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Zacks News
Acadia (ACAD) Up on FDA Briefing Document for Nuplazid sNDA
by Zacks Equity Research
The FDA issues briefing documents related to Acadia's (ACAD) resubmitted sNDA for Nuplazid for treating hallucinations and delusions associated with Alzheimer's disease psychosis. Shares rise.
Deciphera (DCPH) Up More Than 30% in Past 3 Months: Here's Why
by Zacks Equity Research
Deciphera's (DCPH) Qinlock, approved for treating advanced gastrointestinal stromal tumors, has seen strong uptake since its approval. The recent restructuring initiative is saving costs.
Alnylam's (ALNY) Rare Disease Drug, Amvuttra, Gets FDA Nod
by Zacks Equity Research
The FDA approves Alnylam's (ALNY) Amvuttra (vutrisiran) to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
Immunovant (IMVT) Set on Lead Candidate Batoclimab's Development
by Zacks Equity Research
Immunovant (IMVT) remains focused on developing lead pipeline candidate, batoclimab for treating several types of autoimmune diseases. Lack of other pipeline candidate remains a concern.
Alnylam (ALNY) Posts Positive Data From IgA Nephropathy Study
by Zacks Equity Research
Alnylam (ALNY) reports top-line data from a phase II study evaluating its investigational RNAi therapeutic, cemdisiran, for the treatment of immunoglobulin A nephropathy.
Immunovant (IMVT) Sees Wider Q4 Loss, to Study Batoclimab in TED
by Zacks Equity Research
Immunovant's (IMVT) earnings miss estimates in fiscal fourth quarter ended on Mar 31, 2022. The company achieves FDA alignment for phase III study on batoclimab in thyroid eye disease.
Apellis (APLS), Sobi Begin Pegcetacoplan Dosing in Kidney Disease
by Zacks Equity Research
Apellis (APLS) and Sobi dose the first patient in phase III VALIANT study evaluating pegcetacoplan in primary immune-complex membranoproliferative glomerulonephritis and C3 glomerulopathy. Stock up.
Praxis (PRAX) Tanks on Negative Data From Depression Study
by Zacks Equity Research
Praxis (PRAX) posts negative data from the phase II/III Aria study that evaluated PRAX-114 for monotherapy treatment of major depressive disorder. Shares fall.
Global Blood's (GBT) Candidates for SCD Get Two FDA Tags
by Zacks Equity Research
The FDA bestows both orphan drug and rare pediatric disease designations to Global Blood's (GBT) inclacumab and GBT021601 (GBT601) for the treatment of sickle cell disease.
GSK Gets FDA Nod for Measles, Mumps & Rubella Vaccine, Priorix
by Zacks Equity Research
The FDA approves GSK's Priorix vaccine for active immunization for the prevention of measles, mumps and rubella in individuals aged 12 months and older.
Immunocore (IMCR) Up on Deal With Sanofi for Skin Cancer Study
by Zacks Equity Research
Immunocore (IMCR) signs a collaboration agreement with Sanofi to study the combination of Kimmtrak with the latter's SAR444245 for treating metastatic cutaneous melanoma. Shares up.
Immunic (IMUX) Falls as Phase II Ulcerative Colitis Study Fails
by Zacks Equity Research
Immunic's (IMUX) phase II CALDOSE-1 study, evaluating vidofludimus calcium in patients with moderate-to-severe ulcerative colitis, fails to meet primary endpoint. Stock down.
Aeglea (AGLE) Down on RTF Letter from FDA for Rare Disease Drug
by Zacks Equity Research
Aeglea (AGLE) gets a Refusal to File letter from the FDA related to the biologics license application for pegzilarginase to treat arginase 1 deficiency. Stock down.
Apellis (APLS) Files NDA for Pegcetacoplan in Geographic Atrophy
by Zacks Equity Research
Apellis (APLS) submits a new drug application to the FDA for pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.
Sanofi (SNY) Gets Breakthrough Therapy Tag for Hemophilia A Drug
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to Sanofi's (SNY) efanesoctocog alfa for the treatment of people with hemophilia A.
GSK to Boost Vaccine Portfolio With Affinivax Acquisition
by Zacks Equity Research
GSK signs an agreement to acquire Affinivax, Inc. for a $2.1 billion upfront payment. The company is looking to boost its vaccine pipeline with this acquisition.
Global Blood (GBT) Thrives on Oxbryta, Overdependence a Woe
by Zacks Equity Research
Global Blood's (GBT) Oxbryta is approved for treating sickle cell disease. The recent label expansion nod to Oxbryta is a positive. However, sole dependence on Oxbryta for growth is a concern.
INmune Bio (INMB) Down on Clinical Hold for Alzheimer's Study
by Zacks Equity Research
The FDA places clinical hold on INmune Bio's (INMB) IND application to begin a phase II study on the investigational TNF inhibitor, XPro1595, for Alzheimer's disease.
SpringWorks (SWTX) Down Despite Desmoid Tumors Study Meeting Goal
by Zacks Equity Research
SpringWorks' (SWTX) phase III study evaluating its investigational candidate, nirogacestat, in adult patients with progressing desmoid tumors, meets primary and key secondary endpoints.
Seagen (SGEN) Posts Positive Data from New Study on Tukysa
by Zacks Equity Research
Seagen (SGEN) reports favorable data on the pivotal phase II MOUNTAINEER study evaluating Tukysa in combination with Herceptin for treating HER2-positive metastatic colorectal cancer.
AbbVie (ABBV) Files NDA for Parkinson's Disease Candidate
by Zacks Equity Research
AbbVie (ABBV) submits a new drug application to the FDA for ABBV-951, which has been developed for treating advanced Parkinson's disease.
Lilly's (LLY) Olumiant Gets CHMP Nod for Alopecia Areata
by Zacks Equity Research
The CHMP gives a positive opinion and recommends approval of Lilly's (LLY) Olumiant to treat adults with severe alopecia areata.
Precigen, Inc. (PGEN) Reports Q4 Loss, Tops Revenue Estimates
by Zacks Equity Research
Precigen, Inc. (PGEN) delivered earnings and revenue surprises of 7.14% and 14.63%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?
Biohaven Pharmaceutical Holding Company Ltd. (BHVN) Reports Q4 Loss, Tops Revenue Estimates
by Zacks Equity Research
Biohaven Pharmaceutical Holding Company Ltd. (BHVN) delivered earnings and revenue surprises of -45.41% and 0.06%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?
Earnings Preview: Leap Therapeutics, Inc. (LPTX) Q3 Earnings Expected to Decline
by Zacks Equity Research
Leap Therapeutics, Inc. (LPTX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.