|Bid||15.86 x 1800|
|Ask||15.87 x 1800|
|Day's range||15.68 - 16.22|
|52-week range||11.15 - 31.97|
|Beta (5Y monthly)||1.14|
|PE ratio (TTM)||N/A|
|Forward dividend & yield||N/A (N/A)|
|Ex-dividend date||10 Nov 2010|
|1y target est||26.76|
Presented the most robust aggregate dataset of suprachoroidal clinical injections demonstrating reliability and consistency of procedureALPHARETTA, Ga., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today several clinical data presentations were given at the virtual 53rd Annual Scientific Meeting of The Retina Society. Clearside also announced that data from the Company’s Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina and can be accessed here. The trial, entitled TYBEE, evaluated the investigational drug XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) when used with intravitreally administered aflibercept in patients with DME over a 6-month evaluation period. This early data suggests that, if approved, XIPERE administered suprachoroidally, may have the potential to reduce treatment burden for some patients.“Our primary goal at Clearside is to deliver targeted treatments for patients suffering from serious retinal diseases,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “We are committed to educating physicians and the broader retinal community on our programs. The presentations delivered this week and the publication of our work in DME underscore the broad scope of development activities for our suprachoroidal injection platform. We continue to expand our pipeline with new opportunities and indications and look forward to starting our Phase 1/2a clinical trial with CLS-AX in neovascular age-related macular degeneration (wet AMD) this year.”Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD) Authors: David Brown; Viral Kansara; Thomas Ciulla Conclusions: CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity. There was sustained, high exposure observed in ocular tissues with the highest concentration found in the tissues of the sclera, choroid, and retinal pigment epithelium (RPE), followed by the retina. CLS-AX has intrinsic high potency, pan-VEGF inhibition through receptor blockade, and demonstrated prolonged duration observed in pharmacokinetic studies, as well as pharmacodynamic effect in multiple animal models. CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection and has the potential to be a bi-annual therapy for wet AMD.Title: Post Hoc Analysis of Clinical Suprachoroidal Injection Experience Across Indications Author: Chris Henry; faculty sponsor Amy Schefler; Cherry Wan; Barry Kapik; Colette Hall; Thomas Ciulla Conclusions: To date, this is the most robust aggregate dataset of clinical suprachoroidal injections with mounting evidence pointing to the potential reliability and consistency of the procedure. The results from the retrospective analysis demonstrated the robustness of the suprachoroidal injection regardless of indications. The two needle length options successfully accommodated for anatomical variations across patients.Title: Suprachoroidal Delivery of Small Molecule Suspensions and Nanoparticles Authors: Judy Kim; Viral Kansara; Thomas Ciulla Conclusions: Delivery of small molecule suspensions may provide targeted, well-tolerated, and long-acting delivery of a wide variety of pharmacologic agents, including corticosteroids, tyrosine kinase inhibitors (TKIs), and complement inhibitors to the RPE, sclera and choroid. Preclinical models for these compounds were promising and based on the favorable clinical results of a small molecule corticosteroid for macular edema associated with noninfectious uveitis, further testing is warranted for these other molecules. Additionally, suprachoroidal delivery of DNA nanoparticle-based gene has potential as an office-based retinal gene therapy; and further testing is warranted.Title: Suprachoroidally delivered non-viral DNA nanoparticles transfect chorioretinal cells in non-human primates and rabbits Authors: Nancy Holekamp; Viral Kansara; Thomas Ciulla Conclusions: Suprachoroidal injections of DNA Nanoparticles may address several unmet needs in ocular gene delivery. DNA nanoparticles are relatively non-immunogenic compared to viral vector-based gene therapy, and suprachoroidal injection facilitates the potential for office-based repeat dosing with fewer safety risks compared to subretinal injection via pars plana vitrectomy surgery. In addition, DNA nanoparticles can transfer genes beyond the capacity of viral vectors, including those in common inherited retinal diseases (IRDs) such as Stargardt disease and Usher syndrome. Additional research evaluating suprachoroidal injection in non-human primates and delivery of a therapeutic transgene is needed.Title: Results from the Phase 3 PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy of CLS-TA, a Post-Hoc Analysis Authors: Pauline Merrill; Thomas