|Bid||82.82 x 0|
|Ask||82.85 x 0|
|Day's Range||82.15 - 83.87|
|52 Week Range||65.09 - 96.38|
|Beta (5Y Monthly)||0.51|
|PE Ratio (TTM)||16.35|
|Earnings Date||Jul 21, 2020|
|Forward Dividend & Yield||2.95 (3.58%)|
|Ex-Dividend Date||Mar 03, 2020|
|1y Target Est||94.10|
Investors are excited about the biotech's prospects, but the company still has a long road ahead.
The FDA stretches the review period for Novartis' (NVS) sBLA, seeking approval for ofatumumab to treat patients with relapsing multiple sclerosis. A new date in September 2020 is set for the decision.
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 June 2) * Agenus Inc (NASDAQ: AGEN)(announced FDA clearance of its IND for evaluating its allogeneic iNKT therapy as a COVID-19 treatment option) * Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)(moved on a positive readout for a rival ulcerative colitis drug from Bristol-Myers Squibb Co (NYSE: BMY)) * argenx SE - ADR (NASDAQ: ARGX) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) * Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) * Cardiff Oncology Inc (NASDAQ: CRDF) * Fortress Biotech (NASDAQ: FBIO) * Imara Inc (NASDAQ: IMRA) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * ORIC Pharmaceuticals Inc (NASDAQ: ORIC) * Protara Therapeutics Inc (NASDAQ: TARA) * Qiagen NV (NYSE: QGEN) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) * Tenax Therapeutics Inc (NASDAQ: TENX)( announced a positive Phase 3 readout) * Trillium Therapeutics Inc (NASDAQ: TRIL) * Turning Point Therapeutics Inc (NASDAQ: TPTX) * Unity Biotechnology Inc (NASDAQ: UBX) * Vermillion, Inc. (NASDAQ: VRML) * Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)(announced FDA acceptance of its BLA for Danyelza for the treatment of patients with relapsed/refractory high-risk neuroblastoma)Down In The Dumps (Biotech Stocks Hitting 52-week Lows June 2) * Exagen Inc (NASDAQ: XGN)Stocks In Focus Novartis Announces 3-Month Extension In Regulatory Review Period For Multiple Sclerosis Drug Novartis AG (NYSE: NVS) announced the receipt of a notification from the FDA, extending the review of its sNDA for ofatumumab for patients with relapsing multiple sclerosis. The company said the regulatory action would happen in September.The company said it will continue to work with the FDA to complete the review as soon as possible. It also said additional regulatory filings are underway and that European approval of ofatumumab is expected in the second quarter of 2021.FSD Pharma Gets FDA Nod For Initiating Proof-of-concept Study Of COVID-19 Treatment Candidate FSD Pharma Inc (NASDAQ: HUGE) said the FDA has given it permission to submit an IND for the use of its FSD-201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. The company said it's focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.In pre-market trading, the stock was galloping 129.03% to $7.10.Novavax Partners With AGC Biologics to Manufacture Adjuvant Component of Coronavirus Vaccine partner AGC Biologics said Novavax, Inc. (NASDAQ: NVAX) has selected it for manufacturing Matrix-M, the adjuvant component of the latter's SARS-CoV-2 vaccine candidate, NVX-CoV2373, which enhances the immune response and stimulate high levels of neutralizing antibodies. AGC said it will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax' capacity to deliver doses in 2020 and 2021.Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates Anika's CFO to Quit Following a Transition Period Anika Therapeutics Inc (NASDAQ: ANIK) said its CFO Sylvia Cheung communicated her decision to relinquish office, effective August 21, 2020. The company said it has initiated a search to identify a successor.AnPac Bio Names New CFO AnPac Bio-Medical Science Co Ltd - ADR (NASDAQ: ANPC) announced the appointment of Jinqiu Tang as CFO of the company, effective June 1, succeeding Yu Zhang, who stepped down, effective May 31.Offerings Evofem Biosciences, Inc. (NASDAQ: EVFM) said it has priced its underwritten public offering of 28.50 million shares at $3.50 per share, for raising gross proceeds of $100 million. All the shares are being offered by the company. The company expects the offering to close on or about June 5.In pre-market trading, Evofem shares were slipping 12.66% to $4.07.EULAR 2020 Congress Presentations Eli Lilly And Co (NYSE: LLY) announced long-term data on Olumiant in patients with moderate to severe rheumatoid arthritis is to be presented at the at the European League Against Rheumatism, or EULAR, 2020 E-Congress. The study, according to the company, found that among patients with an inadequate response to methotrexate, or MTX, from drug initiation up to three years, 52% of patients initially treated with Olumiant (+MTX) were in a state of low disease activity at week 24 and this rate was maintained through week 148. The company also shared updated integrated safety analysis of Olumiant in the treatment