Update

Oxurion NV Business and Financial Update – FY 2020

By Myra Myrna 1 year ago

The MarketWatch News Department was not involved in the creation of this content.

Mar 17, 2021 (GLOBE NEWSWIRE via COMTEX) —
Advancing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – with Novel MoAs Beyond anti-VEGF

Recruiting Phase 2 study (‘KALAHARI’) evaluating THR-149, a potent plasma kallikrein inhibitor in DME – On track for Part A data by mid-year

Positive data from Phase 1 study evaluating THR-687, potential best in class pan-RGD integrin antagonist in DME – On track to start Phase 2 by mid-year

Highlights

  • Industry-leading pipeline targeting a total potential market opportunity of $12 billion in
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Histogen Reports Fourth Quarter and Year-End 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago

Strengthened Balance Sheet with $25.3 Million of Gross Proceeds from Financings and Warrant Exercises

Initiation of Phase 1 Study of Emricasan in Symptomatic COVID-19 Patients Anticipated in the First Quarter of 2021

HST 003 Trial Initiation for Cartilage Regeneration in the Knee Anticipated in the Second Quarter of 2021

Appointment of Industry Leader Dr. Susan Windham-Bannister to Board of Directors

SAN DIEGO, March 11, 2021 (GLOBE NEWSWIRE) — Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today reported financial results

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Adicet Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago

  • Received IND clearance and initiated first-in-human Phase 1 clinical trial for lead asset, ADI-001, an anti-CD20 allogeneic CAR gamma-delta T cell therapy, interim clinical data expected in 2021

  • Successfully raised $143.6 million in net proceeds through a public offering and concurrent private placement to advance a pipeline of CAR gamma-delta T cell therapies

MENLO PARK, Calif. and BOSTON, March 11, 2021 (GLOBE NEWSWIRE) — Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today reported financial results and provided a business update for the fourth quarter and

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Eloxx Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial and Operating Results and Provides Business Update

By Myra Myrna 1 year ago

We expect to report top line data from our Phase 2 cystic fibrosis clinical trials in the first half of this year

We have expanded our global Phase 2 clinical trial beyond the U.S., Europe and Israel; opening additional clinical sites in Australia and Canada

Cystic Fibrosis Foundation (CF Foundation) has increased its partial funding of our clinical trial program beyond the U.S. portion to include Europe and Israel

The independent Safety Review Committees for our Phase 2 cystic fibrosis clinical trial program have allowed dose escalation up to the fourth and highest dose level

Cash and cash equivalents of

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Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago


Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the fourth quarter and full year 2020. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2020 financial and operating results and to provide a business update.


“Our goal is to build Lineage into the preeminent allogeneic cell transplant company, and we hit our stride in 2020, reaching significant clinical, manufacturing, and business

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Health: Aquestive Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update Nasdaq:AQST

By Myra Myrna 1 year ago

News Highlights

  • Libervant™ (diazepam) Buccal Film New Drug Application (NDA) resubmission expected end of second quarter 2021
  • Epinephrine program and development strategy to be highlighted at a virtual investor event to be held at 9:00 a.m. ET on March 25, 2021
  • Entered U.S. licensing and supply agreement for Riluzole Oral Film for treatment of ALS with Mitsubishi Tanabe Pharma America
  • Sympazan® (clobazam) continues to meet key performance metrics
  • Management to host conference call and webcast at 8:00 a.m. ET on March 10, 2021

WARREN, N.J., March 09, 2021 (News) — Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing

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Aquestive Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago
  • Libervant™ (diazepam) Buccal Film New Drug Application (NDA) resubmission expected end of second quarter 2021
  • Epinephrine program and development strategy to be highlighted at a virtual investor event to be held at 9:00 a.m. ET on March 25, 2021
  • Entered U.S. licensing and supply agreement for Riluzole Oral Film for treatment of ALS with Mitsubishi Tanabe Pharma America
  • Sympazan® (clobazam) continues to meet key performance metrics
  • Management to host conference call and webcast at 8:00 a.m. ET on March 10, 2021

WARREN, N.J., March 09, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing

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Marinus Pharmaceuticals Provides Business Update and Reports Fourth Quarter 2020 Financial Results

