|Bid||112.00 x 1400|
|Ask||127.64 x 800|
|Day's Range||126.07 - 128.93|
|52 Week Range||112.00 - 274.03|
|Beta (5Y Monthly)||0.70|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||166.01|
Citigroup analyst Mohit Bansal rates Gilead stock at Buy but lowered his target price to $75 from $80. He sees two more years of revenue decline.
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 15) * Amicus Therapeutics, Inc. (NASDAQ: FOLD) * Beam Therapeutics Inc (NASDAQ: BEAM) * Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO) * Kronos Bio Inc (NASDAQ: KRON) (IPOed Friday) * Larimar Therapeutics Inc (NASDAQ: LRMR) * Pacific Biosciences of California Inc (NASDAQ: PACB) * Rocket Pharmaceuticals Inc (NASDAQ: RCKT) * Twist Bioscience Corp (NASDAQ: TWST)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Oct. 15) * ADC Therapeutics SA (NYSE: ADCT) * Alector Inc (NASDAQ: ALEC) * Artelo Biosciences Inc (NASDAQ: ARTL) * Aziyo Biologics Inc (NASDAQ: AZYO) * Codiak BioSciences Inc (NASDAQ: CDAK) (listed on Nasdaq Wednesday) * Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) * Dyne Therapeutics Inc (NASDAQ: DYN) * Pandion Therapeutics Inc (NASDAQ: PAND) * ProQR Therapeutics NV (NASDAQ: PRQR) * Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN) * Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP) (provided a strategic and corporate update) * Uniqure NV (NASDAQ: QURE)Stocks In Focus Zogenix Presents Data Showing Durability of Response For Seizure Drug Zogenix, Inc. (NASDAQ: ZGNX) released interim data from open-label extension trial, showing substantial seizure reductions were maintained when treated with Fintepla oral solution for up to two years. Post-hoc analysis showed number needed to treat to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies, the company added.Fintepla was approved by the FDA for the treatment of seizures associated with Dravet syndrome in June.The data was presented at the Child Neurology Society and International Child Neurology Congress.The stock rose 7.03% to $21 in after-hours trading.Amarin Presents Positive Post-hoc Analyses of Vascepa Data Amarin Corporation plc (NASDAQ: AMRN) presented at the Transcatheter Cardiovascular Therapeutics Connect 2020 post hoc subgroup analyses of REDUCE-IT study, showing Vascepa compared with placebo, significantly reduced primary composite first and total major adverse cardiovascular events, or MACE, in patients with a history of percutaneous coronary intervention by 34% and 39%, respectively.Vascepa reduced key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 34%, it added.In after-hours trading, the stock added 3.96% to $5.25.Chembio Submits EUA Application For Rapid COVID Antigen Test Chembio Diagnostics Inc (NASDAQ: CEMI) announced the submission of an application for emergency use authorization to the FDA for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes.The stock gained 3.53% to $4.99 in after-hours trading.Orchard Gets European Medicines Agency Committee's Recommendation For Rare Inherited Disease Orchard Therapeutics PLC - ADR (NASDAQ: ORTX) said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy, an investigational gene therapy for the treatment of metachromatic leukodystrophy, characterized by biallelic mutations in the ARSA gene.A final decision by the EC for Libmeldy is anticipated before the end of 2020, the company said.In premarket trading Friday, the stock was up 7.14% to $4.50.Galapagos' Osteoarthritis Drug Fails to Meet Primary, Secondary Endpoints In a Phase 2 Study Galapagos ADR Representing Ord Shs (NASDAQ: GLPG) and Servier announced topline results from their ROCCELLA Phase 2 study of GLPG1972/S201086 in osteoarthritis patients, showing no signal of activity was observed.The study participants were treated with three different once-daily oral doses of the combo over 52 weeks of treatment period. The primary objective of the study was to show efficacy of in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.Galapagos shares were slipping 8.48% to $126.75 in premarket trading.Intersect ENT Expects Q3 Revenues to Exceed Expectation Intersect ENT Inc (NASDAQ: XENT) announced preliminary third-quarter revenues of $22.4 million to $22.8 million, ahead of the $21.37-million consensus estimate. As of Sept. 30, cash and marketable securities stood at $130 million."Our solid third quarter preliminary revenue reflects a continuation of increased sequential sinus surgery procedure demand leading to strong volumes of PROPEL, with notable year-on-year growth of PROPEL in the office setting," the company said.Based on current trends, the company projected fourth-quarter revenues to be 85-90% of the year-ago revenues, while analyst estimate revenues to be about 95% of 2019 fourth-quarter levels.Offerings Rocket Pharmaceuticals announced the secondary offering of 17.34 million shares of its Class A ordinary shares by selling shareholders in an underwritten public offering has been priced at $42 apiece.The offering is expected to close Oct. 20.On The Radar Clinical Readouts Rocket Pharma is scheduled to present at the European Society for Immunodeficiencies 2020 meeting an update on data from the Phase 1 portion of the Phase 1/2 clinical trial of RP-L201, lentiviral-mediated ex-vivo gene therapy, for leukocyte adhesion deficiency-I. The company will also present an e-poster consisting of preclinical study data on RP-L401 for infantile malignant osteopetrosis.IPOs Irvine, California-based Tarsus Pharmaceuticals, Inc., which is focused on developing therapies primarily for ophthalmic conditions, priced its upsized initial public offering, or IPO, of 5.5 million shares at $16 for raising gross proceeds of $88 million. The company had earlier estimated a price range of $15-$17. The shares are expected to begin trading on the Nasdaq under the ticker symbol TARS.Aligos Therapeutics, Inc., a South San Francisco, California-based