ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results  On April 28, 2023, ImmunoGen (IMGN) reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2023.  Immunogen's drug ELAHERE® (mirvetuximab soravtansine-gyn) is a first-in-class antibody drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid . . . This content is for paid subscribers. Please …

Vertex Pharmaceuticals ORKAMBI Receives Positive CHMP Opinion Today, April 27, Vertex Pharmaceuticals  (VRTX) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) embraced a positive opinion for the label extension of ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Apellis Pharmaceuticals Validation for Pegcetacoplan Apellis Pharmaceuticals (APLS) announced the receival of validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for intravitreal pegcetacoplan regarding the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The decisions by the local regulatory authorities in these four countries are . . . This content is for paid subscribers. Please …

Important News from CymaBay Therapeutics Primary Biliary Cholangitis Today, April 21, 2023, CymaBay Therapeutics (CBAY) announced that results from the ENHANCE phase 3 global study evaluating seladelpar for Primary Biliary Cholangitis (PBC) have been published in Hepatology. The authors . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

From Novartis on April 20, 2023 The ALITHIOS open-label extension study demonstrated that continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) was associated with reduced risk of disability progression versus those who switched later from teriflunomide to Kesimpta. Outcomes related to both disability progression and brain volume change up to five years favored earlier initiation of Kesimpta in people …

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.