By Myra Myrna 1 year ago

  • PCDH19 related epilepsy (PCDH19-RE) Phase 2 Violet Study Proof-of-Concept Trial (n=21) shows a median 61.5{f13b67734a7459ff15bce07f17c500e58f5449212eae0f7769c5b6fbcf4cc0c4} reduction in seizure frequency for ganaxolone compared to 24.0{f13b67734a7459ff15bce07f17c500e58f5449212eae0f7769c5b6fbcf4cc0c4} for placebo (p=0.17)

  • Interim efficacy and safety evaluation of the CALM Study (open label Phase 2 trial) designed to evaluate the preliminary efficacy and safety of adjunctive ganaxolone treatment in tuberous sclerosis complex (TSC), supports advancing to Phase 3

  • CALM Study (in TSC) will complete enrollment this week with top line data expected in Q3 2021

  • Remain on track to submit NDA for use of ganaxolone in CDKL5 deficiency disorder (CDD) in mid-2021

  • Site initiations and

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ERYTECH Provides Business Update and Reports Financial Results for the Full Year 2020

By Myra Myrna 1 year ago

ERYTECH Provides Business Update and
Reports Financial Results for the Full Year 2020

Conference call and webcast on Tuesday, March 9, 2021
at 8:30am EST/ 2:30pm CET

  • Strong execution and achievement of key milestones in challenging year 2020
  • Four clinical programs with lead product candidate eryaspase expected to report results and/or regulatory milestones in 2021. Two major catalysts:
    • TRYBeCA-1, Phase 3 in 2L pancreatic cancer, expected to report final results in Q4 2021
    • Update on potential path to BLA in hypersensitive ALL, expected in 1H 2021
  • Cash and cash equivalents of €44.4 million ($54.4 million) at the end of December
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Comstock Mining Announces Observe of 2020 Year Close Success and Organization Update Webcast Through Zoom

By Myra Myrna 1 year ago

The MarketWatch Information Section was not concerned in the creation of this content.

VIRGINIA Town, Mar 08, 2021 (World NEWSWIRE by way of COMTEX) —
VIRGINIA City, Nev., March 08, 2021 (World NEWSWIRE) — Comstock Mining Inc. (the “Company”) (NYSE American: LODE), an emerging leader in weather-smart, sustainable mineral growth and output, will host a convention simply call on Thursday, March 11, 2021 at 8:00 a.m. Pacific Time/11:00 a.m. Eastern Time to report its 2020 yr close success and provide a organization update. The Webcast will involve a moderated Q&A, right after the well prepared remarks. You should join the …

Comstock Mining Announces See of 2020 Year End Benefits and Business enterprise Update Webcast By way of Zoom

By Myra Myrna 1 year ago

VIRGINIA Town, Nev., March 08, 2021 (World NEWSWIRE) — Comstock Mining Inc. (the “Company”) (NYSE American: LODE), an emerging leader in weather-smart, sustainable mineral progress and generation, will host a conference simply call on Thursday, March 11, 2021 at 8:00 a.m. Pacific Time/11:00 a.m. Jap Time to report its 2020 yr finish effects and offer a small business update. The Webcast will consist of a moderated Q&A, soon after the ready remarks. You should be part of the event 5-10 minutes prior to the scheduled commence time. The link and/or dial-in telephone quantities for the are living Webcast are as

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Acorda Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results

By Myra Myrna 1 year ago

  • Sale of Manufacturing Operations to Catalent with net proceeds of ~$74 million

  • Annual operating expenses cut by ~$40 million via sale, restructuring, and other reductions

  • Total 2021 non-GAAP operating expense expected to be $130-$140 million1

  • AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg 2021 net revenue expected to be $75-$85 million

  • INBRIJA® (levodopa inhalation powder) 2020 net revenue $24 million

  • AMPYRA 2020 net revenue $99 million

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a business update and reported its financial results for the fourth quarter and full year ended December 31, 2020.

“We have improved our financial position

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Cellectis Provides Business Update and Reports 4th Quarter and Full Year 2020 Financial Results

By Myra Myrna 1 year ago

  • Enrollment ongoing in 3 Cellectis-sponsored Phase 1 dose-escalation trials BALLI-01 in r/r B-ALL patients, AMELI-01 in r/r AML patients and MELANI-01 in r/r MM patients in 7 leading US clinical centers

  • Partner Allogene Therapeutics presented initial results from Phase 1 ALPHA clinical study of licensed ALLO-501 in r/r NHL at 2020 ASCO Annual Meeting and from Phase 1 UNIVERSAL clinical study of licensed ALLO-715 in r/r MM at 2020 ASH Annual Meeting

  • New collaboration with Cytovia Therapeutics, Inc. to develop 5 TALEN® gene-edited iPSC-derived NK and CAR NK cell programs, including solid tumor targets

  • Completed construction of in-house manufacturing

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VYNE Therapeutics Reports Year-End 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago

BRIDGEWATER, N.J., March 04, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update.

