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Zacks News
Intra-Cellular (ITCI) Q2 Earnings & Sales Top, '23 View Raised
by Zacks Equity Research
Intra-Cellular (ITCI) reports better-than-expected second-quarter results. Caplyta sales continue to drive growth. The company raises its financial outlook for full-year Caplyta sales.
Acadia (ACAD) Q2 Earnings & Revenues Beat Estimates, '23 View Up
by Zacks Equity Research
Acadia (ACAD) reports better-than-expected second-quarter 2023 results, raising its financial guidance for the year. The company also provides updates on its pipeline.
Pacira (PCRX) Q2 Earnings and Sales Miss, '23 View Updated
by Zacks Equity Research
Pacira (PCRX) announces weaker-than-expected second-quarter 2023 results. The company updates its 2023 financial guidance.
Apellis (APLS) Q2 Earnings Top, Syfovre Sales Boost Revenues
by Zacks Equity Research
Apellis (APLS) reports better-than-expected second-quarter 2023 results. However, the stock falls 20% due to ambiguity surrounding Syfovre's safety profile.
ADMA Biologics (ADMA) to Report Q2 Earnings: What's in Store?
by Zacks Equity Research
On ADMA Biologics' (ADMA) Q2 earnings call, investors will likely focus on the sales performance of its immune deficiency disorder drugs.
Adma Biologics (ADMA) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Adma Biologics (ADMA) closed the most recent trading day at $3.76, moving +0.53% from the previous trading session.
Adma Biologics (ADMA) Gains But Lags Market: What You Should Know
by Zacks Equity Research
In the latest trading session, Adma Biologics (ADMA) closed at $3.49, marking a +0.58% move from the previous day.
New Strong Buy Stocks for July 7th
by Zacks Equity Research
ADMA, APOG, KIND, JBL and OII have been added to the Zacks Rank #1 (Strong Buy) List on July 7, 2023.
Vertex (VRTX) Gets Nod in EU for Orkambi Expanded Indication
by Zacks Equity Research
Vertex's (VRTX) Orkambi gets approval from the European Commission in the EU for the treatment of cystic fibrosis in patients (aged 1 to <2 years) who have two copies of the F508del mutation.
CRISPR (CRSP) Shares Rise 24% in the Last Quarter: Here's Why
by Zacks Equity Research
Shares of CRISPR (CRSP) surge 24% in the last quarter after the company, along with Vertex, provides positive regulatory updates on exa-cel BLAs in SCD and TDT treatment.
Alnylam (ALNY) Announces FDA Committee Onpattro sNDA Review Date
by Zacks Equity Research
Alnylam (ALNY) reports that the FDA has set Sep 13, 2023, as the day for the meeting of the Advisory Committee to review its sNDA application for patisiran in treating the cardiomyopathy of ATTR amyloidosis.
Kintara (KTRA) Rises 41% on $2M Grant for Breast Cancer Therapy
by Zacks Equity Research
Kintara (KTRA) receives a $2 million grant from the National Institutes of Health to develop its breast cancer treatment candidate, REM-001. The stock surges 41%.
Liquidia (LQDA) Up on Deal With Pharmosa to Co-Develop PH Drug
by Zacks Equity Research
Liquidia (LQDA) signs an exclusive licensing agreement with Pharmosa to jointly develop and commercialize PAH and PH-ILD treatment candidate, L606, in North America. Shares of the company rise 11%.
Aeglea (AGLE) Soars 329% on Acquiring Spyre Therapeutics
by Zacks Equity Research
Aeglea's (AGLE) shares surge as it acquires Spyre Therapeutics, a private company that focuses on developing antibody therapeutics for inflammatory bowel disease.
uniQure (QURE) Falls on Mixed Huntington's Disease Study Results
by Zacks Equity Research
uniQure (QURE) stock declines after the company announces mixed results from its biomarkers analysis in the early-to-mid-stage study of AMT-130 in Huntington's disease.
Amgen's (AMGN) Blincyto sBLA Gets FDA Nod in Treating Leukemia
by Zacks Equity Research
Amgen (AMGN) announces full approval of its sBLA for Blincyto as an immune-oncology therapy for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia.
Alderya (ALDX) Stock Declines on Getting CRL for PVRL Candidate
by Zacks Equity Research
Alderya's (ALDX) shares decline on receiving a complete response letter for an investigational candidate, ADX-2191, treating primary vitreoretinal lymphoma.
Denali (DNLI) Provides Update on Hunter Syndrome Study
by Zacks Equity Research
Denali's (DNLI) early-to-mid-stage study of DNL310 shows a robust reduction in neurofilament light levels for patients with MPS II (Hunter syndrome).
Aridis (ARDS) Up on Regulatory Update for Pneumonia Drug
by Zacks Equity Research
Aridis (ARDS) announces that its AR-301 clinical program is eligible for availing the FDA's special pathway for satisfying the unmet medical need of a predefined limited population.
Merck's (MRK) Gastric Cancer Study Fails to Meet a Primary Goal
by Zacks Equity Research
Merck's (MRK) late-stage study evaluating Keytruda in advanced gastric cancer fails to meet one of the primary endpoints.
Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
by Zacks Equity Research
Reata (RETA) gets FDA acceptance for the filing of new drug application supplement approval for Skyclarys' release.
GSK Announces Extension of FDA Review for Rare Blood Therapy
by Zacks Equity Research
GSK announces the FDA's extension of the review period of its new drug application for momelotinib to treat myelofibrosis by three months. A decision is now expected on Sep 16, 2023.
Mersana (MRSN) Down on Partial Ovarian Cancer Study Hold
by Zacks Equity Research
Mersana's (MRSN) shares decline on partial clinical hold by the FDA on UP-NEXT and UPGRADE-A studies evaluating upifitamab rilsodotin to treat platinum-sensitive ovarian cancer.
Aldeyra (ALDX) Up On Positive Data From Conjunctivitis Study
by Zacks Equity Research
Aldeyra (ALDX) soars on meeting primary and secondary endpoints in the late-stage study of reproxalap for patients with allergic conjunctivitis.
Blue Water (BWV) Up on Acquisition of 6 FDA-Approved Drugs
by Zacks Equity Research
Blue Water (BWV) soars 62% after declaring its deal to purchase six FDA-approved products for $8.5 million. The agreement will help expand the company's portfolio into cardiology and pain management.