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Zacks News
AMGN's Uplizna Gets FDA Nod for 2nd Rare Autoimmune Disease Indication
by Zacks Equity Research
The FDA approves Amgen's Uplizna as the first and only drug for the treatment of immunoglobulin G4-related disease.
SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases
by Zacks Equity Research
The FDA bestows an orphan drug designation to Sanofi's rilzabrutinib for treating warm autoimmune hemolytic anemia and IgG4-related disease.
AXSM Stock Down on Top-Line Data From Depression Study on Solriamfetol
by Zacks Equity Research
Axsome's phase III PARADIGM study evaluating solriamfetol in major depressive disorder fails to show a statistically significant change in the primary endpoint.
Alkermes Begins Idiopathic Hypersomnia Study on ALKS 2680
by Zacks Equity Research
ALKS' phase II Vibrance-3 study investigates the safety and efficacy of ALKS 2680 versus placebo for treating adults with idiopathic hypersomnia.
VRTX Provides Mixed Updates for Type 1 Diabetes Pipeline Candidates
by Zacks Equity Research
Vertex plans to submit regulatory filings seeking approval for zimislecel in type 1 diabetes in 2026. However, it is likely to stop further development of VX-264.
Mirum Pharmaceuticals (MIRM) Down 1.9% Since Last Earnings Report: Can It Rebound?
by Zacks Equity Research
Mirum Pharmaceuticals (MIRM) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
BEAM's IND for BEAM-302 in Genetic Disorder Study Gets FDA Clearance
by Zacks Equity Research
The FDA clears Beam Therapeutics' investigational new drug application for BEAM-302 for the treatment of alpha-1 antitrypsin deficiency in the United States.
NTLA Genome-Editing Therapy Gets FDA's RMAT Tag for New Indication
by Zacks Equity Research
The FDA bestows a Regenerative Medicine Advanced Therapy tag to Intellia's nex-z for treating transthyretin amyloidosis with cardiomyopathy.
Sanofi's Chlamydia Vaccine Candidate Gets FDA's Fast Track Tag
by Zacks Equity Research
The FDA bestows a fast-track designation to SNY's mRNA vaccine candidate for the prevention of chlamydia infection.
AXSM Stock Down Despite ADHD Study Meeting Primary Endpoint
by Zacks Equity Research
Axsome's phase III FOCUS study, evaluating solriamfetol for treating attention deficit hyperactivity disorder, meets its primary and key secondary endpoints.
Will Alkermes' Proprietary Drugs Aid Growth Amid Stiff Competition?
by Zacks Equity Research
ALKS' set of proprietary products, Vivitrol, Aristada and Lybalvi, is driving the top-line. However, stiff competition in the target remains a woe.
EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD
by Zacks Equity Research
The European Medicines Agency accepts GSK's regulatory filing for expanded use of Nucala to treat COPD for review.
Krystal Biotech (KRYS) Up 3.3% Since Last Earnings Report: Can It Continue?
by Zacks Equity Research
Krystal Biotech (KRYS) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Here's Why Krystal Biotech, Inc. (KRYS) is a Strong Momentum Stock
by Zacks Equity Research
Whether you're a value, growth, or momentum investor, finding strong stocks becomes easier with the Zacks Style Scores, a top feature of the Zacks Premium research service.
Krystal Biotech Rises 15.8% in a Month: Should You Buy Now or Wait?
by Zacks Equity Research
KRYS stock surges 15% in a month on strong uptake of Vyjuvek and encouraging pipeline progress. We are optimistic about the stock as we believe there is room for further growth.
KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug
by Zacks Equity Research
Krystal Biotech receives positive CHMP opinion recommending the approval of Vyjuvek for treating dystrophic epidermolysis bullosa in the EU.
Why Krystal Biotech (KRYS) Might be Well Poised for a Surge
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.
Why Krystal Biotech, Inc. (KRYS) is a Top Momentum Stock for the Long-Term
by Zacks Equity Research
Wondering how to pick strong, market-beating stocks for your investment portfolio? Look no further than the Zacks Style Scores.
Krystal Biotech (KRYS) Upgraded to Buy: Here's What You Should Know
by Zacks Equity Research
Krystal Biotech (KRYS) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Krystal Biotech Q4 Earnings Beat Estimates, Sales Miss, Stock Up
by Zacks Equity Research
KRYS stock gains despite reporting mixed fourth-quarter results as lead drug Vyjuvek's launch in the United States shows strong uptake.
Strength Seen in Ginkgo Bioworks (DNA): Can Its 14.5% Jump Turn into More Strength?
by Zacks Equity Research
Ginkgo Bioworks (DNA) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Is the Options Market Predicting a Spike in Krystal Biotech (KRYS) Stock?
by Zacks Equity Research
Investors need to pay close attention to Krystal Biotech (KRYS) stock based on the movements in the options market lately.
KRYS Reports Upbeat Initial Data From Lung Cancer Study of KB707
by Zacks Equity Research
Krystal Biotech reports initial data from a phase I/II study showing therapeutic benefit in NSCLC patients treated with its immunotherapy candidate, KB707.
KRYS Stock Down on Initial Clinical Updates on KB407 & KB408
by Zacks Equity Research
Krystal Biotech posts initial clinical updates on its two pipeline candidates, KB407 and KB408, which are being developed to treat rare respiratory diseases.
Why Is Prothena (PRTA) Down 17.9% Since Last Earnings Report?
by Zacks Equity Research
Prothena (PRTA) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.