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AXGT

Axovant

$5.54

0.22 (4.14%)

07:24
10/23/19
10/23
07:24
10/23/19
07:24

Axovant presents preliminary data from expanded access study of AXO-AAV-GM2

Axovant Gene Therapies announced preliminary data from an expanded access study administering investigational AXO-AAV-GM2 gene therapy in two patients with infantile Tay-Sachs disease at the 27th Annual Congress of the European Society of Gene and Cell Therapy. Infantile TSD, a rapidly progressive and fatal pediatric neurodegenerative genetic disorder, has a median life expectancy of approximately 3-4 years. This data indicates the potential to modify the rate of disease progression in children with infantile TSD. Key findings from this first-in-human study in patients treated with AXO-AAV-GM2, an investigational gene therapy designed to restore beta-Hexosaminidase A enzyme activity in the central nervous system, include: AXO-AAV-GM2 was successfully administered in both patients and has been generally well-tolerated to date, with no serious adverse events or clinically-relevant laboratory abnormalities related to therapy. First child with advanced infantile TSD, dosed in November 2018, is clinically stable at 41 months of age. Patient had severe, advanced disease at time of dosing. Route of administration included cisterna magna and lumbar region delivery via intrathecal catheter. Intra-thalamic dosing was not possible due to the patient's advanced disease. Observed maintenance of motor skills, as measured by the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders, with baseline total score of 14 increased to a total score of 18 at month 6 following gene transfer and ranged between 14-18 from week 1 to month 6. Hex A enzyme activity in cerebrospinal fluid increased by approximately 3-fold at month 3 and month 6 relative to baseline. Second child with infantile-onset TSD, dosed in June 2019, is clinically stable at 11 months of age. Patient was dosed with gene therapy prior to onset of severe symptoms. The route of administration was bilateral intraparenchymal thalamic and intracisternal/intrathecal. Clinical disease stabilization was observed in the treated child, with attainment of normal developmental milestones and a normal neurologic exam at 10 months of age. No seizure activity and no exaggerated startle responses were observed. By contrast, the patient's untreated, two older siblings with TSD exhibited rapid disease progression, clinical regression and seizure onset at 10-12 months of age.Brain MRI taken at 10 months of age demonstrated normal brain anatomy and increased myelination, consistent with normal brain development at this age. By contrast, commonly reported MRI findings in infantile TSD at this age include demyelination and cerebral and cerebellar atrophy. CHOP INTEND total score was 58 at baseline, increased to a total score of 60 at month 3 following gene transfer and ranged between 58-61 from week 2 to month 3. Hex A enzyme activity in CSF increased to 1.8% of normal enzyme activity between baseline and 3 months/

AXGT Axovant
$5.54

0.22 (4.14%)

06/06/19
JMPS
06/06/19
NO CHANGE
Target $28
JMPS
Outperform
Axovant price target raised to $28 after reverse split at JMP Securities
JMP Securities analyst Jason Butler raised his price target on Axovant shares to $28 from $8 to account for the stock's 1-for-8 reverse split and other share count changes. Additionally, he noted that he is enthused by the sustained improvements in OFF score that were reported at six months in the first cohort in the ongoing SUNRISE-PD Phase 2 trial in Parkinson's disease. Butler keeps an Outperform rating on Axovant shares, telling investors that today's updated results give him greater confidence in both the consistency and durability of benefits for AXO-Lenti-PD.
06/21/19
LEER
06/21/19
INITIATION
Target $18
LEER
Outperform
Axovant initiated with an Outperform at SVB Leerink
SVB Leerink initiated Axovant with an Outperform and $18 price target.
08/12/19
BARD
08/12/19
UPGRADE
Target $13
BARD
Outperform
Axovant upgraded to Outperform from Neutral at Baird
Baird analyst Brian Skorney upgraded Axovant Gene Therapies to Outperform from Neutral while lowering his price target for the shares to $13 from $16.
08/12/19
BARD
08/12/19
UPGRADE
Target $13
BARD
Outperform
Axovant upgraded to Outperform at Baird
As reported previously, Baird analyst Brian Skorney upgraded Axovant to Outperform from Neutral. The analyst cited excitement over the upcoming release of its gene-therapy data. He believes success in anyone of its three ongoing gene therapy programs would represent significant upside to today's value. Skorney lowered his price target to $13 from $16 on Axovant shares.

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$NSD

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