Mountain View

Positive Recommendation for Use of TAVNEOS™ (avacopan) in ANCA Vasculitis Adopted by European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)

Retrieved on: 
Friday, November 12, 2021

Following the CHMPs positive opinion, theEuropean Commissionwill render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022.

Key Points: 
  • Following the CHMPs positive opinion, theEuropean Commissionwill render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022.
  • ViforPharmahas granted Kissei Pharmaceutical Co., Ltd. an exclusive license to commercialize TAVNEOS (avacopan), in Japan, where TAVNEOS was approved for use in ANCA vasculitis patients in September.
  • Vifor Pharma will pay ChemoCentryx royalties in the teens to the mid-twenties percent on potential ex-US net sales off one aggregate net sales line.
  • Please click here for Patient Information for TAVNEOS in the United States, including Important Safety Information and Full Prescribing Information.

Iridex to Present at the 2021 Stifel Virtual Healthcare Conference

Retrieved on: 
Friday, November 12, 2021

MOUNTAIN VIEW, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today announced the Company plans to participate in the upcoming 2021 Stifel Virtual Healthcare Conference.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today announced the Company plans to participate in the upcoming 2021 Stifel Virtual Healthcare Conference.
  • David Bruce, Iridexs President and Chief Executive Officer, is scheduled to present on Tuesday, November 16, 2021, at 2:00 pm ET.
  • Iridex Corporationis a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market.
  • The Companys proprietaryMicroPulse technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions.

Iridex Announces Third Quarter 2021 Financial Results

Retrieved on: 
Thursday, November 11, 2021

MOUNTAIN VIEW, Calif., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX) today reported financial results for the third quarter ended October 2, 2021.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX) today reported financial results for the third quarter ended October 2, 2021.
  • Net loss for the third quarter of 2021 was $2.2 million, compared to a net loss $1.7 million in the same period of the prior year.
  • Net loss on a per share basis was $0.14 in 2021 versus a loss of $0.12 in the third quarter of 2020.
  • Iridex nowexpects total revenue for fiscal year 2021 to range from $52 million to $53 million, reflecting growth of 43% - 46% over fiscal year 2020.

CanonX.Finance Launches Its Platform, to Work as Incubator for the 140+ DeFi Projects Launching on Cardano

Retrieved on: 
Thursday, November 11, 2021

Serving over 140+ companies in the Cardano DeFi ecosystem, CanonX.finance is helping usher in the age of DeFi.

Key Points: 
  • Serving over 140+ companies in the Cardano DeFi ecosystem, CanonX.finance is helping usher in the age of DeFi.
  • Figure 1: CanonX.Finance launches its platform, to work as incubator for the 140+ DeFi projects launching on Cardano.
  • CanonX.finance will serve as the ultimate incubator for the 140+ DeFi projects launching on Cardano.
  • CanonX.finance accelerates DeFi projects launching on Cardano to build the next generation of decentralized financial applications.

NeuroPace Reports Third Quarter 2021 Financial Results

Retrieved on: 
Wednesday, November 10, 2021

MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy, today reported financial results for the quarter ended September 30, 2021.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy, today reported financial results for the quarter ended September 30, 2021.
  • Total revenue was $10.3 million in the third quarter of 2021, a 19% decrease from $12.8 million in the prior year period.
  • Gross margin for the third quarter of 2021 was 72.6% compared to 75.0% in the third quarter of 2020.
  • NeuroPace will host a conference call to discuss the third quarter 2021 financial results after market close on Wednesday, November 10, 2021, at 4:30 P.M. Eastern Time.

IGM Biosciences to Present at the Jefferies London Healthcare Conference

Retrieved on: 
Wednesday, November 10, 2021

MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 1:40 p.m. GMT/ 8:40 a.m. EST.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 1:40 p.m. GMT/ 8:40 a.m. EST.
  • Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.
  • Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies.
  • Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

NeuroPace Receives IDE Approval to Initiate NAUTILUS Pivotal Study of its RNS System for Idiopathic Generalized Epilepsy

Retrieved on: 
Wednesday, November 10, 2021

MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc., a medical technology company dedicated to transforming the lives of people suffering from epilepsy, today announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to study the company’s RNS® System in patients with drug-resistant idiopathic generalized epilepsy.

Key Points: 
  • The NAUTILUS pivotal study will be the first in the United States to evaluate use of brain-responsive neuromodulation for the treatment of IGE.
  • We are pleased with FDAs decision to grant IDE approval for the pivotal study, allowing us to evaluate the safety and effectiveness of the RNS System in patients who are living with drug-resistant, idiopathic generalized epilepsy, said Martha Morrell, MD, Chief Medical Officer of NeuroPace.
  • In March 2021, the company received Breakthrough Device Designation status from the FDA for the potential use of its RNS System to treat idiopathic generalized epilepsy.
  • The RNS System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA.

ChemoCentryx to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Wednesday, November 10, 2021

Replays of both the Stifel and Piper Sandler presentations will be available on the Company's website for two weeks following the respective presentation dates.

Key Points: 
  • Replays of both the Stifel and Piper Sandler presentations will be available on the Company's website for two weeks following the respective presentation dates.
  • ChemoCentryx is a biopharmaceutical company commercializing and developing new medications for inflammatory and autoimmune diseases and cancer.
  • ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies.
  • Additionally, ChemoCentryx has early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

ChemoCentryx Reports Third Quarter 2021 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, November 9, 2021

-- Clinical development underway of next generation orally-administered immune checkpoint inhibitor CCX559 --

Key Points: 
  • TAVNEOS is approved and now launched in the U.S., said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx.
  • Revenue was $17.7 million for the third quarter of 2021, compared to $5.1 million for the same period in 2020.
  • Research and development expenses were $20.0 million for the third quarter of 2021, compared to $18.6 million for the same period in 2020.
  • General and administrative expenses were $19.6 million for the third quarter of 2021, compared to $10.4 million for the same period in 2020.

BigPanda Accelerates AIOps Adoption With New Integrations and Self-Service APIs

Retrieved on: 
Tuesday, November 9, 2021

SAN FRANCISCO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- BigPanda, Inc., the leader in Event Correlation and Automation powered by AIOps, today announced a suite of new and updated integrations and self-service APIs designed to accelerate AIOps adoption across fragmented teams and tools.

Key Points: 
  • SAN FRANCISCO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- BigPanda, Inc., the leader in Event Correlation and Automation powered by AIOps, today announced a suite of new and updated integrations and self-service APIs designed to accelerate AIOps adoption across fragmented teams and tools.
  • Specifically, native integrations with Jira and AppDynamics deliver a new framework for collaboration and communication, while a trio of self-service APIs enables organizations to scale AIOps deployments with ease.
  • BigPandas new native and improved integrations include:
    Jira Cloud: An all-new Jira integration allows teams to automatically create Jira Issues based on correlated BigPanda incidents and keep them in sync bi-directionally.
  • This makes it easier for BigPanda to ingest these changes and match them against associated BigPanda incidents as part of BigPandas Root Cause Changes capability.