BioSpecifics Announces Label Expansion for Xiaflex in EU - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Feb 05, 2:31PM CST
Positive news flowed in for BioSpecifics Technologies Corp. (BSTC) when Swedish Orphan Biovitrum AB received approval from the European Commission to market Xiapex for an additional indication.
ENDP: 84.01 (+1.12), BSTC: 38.14 (-0.85), SCMP: 15.32 (+0.04), BIOD: 1.38 (-0.14)
BioSpecifics Technologies wins approval for XIAPEX in the EU for treating Peyronie's Disease
M2 - Tue Feb 03, 5:16AM CST
Biopharmaceutical company BioSpecifics Technologies (NasdaqGM:BSTC) reported on Monday the receipt of approval by the Swedish Orphan Biovitrum AB (Sobi) from the EU Commission to market XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces Approval of XIAPEX® in the EU for the Treatment of Peyronie's Disease
PR Newswire - Mon Feb 02, 7:30AM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced that Swedish Orphan Biovitrum AB (Sobi) has received approval from the EU Commission to market XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been approved in the U.S. for Peyronie's disease since December 2013 and is marketed by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium), now a wholly-owned subsidiary of Endo International plc.
BSTC: 38.14 (-0.85), AUXL: 36.47 (-0.06)
BioSpecifics Announces Positive Opinion by CHMP for XIAPEX® for the Treatment of Peyronie's Disease
PR Newswire - Mon Dec 22, 3:01PM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy.
BSTC: 38.14 (-0.85)
Insider Trading Alert - JBHT, BSTC And AAPL Traded By Insiders
at The Street - Wed Nov 26, 9:00AM CST
Stocks with insider trader activity include JBHT, BSTC and AAPL
BSTC: 38.14 (-0.85), JBHT: 82.88 (+1.09), AAPL: 127.08 (+0.62)
BioSpecifics Technologies Corp. Announces New Data on XIAFLEX® for Peyronie's Disease Presented at SMSNA Scientific Meeting
PR Newswire - Fri Nov 21, 7:30AM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced new data on XIAFLEX for the treatment of Peyronie's disease from the Phase 2 and the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, presented by BioSpecifics' licensee, Auxilium Pharmaceuticals, Inc. (Auxilium) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami, FL from November 20-23, 2014.
BSTC: 38.14 (-0.85), AUXL: 36.47 (-0.06)
Update: BioSpecifics Technologies Q3 2014 Earnings
Andy Batts - at Seeking Alpha - Fri Nov 21, 6:37AM CST
ENDP: 84.01 (+1.12), BSTC: 38.14 (-0.85), AUXL: 36.47 (-0.06)
BioSpecifics Technologies Corp. to Present at the Stifel 2014 Healthcare Conference
PR Newswire - Wed Nov 12, 3:01PM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that BioSpecifics' President, Tom Wegman, will present a corporate overview at the Stifel 2014 Healthcare Conference.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies (BSTC) Q3 2014 Results - Earnings Call Transcript
SA Transcripts - at Seeking Alpha - Mon Nov 10, 6:09PM CST
BSTC: 38.14 (-0.85)
BioSpecifics Tech beats by $0.01, beats on revenue
Seeking Alpha - at Seeking Alpha - Mon Nov 10, 7:11AM CST
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Reports Third Quarter 2014 Financial Results
PR Newswire - Mon Nov 10, 7:00AM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced its financial results for the third quarter ended September 30, 2014 and provided a corporate update.
BSTC: 38.14 (-0.85)
BioSpecifics Tech reports November 10
Seeking Alpha - at Seeking Alpha - Mon Nov 03, 12:11PM CST
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. to Host Conference Call to Report Third Quarter 2014 Financial Results on Monday, November 10, 2014
PR Newswire - Mon Nov 03, 7:30AM CST
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, announced today that it will host a conference call and live audio webcast at 8:30 a.m. EST on Monday, November 10, 2014 to report its third quarter 2014 financial results and provide a corporate update.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces FDA Approval of sBLA for XIAFLEX® for the Concurrent Treatment of Two Dupuytren's Contracture Cords
PR Newswire - Tue Oct 21, 7:00AM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) submitted by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) for XIAFLEX for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit. XIAFLEX obtained FDA approval in 2010 as the first and only nonsurgical treatment for adult Dupuytren's contracture patients with a palpable cord in the palm.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces Presentation of Encouraging Preclinical Data for CCH from Collaborative Uterine Fibroid Study with Duke Medicine
PR Newswire - Thu Oct 16, 7:30AM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, announces that a paper titled, "Stiffness of Human Uterine Fibroids is Reduced After Treatment with Purified Clostridial Collagenase due to Collagen Degradation" was presented at the Mechanotransduction in the Reproductive Tract conference hosted by the Campion Fund of the Phyllis and Mark Leppert Foundation for Fertility Research in Durham, North Carolina. The data being presented show that highly purified collagenase can reduce the rigidity of human uterine fibroid tissue and potentially shrink uterine fibroid tumors by interrupting the accumulation of poorly aligned and altered collagen.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces Sudden Passing of Director Max Link, Ph.D.
PR Newswire - Wed Oct 08, 3:05PM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), today announced with great sadness that Max Link, Ph.D., a member of its Board of Directors, passed away unexpectedly on October 5, 2014. He was 74 years old. Dr. Link served as the Chair of the Compensation Committee, as the Audit Committee Financial Expert and as a member of the Board's Audit, Compensation and Nominating and Corporate Governance Committees.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. to Present at the 21st Annual BioCentury NewsMakers in the Biotech Industry Conference
PR Newswire - Fri Sep 19, 7:30AM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that BioSpecifics' President, Tom Wegman, will present a corporate overview at the 21st Annual BioCentury NewsMakers in the Biotech Industry Conference.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces New MULTICORD and Retreatment Data for XIAFLEX® for Dupuytren's Contracture Presented at American Society for Surgery of the Hand Annual Meeting
PR Newswire - Thu Sep 18, 3:17PM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced that positive safety and efficacy data from the MULTICORD (MULtiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) Phase 3b study will be presented by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) at the 69th Annual Meeting of the American Society for Surgery of the Hand (ASSH) being held in Boston on September 18-20, 2014. Positive data were also presented from an additional study evaluating the retreatment of recurrent contracture in joints that were previously treated with CCH.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces Presentations at Upcoming Investor Conferences
PR Newswire - Tue Sep 02, 7:00AM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that BioSpecifics' President, Tom Wegman, will present at the following upcoming investor conferences.
BSTC: 38.14 (-0.85)
BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite
PR Newswire - Thu Aug 21, 4:36PM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced positive, statistically significant results from a randomized, double-blind Phase 2a study of CCH for the potential treatment of cellulite, or edematous fibrosclerotic panniculopathy. The results showed that all three doses of CCH used in the study, including a low, medium and high dose, demonstrated an improvement in the appearance of cellulite as measured by the trial endpoints of physician and patient-assessed improvements. CCH was well-tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.
BSTC: 38.14 (-0.85)