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biotechs: Archive

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Mustang (MBIO) Soars 477% on Data From Rare Blood Cancer Study

Updated data from a clinical study shows that treatment with Mustang Bio's (MBIO) experimental cell therapy achieved an overall response rate of 90% in patients with a rare form of blood cancer.

JNJPositive Net Change ABBVPositive Net Change BGNEPositive Net Change MBIONegative Net Change

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OVID Slumps 76% on Epilepsy Drug Failing Two Pivotal Studies

Two late-stage studies, which evaluated Ovid Therapeutics' (OVID) experimental drug for two forms of epilepsy, fail to meet their primary endpoints.

HRTXPositive Net Change OVIDPositive Net Change TAKPositive Net Change ARQTPositive Net Change

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Aerovate (AVTE) Down as Lead Drug Fails to Meet PAH Study Goals

Aerovate's (AVTE) shares plunge 93% as its lead candidate, AV-101, fails to meet the primary and secondary endpoints in the phase IIb/III study to treat pulmonary arterial hypertension patients.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Novavax (NVAX) Seeks FDA Nod for Updated COVID-19 Vaccine

Novavax (NVAX) seeks FDA???s approval to update its COVID-19 vaccine for the 2024-2025 fall season against current circulating strains, including KP.2 and KP.3.

SNYPositive Net Change PFEPositive Net Change MRNAPositive Net Change NVAXPositive Net Change

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Roche (RHHBY) Reports Upbeat Data on Columvi From STARGLO Study

Roche's (RHHBY) Columvi significantly extends survival in patients with relapsed or refractory diffuse large B-cell lymphoma in the phase III STARGLO study.

RHHBYPositive Net Change LGNDPositive Net Change NERVPositive Net Change ALXOPositive Net Change

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Amgen's (AMGN) Blincyto Gets FDA Nod for Consolidation Treatment

Amgen's (AMGN) Blincyto is now approved for the treatment of adult and pediatric patients one month and older with Philadelphia chromosome-negative B-ALL in the consolidation phase, regardless of MRD status.

AMGNNegative Net Change LGNDPositive Net Change TWSTPositive Net Change ANVSNegative Net Change

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Editas (EDIT) Reports Upbeat New Data From Reni-Cel Studies

Editas (EDIT) reports positive new safety and efficacy data from the RUBY and EdiTHAL studies evaluating its investigational gene therapy, reni-cel, for SCD and TDT, respectively.

VRTXNegative Net Change EDITPositive Net Change CRSPPositive Net Change ALXOPositive Net Change

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Moderna's (MRNA) Next-Gen COVID-19 Jab Study Meets Efficacy Goal

Data from a late-stage study shows that Moderna's (MRNA) next-generation COVID-19 vaccine achieved non-inferior vaccine efficacy against COVID-19 when compared with its previously approved bivalent COVID-19 vaccine.

PFEPositive Net Change MRNAPositive Net Change NVAXPositive Net Change BNTXPositive Net Change

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Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro

The FDA approves Bristol Myers' (BMY) cancer drug Augtyro for the treatment of adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

BMYNegative Net Change LGNDPositive Net Change NERVPositive Net Change ALXOPositive Net Change

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Shattuck (STTK) Announces Positive Interim Data on Cancer Drug

Shattuck (STTK) will now focus on higher-risk myelodysplastic syndromes and TP53 mutant acute myeloid leukemia indications for lead candidate SL-172154, following encouraging interim data from the phase IB dose expansion study.

LGNDPositive Net Change NERVPositive Net Change ALXOPositive Net Change STTKPositive Net Change

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Enzo Biochem (ENZ) Q3 Earnings Improve Y/Y, Gross Margin Up

Enzo Biochem's (ENZ) overall topline benefits from revenue growth in the majority of its geographic regions.

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Intellia (NTLA) Banks on Genome Editing Pipeline Amid Rivalry

Intellia's (NTLA) lead genome-editing candidate, NTLA-2001 being developed to treat transthyretin (ATTR) amyloidosis, holds promise. Other pipeline candidates are also progressing well.

