway into mid-2021. The analyst, who believes the company's pivotal EB-101 program for recessive dystrophic epidermolysis bullosa is "likely to be rapid," keeps a Buy rating on Abeona shares.

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