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CLSD

Clearside Biomedical

$1.45

-0.135 (-8.52%)

07:08
02/20/19
02/20
07:08
02/20/19
07:08

Clearside receives notification of FDA acceptance of NDA filing for Xipere

Clearside Biomedical announced that it received notification from the U.S. Food and Drug Administration that the Agency has accepted for review the New Drug Application for XIPERE for Suprachoroidal Injection for the treatment of macular edema associated with uveitis. The FDA has determined that the application is sufficiently complete to permit a substantive review. The PDUFA goal date has been assigned for October 19, 2019. This date reflects a standard review period and is consistent with management's expectations for the 505(b)(2) filing. The NDA filing is supported by data from the Phase 3, PEACHTREE clinical trial that demonstrated significant and clinically meaningful improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. Also, in patients with active inflammation at baseline, resolution was achieved in more than two-thirds of those treated with XIPERE across three commonly used measures of inflammation: vitreous haze, anterior chamber cells and anterior chamber flare.

CLSD Clearside Biomedical
$1.45

-0.135 (-8.52%)

11/05/18
JPMS
11/05/18
DOWNGRADE
Target $8
JPMS
Underweight
JPMorgan double downgrades Clearside to Underweight on study failure
JPMorgan analyst Anupam Rama double downgraded Clearside Biomedical to Underweight from Overweight and lowered his price target for the shares to $8 from $16. The stock in early trading is down 56%, or $3.12, to $2.44. The analyst also removed Clearside from his firm's Analyst Focus List. The company this morning announced that the Phase 3 Sapphire results for Xipere plus Eylea in retinal vein occlusion did not meet the primary endpoint of third-line gainers versus Eylea alone, Rama tells investors in a research note. The results are "clearly disappointing," says Rama. The analyst sees no material value creation catalysts on the horizon and believes the overall negative sentiment on shares is unlikely to change until the company is closer to approval/commercialization.
11/05/18
COWN
11/05/18
DOWNGRADE
COWN
Market Perform
Clearside Biomedical downgraded earlier to Market Perform at Cowen
11/05/18
STFL
11/05/18
DOWNGRADE
Target $4
STFL
Hold
Clearside Biomedical downgraded to Hold from Buy at Stifel
Stifel analyst Annabel Samimy earlier downgraded Clearside Biomedical to Hold from Buy following the failure of the SAPPHIRE trial in RVO and subsequent discontinuation of the program. Clearside's value now depends primarily on the success of Xipere for the treatment of macular edema associated with non-infectious uveitis, said Samimy, who lowered her price target on the stock to $4 from $20. The SAPPHIRE failure also has implications for the future clinical design for DME, since "designing it as a superiority trial appears off the table now," Samimy believes.
11/06/18
NEED
11/06/18
NO CHANGE
Target $4
NEED
Buy
Clearside Biomedical price target lowered to $4 from $22 at Needham
Needham analyst Serge Belanger lowered his price target on Clearside Biomedical to $4 after its announcement yesterday that the Sapphire Phase 3 study evaluating Xipere in RVO patients did not meet its primary endpoint. The analyst also keeps his Buy rating, stating that while Clearside Biomedical is discontinuing the clinical development of its RVO program, it will remain focused on the Xipere opportunity in uveitis. Belanger adds that the valuation on the shares is now below cash levels and fails to capture the uveitis opportunity with potential peak sales of as high as $150M.

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