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ATOS

Atossa Genetics

$2.07

-0.03 (-1.43%)

08:31
07/17/19
07/17
08:31
07/17/19
08:31

Atossa Genetics provides information on FDA Expanded Acess policy

Atossa Genetics reported that patients and their doctors can now visit the company's website to obtain information about gaining access to the company's proprietary Endoxifen pursuant to the FDA's "Expanded Access" guidelines. The company's website includes its Expanded Access policy as well as an automated form that can be used by physicians to request that their patients be considered for this program. In December 2018, Atossa began providing its oral Endoxifen to a pre-menopausal, estrogen-receptor positive lacking CYP2D6 function, breast cancer patient under an FDA-approved "Single-Patient Expanded Access" IND. The purpose of this therapeutic approach was to reduce activity of the cancer cells prior to surgery. The patient received daily doses of Atossa's oral Endoxifen for approximately three weeks prior to surgery. There were no safety or tolerability issues and her surgery was successfully completed. The cancer cell biological activity was reduced, based on the estrogen receptor activity of the tumor cells and a 50 percent reduction in Ki-67. The FDA subsequently approved the use of Atossa's oral Endoxifen for this patient following her surgery under the same program.

ATOS Atossa Genetics
$2.07

-0.03 (-1.43%)

06/27/19
MAXM
06/27/19
DOWNGRADE
MAXM
Hold
Atossa Genetics downgraded to Hold from Buy at Maxim
Maxim analyst Jason McCarthy downgraded Atossa Genetics to Hold from Buy.
06/27/19
MAXM
06/27/19
DOWNGRADE
MAXM
Hold
Maxim downgrades Atossa Genetics to Hold on high endoxifen discontinuations
As previously reported, Maxim analyst Jason McCarthy downgraded Atossa Genetics to Hold from Buy after the company announced results from its Phase 2 study evaluating topical endoxifen in patients with mammographic breast density. Topical endoxifen showed a signal of efficacy and the trial hit its primary endpoint, but an 80% discontinuation rate due to skin rashes and local irritation raises questions and leaves him with doubt about the program, McCarthy tells investors. Based on his questions about the next steps and potential for short-term use, lower dose, or alternate delivery route, McCarthy removed topical endoxifen from his model and removed his prior price target of $9 on Atossa shares.

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