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Zacks News
Sarepta's Casimersen NDA Gets Priority Review From FDA
by Zacks Equity Research
Sarepta (SRPT) is seeking accelerated approval for exon 45 amenable DMD candidate, casimersen. Amondys 45 is likely to be the brand name for the candidate.
Pharma Stock Roundup: SNY, JNJ Acquisition Deals, FDA Approvals
by Kinjel Shah
J&J (JNJ) proposes to buy Momenta Pharmaceuticals while Sanofi (SNY) offers to buy Principia Biopharma
Regeneron Gains on Coronavirus Treatment Development Efforts
by Zacks Equity Research
Regeneron's (REGN) shares grow year to date owing to focus on developing a treatment for the novel coronavirus.
Regeneron, Roche to Distribute Antibody Cocktail for Coronavirus
by Zacks Equity Research
Regeneron (REGN) teams up with Roche to develop and distribute REGN-COV2, its experimental dual antibody cocktail for the prevention and treatment of COVID-19.
Gilead (GILD) Gets CRL From FDA for Rheumatoid Arthritis Drug
by Zacks Equity Research
Gilead (GILD) suffers a setback as the FDA issues a CRL for its rheumatoid arthritis drug.
AstraZeneca's Imfinzi Gets Priority Tag for 4-Week Dosing
by Zacks Equity Research
The FDA grants priority review to AstraZeneca's (AZN) sBLA seeking approval of Imfinzi for a four-week fixed-dose regimen for its approved indications in bladder cancer and non-small cell lung cancer.
PTC Therapeutics' Application for SMA Drug Accepted by EU
by Zacks Equity Research
PTC Therapeutics??? (PTCT) MAA for Evrysdi is accepted by the European Medicines Agency for the treatment of spinal muscular atrophy.
Bristol Myers & Dragonfly Team Up for Immunotherapy Program
by Zacks Equity Research
Bristol Myers (BMY) collaborates with Dragonfly Therapeutics, Inc. for its experimental immunotherapy program.
Gilead Expands Collaboration With Tango for Cancer Therapies
by Zacks Equity Research
Gilead (GILD) expands its partnership with biotech company, Tango, for innovative targeted immune evasion cancer therapies.
Roche Gets FDA Nod for Nervous System Disorder Drug Enspryng
by Zacks Equity Research
Roche (RHHBY) obtains FDA approval for NMOSD drug under the brand name, Enspryng.
Sanofi to Buy Immunology Firm Principia Biopharma for $3.7B
by Zacks Equity Research
Sanofi (SNY) offers $3.68 billion to buy Principia Biopharma. The deal is likely to strengthen the company's core R&D areas of autoimmune and allergic diseases.
Pharma Stock Roundup: FDA Approval for Roche's SMA Drug & Other Updates
by Kinjel Shah
Teaser: FDA approves Roche's (RHHBY) new SMA drug, Evrysdi (risdiplam).
Roche's Xolair sBLA for Self Administration Accepted by FDA
by Zacks Equity Research
The FDA accepts Roche's (RHHBY) sBLA for a new self-administration option for Xolair across all approved U.S. indications.
AbbVie Outperforms Large-Cap Pharma Industry Year to Date
by Zacks Equity Research
AbbVie's (ABBV) key drug, Humira is seeing strong demand in the United States while generics are eroding ex-U.S. sales. New drugs Skyrizi and Rinvoq are seeing strong sales uptake.
Halozyme (HALO) Q2 Earnings and Revenues Miss Estimates
by Zacks Equity Research
Halozyme (HALO) reports lower-than-expected Q2 earnings. Shares down.
Alzheimer's in Focus as Biogen's Aducanumab Gets Priority Tag
by Kinjel Shah
If Biogen's (BIIB) aducanumab is approved by the FDA, it will become the first medicine to be approved to reduce the clinical decline associated with Alzheimer's disease.
Puma's (PBYI) Earnings and Revenues Beat Estimates in Q2
by Zacks Equity Research
Puma Biotech's (PBYI) bottom and the top line better estimates for the second quarter of 2020.
Exelixis' (EXEL) Q2 Earnings and Revenues Surpass Estimates
by Zacks Equity Research
Exelixis (EXEL) beats on earnings and sales in the second quarter.
Teva (TEVA) Q2 Earnings Top, Stock Up Despite Coronavirus Woes
by Zacks Equity Research
Teva (TEVA) beats second-quarter estimates for earnings while missing the same for sales. It maintains its previously issued guidance for 2020. Stock up.
Bayer (BAYRY) Q2 Earnings & Sales Fall Y/Y, Guidance Tweaked
by Zacks Equity Research
Bayer's (BAYRY) earnings and sales fall year over year in the second quarter of 2020.
Will Eliquis, Revlimid Drive Bristol-Myers (BMY) Q2 Earnings?
by Zacks Equity Research
Investors will focus on regular top and bottom-line numbers along with key pipeline updates when Bristol-Myers (BMY) reports second-quarter 2020 results.
ImmunoGen (IMGN) Q2 Earnings and Sales Beat, Shares Down
by Zacks Equity Research
ImmunoGen (IMGN) reports encouraging second-quarter results. Top-line data from pivotal study on its lead candidate, mirvetuximab soravtansine, likely to be delayed by six to eight weeks.
AbbVie's (ABBV) Q2 Earnings and Revenues Beat Estimates
by Zacks Equity Research
AbbVie (ABBV) beats on second-quarter 2020 earnings and revenues. Shares up in pre-market trading.
Merck (MRK) Beats on Q2 Earnings, Misses Sales, Ups View
by Zacks Equity Research
Merck (MRK) increases earnings and sales guidance for the year, which pushes shares up in pre-market trading.
Gilead (GILD) Misses on Q2 Earnings & Sales, Ups '20 Guidance
by Zacks Equity Research
Gilead (GILD) reports weaker-than-expected results for the second quarter but ups annual guidance.