19:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
17:51 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Clearside discontinues combo therapy for retinal vein occlusion

Clearside Biomedical Inc. (NASDAQ:CLSD) discontinued development of Xipere (formerly CLS-TA) plus Eylea aflibercept to treat macular edema following retinal vein occlusion (RVO) after the combination missed the primary endpoint in the Phase III SAPPHIRE trial....
19:46 , Sep 12, 2018 |  BC Extra  |  Company News

Management tracks: Clearside, ImCheck

Clearside Biomedical Inc. (NASDAQ:CLSD) hired Leslie Zacks as general counsel and chief compliance officer. He was VP, general counsel and chief compliance officer at Arbor Pharmaceuticals Inc. (Atlanta, Ga.). Clearside plans to submit an NDA...
18:17 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Clearside reports Phase II DME data for CLS-TA

Clearside Biomedical Inc. (NASDAQ:CLSD) reported that suprachoroidal CLS-TA plus Eylea aflibercept led to a smaller gain in visual acuity and a greater incidence of both elevated intraocular pressure and cataracts compared with Eylea alone in...
21:35 , May 31, 2018 |  BC Extra  |  Clinical News

Clearside falls on Phase II DME data

Clearside Biomedical Inc. (NASDAQ:CLSD) lost $4.68 (32%) to $9.86 on Thursday after reporting that suprachoroidal CLS-TA plus Eylea aflibercept led to a smaller gain in visual acuity and a greater incidence of both elevated intraocular...
17:03 , Mar 16, 2018 |  BC Week In Review  |  Financial News

Clearside, G1 price upsized follow-ons

Ophthalmology company Clearside Biomedical Inc. (NASDAQ:CLSD) and cancer company G1 Therapeutics Inc. (NASDAQ:GTHX) each priced bumped-up follow-ons on the back of positive data, raising a total of $199.8 million. Clearside raised $85 million on March...
17:18 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Clearside macular edema program headed for submission

Clearside Biomedical Inc. (NASDAQ:CLSD) reported that suprachoroidal CLS-TA met the primary endpoint in the Phase III PEACHTREE trial to treat macular edema associated with non-infectious uveitis. Clearside plans to submit an NDA to FDA in...
21:38 , Mar 8, 2018 |  BC Extra  |  Financial News

Clearside, G1 price upsized follow-ons

Ophthalmology company Clearside Biomedical Inc. (NASDAQ:CLSD) and cancer company G1 Therapeutics Inc. (NASDAQ:GTHX) each priced bumped-up follow-ons on the back of positive data, raising a total of $185.3 million. Clearside raised $85 million through the...
21:24 , Mar 5, 2018 |  BC Extra  |  Clinical News

Clearside macular edema program headed for submission

Clearside Biomedical Inc. (NASDAQ:CLSD) added $2.51 (32%) to $10.33 on Monday after reporting that suprachoroidal CLS-TA met the primary endpoint in the Phase III PEACHTREE trial to treat macular edema associated with non-infectious uveitis. Clearside...
20:46 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

FDA lifts clinical hold on Cellectis' CAR T candidate

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) said FDA lifted a clinical hold on Phase I testing of its chimeric antigen receptor (CAR) T cell candidate UCART123 to treat acute myelogenous leukemia (AML) and blastic plasmacytoid dendritic cell...