“We continue to make progress in the trial and utilization of our two commercially launched products, driving market share in the acne and rosacea categories,” said David Domzalski, Chief Executive Officer of VYNE. “Our R&D team has made significant strides in developing our investigational product pipeline, having successfully advanced FCD105, our minocycline-adapalene combination product candidate for moderate-to-severe acne, which we anticipate commencing a Phase

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Ampio Pharmaceuticals, Inc. Reports Fourth Quarter 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago

The MarketWatch News Department was not involved in the creation of this content.

ENGLEWOOD, Colo., March 3, 2021 /PRNewswire via COMTEX/ —
ENGLEWOOD, Colo., March 3, 2021 /PRNewswire/ — Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today reported annual financial results for the year ended December 31, 2020 and provided a corporate overview / business update.

Mr. Michael Macaluso, President and CEO, noted, “The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded,

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Nanox Announces Fourth Quarter 2020 Results and Provides Business Update

By Myra Myrna 1 year ago

The MarketWatch News Department was not involved in the creation of this content.

NEVE ILAN, Israel, Mar 02, 2021 (GLOBE NEWSWIRE via COMTEX) —
Successfully demonstrates the Nanox.ARC in range of 2D and 3D imaging applications at the 2020 Radiology Society of North America (RSNA) Virtual Annual Meeting

Continues to build out commercial and manufacturing infrastructure ahead of initial product shipments expected to commence in Q4 2021 and into Q1 2022

Ended Q4 with cash and cash equivalents of $213millionand no debt

Management to host conference call and webcast today, March 2, at

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Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results

By Myra Myrna 1 year ago

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb 23, 2021–

Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today provided business and portfolio updates and reported fourth quarter and full year 2020 financial results.

“Epizyme cemented its position as a leader in epigenetics in 2020, with back-to-back accelerated approvals for TAZVERIK, the first and only FDA-approved EZH2 inhibitor. Following the approvals, we quickly reached epithelioid sarcoma and follicular lymphoma patients in need, adapting our physician and patient outreach efforts to meet the unique challenges presented by the evolving COVID-19 pandemic,” said Robert Bazemore, President and Chief Executive Officer

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Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

By Myra Myrna 1 year ago

2020 Net Revenues of $83.1 Million Increased 19{f13b67734a7459ff15bce07f17c500e58f5449212eae0f7769c5b6fbcf4cc0c4} over 2019

Fourth Quarter Net Revenues of $24.7 Million or $80 Per Bottle

New Sustained Release Pan-VEGF Inhibitor Pipeline Candidate Announced Today

Conference Call and Webcast Today, February 25th, at 5:00 p.m. ET

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided a general business update.

“Our fourth quarter 2020 net

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Albireo Reports Q4 and Year-End 2020 Financial Results and Business Update

By Myra Myrna 1 year ago

–
NDA and MAA for odevixibat accepted, on track for anticipated H2 21 launch –

– Announces odevixibat co-promotion agreement with Travere, a leading rare disease company –

– ASSERT global pivotal Phase 3 trial in Alagille syndrome initiated and enrolling
–

– BOLD global pivotal Phase 3 study in biliary atresia initiated and enrolling
–

–
Pipeline expansion with two new lead compounds in adult cholestatic and viral liver diseases –

–
Company to host a conference call and webcast today at 10:00 a.m. ET
–

BOSTON, Feb. 25, 2021 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a

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Dicerna Announces Full Year 2020 Financial Results and Provides a Business Update

By Myra Myrna 1 year ago

LEXINGTON, Mass.–(BUSINESS WIRE)–Feb 25, 2021–

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today reported its financial results for the full year ended Dec. 31, 2020 and provided a corporate update.

“Despite pandemic headwinds, 2020 was an incredibly productive year for Dicerna as we grew and advanced our pipeline of GalXC™ RNAi therapeutics while expanding our reach to include diverse tissues around the body. Led by pivotal-stage nedosiran for primary hyperoxaluria, belcesiran for alpha-1 antitrypsin deficiency-associated liver disease, RG6346 for chronic HBV and ANGPTL3 -targeted LY3561774 for dyslipidemia, we

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