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Zacks News
Evaxion (EVAX) Up on Partnership With Afrigen for Gonorrhea Jab
by Zacks Equity Research
Evaxion's (EVAX) shares gain as it collaborates with Afrigen Biologics to develop prophylactic mRNA vaccine targeting gonorrhea, based on Evaxion's EDEN technology.
Aquestive (AQST) Up on Reaffirming Anaphylm Development Pathway
by Zacks Equity Research
Aquestive (AQST) stock rises 11.8% as the company intends to begin a pivotal pharmacokinetic study of Anaphylm as an oral epinephrine product candidate in the fourth quarter of 2023.
Atara (ATRA) Up 11% on Regulatory Update From Blood Cancer Study
by Zacks Equity Research
Atara (ATRA) rises 11% on an update regarding the regulatory pathway for the company's lead product candidate, tab-cel, in the treatment of a rare, deadly and hematologic malignancy.
Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag
by Zacks Equity Research
The FDA grants priority review to Merck's (MRK) sBLA seeking expanded use of Keytruda for an earlier stage of cervical cancer disease.
Is it a Good Idea to Invest in KalVista (KALV) Stock Now?
by Zacks Equity Research
Here we discuss some reasons why investing in KalVista Pharmaceuticals (KALV) stock now may turn out to be a prudent move now.
Marinus (MRNS) Up 20% on Financial and Pipeline Updates
by Zacks Equity Research
Marinus' (MRNS) shares rise as it provides revenue and cash guidance for third-quarter 2023. The company also updates on the progress of its pipeline candidates targeting major central nervous system disorders.
Gilead's (GILD) Veklury Gets CHMP Nod in Damaged Liver Patients
by Zacks Equity Research
Gilead's (GILD) Veklury gets a positive CHMP opinion, recommending the use of the drug to treat people with COVID-19 with mild to severe hepatic impairment.
Strength Seen in Profound Medical (PROF): Can Its 19.5% Jump Turn into More Strength?
by Zacks Equity Research
Profound Medical (PROF) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
Orchard's (ORTX) Rare Neuro Drug Gets FDA Priority Tag, Stock Up
by Zacks Equity Research
Orchard's (ORTX) regulatory filing for OTL-200, in the treatment of pediatric patients suffering from metachromatic leukodystrophy, gets FDA acceptance under Priority Review. The stock rises 16%.
Pfizer's (PFE) Alopecia Areata Drug Litfulo Receives EU Nod
by Zacks Equity Research
Pfizer (PFE) gets marketing authorization in the EU for Litfulo to treat adults and adolescent patients aged 12 years and older with severe alopecia areata.
Here's Why You Should Invest in Alpine (ALPN) Stock Now
by Zacks Equity Research
Alpine (ALPN) plans to begin a broad and accelerated development program for povetacicept across multiple indications in 2024.
Zacks Industry Outlook Highlights Corcept Therapeutics, Aurinia Pharmaceuticals, Alpine Immune Sciences, KalVista Pharmaceuticals and Cardiol Therapeutics
by Zacks Equity Research
Corcept Therapeutics, Aurinia Pharmaceuticals, Alpine Immune Sciences, KalVista Pharmaceuticals and Cardiol Therapeutics are part of the Zacks Industry Outlook article.
GSK's Momelotinib Gets FDA Nod for Myelofibrosis-Related Anemia
by Zacks Equity Research
GSK's Ojjaara (momelotinib) is the first and the only drug approved to treat myelofibrosis patients with anemia in the United States.
5 Stocks to Buy as Drug Industry Displays Strong Fundamentals
by Kinjel Shah
Innovation is expected to continue driving growth in the Medical-Drugs industry. CORT, AUPH, ALPN, KALV and CRDL may prove to be good additions to one's portfolio.
Merck (MRK) Gets CHMP Nod for Keytruda in Adjuvant Lung Cancer
by Zacks Equity Research
Merck's (MRK) Keytruda gets a positive CHMP opinion, recommending the approval of the drug for the adjuvant treatment of adults with non-small cell lung cancer, who are at high risk of recurrence, in the EU.
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.