ImmunoGen in the News WALTHAM, Mass.--(BUSINESS WIRE) --Jul. 31, 2023-- ImmunoGen (IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023. From ImmunoGen Mark Enyedy, ImmunoGen’s President and Chief Executive Officer said, “This quarter we achieved a . . . This content …

Merck and Moderna Inc Announcement Merck (MRK) and Moderna Inc (MRNA . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Syndax Pharmaceuticals and Incyte Syndax Pharmaceuticals (SNDX) and Incyte (INCY) announced positive data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

AIM ImmunoTech Announcement AIM ImmunoTech (AIM) - an immuno-pharma company focused on the research and development of its TLR-3 agonist Ampligen (rintatolimod) as a novel and potentially powerful therapeutic in locally advanced pancreatic cancer (“LAPC”) and metastatic pancreatic cancer, announced the required approvals from the Netherlands for Erasmus Medical Center (“Erasmus MC”) to begin a . . . This content is for paid subscribers. Please …

Arbutus Biopharma Announcement Today, June 21, 2023, Arbutus Biopharma (ABUS) announced that the first patient has been dosed in the additional treatment arm of the AB-729 Phase 2a triple combination clinical trial, which has been expanded to include a PD-1 monoclonal antibody, nivolumab. Please note that . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

UT Southwestern Medical Center and RenovoRx RenovoRx Inc (RNXT) announced that the University of Texas (UT) Southwestern Medical Center is now enrolling pancreatic cancer patients in the open label, randomized Phase III TIGeR-PaC clinical trial. The study is investigating RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, Trans-Arterial Micro-Perfusion (TAMPä), to provide improved . . . This content is for paid subscribers. Please click here to subscribe …

Amylyx Pharmaceuticals  Amylyx Pharmaceuticals (AMLX) announced an update on the ongoing review of its Marketing Authorization Application (MAA) for AMX0035 (taurursodiol]) regarding the treatment of adults with amyotrophic lateral sclerosis (ALS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the . . . This content is for paid subscribers. Please click here …

Prostate Cancer Prostate cancer is the most common type of cancer found in men, accounting for more than a quarter of all newly diagnosed cancer cases. Early detection is linked to improved survival rates, but typical screening recommendations — such as digital rectal exams or testing for the prostate specific antigen (PSA) biomarker — do not give the full picture. Halfway through 5-year study, ExoDx …

Celldex Therapeutics Announcement Celldex Therapeutics (CLDX) announced today preclinical data from its CDX-622 bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF demonstrated their contribution to the pathophysiology of various inflammatory, fibrotic and allergic disorders. The data . . . This content is for paid …

CureVac B.V. CureVac (CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology with more than 20 years of expertise in developing, optimizing and manufacturing this versatile biological molecule for medical purposes. CureVac’s proprietary technology uses optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable . . . This content is for paid …

Gilead Sciences CHMP Adopted Positive Opinion for Hepcludex® Today, May 4, 2023, Gilead Sciences (GILD) acknowledged that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex® (bulevirtide) for adults having chronic HDV and compensated liver disease,  recommended granting full Marketing Authorization (MA) that . . . This content is for paid subscribers. …

 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. …