REGNNegative Net Change NTLAPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

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Repligen (RGEN) Promotes CCO, Shares Fall on Leadership Change

Repligen (RGEN) appoints Olivier Loeillot as the company's new president and chief executive officer, effective from Sep 1, 2024. Stock falls on the news.

RGENPositive Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

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Avidity (RNA) Up 33% on Rare Muscle Disease Study Results

Initial data from an early-stage study shows that treatment with Avidity's (RNA) experimental therapy could address the underlying cause of a rare muscle-weakening condition.

RNAPositive Net Change HRTXPositive Net Change MRNSPositive Net Change ARQTPositive Net Change

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Ultragenyx (RARE) to Seek Accelerated Nod for Rare Disease Drug

Following a fruitful meeting with the FDA, Ultragenyx (RARE) plans to seek accelerated approval for UX111 for the treatment of Sanfilippo syndrome type A.

RAREPositive Net Change NERVPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

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FDA Expands AstraZeneca's (AZN) Farxiga Label in Pediatric T2D

Following the label expansion, AstraZeneca's (AZN) Farxiga is now approved to improve glycemic control in patients aged 10 years and older with T2D. It was previously approved for such use in adults.

AZNPositive Net Change LLYPositive Net Change HRTXPositive Net Change ARQTPositive Net Change

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Simulations Plus (SLP) Buys Pro-ficiency Holdings for $100M

Simulation Plus (SLP) acquires Pro-ficiency from QHP Capital for $100 million in an all-cash transaction.

NVDAPositive Net Change SLPPositive Net Change MSINegative Net Change ANETPositive Net Change

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Ultragenyx (RARE) Posts New Data From Bone Disease Study

Ultragenyx's (RARE) pipeline candidate setrusumab shows sustained reductions in fracture rates in patients with osteogenesis imperfecta in new data from the Orbit study.

RAREPositive Net Change NERVPositive Net Change MRNSPositive Net Change ACRVPositive Net Change

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Viridian (VRDN) Up 10% on Clinical Updates for Eye Disease Drug

Viridian (VRDN) intends to initiate two late-stage studies on its experimental thyroid eye disease drug this August. Top-line data from both studies are expected in first-half 2026

AMGNNegative Net Change HRTXPositive Net Change ARQTPositive Net Change VRDNPositive Net Change

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Regeneron (REGN), SNY Win FDA Nod for Kevzara Label Expansion

The FDA approves label expansion of Regeneron (REGN) and Sanofi's Kevzara for the treatment of polyarticular juvenile idiopathic arthritis.

REGNNegative Net Change SNYPositive Net Change NERVPositive Net Change ALXOPositive Net Change

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Moderna (MRNA) COVID-Flu Combo Jab Meets Late-Stage Study Goal

Data from a late-stage study shows that Moderna's (MRNA) experimental COVID-19-influenza combination vaccine generates higher immune responses when compared to co-administered licensed flu and COVID vaccines.

PFEPositive Net Change MRNAPositive Net Change NVAXPositive Net Change BNTXPositive Net Change

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Structure Therapeutics (GPCR) Rallying on Obesity Drug Data

Structure Therapeutics (GPCR) stock sees an upside on positive top-line data from a phase IIa obesity study as well as a capsule-to-tablet PK study on its obesity candidate, GSBR-1290.

NVOPositive Net Change LLYPositive Net Change AMGNNegative Net Change GPCRPositive Net Change

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Apellis (APLS) Up on Upbeat GA Data From Long-Term Syfovre Study

Apellis (APLS) rises 3.3% as the treatment of GA patients with Syfovre demonstrates a visual function benefit in a prespecified endpoint at month 36 in a late-stage, long-term extension study.

CGENPositive Net Change APLSPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Eli Lilly (LLY) Alzheimer's Drug Donanemab Gets FDA Panel Nod

Eli Lilly (LLY) Alzheimer's disease drug, donanemab, receives Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) recommendation.

BIIBPositive Net Change LLYPositive Net Change PRTAPositive Net Change

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Geron (GERN) Wins FDA Approval for Blood Cancer Drug, Stock Up

Geron's (GERN) shares rise on approval of its first drug. The FDA approves imetelstat for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia.

BMYNegative Net Change GERNPositive Net Change KRYSPositive Net Change ALXOPositive Net Change