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biotechnology: Archive

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Agios' (AGIO) Sickle Cell Disease Study Meets Primary Endpoint

Agios' (AGIO) mid-stage, label expansion study of mitapivat meets its primary endpoint. The data from the study supports AGIO's decision to proceed with the phase III portion of the investigation.

NVSPositive Net Change AGIOPositive Net Change AKROPositive Net Change

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Bristol Myers (BMY) Heart Drug Camzyos Wins EC Approval

Bristol Myers (BMY) receives EC approval for Camzyos for treating symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients.

NVSPositive Net Change BMYPositive Net Change LGNDNegative Net Change

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Intercept (ICPT) to Restructure Operations, Cut Workforce

Intercept (ICPT) looks to restructure operations, discontinue all NASH-related investments and reduce its workforce by one-third.

LGNDNegative Net Change ICPTPositive Net Change VKTXPositive Net Change

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Gilead (GILD) Breast Cancer Drug Gets Positive CHMP Opinion

Gilead's breast cancer drug Trodelvy gets positive CHMP opinion for a second indication in Europe.

NVSPositive Net Change GILDNegative Net Change LGNDNegative Net Change

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Amylyx (AMLX) Down on Negative CHMP Opinion for ALS candidate

Amylyx's (AMLX) shares plunge on getting a negative opinion from the Committee for Medicinal Products for Human Use for the marketing authorization of AMX0035, used to treat amyotrophic lateral sclerosis.

NVSPositive Net Change AMLXPositive Net Change AKROPositive Net Change

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Pfizer's (PFE) Litfulo Receives FDA Nod for Alopecia Areata

Pfizer's (PFE) Litfulo becomes the first kinase inhibitor approved for treating severe alopecia areata in adolescents, following FDA's approval.

NVSPositive Net Change PFEPositive Net Change AKROPositive Net Change

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Gilead Sciences (GILD) Announces Positive HDV Treatment Data

Gilead Sciences, Inc. (GILD) announces data on Hepcludex that reinforces the potential of bulevirtide as an effective and well-tolerated treatment for chronic HDV after 96 weeks.

NVSPositive Net Change GILDNegative Net Change LGNDNegative Net Change

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Intercept (ICPT) NDA for NASH Treatment Gets CRL From FDA

Intercept's (ICPT) NDA for obeticholic acid (OCA) gets a complete response letter (CRL) from the FDA for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).

LGNDNegative Net Change ICPTPositive Net Change MDGLPositive Net Change

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Pieris (PIRS) Declines as AZN Halts Study of Asthma Candidate

Pieris' (PIRS) shares nosedive as its partner decides to discontinue a phase IIa study evaluating elarekibep for treating asthma, based on non-clinical safety data from a toxicology study.

AZNNegative Net Change PIRSPositive Net Change AKROPositive Net Change

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Aeglea (AGLE) Soars 329% on Acquiring Spyre Therapeutics

Aeglea's (AGLE) shares surge as it acquires Spyre Therapeutics, a private company that focuses on developing antibody therapeutics for inflammatory bowel disease.

ADMAPositive Net Change AGLEPositive Net Change AKROPositive Net Change

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bluebird's (BLUE) Gene Therapy for SCD Gets Priority Review

bluebird's (BLUE) gene therapy lovotibeglogene autotemcel gets Priority Review in the United States for sickle cell disease.

NVSPositive Net Change LGNDNegative Net Change

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Biotech Stock Roundup: DICE Gains on LLY Buyout, MRSN Down on Update & More

Acquisition and regulatory updates from DICE and GSK plc (GSK ) are in focus in the biotech sector.

GSKPositive Net Change LLYNegative Net Change MRSNNegative Net Change ACLXNo Net Change

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Alderya (ALDX) Stock Declines on Getting CRL for PVRL Candidate

Alderya's (ALDX) shares decline on receiving a complete response letter for an investigational candidate, ADX-2191, treating primary vitreoretinal lymphoma.

ADMAPositive Net Change ALDXNegative Net Change AKROPositive Net Change

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Denali (DNLI) Provides Update on Hunter Syndrome Study

Denali's (DNLI) early-to-mid-stage study of DNL310 shows a robust reduction in neurofilament light levels for patients with MPS II (Hunter syndrome).

ADMAPositive Net Change DNLIPositive Net Change AKROPositive Net Change

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Merck's (MRK) Gastric Cancer Study Fails to Meet a Primary Goal

Merck's (MRK) late-stage study evaluating Keytruda in advanced gastric cancer fails to meet one of the primary endpoints.

MRKNegative Net Change ADMAPositive Net Change AKROPositive Net Change

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Arcellx (RCLX) Down on Hold for Lead Program CART-ddBCMA

Arcellx's (ACLX) study on lead program CART-ddBCMA for treating adult patients with relapsed or refractory multiple myeloma has been put on hold by the FDA. The company's shares decline on the same.

NVSPositive Net Change GILDNegative Net Change LGNDNegative Net Change ACLXNo Net Change

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Verve (VERV) Up 9.9% in a Week on Collaboration With Eli Lilly

Verve's (VERV) shares rise on collaboration with Eli Lilly to develop gene editing treatment for cardiovascular disease.

LLYNegative Net Change VRTXPositive Net Change AKROPositive Net Change

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Bristol Myers (BMY) Announces CAR T Cell Therapy Breyanzi Data

Bristol Myers' (BMY) CAR T cell therapy Breyanzi (lisocabtagene maraleucel) shows deep and durable responses in relapsed or refractory follicular lymphoma and mantle cell lymphoma.

NVSPositive Net Change BMYPositive Net Change GILDNegative Net Change

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Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS

Reata (RETA) gets FDA acceptance for the filing of new drug application supplement approval for Skyclarys' release.

ADMAPositive Net Change RETAPositive Net Change AKROPositive Net Change

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Bristol Myers (BMY) Gets FDA Nod for Data Addition to Camzyos

Bristol Myers (BMY) receives FDA approval for additional data to be added to the label of the heart drug Camzyos.

NVSPositive Net Change BMYPositive Net Change LGNDNegative Net Change

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Mersana (MRSN) Down on Partial Ovarian Cancer Study Hold

Mersana's (MRSN) shares decline on partial clinical hold by the FDA on UP-NEXT and UPGRADE-A studies evaluating upifitamab rilsodotin to treat platinum-sensitive ovarian cancer.

JNJPositive Net Change ADMAPositive Net Change MRSNNegative Net Change