Clearside Biomedical price target raised to $15 from $9 at Roth Capital » 09:4706/1806/18/21
Roth Capital analyst…
Roth Capital analyst Zegbeh Jallah raised the firm's price target on Clearside Biomedical to $15 from $9 and keeps a Buy rating on the shares after the company earlier this week reported data from Cohort 1 of its Phase 1/2a dose-escalation study of CLS-AX in pretreated wet age-related macular degeneration patients. Jallah says that while she expected clean safety given the low dose, increases in best corrected visual acuity beyond that achieved with Eylea were a surprise. With this "encouraging start," the analyst added CLS-AX to her model.
|Over a week ago|
Clearside Biomedical price target raised to $18 from $6 at Wedbush » 08:1306/1706/17/21
Wedbush analyst Liana…
Wedbush analyst Liana Moussatos raised the firm's price target on Clearside Biomedical to $18 from $6 and keeps an Outperform rating on the shares after the company reported positive initial safety results from cohort 1 of the Phase 1/2a OASIS study of CLS-AX in wAMD. The analyst argues that Clearside BioMedical is leveraging its proprietary suprachoroidal space microinjection platform to improve the delivery of drugs to treat eye diseases.
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Clearside reported 'impressive' data in wet AMD, says Roth Capital » 11:4806/1506/15/21
Roth Capital analyst…
Roth Capital analyst Zegbeh Jallah reiterates a Buy rating on Clearside Biomedical with a $9 price target after the company announced "impressive" early safety and efficacy data from Cohort 1 of its Phase 1/2a study of CLS-AX in pretreated wet age-related macular degeneration patients. CLS-AX was safe and well-tolerated with no inflammation, allowing for enrollment into Cohort 2, Jallah tells investors in a research note. Even "more impressive" was the early efficacy data showing that a single-dose of CLX-AX led to best corrected visual acuity improvements, beyond that achieved with "gold-standard" Eylea, which is a "game changer," says the analyst.
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Clearside report 'positive' safety results from OASIS Phase 1/2a trial of CLS-AX » 07:2506/1506/15/21
Clearside Biomedical announced positive safety results from Cohort 1 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX administered by suprachoroidal injection via Clearside's SCS Microinjector in six patients with neovascular age-related macular degeneration. The primary endpoints were achieved in Cohort 1, as the initial lowest planned dose of 0.03 mg CLS-AX was well tolerated with no serious adverse events and no drug related treatment emergent adverse events observed throughout the study period. There were no signs of inflammation, no vasculitis, no intraocular pressure safety signals, no dispersion of drug into the vitreous, or any other drug related adverse events observed in any of the patients. The OASIS Safety Monitoring Committee has reviewed the data and the trial will advance to Cohort 2. Clearside expects to begin Cohort 2 patient screening for a dose of 0.1 mg CLS-AX in June 2021 with completion of this four month study period expected by the end of the year. "We are very encouraged by the Cohort 1 results of the OASIS trial and we are immediately beginning Cohort 2 enrollment as planned," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "The initial data from Cohort 1 clearly achieved our safety and tolerability endpoints. While still early and recognizing there are a limited number of patients, we believe the Cohort 1 data supports our hypothesis that the combination of targeted and compartmentalized suprachoroidal delivery and the potent pan-VEGF attributes of axitinib may facilitate an effective treatment option for patients suffering from wet AMD."
Clearside success with Xipere can derisk pipeline, says Roth Capital » 13:3806/0206/02/21
After Clearside Biomedical (CLSD) and partner Bausch Health Companies (BHC) announced that the FDA has accepted the resubmitted New Drug Application for Xipere, Roth Capital analyst Zegbeh Jallah noted that progress had been slowed by manufacturing issues that resulted in a CRL. However, based on the NDA acceptance, the FDA's concerns have now been addressed, said Jallah, who is "clearly very bullish" on approval in October and a commercial launch in 2022. The analyst, who thinks approval of Xipere should derisk Clearside's SCS Microinjector and give Clearside some non-dilutive capital to advance its pipeline, keeps a Buy rating on the shares and identifies the stock as a 2021 top pick.
Bausch Health, Clearside announce FDA filing acceptance for XIPERE » 07:0306/0206/02/21
Bausch Health Companies…
Bausch Health Companies (BHC) along with Clearside Biomedical (CLSD) announced that the U.S. Food and Drug Administration has accepted the resubmitted New Drug Application for XIPERE. FDA determined that the filing is a Class 2 resubmission and therefore assigned a Prescription Drug User Fee Act action date of October 30, 2021. XIPERE is an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis.
|Over a month ago|
Clearside Biomedical price target raised to $9 from $8 at Roth Capital » 10:3105/1805/18/21
Roth Capital analyst…
Roth Capital analyst Zegbeh Jallah raised the firm's price target on Clearside Biomedical to $9 from $8 and keeps a Buy rating on the shares following the company's Q1 update. The analyst expects approval of Xipere by the end of 2021. The new drug application has been filed for Xipere, Clearside's suprachoroidally-delivered, proprietary formulation of triamcinolone for uveitis, which should trigger milestones from Bausch and Arctic Vision, Jallah tells investors in a research note. The analyst expects management to receive a response from the FDA around June 4 that should confirm the timing of the action date. Given expectations for a six-month review process, this could set the stage for a PDUFA by the end of 2021, says Jallah.
Clearside Biomedical reports Q1 EPS (10c), consensus (13c) » 16:2305/1705/17/21
Reports Q1 revenue…
Reports Q1 revenue $34,000, consensus $2.12M. "We have made meaningful, value-creating progress over the past several months," said George Lasezkay, Clearside's president and CEO. "In late April, we resubmitted our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for XIPERETM for the treatment of macular edema associated with uveitis. This milestone is important as XIPERE would be Clearside's first commercial product if approved by the FDA, and it would also be the first approved drug to be delivered into the suprachoroidal space (SCS(R)). Our innovative platform represents a potential breakthrough for delivering drugs to the back of the eye using a reliable, non-surgical, office-based method."