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Zacks News
Is a Surprise Coming for Spero Therapeutics (SPRO) This Earnings Season?
by Zacks Equity Research
Spero Therapeutics (SPRO) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
What to Expect Ahead of BlackBerry's (BB) Q4 Earnings Release
by Zacks Equity Research
BlackBerry's (BB) revenues in fourth-quarter fiscal 2022 are likely to have benefited from its investments in product development and go-to-market strategy.
Spero (SPRO) Application for UTI Drug Gets Priority Review
by Zacks Equity Research
Spero's (SPRO) NDA for tebipenem HBr oral tablets for complicated urinary tract infections gets Priority Review.
Spero Therapeutics, Inc. (SPRO) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Spero Therapeutics, Inc. (SPRO) delivered earnings and revenue surprises of 0.00% and 2.13%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?
Spero Therapeutics, Inc. (SPRO) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
by Zacks Equity Research
Spero Therapeutics, Inc. (SPRO) 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.
Evelo (EVLO) Posts Positive Data from Phase II Psoriasis Study
by Zacks Equity Research
Evelo Biosciences (EVLO) reports encouraging data from a phase II study evaluating EDP1815 for the treatment of mild and moderate psoriasis. Shares up in pre-market trading.
Ultragenyx (RARE) Reports FDA Removal of Clinical Hold on Study
by Zacks Equity Research
Ultragenyx (RARE) and GeneTx Biotherapeutics to start dosing in the phase I/II study on GTX-102 for treating pediatric patients with Angelman syndrome after the FDA removes its clinical hold on the same.
Mirum (MIRM)-Takeda Collaborate for Liver Disease Drug in Japan
by Zacks Equity Research
Mirum (MIRM) signs an agreement with Takeda for developing/commercializing maralixibat for Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia, in Japan.
Seagen (SGEN) Gets Early FDA Nod for Tivdak in Cervical Cancer (Revised)
by Zacks Equity Research
The FDA grants accelerated nod to Seagen (SGEN) and Genmab's Tivdak for treating adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy.
Seagen (SGEN) Gets Early FDA Nod for Tivdak in Cervical Cancer
by Zacks Equity Research
The FDA grants accelerated nod to Seagen (SGEN) and Genmab's Tivdak for treating adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy.
BeiGene (BGNE) Scores Third FDA Nod for Brukinsa in Lymphoma
by Zacks Equity Research
The FDA grants accelerated nod to BeiGene's (BGNE) Brukinsa for treating adults with relapsed or refractory marginal zone lymphoma. This marks the third approval for the drug in the United States.
RedHill (RDHL) Down on Unsatisfactory Data From COVID-19 Study
by Zacks Equity Research
RedHill (RDHL) posts preliminary top-line data from a phase II/III study evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia. Stocks falls as the study fails to achieve its goal.
Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran
by Zacks Equity Research
Alnylam (ALNY) submits a marketing authorization application to the EMA for vutrisiran to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA
by Zacks Equity Research
The FDA accepts for review BeiGene's (BGNE) BLA for tislelizumab to treat patients with locally advanced/metastatic esophageal squamous cell carcinoma after prior systemic therapy.
Apellis (APLS) Down on Mixed Data From Studies on GA Candidate
by Zacks Equity Research
Apellis (APLS) posts mixed top-line data from the phase III DERBY and OAKS studies testing pegcetacoplan in adults with geographic atrophy secondary to age-related macular degeneration. Stock falls.
Erasca (ERAS) Inks Deal With Pfizer for Colorectal Cancer Study
by Zacks Equity Research
Erasca (ERAS) signs an agreement with Pfizer for a clinical study, which will evaluate ERAS-007 in combination with encorafenib and cetuximab for BRAF V600E-mutant metastatic colorectal cancer.
Global Blood's (GBT) NDA & sNDA for Oxbryta Get Priority Review
by Zacks Equity Research
The FDA grants priority review to Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to 11 years, as well as to its NDA for a pediatric weight-based formulation of the drug.
Precision (DTIL) Inks Deal With Tiziana for Cancer Candidate
by Zacks Equity Research
Precision (DTIL) signs an exclusive license agreement with Tiziana to explore the latter's fully human anti-CD3 mAb, foralumab, for treating various cancer indications. Stock up.
Here's Why Momentum Investors Will Love Spero Therapeutics, Inc. (SPRO)
by Zacks Equity Research
Does Spero Therapeutics, Inc. (SPRO) have what it takes to be a top stock pick for momentum investors? Let's find out.
Stealth (MITO) Files NDA for Ultra-Rare Disease Candidate
by Zacks Equity Research
Stealth BioTherapeutics (MITO) files a new drug application for elamipretide to the FDA for the treatment of Barth syndrome, an ultra-rare genetic condition.
Bristol Myers' (BMY) sBLA for Orencia Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Bristol Myers' (BMY) sBLA for Orencia under a priority review to prevent moderate to severe acute graft versus host disease. A verdict is pending on Dec 23, 2021.
Apellis' (APLS) Q2 Earnings & Revenues Fall Shy of Estimates
by Zacks Equity Research
Apellis (APLS) reports a wider-than-expected loss for the second quarter of 2021. Revenues too miss expectations.
Immunovant (IMVT) Reports Wider-Than-Expected Loss in Q1
by Zacks Equity Research
Immunovant's (IMVT) earnings miss estimates in first-quarter fiscal 2022 (ended Jun 30, 2021). Focus remains on lead pipeline candidate IMVT-1401.
bluebird (BLUE) Q2 Loss Wider Than Expected, Revenues Fall Y/Y
by Zacks Equity Research
bluebird (BLUE) reports a wider-than-expected loss in second-quarter 2021 and also misses revenue estimates. Shares down in pre-market trading as FDA places clinical hold eli-cel.
Spero Therapeutics, Inc. (SPRO) Reports Q2 Loss, Tops Revenue Estimates
by Zacks Equity Research
Spero Therapeutics, Inc. (SPRO) delivered earnings and revenue surprises of 18.18% and 101.88%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?