Merck in the NEWS Merck (MRK) announced that the U.S. FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of HER2 negative patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The American Agency's acceptance of . . . This content is …

Regenxbio in the NEWS Today, the U.S. FDA granted Fast Track designation for Regenxbio (RGNX) Gene therapy RGX-202 a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may qualify for priority review. The FDA has granted RGX-202 . . . This content is for paid …

Vertex Pharmaceuticals and CRISPR Therapeutics Completion of BLAs Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced the completion of the . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

TG Therapeutics TG Therapeutics, Inc. (TGTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVITM (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features . . . This content is for paid subscribers. …

Checkpoint Therapeutics Checkpoint Therapeutics (CKPT) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort . . . This content is for paid subscribers. Please …

BrainStorm Cell Therapeutics Inc BrainStorm Cell Therapeutics Inc (BCLI) develops innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. FDA . . . This content is …

Intellia Therapeutics  Intellia Therapeutics (NTLA) announced that the U.S. FDA has cleared the company’s Investigational New Drug (IND) application for NTLA-2002.  About NTLA-2002 Based on Nobel Prize-winning CRISPR/Cas9 technology, NTLA-2002 is the first single-dose investigational treatment. NTLA-2002 is Intellia wholly owned investiga- tional CRISPR therapeutic candidate designed to inactivate the kallikrein B1 . . . This content is for paid subscribers. Please click here to subscribe or here to …

The Bear Market The volatility in the Bear stock market continues to plunge the values of biotech stocks. The Bear market is sucking investors’ capitals who bet on firms with future growth potential based on early, mid term and late clinical trial results.      Travere Therapeutics Good News On February 17, 2023, before the long weekend that ended on Tuesday, Travere Therapeutics (TVTX) announced …

Merck KEYTRUDA Announcement Merck (MRK) announced today that Phase 3 NRG-GY018 trial evaluating KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) in patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status. NRG-GY018 is a randomized, blinded, placebo-controlled Phase 3 trial (ClinicalTrials.gov, 

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.

CytomX and Moderna in the NEWS On January 05, 2023, CytomX Therapeutics (CTMX) and Moderna Inc (MRNA) announced a collaboration and licensing agreement to create . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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.

Treatments for NASH Madrigal Pharmaceuticals (MDGL) is the second company after Akero Therapeutics (AKRO) to . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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.

Gilead Sciences and MacroGenics Collaboration Announcement Gilead Sciences (GILD) and MacroGenics (MGNX) announced an exclusive option and collaboration agreement to develop MGD024 using MacroGenics DART . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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, …

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 (

Intellia Therapeutics  Intellia Therapeutics.(NTLA) and Regeneron Pharmaceuticals (REGN) today announced positive interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 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 …