|Bid||3.3700 x 1100|
|Ask||3.3900 x 1100|
|Day's Range||3.3500 - 3.4900|
|52 Week Range||2.8500 - 12.2000|
|Beta (5Y Monthly)||0.83|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 16, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
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 March 8) Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) Bausch Health Companies Inc. (NYSE: BHC) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) Second Sight Medical Products, Inc. (NASDAQ: EYES) (follow-on buying following FDA nod for its Argus 2 retinal prosthesis system) Surmodics, Inc. (NASDAQ: SRDX) Down In The Dumps (Biotech Stocks Hitting 52-week Lows March 8) Decibel Therapeutics, Inc. (NASDAQ: DBTX) Foghorn Therapeutics Inc. (NASDAQ: FHTX) Freeline Therapeutics Holdings plc (NASDAQ: FRLN) Galapagos NV (NASDAQ: GLPG) Immunocore Holdings plc (NASDAQ: IMCR) Lucira Health, Inc. (NASDAQ: LHDX) Opthea Limited (NASDAQ: OPT) Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) Talis Biomedical Corporation (NASDAQ: TLIS) (announced withdrawal of application for emergency use authorization for One COVID-19 test in the CLIA moderate setting) Stocks In Focus FDA Finds Deficiencies In Acadia's Regulatory Application For Dementia Drug As part of its ongoing review of ACADIA Pharmaceuticals Inc.'s (NASDAQ: ACAD) supplemental new drug application for pimavanserin, the FDA said in a March 3 letter it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. Pimavanserin is being evaluated for the treatment of hallucinations and delusions associated with dementia-related psychosis. The notification does not reflect a final decision on the information under review, the FDA said. The agency has assigned a PDUFA action date of April 3 for completing the review. Acadia said it plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. The stock was down 44.67% premarket at $25.33. Lilly To Collaborate With Biolojic To Develop Diabetes Antibody Therapy Eli Lilly and Company (NYSE: LLY) announced a research collaboration and license agreement with Biolojic that will leverage the latter's AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes. Under the terms of the agreement, Lilly will pay research fees associated with the collaboration. Biolojic is eligible to receive up to a total of $121 million, consisting of potential development and commercialization milestones and a promissory note that may be convertible into Biolojic equity at a future date. Biolojic is also eligible to receive tiered royalties in the low- to mid-single digits on product sales should Lilly successfully commercialize a therapy from the collaboration. Aytu Reports Positive Results For Pilot Study Of Ultraviolet Ray Treatment In COVID-19 Patients Aytu BioScience, Inc. (NASDAQ: AYTU) announced positive results from a pilot study that evaluated endotracheal application of ultraviolet A light in critically ill coronavirus-2 patients with severe acute respiratory syndrome. The treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well-tolerated. The stock was up 11.01% premarket at $8.57. Novartis Partner Reports Positive Results For Phase 1 Study of COVID-19 Antiviral Treatment Novartis AG (NASDAQ: NVS) and Molecular Partners announced positive results for the Phase 1 study of ensovibep, a tri-specific COVID-19 antiviral treatment, in healthy volunteers. Preliminary results showed extended exposure of the candidate in serum, with a half-life of two to three weeks, in line with the results from preclinical experiments. These data confirm the systemic administration of a multi-specific DARPin antiviral therapy to be safe and well-tolerated, and support advanced plans for additional clinical work in positively diagnosed patients. Roche's Companion Diagnostic Test For Lung Cancer Approved By FDA Roche Holding AG (OTC: RHHBY) announced FDA approval of the ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer Inc.'s (NYSE: PFE) drug Lorbrena. It is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Lorbrena, the company said. Related Link: The Week Ahead In Biotech (March 7-13): Conference Presentations And More Earnings Xenon To Collaborate With Icahn School of Medicine On Midstage Study Of Depression Drug Xenon Pharmaceuticals Inc. (NASDAQ: XENE) announced a collaboration with the Icahn School of Medicine at Mount Sinai for an investigator-sponsored Phase 2 proof-of-concept clinical trial of XEN1101 for the treatment of major depressive disorder and anhedonia, which is an inability to feel pleasure. Xenon will supply the study drug. View more earnings on IBB The study is expected to commence in the second quarter of 2021. Titan Medical Rallies On Corporate Update In conjunction with a presentation at H.C. Wainwright conference, Titan Medical Inc. (NASDAQ: TMDI) issued a corporate update, highlighting a market opportunity that it said is running at an annual rate of $18 billion. The company said it expects to generate $21 million