of RA in patients treated up to 8.4 years, which showed no new safety signals.Replimune Group Inc (NASDAQ: REPL) announced new interim data from the study of patients with melanoma and non-melanoma skin cancers treated with RP1 combined with Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo, which showed the investigational asset continued to provide strong support for its lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD-1 refractory melanoma.On The Radar Clinical Readouts Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) will present at the EULAR, 2020 E-Congress Phase 1 data for mavrilimumab in COVID-19 treatment.IPOs San Francisco, California-based Pliant Therapeutics, Inc. priced its upsized initial public offering of 9-million share offering at $16, the upper bound of the estimated range of $14-$16. The clinical stage biopharma focused on discovering and developing novel therapies for the treatment of fibrosis said its shares will be listed on the Nasdaq under the ticker symbol PLRX.See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Roche's Combo Therapy In Liver Cancer, Allena Rips Higher, Pfizer To Invest Up To 0M In Biotechs * The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Phase III PREVENT data show Cosentyx® 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to.
Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the.
The company produced expectation-beating results. The acquisition of Celgene has gone very well, but shares trade with a multiple of less than 10 times earnings Continue reading...
Novartis announced today updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma1. Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years1.
Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in.
A subsidiary of the pharmaceutical giant will soon ramp up production of the nonprofit hospital's SARS-CoV-2 vaccine candidate, which has yet to enter human clinical trials.
Q1 GDP, Durable Goods and, of course, Initial Jobless Claims all hit the tape an hour before the bell, along with a new COVID-19 vaccine candidate and an executive order on social media.
Novartis re-entered vaccine making on Thursday, inking a manufacturing deal with a U.S. team whose COVID-19 candidate relies on technology similar to that of the Swiss drugmaker's $2.1 million-per-patient gene therapy, Zolgensma. Human trials are planned this year, said Massachusetts General Hospital and Massachusetts Eye and Ear, which are behind the early stage project, adding vaccine manufacturing at Novartis's AveXis gene therapy unit will start before Monday. While Novartis divested its vaccines business to GlaxoSmithKline in 2015, AveXis President David Lennon said his unit's gene therapy expertise made it a good fit to join the Massachusetts' effort, a major departure from traditional vaccine making.
Swiss drugmakers Roche and Novartis released data on Wednesday on treatments aimed at winning sales from each other in eye disease and multiple sclerosis, in a sign of rising rivalry. Facing each other across the Rhine in Basel, the drugmakers have clashed and cooperated over the years, but their latest products point to more direct competition. Roche <ROG.S> Chief Executive Severin Schwan is looking beyond cancer drugs to fresh treatment areas, while Novartis <NOVN.S> CEO Vas Narashiman bulks up in the same territory.
New MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program Subgroup analysis shows Kisqali plus endocrine therapy.
Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab.
Telehealth companies enabling individuals to see physicians without stepping foot into a physical doctor’s office are having their moment, as the coronavirus pandemic confines individuals and would-be patients across the country largely to their homes.
The hydroxychloroquine debate is far from over, as the drug gets qualified support from others deeply involved in the war against the coronavirus.
Zolgensma® (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy (SMA) and a clinical diagnosis of SMA Type.
The FDA lends a speedy nod to Deciphera's (DCPH) Qinlock for the treatment of fourth-line gastrointestinal stromal tumors. The approval comes three months ahead of schedule.
Any vaccine to fight the new coronavirus will not be ready for use for at least two years, the chief executive of Swiss pharmaceutical company Novartis, which no longer makes vaccines itself, told a German newspaper. Novartis sold its vaccine business in 2015 to GlaxoSmithKline, one of many companies around the world now racing to make a drug. "The results of the first clinical studies on the vaccine candidates should be available in autumn," Novartis CEO Vas Narasimhan told Frankfurter Allgemeine Zeitung (FAZ).
New Kisqali® (ribociclib)* overall survival subgroup analysis in HR+/HER2- advanced breast cancer (ABC) and additional Piqray® (alpelisib) data in patients in HR+/HER2- ABC.