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Zacks News
Immix (IMMX) Up on Orphan Drug Tag for AL Amyloidosis Therapy
by Zacks Equity Research
Immix (IMMX) gets ODD designation in the United States for lead candidate NXC-201 for the treatment of amyloid light chain (AL) Amyloidosis.
Moleculin (MBRX) Posts Update From Lung Cancer Study, Stock Up
by Zacks Equity Research
Moleculin (MBRX) completes enrollment in the phase II portion of the development program for its lead candidate, Annamycin, to treat soft tissue sarcoma lung metastases. The stock rises 10%.
ARS Pharmaceuticals (SPRY) Down on CRL for Nasal Spray
by Zacks Equity Research
ARS Pharmaceuticals, Inc. (SPRY) plunges on a surprise CRL by the FDA for its nasal spray curated for allergic reactions.
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.
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.
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.
Incyte (INCY) Down on FDA Nod for Another Myelofibrosis Drug
by Zacks Equity Research
Incyte (INCY) declines on potential competition for lead drug Jakafi from Ojjaara for the treatment of intermediate or high-risk myelofibrosis.
Novartis' (NVS) Shareholders Approve Sandoz Separation
by Zacks Equity Research
Novartis' (NVS) shareholders vote in favor of the 100% spin-off of Sandoz into a new publicly traded standalone company.
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.
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.
Here's Why Rocket Pharmaceuticals (RCKT) Rises 53.8% in a Week
by Zacks Equity Research
Rocket Pharmaceucticals (RCKT) soars 53.8% in a week on news of alignment with the FDA for the mid-stage study of RP-A501, an investigational gene therapy for treating Danon Disease.
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.
Exelixis (EXEL) Gets Rights for Tumor Candidate From Insilico
by Zacks Equity Research
Exelixis (EXEL) enters into a license agreement with Insilico Medicine for ISM3091, a potentially best-in-class USP1 inhibitor.
Avalo (AVTX) Up 45% on Deal to Divest Certain Pipeline Drugs
by Zacks Equity Research
Avalo (AVTX) will receive an upfront payment of $150,000 on selling three compounds to AUG Therapeutics. The company is also eligible to receive milestone payments of up to $45 million.
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%.
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.
Bicycle (BCYC) to Begin Pivotal Bladder Cancer Study, Stock Up
by Zacks Equity Research
Bicycle (BCYC) aligns with the FDA on the design of a mid-late-stage registrational study for its bladder cancer drug, BT8009, with the potential to support its accelerated approval. The stock rises 9%.
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.
Bristol Myers' (BMY) Pulmonary Fibrosis Drug Positive in Phase II
by Zacks Equity Research
Bristol Myers (BMY) posts encouraging data from a phase II study in progressive pulmonary fibrosis.
Gilead's (GILD) Trodelvy Combo Shows Promise in NSCLC Study
by Zacks Equity Research
Gilead's (GILD) breast cancer drug Trodelvy, in combination with Keytruda, shows positive data in a phase II lung cancer study.
Codexis (CDXS) Transfers Leasing Rights to Vaxcyte, Stock Up
by Zacks Equity Research
Codexis (CDXS) transfers the leasing rights of its San Carlos, CA location to Vaxcyte to focus on technology development, inducing cost savings, to extend its cash runway to mid-2026. The stock rises 7%.
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.