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Zacks News
Novo Nordisk (NVO) to Begin Study on Oral Semaglutide in Obesity
by Zacks Equity Research
Novo Nordisk (NVO) to start a phase IIIa study testing oral semaglutide 50 mg in people with obesity or those who are overweight with comorbidities. The study is expected to begin in second-half 2021.
Roche (RHHBY) Q1 Sales Affected by Biosimilars & COVID-19
by Zacks Equity Research
Roche's (RHHBY) performance in the first quarter of 2021 gets negatively impacted by biosimilar competition and coronavirus-related disruptions. Nevertheless, the diagnostics division maintains momentum.
Seagen's (SGEN) Two sBLAs for Padcev Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Seagen (SGEN) and Astellas' two sBLAs for Padcev under a priority review to treat patients with locally advanced or metastatic urothelial carcinoma. A verdict is pending on Aug 17, 2021.
Incyte (INCY), MorphoSys Initiate Dosing in Lymphoma Study
by Zacks Equity Research
Incyte (INCY) and MorphoSys begin dosing in a study evaluating tafasitamab or placebo, in combination Revlimid and Rituxan, in patients with relapsed or refractory FL or marginal zone lymphoma.
AstraZeneca (AZN) Gets FTC Clearance for Alexion Acquisition
by Zacks Equity Research
AstraZeneca (AZN) obtains U.S. Federal Trade Commission's permission for the Alexion acquisition. The deal is expected to close in the third quarter of 2021.
Gilead (GILD) Gets FDA Nod for Trodelvy in Urothelial Cancer
by Zacks Equity Research
The FDA grants accelerated approval to Gilead's (GILD) Trodelvy for treating adult patients with locally-advanced or metastatic urothelial cancer.
vTv Therapeutics (VTVT) Gets Breakthrough Tag for Diabetes Drug
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to vTv Therapeutics' (VTVT) TTP399 as an adjunctive therapy to insulin for treating type I diabetes. Shares rise.
Sage (SAGE), Biogen Report Positive Data on Essential Tremor Study
by Zacks Equity Research
Sage (SAGE) and partner Biogen (BIIB) announce positive top-line results from the phase II, placebo-controlled KINETIC study in patients with essential tremor.
Myovant (MYOV), Pfizer Start Dosing in Relugolix Combo Study
by Zacks Equity Research
Myovant (MYOV) and Pfizer (PFE) initiate dosing in the phase III SERENE study evaluating the contraceptive efficacy of the relugolix combination tablet.
Seagen's (SGEN) Tisotumab Vedotin BLA Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Seagen (SGEN) and Genmab's BLA for tisotumab vedotin under a priority review to treat recurrent/metastatic cervical cancer. A verdict is pending on Oct 10, 2021.
Sanofi (SNY) Acquires Tidal to Aid mRNA-Based Research Platform
by Zacks Equity Research
Sanofi's (SNY) acquisition of Tidal Therapeutics for $160 million is set to aid innovative mRNA-based research platform with applications in oncology, immunology and other diseases.
Merck (MRK) Keytruda Meets Endpoint in Kidney Cancer Study
by Zacks Equity Research
Merck (MRK) is developing a Keytruda monotherapy regimen for adjuvant treatment of renal cell carcinoma patients.
Syndax's (SNDX) Axatilimab Gets FDA's Orphan Drug Tag for IPF
by Zacks Equity Research
The FDA grants orphan drug designation to Syndax's (SNDX) axatilimab for the treatment of patients with idiopathic pulmonary fibrosis. Shares up.
Alkermes (ALKS) Inks Deal With Merck for Ovarian Cancer Study
by Zacks Equity Research
Alkermes (ALKS) signs a clinical trial collaboration and supply agreement with Merck to evaluate nemvaleukin alfa in combination with Keytruda for treating platinum-resistant ovarian cancer.
Exelixis' (EXEL) IND for Oncology Candidate Accepted by FDA
by Zacks Equity Research
The FDA accepts Exelixis' (EXEL) IND for XB002 in patients with advanced solid tumors and a phase I study is expected to start in the second quarter.
ACADIA (ACAD) Gets CRL From FDA for Nuplazid sNDA, Shares Down
by Zacks Equity Research
The FDA issues a Complete Response Letter to ACADIA's (ACAD) sNDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis. Stock falls.
Supernus (SUPN) Receives FDA Approval for ADHD Treatment
by Zacks Equity Research
Supernus (SUPN) gets FDA approval for ADHD treatment, Qelbree, in pediatric patients 6 to 17 years of age.
Syndax's (SNDX) Axatilimab Gets FDA's Orphan Drug Tag for GVHD
by Zacks Equity Research
The FDA bestows an orphan drug designation on Syndax's (SNDX) axatilimab for the treatment of patients with chronic graft versus host disease. Shares up.
Amgen (AMGN) to Boost Inflammation Pipeline With Rodeo Buyout
by Zacks Equity Research
Amgen (AMGN) inks an agreement to acquire privately held company, Rodeo Therapeutics Corporation, to boost its inflammation portfolio.
Encompass Health (EHC) Opens Hospital, Boosts Texas Presence
by Zacks Equity Research
Encompass Health (EHC) opens an inpatient rehabilitation hospital in Texas, which reinforces the company's efforts to broaden presence in the state.
Incyte (INCY) Gets EU Nod for Cholangiocarcinoma Drug Pemazyre
by Zacks Equity Research
The European Commission approves Incyte's (INCY) Pemazyre (pemigatinib) for the treatment of locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion.
Why Is Repligen (RGEN) Down 12.9% Since Last Earnings Report?
by Zacks Equity Research
Repligen (RGEN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Is Repligen (RGEN) a Great Growth Stock?
by Zacks Equity Research
If you are looking for a fast-growing stock that is still seeing plenty of opportunities on the horizon, make sure to consider Repligen (RGEN).
Myovant's (MYOV) Data on Relugolix for Uterine Fibroids Positive
by Zacks Equity Research
Myovant (MYOV) and partner Pfizer report positive data from the phase III LIBERTY study evaluating relugolix combination therapy for treating women with uterine fibroids.
Novartis (NVS) Posts Positive Data From Prostate Cancer Study
by Zacks Equity Research
Novartis (NVS) reports positive data from the phase III VISION study evaluating its radioligand therapy, 177Lu-PSMA-617, in patients with advanced prostate cancer.