clinical-stage biopharma currently focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, priced its IPO of 10 million shares at $15 per share, which is at the mid-point of the estimated price range of $14-$16. The company expects to raise gross proceeds of $150 million from the offering. The shares will likely begin trading on the Nasdaq under the ticker symbol ALGS.Houston, Texas-based Kiromic biopharma, Inc. priced its upsized IPO of 1.25 million shares at $12 apiece, which is the lower bound of the estimated price range of $12-$14. Gross proceeds from the offering is estimated at $15 million. The immuno-oncology company said its shares will begin trading on the Nasdaq under the ticker symbol KRPB.Cambridge in Massachusetts-based Praxis Precision Medicines Inc. priced its upsized IPO of 10 million shares at $19, above the estimated price range of $16-$18. The company, which translates genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, expects the shares to be listed on the Nasdaq under the ticker symbol PRAX. Gross proceeds from the offering are expected at $190 million.Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * The Daily Biotech Pulse: Vertex Pulls Plug On Protein Deficiency Drug, FDA Nod For Regeneron's Ebola Treatment, Can Fite Issues Psoriasis Readout * The Daily Biotech Pulse: Patent Award For Theratechnologies, Enzo Biochem's Q4, Codiak Debuts(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Mechelen, Belgium and Paris, France, 15 OCTOBER 2020, 22.01 CET; regulated information –Servier and Galapagos NV (Euronext & NASDAQ: GLPG) report that no signal of activity was observed in the topline results in their ROCCELLA Phase 2 trial with GLPG1972/S201086. ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in 932 patients with knee osteoarthritis (OA) over 52 weeks of treatment. The study population was aged between 40 to 76 years (mean age was 63), mainly female (70%), and with a mean disease duration of 7 years.The primary objective of ROCCELLA was to demonstrate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.The trial failed to meet the primary objective. The change from baseline to week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for the placebo group and -0.068 (0.20), -0.097 (0.27) and -0.085 (0.22), for the low, medium and high dose, respectively. Statistically significant difference versus placebo was not reached in any of the treated groups.There was no significant difference compared to placebo observed on secondary endpoints, including clinical outcomes.Additional analyses are being conducted to fully evaluate the results, which will be presented at upcoming medical conferences.GLPG1972/S201086 was generally well-tolerated by patients in this Phase 2 trial.“While we are disappointed that ADAMTS-5 inhibition by GLPG1972/S201086 proved not to make a difference in this trial, we want to express our gratitude to all participating patients and investigators. This study result, while not what we hoped for, does add to the body of knowledge to help fight OA, a disease with substantial unmet medical need,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.“We are pleased to have performed this study with Galapagos. Unfortunately, the ROCCELLA results provided insufficient evidence of GLPG1972/S201086 efficacy in patients with knee osteoarthritis. We acknowledge the importance of assessing this innovative mechanism of action in the clinical setting and we will continue analyzing the data for better knowledge of the disease for the benefit of the patients and for future developments. We would like also to thank all patients and investigators for participating in this very important study,” said Dr. Patricia Belissa-Mathiot, Director of Clinical Development and R&D Chief Medical Officer at Servier.About the ROCCELLA trialROCCELLA was a multi-regional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in patients with knee osteoarthritis. ROCCELLA included 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos was responsible for ROCCELLA in the United States, where 326 patients were recruited. Servier was responsible for this trial in 11 countries, where 606 patients were recruited.About GalapagosGalapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.About ServierServier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 150 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier’s constant commitment in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, oncology and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. More information: www.servier.com.Contacts Galapagos Investor contacts Galapagos: Elizabeth Goodwin VP IR +1 781 460 1784 Sofie Van Gijsel Senior Director IR +32 485 19 14 15 email@example.com Media contacts Galapagos: Carmen Vroonen Global Head of Communications & Public Affairs +32 473 82 48 74 Anna Gibbins Senior Communications Director - Therapeutic Areas +44 7717 801900 firstname.lastname@example.org Contacts Servier:Media Relations:Sonia Marques : email@example.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13 Jean-Clément Vergeau : firstname.lastname@example.org – Tel. +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96Galapagos forward-looking statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to diﬀer materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with GLPG1972/S201086 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG1972/S201086 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including our collaboration partner for GLPG1972/S201086, Servier) and that Galapagos’ estimations regarding its GLPG1972/S201086 development program and regarding the commercial potential of GLPG1972/S201086, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation). Attachment * Galapagos and Servier report topline results for ROCCELLA Phase 2 clinical trial with GLPG1972 S201086 in knee osteoarthritis patients