Ciulla Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. With respect to best corrected visual acuity (BCVA) and central subfield thickness (CST), CLS-TA showed a clinically meaningful relative benefit over control in patients receiving systemic immunosuppression and patients not receiving systemic immunosuppression.Title: Correlation of Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Uveitis Authors: Michael Ip; Thomas Ciulla Conclusions: In this cohort of over 1,000 eyes, there were moderate baseline relationships between BCVA and CST in patients with macular edema (ME) due to retinal vein occlusion (RVO), diabetic macular edema (DME) and noninfectious uveitis. There were also moderate relationships between BCVA and CST across these disease states with respect to change from baseline to 6 months. These correlations provide context around the use of CST in clinical decision making.Title: Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Macular Edema Due to Retinal Vein Occlusion: An Analysis of 12,214 Eyes Authors: Thomas Ciulla; John Pollack; David Williams Conclusions: Real-world RVO patients with macular edema experience worse visual outcomes compared with patients in randomized controlled trials. Mean change in visual acuity (VA) correlated with treatment intensity at 1 year. Patients with better VA at presentation tended to be particularly vulnerable to vision loss.Copies of these presentations will be available on Clearside’s website under the Publications & Presentations page here: https://www.clearsidebio.com/publications.htm.About Clearside’s Suprachoroidal Space (SCS®) Injection PlatformClearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The company’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.About CLS-AX (axitinib injectable suspension)CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.About Clearside BiomedicalClearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.Cautionary Note Regarding Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of the Phase 1/2a clinical trial for CLS-AX in wet AMD. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.Investor and Media Contacts: Jenny Kobin Remy Bernarda firstname.lastname@example.org (678) 430-8206Source: Clearside Biomedical, Inc.
Bausch (BHC) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
* Patent challenge initiated by Bausch Health Companies NESS ZIONA, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that Bausch Health Companies, Inc. (NYSE:BHC) initiated patent infringement action in the U.S. District Court for the District of New Jersey on August 31, 2020 with regards to Perrigo Company plc (“Perrigo”) (NYSE; TASE: PRGO) Abbreviated New Drug Application (“ANDA”) for a generic version of Duobrii® (halobetasol propionate and tazarotene) lotion, for the treatment of plaque psoriasis in adults1.On July 23, 2020, Sol-Gel’s partner Perrigo filed a Notice of first-to-file Paragraph IV Certification asserting that certain U.S. patents, each of which is listed in the FDA's Orange Book for Duobrii® (halobetasol propionate and tazarotene) lotion, are either invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of Perrigo’s generic lotion.Development of halobetasol propionate and tazarotene lotion is covered under a previous collaboration between Sol-Gel and Perrigo. Consistent with Sol-Gel’s prior agreements with Perrigo, Perrigo will seek regulatory approval with the U.S. Food and Drug Administration (“FDA”) for the generic product candidate. If approved by the FDA, Perrigo will lead the commercialization efforts for the generic product candidate in the United States. Sol-Gel and Perrigo will share the development costs and any gross profits generated from potential sales of the generic product candidate.Annual market sales of Duobrii® for the last 12 months ended July 2020 amounted to $88.4 million2.About Sol-Gel TechnologiesSol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of Twyneo, under investigation for the treatment of acne vulgaris, and Epsolay, under investigation for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding that Perrigo will seek regulatory approval of the generic product candidate. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, risks relating to the effects of COVID-19 (coronavirus), the timing of a launch of a branded tapinarof product and the launch of a branded topical roflumilast in the U.S., risks related to the timing of the submission of an NDA for Epsolay and an NDA for Twyneo as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 24, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.For further information, please contact:Sol-Gel Contact: Gilad Mamlok Chief Financial Officer +972-8-9313433Investor Contact: Lee M. Stern Solebury Trout 646-378-2922 email@example.comSource: Sol-Gel Technologies Ltd.1 The patents-in-suit are U.S. Patent Nos. 8,809,307; 10,478,502; 10,251,895; and 10,426,787. 2 Source: Symphony Health