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Zacks News
Alnylam (ALNY) Receives CRL for the Label Expansion of Onpattro
by Zacks Equity Research
Alnylam's (ALNY) label expansion-seeking application for Onpattro, to treat transthyretin-mediated amyloidosis with cardiomyopathy, gets the FDA's CRL on the grounds of insufficient data. The stock falls 5%.
Coherus (CHRS) Stock Rises on BLA Re-Filing for Udenyca Onbody
by Zacks Equity Research
Coherus (CHRS) resubmits biologics license application for Udenyca Onbody, an on-body injector presentation of Udenyca to the FDA. Stock rises.
Arcutis (ARQT) Up on FDA Nod for Zoryve Label Expansion
by Zacks Equity Research
Arcutis (ARQT) gains on receiving FDA approval for label expansion of Zoryve (roflumilast) cream 0.3% to treat patients in the age group of 6-11 years with plaque psoriasis.
Merck's (MRK) Meets Goal in Muscle-Invasive Bladder Cancer Study
by Zacks Equity Research
Data from a late-stage study shows that Merck's (MRK) Keytruda lowered the risk of disease recurrence or death when used after surgery in certain patients with urothelial carcinoma.
Apellis (APLS) Provides Syfovre Q3 Preliminary Revenues Guidance
by Zacks Equity Research
Apellis' (APLS) shares rise as it provides third-quarter 2023 preliminary revenues guidance for Syfovre, approved for the treatment of geographic atrophy.
Orchard (ORTX) Up 97% on $478M Acquisition Deal With Kyowa Kirin
by Zacks Equity Research
Orchard (ORTX) is set to be acquired by Kyowa Kirin for a consideration of $17 per American Depositary Share, which amounts to a total transaction value of approximately $478 million. Shares rise 97%.
ALX Oncology (ALXO) Up 56% on Upbeat Gastric Cancer Study Data
by Zacks Equity Research
Interim data from a mid-stage study shows that a combination regimen of ALX Oncology's (ALXO) lead candidate achieved 52% ORR in certain gastric cancer patients.
Kezar (KZR) Falls 10% on Strategic Update, Reduces Workforce
by Zacks Equity Research
Kezar (KZR) falls 10% on the decision to channel resources to one clinical candidate as part of its reprioritization efforts and slash the workforce by 41%.
Intellia (NTLA), Regeneron Expand Deal for Gene-Editing Therapies
by Zacks Equity Research
Intellia (NTLA) expands partnership with Regeneron, to develop potential treatments for neurological and muscular diseases.
Sanofi (SNY) Inks Deal With J&J to Develop E. coli Vaccine
by Zacks Equity Research
Per the terms of the deal, Sanofi (SNY) and J&J will co-fund current and future R&D costs to develop a potential first-in-class vaccine against extraintestinal pathogenic E. coli.
Apellis' (APLS) Empaveli Injector Gets FDA Nod for PNH
by Zacks Equity Research
Apellis (APLS) receives the FDA approval for Empaveli Injector, a self-administred on-body device, to treat patients with paroxysmal nocturnal hemoglobinuria.
NRx Pharma (NRXP) to Initiate Clinical Study on NRX-101, Stock Up
by Zacks Equity Research
NRx Pharma (NRXP) receives FDA clearance to begin clinical development for its lead candidate, NRX-101, to treat chronic pain.
Karuna (KRTX) Submits NDA Filing to FDA for Schizophrenia Drug
by Zacks Equity Research
If approved, Karuna's (KRTX) KarXT will be the first new mechanism of action to treat schizophrenia in several decades. Data from three clinical studies support the FDA filing.
Amicus (FOLD) Gets FDA Approval for Pompe Disease Drug
by Zacks Equity Research
Amicus (FOLD) receives approval for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) from the FDA to treat the adult late-onset Pompe disease.
Nektar (NKTR), Cellular Biomedicine Join for Lung Cancer Studies
by Zacks Equity Research
Nektar (NKTR) enters into a deal with Cellular Biomedicine Group to develop NKTR-255 in combination with C-TIL05 to treat advanced NSCLC.
Biohaven (BHVN) Up on Positive Data from Autoimmune Disease Drug
by Zacks Equity Research
Biohaven (BHVN) gains on preliminary data from a pre-clinical study on its pipeline candidate BHV-1300 targeting various autoimmune diseases.
Soleno (SLNO) Soars as Prader-Willi Syndrome Study Meets Goal
by Zacks Equity Research
Soleno's (SLNO) shares rally as the late-stage study evaluating diazoxide choline for patients with Prader-Willi syndrome meets its primary and secondary endpoints.
Repligen (RGEN) to Acquire Fluid Management Company Metenova
by Zacks Equity Research
Repligen (RGEN) is set to acquire a Swedish company, Metenova, which focuses on manufacturing magnetic mixers for pharmaceutical and biotechnology applications.
Biophytis (BPTS) Soars 73% on Partnership With Skyepharma
by Zacks Equity Research
Biophytis (BPTS) gains on signing a partnership with Skyepharma, for the production of regulatory batches of its lead candidate, Sarconeos (BIO101).
Merck (MRK), Eisai Combo Therapy Fail Two Lung Cancer Studies
by Zacks Equity Research
Data from both late-stage studies evaluating Merck's (MRK) Keytruda and Eisai's Lenvima combination in certain types of metastatic non-small cell lung cancer, fail to achieve their primary endpoints.
FDA Expands Lilly (LLY) Jardiance Label in Chronic Kidney Disease
by Zacks Equity Research
Following the latest approval, Lilly's (LLY) Jardiance can access a target market that affects more than 35 million adults in the United States.
Travere (TVTX) Slumps 41% on Mixed Results From IgAN Drug Study
by Zacks Equity Research
Data from a confirmatory study shows that Travere's (TVTX) IgAN therapy did not achieve one of its confirmatory secondary endpoints. This will likely hurt the company's chances for the drug's full approval.
Jazz Pharma (JAZZ) Gets EU Nod for Cancer Drug Enrylaze
by Zacks Equity Research
The approval is based on data from a phase II/III study, which showed that treatment with Jazz's (JAZZ) Enrylaze achieved sustained asparagine activity in two cancer indications.
Puma's (PBYI) Alisertib Gets FDA's Orphan Drug Tag for SCLC
by Zacks Equity Research
Puma's (PBYI) alisertib receives the Orphan Drug designation from the FDA for treating patients with small cell lung cancer.
Relmada (RLMD) Up on Positive Data for Anti-Depressant Candidate
by Zacks Equity Research
Relmada's (RLMD) shares rise on long-term efficiency and safety data from the phase III study of its lead candidate REL-1017 to treat patients with major depressive disorder.