in additional license revenue in 2021. The stock was jumping 5.17% to $1.83 in premarket trading Tuesday. NanoViricides Reports Positive Preclinical Results For COVID-19 Drug Candidates NanoViricides, Inc. (NASDAQ: NNVC) reported on the strong effectiveness of its two COVID-19 clinical drug candidates in an animal model of coronavirus infection. The company said it is preparing a pre-IND application encompassing its two clinical drug candidates for the treatment of COVID-19 infected patients. The stock was rallying 8.25% to $5.38 in premarket trading Tuesday. Takeda To Acquire Immunotherapy Company Maverick Therapeutics Takeda Pharmaceutical Company Limited (NYSE: TAK) announced the exercising of its option to acquire Maverick Therapeutics, a private biotech engaged in the development of immunotherapies. Under the agreement, Takeda will obtain Maverick's T-cell engager COBRA platform and a broad development portfolio. The portfolio includes Maverick's lead development candidate TAK-186, which is in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280, which is anticipated to enter the clinic in the second half of Takeda's fiscal 2021 for the treatment of patients with B7H3-expressing solid tumors. Earnings Skin cancer diagnostics company Castle Biosciences, Inc. (NASDAQ: CSTL) reported a decline in its fourth-quarter revenue from $17.6 million in 2019 to $17.3 million in 2020. The company reversed from a profit of 11 cents per share to a loss of 23 cents per share. Separately, the company said its DecisionDx-Melanoma prognostic gene expression profile test for cutaneous melanoma now utilizes an integrated test result that is designed to provide a more precise risk prediction in patients with stage I, II or III melanoma. The company said it plans to launch an app later in 2021 for dermatology clinicians, featuring an interactive algorithm using the 31-GEP test score and traditional clinicopathologic factors to predict risk. In after-hours trading, the stock fell 6.1% to $62.05. Cerecor Inc. (NASDAQ: CERC) reported a decline in revenue from $6.75 million in fiscal year 2019 to $6.7 million in 2021. The net loss per share widened from $1.41 to $4.32, dragged by higher R&D expenses and one-time charges. The stock moved down 5.23% to $2.90 in after-hours trading. Offerings Hoth Therapeutics, Inc. (NASDAQ: HOTH) said it has entered a definitive agreement with certain institutional and accredited investors for the sale of an aggregate of 7.595 million shares of its common stock, and warrants to purchase up to an aggregate of 7.595 million shares of common stock, at a purchase price of $1.975 per share and accompanying warrant in a private placement priced at-the-market. The gross proceeds to the company from the private placement are expected to be approximately $15 million. The private placement is expected to close on or about March 10, subject to the satisfaction of customary closing conditions. The stock was down 5.7% premarket at $1.82. On The Radar Earnings Orgenesis Inc. (NASDAQ: ORGS) (before the market open) Xeris Pharmaceuticals, Inc. (NASDAQ: XERS) (before the market open) Trevena, Inc. (NASDAQ: TRVN) (before the market open) InspireMD, Inc. (NYSE: NSPR) (before the market open) Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) (before the market open) DarioHealth Corp. (NASDAQ: DRIO) (before the market open) Gamida Cell Ltd. (NASDAQ: GMDA) (before the market open) Evelo Biosciences, Inc. (EVLO) (before the market open) ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (before the market open) Aquestive Therapeutics, Inc. (NASDAQ: AQST) (after the close) Brickell Biotech, Inc. (NASDAQ: BBI) (after the close) Cytosorbents Corporation (NASDAQ: CTSO) (after the close) Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) (after the close) MiMedx Group, Inc. (NASDAQ: MDXG) (after the close) Inari Medical, Inc. (NASDAQ: NARI) (after the close) Lyra Therapeutics, Inc. (NASDAQ: LYRA) (after the close) Lumos Pharma, Inc. (NASDAQ: LUMO) (before the market open) Outset Medical, Inc. (NASDAQ: OM) (before the market open) Other Events CorMedix Inc. (NASDAQ: CRMD) is scheduled to host a conference call relating to a regulatory update for DefenCath at 8:30 a.m. Defencath is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related blood stream infections. The company had a PDUFA date of Feb. 28 for the NDA for defencath, which is being evaluated for preventing catheter-related infections in hemodialysis patients. Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Week Ahead In Biotech (March 7-13): Conference Presentations And More EarningsThe Daily Biotech Pulse: Fulgent's Big Quarter, Gilead Awaits FDA Decision, Apellis Winds Up COVID-19 Study© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
SHELTON, CT / ACCESSWIRE / March 9, 2021 / NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its two COVID-19 clinical drug candidates in an animal model of coronavirus infection.
