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Zacks News
Krystal Biotech (KRYS) Is a Great Choice for 'Trend' Investors, Here's Why
by Zacks Equity Research
Krystal Biotech (KRYS) could be a great choice for investors looking to make a profit from fundamentally strong stocks that are currently on the move. It is one of the several stocks that made it through our "Recent Price Strength" screen.
Geron (GERN) Wins FDA Approval for Blood Cancer Drug, Stock Up
by Zacks Equity Research
Geron's (GERN) shares rise on approval of its first drug. The FDA approves imetelstat for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia.
Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion
by Zacks Equity Research
Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.
AstraZeneca's (AZN) Tagrisso sNDA Gets FDA's Priority Tag
by Zacks Equity Research
The FDA grants priority review to AstraZeneca's (AZN) Tagrisso for treating patients with unresectable, stage III EGFR-mutated lung cancer. A decision is due in the fourth quarter of 2024.
Replimune (REPL) Gains on Positive Data From Melanoma Study
by Zacks Equity Research
Replimune's (REPL) lead pipeline candidate RP1, in combination with Opdivo, leads to an overall response rate of 33.6% in patients with anti-PD1 failed melanoma. Shares gain.
Vir Biotechnology (VIR) Up on Positive Data From HDV Study
by Zacks Equity Research
Vir Biotechnology (VIR) rises on upbeat data from its phase II study evaluating tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta.
Ocugen (OCGN) Skyrockets 209.6% Year to Date: Heres Why
by Zacks Equity Research
Ocugen's (OCGN) shares rise significantly in the year-to-date period on positive progress with its promising pipeline candidates.
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo (Revised)
by Zacks Equity Research
Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.
Denali's (DNLI) Candidate Selected for FDA's START Pilot Program
by Zacks Equity Research
Denali's (DNLI) DNL126, an investigational enzyme replacement therapy, gets selected for the START Pilot Program, intended to accelerate the development of rare disease therapies.
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo
by Zacks Equity Research
Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.
Gilead (GILD), RCUS Announce Data From Colorectal Cancer Study
by Zacks Equity Research
Gilead (GILD) and partner Arcus Biosciences (RCUS) present data from metastatic colorectal cancer and gastrointestinal cancer study.
Novartis (NVS) Reports Positive Long-Term Data on CSU Drug
by Zacks Equity Research
Novartis (NVS) reports phase III data that confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria.
Gilead's (GILD) Urothelial Cancer Study Did Not Meet Its Primary Goal
by Zacks Equity Research
Gilead Sciences, Inc.'s (GILD) confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer fails to achieve its primary endpoint.
Bristol Myers (BMY) Gets EC Nod for Opdivo Label Expansion
by Zacks Equity Research
Bristol Myers' (BMY) Opdivo combination regimen receives the European Commission's approval for the first-line treatment of unresectable or metastatic urothelial carcinoma.
Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
by Zacks Equity Research
The FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
Corcept (CORT) Rises as Cushing's Syndrome Study Meets Goal
by Zacks Equity Research
Corcept's (CORT) phase III GRACE study, evaluating its lead candidate, relacorilant, for treating patients with Cushing's syndrome, meets the primary endpoint in a randomized withdrawal phase.
Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns
by Zacks Equity Research
Mirum's (MIRM) lead drug, Livmarli, continues to generate steady sales. The recent label expansion of the drug should drive sales further. However, overdependence on Livmarli for revenues is a concern.
Novartis (NVS) Presents Positive Data on Renal Drugs at ERA
by Zacks Equity Research
Novartis (NVS) presents data on Fabhalta in adult patients with C3 glomerulopathy and atrasentan in those with IgA nephropathy (IgAN) at the ERA.
Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
by Zacks Equity Research
The FDA grants priority review to Sanofi's (SNY) sBLA for the Sarclisa combination regimen for transplant-ineligible newly diagnosed multiple myeloma. A decision is due on Sep 27, 2024.
Puma Biotechnology (PBYI) Falls 38% in 3 Months: Here's Why
by Zacks Equity Research
Sales of Puma Biotechnology's (PBYI) sole marketed drug, Nerlynx, have been declining in recent quarters. Stiff competition in the target market is also a woe.
Candel (CADL) Reports Upbeat Data From Lung Cancer Study
by Zacks Equity Research
Candel's (CADL) CAN-2409 prolongs overall survival in a phase II study for treating patients with advanced non-small cell lung cancer who are non-responsive to immune checkpoint inhibitor therapy.
Earnings Estimates Moving Higher for Krystal Biotech (KRYS): Time to Buy?
by Zacks Equity Research
Krystal Biotech (KRYS) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.
Cartesian (RNAC) Up as FDA Grants RMAT Tag to Descartes-08
by Zacks Equity Research
The FDA bestows RMAT designation to Cartesian's (RNAC) lead pipeline candidate, Descartes-08, for treating myasthenia gravis. Shares rise.
Esperion's (ESPR) Drugs Get EU Nod for Lowering Heart Risk
by Zacks Equity Research
Esperion's (ESPR) Nilemdo & Nustendi get the European Commission's nod for label expansion based on data from the CLEAR Outcomes study.
Krystal Biotech (KRYS) Gains 36% Year to Date: Here's Why
by Zacks Equity Research
Krystal Biotech (KRYS) soars 36.5% on strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress.