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ABEO

Abeona Therapeutics

$8.90

-0.4 (-4.30%)

08:12
07/18/17
07/18
08:12
07/18/17
08:12

Abeona Therapeutics receives guidance from FDA to commence EB-101 Phase 3 trial

Abeona Therapeutics announced guidance from a recent Type-C meeting with the FDA which has recommended accelerating the EB-101 program into a pivotal Phase 3 trial. The company continues to engage the FDA on the final Phase 3 clinical trial design, planned to commence early 2018, and will provide an update on the program in the coming months. "The FDA guidance is an important milestone in our clinical development plan for EB-101, and we are pleased to be moving forward into a registrational Phase 3 clinical study in 2018. Abeona is committed to advancing innovative gene therapies that address the unmet needs of patients suffering with dystrophic epidermolysis bullosa, a devastating rare skin disease. We are grateful that the FDA has recognized EB-101 as a rare disease product that addresses the underlying disease pathology to offer significant therapeutic benefit for RDEB patients, and we look forward to the collective work ahead in advancing this therapy," stated Timothy J. Miller, Ph.D., President and CEO of Abeona. Abeona's EB-101 product is an autologous, ex-vivo gene therapy in which the COL7A1 gene is inserted into a patient's own skin cells for the treatment of the underlying disease in Recessive Dystrophic Epidermolysis Bullosa. The EB-101 program has been granted Orphan Drug and Rare Pediatric Disease Designations from the FDA and Orphan Drug Designation from the European Medicines Agency.

ABEO Abeona Therapeutics
$8.90

-0.4 (-4.30%)

03/06/17
FBRC
03/06/17
NO CHANGE
FBRC
FBR sees 'prime' merger environment for biotechs under Trump
Potential tax reform and FDA policy changes under President Trump could "prime the pump" for acquisitions of clinical-stage biotech companies by Big Pharma, FBR Capital analysts led by Chris Meekins tell investors in a research note. These police moves, coupled with the repeal of some taxes associated with the Affordable Care Act, are likely to increase funds for companies looking to make acquisitions, the analysts contend. Within its coverage universe, FBR sees TESARO (TSRO), Agile Therapeutics (AGRX), Kite Pharma (KITE), Juno Therapeutics (JUNO), Acceleron Pharma (XLRN), Abeona Therapeutics (ABEO), Aurinia Pharmaceuticals (AUPH), Geron (GERN) and Genocea Biosciences (GNCA) as "primary targets for those looking to make acquisitions."
01/06/17
JEFF
01/06/17
INITIATION
Target $11
JEFF
Buy
Abeona Therapeutics initiated with a Buy at Jefferies
Jefferies analyst Gena Wang started Abeona Therapeutics with a Buy rating and $11 price target. The analyst sees a favorable risk/reward ahead of data readouts in the first half of 2017.
12/12/16
CANT
12/12/16
NO CHANGE
Target $21
CANT
Abeona short report 'factually incorrect and misleading,' says Cantor
Cantor Fitzgerald analyst Elemer Piros said the short report published on Seeking Alpha regarding Abeona Therapeutics is "factually incorrect and misleading." Abeona infuses its drug to the bloodstream, unlike Lysogene, whose failed clinical trial was conducted with a gene therapy that was directly injected into a handful of brain regions, Piros points out. Abeona also employs an AAV9 vector, which "delivers and promotes expression" in both neurons and glial cells, according to Piros, who reiterates his Buy rating and $21 price target on Abeona shares.
09/29/16
MAXM
09/29/16
NO CHANGE
Target $14
MAXM
Buy
Abeona Therapeutics price target raised to $14 from $8 at Maxim
Maxim analyst Jason McCarthy raised Abeona's price target to $14 from $8 saying he expects multiple data points across several gene therapy programs to potentially push shares higher. The analyst said clinical development is underway in Abeona's Sanfilippo with positive data in two patients so far, and data from more patients are expected this fall. The company is also advancing a second Sanfilippo gene therapy, ABO-101, into the clinic later this year. Also, Abeona has brought on board a more advanced gene therapy from Stanford University, EB-101, to treat a rare skin disease which demonstrated positive data in five patients and has advanced to phase II, McCarthy wrote.

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