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CLSD

Clearside Biomedical

$1.27

0.09 (7.66%)

07:10
08/22/19
08/22
07:10
08/22/19
07:10

Clearside Biomedical plans to resubmit XIPERE NDA in 1Q20

Clearside Biomedical announced an update regarding the Company's 505(b)(2) New Drug Application for XIPERE with the U.S. Food and Drug Administration. In a meeting this week, the FDA's Office of Pharmaceutical Quality requested that Clearside provide stability data for the triamcinolone acetonide suspension produced utilizing an enhanced manufacturing process implemented by the Company. The formulation of the TA suspension has not changed; however, OPQ requested the data to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process with that of the batches originally submitted as part of the NDA. The requested data does not relate to or affect the SCS Microinjector platform. As a result of this request, Clearside expects to receive a Complete Response Letter from the FDA on or before its October 19, 2019 PDUFA goal date. The Company plans to re-submit the NDA in the first quarter of 2020 with the requested stability data. "After a productive meeting with the FDA, the Agency has provided clear guidance on the Chemistry, Manufacturing, and Controls data to be included in the NDA resubmission," stated CEO George Lasezkay. "We believe this is primarily a timing issue since our stability data from previously manufactured batches have been consistent and predictable, and we have every reason to believe this will continue to be the case. We will complete these efforts as quickly as possible as we work towards approval of XIPERE as a potential treatment option for patients suffering from uveitic macular edema. Discussions with potential XIPERE out-licensing partners remain ongoing. We continue to expect that we will have sufficient resources to fund operations into the third quarter of 2020, without relying on any partnership-related payments that we might gain through XIPERE partnering or R&D collaboration agreements." Clearside believes the FDA will review the NDA within six months of the receipt of the resubmission.

  • 19

    Oct

CLSD Clearside Biomedical
$1.27

0.09 (7.66%)

08/09/19
NEED
08/09/19
DOWNGRADE
NEED
Hold
Clearside Biomedical downgraded to Hold from Buy at Needham
08/12/19
JMPS
08/12/19
NO CHANGE
Target $4
JMPS
Outperform
Clearside Biomedical price target lowered to $4 from $12 at JMP Securities
JMP Securities analyst Donald Ellis lowered his price target for Clearside Biomedical to $4 from $12 after the company said it will no longer directly commercialize Xipere and now plans to out-license the drug for uveitis and potentially additional indications. The analyst believes we believe Clearside is "highly likely" to find a partner and he expects a mid-teens royalty agreement with several commercial milestone payments and regulatory payments. Ellis now values the company on discounted cash flow based on the potential royalty stream instead of an enterprise value to sales ratio. He keeps an Outperform rating on Clearside Biomedical.
08/13/19
LDLW
08/13/19
DOWNGRADE
LDLW
Hold
Clearside Biomedical downgraded to Hold from Buy at Laidlaw
08/13/19
LDLW
08/13/19
DOWNGRADE
Target $2
LDLW
Hold
Laidlaw downgrades Clearside Biomedical to Hold after Xipere partnering
As previously reported, Laidlaw analyst Francois Brisebois downgraded Clearside Biomedical to Hold from Buy as he believes the company's decision to out-license their main product, Xipere, adds uncertainty for the foreseeable future in terms of topline growth. He lowered his price target on Clearside shares to $2 from $5, stating that he values CLS-TA for U.S. uveitis at $1.50 per share and the company's cash and technology at 50c per share.

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