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 March 1) Acceleron Pharma Inc. (NASDAQ: XLRN) Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) Aslan Pharmaceuticals Ltd (NASDAQ: ASLN) (announced positive results for atopic dermatitis study) AtriCure, Inc. (NASDAQ: ATRC) Bioanalytical Systems, Inc. (NASDAQ: BASI) Cullinan Oncology, Inc. (NASDAQ: CGEM) Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) Gemini Therapeutics, Inc. (NASDAQ: GMTX) Glaukos Corp (NYSE: GKOS) I-Mab (NASDAQ: IMAB) Inspire Medical Systems Inc (NYSE: INSP) Krystal Biotech, Inc. (NASDAQ: KRYS) (reacted to fourth-quarter results) Landos Biopharma, Inc. (NASDAQ: LABP) Morphic Holding, Inc. (NASDAQ: MORF) (announced positive early stage data for irritable bowel syndrome drug) Organogenesis Holdings Inc (NASDAQ: ORGO) Pandion Therapeutics Inc (NASDAQ: PAND) PLx Pharma Inc. (NASDAQ: PLXP) (announced label expansions for lead products Vazalore 325 mg and Vazalore 81 mg) Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) Terns Pharmaceuticals, Inc. (NASDAQ: TERN) Theratechnologies Inc. (NASDAQ: THTX) Down In The Dumps (Biotech Stocks Hitting 52-week Lows March 1) Athenex Inc (NASDAQ: ATNX) (announced FDA rejection for its application for oral paclitaxel combo for breast cancer) Intercept Pharmaceuticals Inc (NASDAQ: ICPT) Karyopharm Therapeutics Inc (NASDAQ: KPTI) Lucira Health Inc (NASDAQ: LHDX) Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) Stocks In Focus Merck Withdraws Keytruda For Metastatic Small-Cell Lung Cancer In US Merck & Co., Inc. (NYSE: MRK) said it is voluntarily withdrawing the U.S. indication for Keytruda for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal of this indication was done in consultation with the FDA, it added. Merck is working to complete this process over the coming weeks. This decision does not affect other indications for the company's anti-PD-1 therapy, it said. Merck received accelerated approval for Keytruda for small-cell lung cancer in 2019. However, the confirmatory trial, dubbed KEYNOTE-604, did not reach statistical significance for one of the two primary endpoints of overall survival. The stock edged down 0.11% to $72.30 in after-hours trading. FibroGen-AstraZeneca's Roxadustat Review Delayed As FDA Schedules Adcom Meeting FibroGen Inc (NASDAQ: FGEN) and AstraZeneca plc (NASDAQ: AZN) announced FDA's Cardiovascular and Renal Drugs Advisory Committee will hold an advisory committee meeting to review the new drug application for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA. "While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible," said Enrique Conterno, CEO of FibroGen. The PDUFA date, originally scheduled for March 20, will now likely be delayed. Separately, FibroGen reported a sharp increase in fourth-quarter revenues to $65 million in 2020 from $8 million in 2019, with $29.2 million of it coming from Roxadustat sales in China. The company reported a wider-than-expected net loss for the fourth quarter. FibroGen shares were down 24.6% at $38.10 premarket Tuesday. Argenx's Regulatory Application For Efgartigimod In Neuromuscular Disease Accepted For Review Argenx SE (NASDAQ: ARGX) announced that FDA has accepted for review the biologics license application for intravenous efgartigimod, the company's investigational FcRn antagonist and lead product candidate, for the treatment of generalized myasthenia gravis. The FDA has set a standard 10-month review process with a PDUFA target action date of Dec. 17, 2021. Related Link: The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings NanoViricides' Coronavirus Drug Candidates Found Effective In Preclinical Lab Studies NanoViricides, Inc. (NASDAQ: NNVC) reported on the strong pan-coronavirus effectiveness of its two COVID-19 clinical drug candidates for which the company is preparing a pre-IND application. NV-CoV-2 is the company's broad-spectrum, anti-coronavirus clinical lead drug candidate for the treatment of COVID-19 patients based on its nanoviricides platform. In addition, the company is also developing NV-CoV-2-R, a drug treatment that combines both NV-CoV-2 and remdesivir in a single drug that encapsulates and protects remdesivir inside NV-CoV-2. Both NV-CoV-2 and NV-CoV-2-R are expected to work against most, if not all, coronaviruses and their variants, the company said. The stock was jumping 108.06% to $8.78 in premarket trading Tuesday. Cerecor Reports Positive Midstage Results For CERC-002 In COVID-19 Cerecor Inc. (NASDAQ: CERC) announced final efficacy data including 60-day mortality from its recently completed U.S.