Category: Today’s Highlights

Shoreline Biosciences to Acquire Editas Medicine’s iNK cell franchise

Shoreline Biosciences to Acquire Editas Medicine’s iNK cell franchise Editas Medicine, Inc. (EDIT), announced that it has entered into a definitive agreement with the private Shoreline Biosciences (Shoreline) to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s preclinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Why Kala Pharmaceuticals Stock is Soaring

Kala Pharmaceuticals  Kala Pharmaceuticals (KALA) announced today that the U.S. FDA has accepted the investigational new drug application (IND) for its lead product candidate, KPI-012, a human Mesenchymal Stem Cell Secretome (MSC-S) for the treatment of persistent corneal epithelial defect (PCED). Kala is a . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Why IVERIC bio Rallied Today

IVERIC bio's Rally IVERIC Bio (ISEE) announced that the U.S. (FDA) has granted Breakthrough Therapy designation for avacincaptad pegol (ACP), also known as Zimura®. Zimura is a novel investigational complement C5 inhibitor aimed at treating geographic atrophy (GA) secondary to Age-Related . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Reata Pharmaceuticals: Good News for the Prohost Pick

Reata Pharmaceuticals Announcement Regarding the NDA for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced that the U.S. Food and Drug Administration (FDA) does not plan to hold an advisory committee meeting in connection with its review of the Company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. From Reata Pharmaceuticals CEO Warren Huff, Reata’s Chief Executive Officer, said, …

From Biogen and Eisai: Lecanemab Confirmatory Phase 3 Clarity Met Primary Endpoint for Early Alzheimer’s Disease  

Biogen & Eisai Co and Early Alzheimer's Disease  From Tokyo and Cambridge, Eisai Co., Ltd. and Biogen Inc. (BIIB) announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab. The product is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (

Akero Therapeutics: Efruxifermin Met Primary Endpoint for Both Dose Groups in NASH Patients

Akero Therapeutics Akero Therapeutics (AKRO) - a clinical-stage company, today released topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). The study met its primary endpoint for both the 50mg . . . This content is for paid subscribers. Please …

Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for ALS

Amylyx Pharmaceuticals in the News Amylyx Pharmaceuticals (AMLX): The U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee has voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol ) for the treatment of amyotrophic lateral sclerosis (ALS). The advisory committee’s decision was based on a review . . . This content is …

IVERIC Bio: Undeniable Promising News Today

IVERIC Bio ~ September 6, 2022 IVERIC bio (ISEE) announced positive results from GATHER2 second Phase 3 clinical trial of Zimura® (avacincaptad pegol) - a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA). GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a . . . This content …

Reata Pharmaceuticals Announces Extension of Review Period for Omaveloxolone NDA for Friedreich’s Ataxia

Reata Pharmaceuticals in the NEWS Reata Pharmaceuticals (RETA) on August 8, 2022, after the U.S. financial markets closed, received a communication from the U.S. Food and Drug Administration (FDA) informing us that they have extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich’s ataxia by three . . . This content is for paid subscribers. Please click here …

Clene Inc: More Promising News for ALS Patients

The clinical-stage Clene Nanomedicine Firm Reported Significantly Decreased Mortality in Amyotrophic Lateral Sclerosis (ALS) CNM-Au8® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs 14 placebo deaths CNM-Au8 treatment was well-tolerated, with no significant safety findings  during this trial Clene Inc in the NEWS Clene Inc (CLNN), along with its subsidiaries, “Clene”, and its wholly owned . . . This content is for paid …

Vertex Pharmaceuticals to Acquire ViaCyte Inc to Accelerate its Potentially Curative VX-880 Programs in Type 1 Diabetes

Vertex Pharmaceuticals and ViaCyte Inc are in the NEWS Vertex Pharmaceuticals (VRTX) entered into a definitive agreement under which it will acquire ViaCyte, a private biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. From Vertex Pharmaceuticals and ViaCyte Inc Reshma Kewalramani, M . . . This content is for paid subscribers. …

CureVac Lawsuit Against BioNTech and Subsidiaries, Seeking Fair Compensation for Infringement of Intellectual Property

CureVac N.V. Files Lawsuit Against BioNTech for Infringement  CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …

Regeneron: The Completed Acquisition of Checkmate Pharmaceuticals is Excellent News Not Bad News

Regeneron Pharmaceuticals Acquisition of Checkmate Pharmaceuticals  Regeneron Pharmaceuticals (REGN) announced a successful acquisition of Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology. The firm has added a new modality to the company's portfolio of potential combination-ready approaches for difficult-to-treat cancers. Checkmate's lead investigational candidate, vidutolimod, is an advanced generation CPG-4 oligodeoxynucleotide toll-like receptor 9 . . . This content is for paid subscribers. Please click here …

Karyopharm Therapeutics: CHMP Recommended Approval of the Firm’s Product NEXPOVIO® for Multiple Melanoma in Europe.

Karyopharm Therapeutics  Karyopharm Therapeutics (KPTI) and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly . . . This content is for paid subscribers. Please click here to subscribe or …