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Zacks News
Iovance (IOVA) Up Despite FDA's Delayed Decision on Melanoma Drug
by Zacks Equity Research
Iovance (IOVA) rises despite the FDA's postponement of the decision date regarding the regulatory filing for its lead candidate, lifileucel, to treat advanced melanoma due to resource constraints.
Alnylam's (ALNY) Onpattro sNDA Gets FDA Advisory Committee Nod
by Zacks Equity Research
Alnylam (ALNY) receives a positive opinion from the FDA's advisory committee regarding the label expansion of patisiran to treat the cardiomyopathy of transthyretin-mediated amyloidosis.
Lyra (LYRA) Posts Upbeat Data on Rhinosinusitis Study, Stock Up
by Zacks Equity Research
Lyra (LYRA) gains on positive data from mid-stage study of LYR-220, treating patients with chronic rhinosinusitis who have had ethmoid sinus surgery.
ACELYRIN (SLRN) Fails to Meet Goal in HS Study, Stock Down 54%
by Zacks Equity Research
ACELYRIN (SLRN) fails to achieve statistically significant primary endpoint result in the hidradenitis suppurativa study of its lead candidate, izokibep. The stock of the company falls 54%.
Arcutis (ARQT) Files sNDA for Zoryve in Atopic Dermatitis, Stock Up
by Zacks Equity Research
Arcutis (ARQT) submits sNDA, seeking label expansion of Zoryve (roflumilast) cream 0.15% to treat patients with atopic dermatitis.
Arbutus (ABUS) to Focus on Hepatitis B Candidates, Stock Up
by Zacks Equity Research
Arbutus (ABUS) makes a strategic decision to focus on the development of hepatitis B virus therapies while discontinuing all coronavirus and oral RNA destabilizer programs.
Aquestive's (AQST) Libervant Accepted for FDA Review, Stock Up
by Zacks Equity Research
Aquestive (AQST) announces FDA acceptance of a regulatory application seeking approval for Libervant to treat pediatric patients with frequent seizure activity. The stock rises 4.7% in response.
Here's Why You Should Add ANI Pharmaceuticals (ANIP) to Your Portfolio
by Zacks Equity Research
ANI Pharmaceuticals (ANIP), a top-ranked stock, has a diverse portfolio of rare disease and generic medicines. Its Purified Cortrophin Gel is witnessing incremental sales in recent quarters.
J&J (JNJ) Seeks Approval for Bladder Cancer Drug in Europe
by Zacks Equity Research
J&J's (JNJ) erdafitinib is already marketed as Balversa in the United States for FGFR-altered metastatic UC. Balversa is approved by the FDA under the accelerated pathway.
Merck's (MRK) Ebola Vaccine Gets Approval for Kids in Europe
by Kinjel Shah
The European Commission approves Merck's (MRK) Ebola vaccine for use in children as young as one year.
Why Is Ionis Pharmaceuticals (IONS) Up 1.4% Since Last Earnings Report?
by Zacks Equity Research
Ionis Pharmaceuticals (IONS) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Lisata (LSTA) Up on Positive Updates for Pancreatic Cancer Study
by Zacks Equity Research
Lisata's (LSTA) shares gain on a favorable outcome in interim futility analysis of its lead candidate, LSTA1, for pancreatic cancer.
Journey Medical (DERM) & Maruho Ink Deal for Qbrexza Asia Rights
by Zacks Equity Research
Journey Medical (DERM) enters into a second licensing agreement with Maruho to develop and commercialize Qbrexza to treat hyperhidrosis in certain Asian countries. The stock surges 18.4%.
Why Is Zoetis (ZTS) Down 1.3% Since Last Earnings Report?
by Zacks Equity Research
Zoetis (ZTS) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
J&J (JNJ) to End Pulmonary Hypertension Study on Opsumit
by Zacks Equity Research
The decision to end the CTEPH study on J&J's (JNJ) Opsumit (macitentan) was made at the recommendation of the study's independent DMC, following a pre-planned interim analysis.
Palisade (PALI) In-Licenses Rights for IBD Candidate, Stock Up
by Zacks Equity Research
Palisade (PALI) gains on entering into global licensing deal with Giiant Pharma to develop gastrointestinal therapies.
Theravance Bio (TBPH) Down 2.3% Since Last Earnings Report: Can It Rebound?
by Zacks Equity Research
Theravance Bio (TBPH) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Mirum Pharma (MIRM) Stock Rises 42% Year to Date: Here's Why
by Zacks Equity Research
Mirum Pharma (MIRM) surges 42% year to date due to encouraging progress in label-expansion efforts of Livmarli, along with strategic initiatives, to expand its commercial portfolio.
Amgen (AMGN) Stock Outperforms Industry YTD: Here's Why
by Zacks Equity Research
Amgen (AMGN) expects strong sales growth of products like Tezspire, Evenity and Repatha to be offset by lower revenues from oncology biosimilars and Enbrel.
AstraZeneca (AZN) Gets FDA CRL for Ultomiris in New Indication
by Zacks Equity Research
AstraZeneca (AZN) said the CRL for Ultomiris for NMOSD indication does not raise any concerns about the efficacy and safety data from the study.
Insmed (INSM) Up on Positive Data From MAC Lung Disease Study
by Zacks Equity Research
Insmed's (INSM) shares rise on positive data from the late-stage ARISE study evaluating Arikayce for newly infected lung disease caused by MAC.
AC Immune (ACIU) Surges 43% in the Past 3 Months: Here's Why
by Zacks Equity Research
AC Immune's (ACIU) shares rose 43% over the past three months, driven by rapid progress in the development of its pipeline candidate, ACI-24.060, for neurodegenerative diseases.
SCYNEXIS (SCYX) Skyrockets 134% Year to Date: Here's Why
by Zacks Equity Research
SCYNEXIS' (SCYX) shares soar 134% year to date, owing to partnership with big wig GSK plc for the development of its antifungal tablet, Brexafemme.
Centessa (CNTA) Surges 72% in the Past 3 Months: Here's Why
by Zacks Equity Research
Centessa (CNTA) shares rise significantly in the past three months due to the encouraging progress in the development of its lead pipeline candidate, SerpinPC, which is currently in mid-late-stage studies.
Why Is Corcept (CORT) Up 4.8% Since Last Earnings Report?
by Zacks Equity Research
Corcept (CORT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.