-based, Phase 2 trial of the human anti-LIGHT monoclonal antibody CERC-002, showing the investigational asset achieved the primary endpoint of achieving statistical significance in reducing respiratory failure and mortality at day 28 in patients hospitalized with COVID-19-associated pneumonia and mild to moderate acute respiratory distress syndrome. The company noted that efficacy was highest in patients over the age of 60, the population most vulnerable to severe complications and death with COVID-19 infection. Cerecor said it has applied for FDA breakthrough therapy and fast track designations, and plans to meet with FDA to discuss a potential path to emergency use authorization. The stock was up 12.87% to $4.21 in premarket trading Tuesday. Earnings Novavax, Inc. (NASDAQ: NVAX) reported fourth-quarter revenues of $279.7 million in 2020 compared with $8.8 million in 2019, with much of the increase due to revenue for services performed under the CEPI agreement and participation on OWS. The net loss per share widened from $1.13 to $2.70. The results trailed expectations. In an interview with CNBC, Novavax CEO Stanley Erck said he expects FDA to authorize the company's coronavirus vaccine candidate as early as May if it decides to base its decision on the results of the U.K. late-stage study. If the FDA opts to wait for results from the ongoing trial in the U.S., the decision could be pushed back by one or two months. View more earnings on IBB The stock was down 4.53% premarket at $229.40. Inovio Pharmaceuticals Inc (NASDAQ: INO) reported better-than-expected fourth-quarter results. The company also said enrollment in the 400-member strong Phase 2 segment of a Phase 2/3 study is complete. The company indicated that it is evaluating pan-COVID-19 vaccine candidates that could be tailored to known and potentially unknown SARS-CoV-2 variants. Separately, the company reported mixed results for a pivotal REVEAL 1 Phase 3 study of VGX-3100 in treating high-grade precancerous cervical dysplasia caused by HPV-16 and/or HV-18. The stock moved down 5.09% to $11.01 in after-hours trading. Regenxbio Inc's (NASDAQ: RGNX) fourth-quarter revenues climbed from $11.8 million in 2019 to $21.4 million in 2020. The loss per share widened from 72 cents to $1.24, while analysts expected a loss of 43 cents per share. In after-hours trading, the stock slipped 7.06% to $39.51. Xenon Pharmaceuticals Inc (NASDAQ: XENE) reported a 371% year-over-year increase in full-year revenues and a narrower loss per share. The stock rallied 6.03% to $19 in after-hours trading. Offerings RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., under which the underwriter has agreed to purchase on a firm commitment basis 1.25 million ADSs at a price to the public of $8 per ADS. The closing of the offering is expected to occur on or about March 4, subject to satisfaction of customary closing conditions. The stock fell 11.16% to $8.20 in after-hours trading. Morphic announced a proposed underwritten public offering in which it intends to offer and sell $200 million of shares of its common stock. All of the shares of common stock are being offered by Morphic. The stock pulled back 5.83% to $79.89 in after-hours trading. Haemonetics Corporation (NASDAQ: HAE) announced its intention to offer, subject to market and other conditions, a $425 million aggregate principal amount of convertible senior notes due 2026 in a private offering to qualified institutional buyers. In after-hours trading, the stock retreated 4.05% to $124.16. Aslan announced that it has commenced an underwritten public offering of $60 million of its ADSs, representing ordinary shares. All ADSs to be sold in the offering will be offered by Aslan. The stock moved down 3.05% to $5.09 in after-hours trading. Karuna Therapeutics, Inc. (NASDAQ: KRTX) priced its underwritten public offering of 2.083 million shares of its common stock at a price of $120 per share, for raising gross proceeds of about $250 million. The offering is expected to close on or about March 4, subject to customary closing conditions. All the shares in the proposed offering are to be sold by Karuna. On The Radar PDUFA Dates The Food and Drug Administration is scheduled to issue its verdict on KemPharm Inc's (NASDAQ: KMPH) NDA for KP415, its product candidate for the treatment of attention deficit hyperactivity disorder. It contains serdexmethylphenidate, KemPharm's prodrug of d-methylphenidate. KemPharm is collaborating with Aquestive Therapeutics Inc (NASDAQ: AQST) for an oral film dosage of KP415. Clinical Readouts At the ESMO Targeted Anticancer Therapies Virtual Conference 2021, Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) will present safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer. The presentation is scheduled at 11:25 am. Earnings Antares Pharma Inc (NASDAQ: ATRS) (before the market open) Eagle Pharmaceuticals Inc (NASDAQ: EGR) (before the market open) GlycoMimetics Inc (NASDAQ: GLYC) (before the market open) Seres Therapeutics Inc (NASDAQ: MCRB) (before the market open) TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open) Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close) Neuronetics Inc (NASDAQ: STIM) (after the close) IPO Filings Achilles Therapeutics plc, a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, announced it has filed a registration statement on Form F-1 with the SEC, relating to a proposed initial public offering in the U.S., its ADSs, each representing one ordinary share of the company. All ADSs to be sold in the proposed IPO will be offered by Achilles. The number of ADSs to be sold and the pricing terms for the proposed IPO have not yet been determined. Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates See more from BenzingaClick here for options trades from BenzingaAttention Biotech Investors: Mark Your Calendar For March PDUFA DatesThe Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.