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Zacks News
Regeneron (REGN) Loses 13% in Three Months: What Lies Ahead?
by Zacks Equity Research
Regeneron (REGN) declines 13% in the last three months due to regulatory setback for 8 mg dose strength of aflibercept and competition for lead drug.
Roche (RHHBY) Announces Positive Long-Term Data on SMA Drug
by Zacks Equity Research
Roche's (RHHBY) SMA drug Evrysdi maintains its efficacy and safety profile in children with type 1 SMA after four years of treatment.
FDA Accepts Pfizer's (PFE) Hemophilia B Gene Therapy Filing
by Zacks Equity Research
A final decision on Pfizer's (PFE) BLA filing, seeking approval for hemophilia B gene therapy, treatment is expected by second-quarter 2024.
Sarepta (SRPT) Gets FDA's Accelerated Nod for DMD Gene Therapy
by Zacks Equity Research
Following FDA???s approval, Sarepta's (SRPT) Elevidys becomes the first gene therapy for treating DMD.
Roche (RHHBY) Gets FDA Approval for Blood Cancer Drug Columvi
by Zacks Equity Research
Roche's (RHHBY) blood cancer portfolio gets a boost with the approval of Columvi (glofitamab-gxbm) for treating patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Novartis (NVS) to Buy Chinook for $3.5B to Strengthen Pipeline
by Zacks Equity Research
Novartis (NVS) is looking to strengthen its renal pipeline with the acquisition of Chinook Therapeutics for $3.5 billion, which adds two late-stage medicines in development for rare, severe chronic kidney diseases.
Roche (RHHBY) Announces Positive Results From PNH Studies
by Zacks Equity Research
Roche (RHHBY) crovalimab achieves disease control in paroxysmal nocturnal hemoglobinuria patients in the phase III COMMODORE 1 and COMMODORE 2 studies.
Biogen (BIIB), Eisai Alzheimer Drug Gets FDA Panel Endorsement
by Zacks Equity Research
An FDA advisory committee supports granting full approval to Biogen (BIIB)/Eisai's Alzheimer's disease antibody. NASDAQ halts BIIB's common stock trading on Jun 9.
Biogen (BIIB), Eisai's Alzheimer Drug Likely to Get Full FDA Nod
by Zacks Equity Research
Based on briefing documents issued by the FDA, a full regulatory approval is expected on Biogen (BIIB)/Eisai's Alzheimer's disease antibody. The final decision is expected in the early next month.
Dr. Reddy's (RDY) Meets Goals in Actemra Biosimilar Study
by Zacks Equity Research
Dr. Reddy's (RDY) announces meeting primary and secondary endpoints in the phase I study of its proposed tocilizumab biosimilar for the treatment of rheumatoid arthritis in adults.
AstraZeneca (AZN) Anticoagulant Drug Study Meets Efficacy Goal
by Zacks Equity Research
At the interim analysis, AstraZeneca's (AZN) drug Andexxa showed superior hemostatic efficacy or in other words improved control of bleeding with targeted anticoagulation reversal versus usual care.
Is Novo Nordisk (NVO) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Here is how Novo Nordisk (NVO) and Roche Holding AG (RHHBY) have performed compared to their sector so far this year.
Zacks Industry Outlook Highlights Eli Lilly, Johnson & Johnson, Novo Nordisk, Roche and Novartis
by Zacks Equity Research
Eli Lilly, Johnson & Johnson, Novo Nordisk, Roche and Novartis have been highlighted in this Industry Outlook article.
Sanofi (SNY) NextGen Multiple Sclerosis Drug Meets Phase II Goal
by Zacks Equity Research
Sanofi's (SNY) phase II study on its novel investigational anti-CD40L antibody, frexalimab, meets the primary endpoint.
5 Large Drug Stocks to Watch From a Thriving Industry
by Kinjel Shah
Drug/biotech companies are likely to see significant advances in innovation in 2023. In the Large-Cap Pharmaceuticals industry, Eli Lilly (LLY), J&J (JNJ), Novo Nordisk (NVO), Roche (RHHBY) and Novartis (NVS) are worth retaining in your portfolio.
Kodiak (KOD) Advances With Tarcocimab Amid Stiff Competition
by Zacks Equity Research
Kodiak (KOD) focuses on completing ongoing studies on tarcocimab for several retinal indications. However, competition in the market and the lack of other candidates in the pipeline are concerns.
Sarepta (SRPT) Down 11% on FDA Extending DMD Gene Therapy Review
by Zacks Equity Research
The FDA extends the review period for Sarepta's (SRPT) BLA for DMD gene therapy by almost four weeks to Jun 22. The agency may limit the use of the therapy in children aged between four and five.
Alimera (ALIM) Completes Enrollment in Eye Disease Study
by Zacks Equity Research
Alimera (ALIM) announces completion of patient enrollment in its NEW DAY study to evaluate Iluvien 0.19 mg as a baseline therapy in diabetic macular edema. The stock surges 8% on Wednesday.
Regeneron (REGN) Faces Challenges as Eylea Sales Decline
by Zacks Equity Research
Regeneron (REGN) loses some of its gains as sales of its lead drug, Eylea, decline. Nevertheless, Dupixent sales boost the top line.
Alimera (ALIM) Up on Deal With Eyepoint for U.S. Rights to Yutiq
by Zacks Equity Research
Alimera's (ALIM) stock jumps 19.4% after the company inks a deal with Eyepoint to acquire additional U.S. commercialization rights for 0.18 mg dose strength of Yutiq
Here's Why You Should Add ImmunoGen (IMGN) to Your Portfolio Now
by Zacks Equity Research
ImmunoGen's (IMGN) recently launched drug, Elahere, is expected to generate incremental revenues for the company and boost its top-line growth in the next few years.
Pharma Stock Roundup: FDA Nod to ABBV's Rinvoq for New Indication & Other Updates
by Kinjel Shah
FDA panel votes in favor of Pfizer's (PFE) experimental maternal RSV vaccine. FDA approves AbbVie's (ABBV) Rinvoq for Crohn's Disease.
Roche's (RHHBY) MS Drug Meets Goals in the Phase II Study
by Zacks Equity Research
Roche's (RHHBY) investigational oral fenebrutinib meets its primary and secondary endpoints in the phase II FENopta study.
Sarepta's (SRPT) DMD Gene Therapy Gets Endorsed by FDA Panel
by Zacks Equity Research
The FDA's CTGTAC narrowly recommends granting accelerated approval to Sarepta's (SRPT) DMD gene therapy. A final decision from the agency is expected by the end of this month.
Eli Lilly (LLY) Stock Up 18.7% YTD, New Drugs Key to Growth
by Zacks Equity Research
Lilly (LLY) expects to launch four new medicines by 2023 end, of which Mounjaro for type II diabetes and cancer drug Jaypirca have already been launched.