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FIXX

Homology Medicines

$29.06

-0.38 (-1.29%)

07:19
04/04/19
04/04
07:19
04/04/19
07:19

Homology Medicines announces FDA clearance HMI-102 IND

Homology Medicines announced that the FDA has provided clearance for Homology to begin its Phase 1/2 pheNIX clinical trial with HMI-102, a one-time gene therapy candidate for adults with the rare genetic disease phenylketonuria, or PKU, an inborn error of metabolism. Homology has been working closely with multiple clinical sites in the U.S. to prepare for potential initiation of the pheNIX trial, which is designed to evaluate the safety and efficacy of the investigational gene therapy in a randomized, concurrently-controlled, dose-escalation study in adult patients with classic PKU. HMI-102 is designed to use one of Homology's proprietary human hematopoietic stem-cell derived adeno-associated virus vectors, or AAVHSCs, to deliver a functional copy of the phenylalanine hydroxylase, or PAH, gene to the liver cells, where there is a missing or mutated PAH gene. This in vivo gene therapy approach is intended to enable the production of the PAH enzyme responsible for metabolizing phenylalanine, or Phe. People with PKU are not able to metabolize Phe properly resulting in elevated levels of Phe and if left untreated, can lead to severe neurological impairment. Phe reduction is an established clinical endpoint for PKU registrational trials. Homology's IND package contained preclinical data demonstrating that HMI-102 restored the normal biochemical pathway, including data showing that treatment with HMI-102 lowered serum Phe to normal levels within one week, which was durable for the lifespan of the murine model and lowered brain Phe to normal levels. HMI-102 also increased tyrosine, brain 5-hydroxyindoleacetic acid and changed coat color, indicating production of melanin.

FIXX Homology Medicines
$29.06

-0.38 (-1.29%)

01/07/19
ADAM
01/07/19
INITIATION
Target $37
ADAM
Buy
Homology Medicines initiated with a Buy at Canaccord
Canaccord analyst Michelle Gilson initiated Homology Medicines with a Buy rating as she views its gene editing platform tool as the most promising for in vivo therapy, overcoming the challenges with safety and efficacy that have limited nuclease-based editing platforms. The analyst expects its KU gene-transfer program updates to be a primary value driver in 2019. Gilson has a $37 price target on Homology Medicines shares.
01/07/19
01/07/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Amazon.com (AMZN) initiated with a Buy at Pivotal Research. 2. Dell Technologies (DELL) initiated with a Buy at Goldman Sachs. 3. Tencent Music (TME) initiated with an Overweight at KeyBanc, a Buy at Goldman Sachs, and a Hold at Stifel. 4. Huntington Ingalls (HII) initiated with a Neutral at JPMorgan. 5. Homology Medicines (FIXX) initiated with a Buy at Canaccord. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
02/20/19
HCWC
02/20/19
INITIATION
Target $36
HCWC
Buy
Homology Medicines initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay started Homology Medicines with a Buy rating and $36 price target. The analyst sees "disruptive potential" of the company's novel vectors and its high precision homologous DNA repair-based knockin applications.
02/20/19
02/20/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Kodiak Sciences (KOD) initiated with a Buy at Chardan. 2. Veeva (VEEV) initiated with an Equal Weight at Barclays. 3. Agios Pharmaceuticals (AGIO) assumed with a Perform at Oppenheimer. 4. OrthoPediatrics (KIDS) initiated with an Outperform at JMP Securities. 5. Homology Medicines (FIXX) initiated with a Buy at H.C. Wainwright. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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AEGN

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AMZN

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F

Ford

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