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Zacks News
uniQure (QURE) Falls on Data From Huntington's Disease Study
by Zacks Equity Research
uniQure (QURE) reports initial data on the first four patients enrolled in the lower-dose cohort of its ongoing phase I/II clinical trial of AMT-130 for treating Huntington's disease.
Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
by Zacks Equity Research
The FDA approves Bristol Myers' (BMY) Orencia in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease. This is the fourth FDA-approved indication for the drug.
Apellis (APLS), Sobi Get EU Nod for Rare Blood Disorder Drug
by Zacks Equity Research
The European Commission approves Apellis (APLS) and Sobi's Aspaveli for the treatment of paroxysmal nocturnal hemoglobinuria in adult patients. Shares rise.
Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
by Zacks Equity Research
Alnylam (ALNY) files regulatory applications to the FDA and the EMA, seeking approval for a new indication of Oxlumo for the treatment of advanced primary hyperoxaluria type 1.
Trevena (TRVN) to Begin Clinical Study on Pain Candidate
by Zacks Equity Research
Trevena (TRVN) advances TRV045 into clinical development as a potential treatment for diabetic neuropathic pain. Enrollment in the study is expected to begin in the first quarter of 2022.
Forma's (FMTX) Etavopivat Proves Safety Profile in SCD Study
by Zacks Equity Research
Forma's (FMTX) investigational PKR activator, etavopivat significantly improves anemia and red blood cell health in patients with sickle cell disease.
Cytokinetics' (CYTK) Aficamten Gets Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy status on Cytokinetics' (CYTK) aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
Aytu BioPharma's (AYTU) AR101 Gets FDA's Orphan Drug Status
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Aytu BioPharma's (AYTU) AR101 for the treatment of vascular Ehlers-Danlos Syndrome.
ACADIA's (ACAD) Rett Syndrome Candidate Meets Goal in Study
by Zacks Equity Research
ACADIA's (ACAD) phase III study, evaluating the efficacy and safety of trofinetide in patients with Rett syndrome, meets co-primary endpoints. Shares rise.
Editas (EDIT) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
by Zacks Equity Research
After losing some value lately, a hammer chart pattern has been formed for Editas (EDIT), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.
After Plunging 30.8% in 4 Weeks, Here's Why the Trend Might Reverse for Editas (EDIT)
by Zacks Equity Research
The heavy selling pressure might have exhausted for Editas (EDIT) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
Here's Why Editas (EDIT) is Poised for a Turnaround After Losing 20.6% in 4 Weeks
by Zacks Equity Research
Editas (EDIT) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.
Ultragenyx (RARE) Begins Dosing in Phase I/II Study of UX053
by Zacks Equity Research
Ultragenyx (RARE) doses the first patient in a phase I/II study evaluating its investigational mRNA candidate, UX053, for treating glycogen storage disease type III.
Fennec (FENC) Gets CRL From FDA for Pedmark, Stock Down
by Zacks Equity Research
Fennec (FENC) suffers a setback again with a CRL for its new drug application (NDA) for Pedmark. Shares are down in pre-market trading.
Blueprint Medicines (BPMC) Set to Acquire Lengo Therapeutics
by Zacks Equity Research
Blueprint Medicines (BPMC) inks an agreement to acquire privately held Lengo Therapeutics. The company is looking to boost its lung cancer portfolio with this acquisition.
BioCryst (BCRX) Begins Enrollment in PNH Study on BCX9930
by Zacks Equity Research
BioCryst (BCRX) starts patient enrollment in the pivotal REDEEM-2 study evaluating BCX9930 for treating patients with paroxysmal nocturnal hemoglobinuria.
Selecta (SELB) Down on FDA's Clinical Hold on Phase I/II Study
by Zacks Equity Research
The FDA issues a clinical hold on Selecta's (SELB) phase I/II study evaluating SEL-302 for the treatment of patients with methylmalonic acidemia. Shares down in after-hours trading.
CRISPR's (CRSP) CAR-T Cell Therapy Gets FDA's RMAT Designation
by Zacks Equity Research
The FDA grants a Regenerative Medicine Advanced Therapy designation to CRISPR Therapeutics' (CRSP) CTX110 targeting CD19+ B-cell malignancies.
Deciphera (DCPH) Gets EU Nod for Qinlock in Fourth-Line GIST
by Zacks Equity Research
The European Commission approves Deciphera's (DCPH) Qinlock for the treatment of fourth-line gastrointestinal stromal tumor.
BioMarin's (BMRN) Dwarfism Drug Gets FDA's Nod, Stock Up
by Zacks Equity Research
Biomarin Pharmaceuticals's (BMRN) Voxzogo is the first medicine in the United States to be approved to treat achondroplasia, the most common form of dwarfism.
Novo Nordisk (NVO) Set to Acquire Dicerna for $3.3 Billion
by Zacks Equity Research
Novo Nordisk (NVO) inks agreement to acquire Dicerna for $3.3 billion. The company is looking to boost its RNAi research platform with this acquisition.
Coherus' (CHRS) Toripalimab Gets Orphan Drug Tag for Rare Cancer
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Coherus (CHRS) and partner Junshi's toripalimab for the treatment of esophageal cancer.
Horizon (HZNP) Gets Positive CHMP Opinion for Uplizna in NMOSD
by Zacks Equity Research
The CHMP gives a positive opinion on, and recommends approval to Horizon's (HZNP) Uplizna for treating adult patients with neuromyelitis optica spectrum disorder.
Amgen's (AMGN) KRAS Inhibitor Gets CHMP Nod for Lung Cancer
by Zacks Equity Research
The CHMP gives a positive opinion on, and recommends approval to Amgen's (AMGN) KRAS inhibitor, Lumykras for the treatment of advanced non-small-cell lung cancer.
Editas (EDIT) Q3 Earnings Beat Estimates, Revenues Fall Y/Y
by Zacks Equity Research
Editas (EDIT) reports narrower-than-expected loss in the third quarter of 2021 while its revenues marginally beat estimates. Focus remains on the development of lead candidate, EDIT-101.