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Zacks News
RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study
by Zacks Equity Research
The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.
Rocket Stock Down More Than 30% in Past Six Months: Here's Why
by Zacks Equity Research
The recent regulatory setbacks related to RCKT's pipeline candidate, Kresladi (marnetegragene autotemcel) weigh heavily on the stock.
IMVT Stock Up on Upbeat Data From Graves' Disease Study of Batoclimab
by Zacks Equity Research
Immunovant stock rises on mid-stage study data of batoclimab for Graves' Disease, showing superior efficacy compared to anti-thyroid drug therapy options.
Hoth Stock Up as Lead Drug Heals Skin Toxicities in Cancer Patient
by Zacks Equity Research
HOTH stock soars on superior efficacy data from the first patient treated with the lead candidate, HT-001, suffering from EGFRI-related skin toxicities.
Novartis to License VYGR's Capsid for Gene Therapy in Neurology
by Zacks Equity Research
NVS has decided to license a novel capsid generated from Voyager's TRACER platform for use in a gene therapy program against an undisclosed rare neurologic disease target.
FDA Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up
by Zacks Equity Research
The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.
BioMarin Posts '27 Biz View, Outlines Growth Plans for Next 10 Years
by Zacks Equity Research
BMRN divulges ambitious plans for business growth over the next 10 years. It expects yearly sales to grow at a mid-teen rate through 2034.
Biogen's Phase II/III SMA Study for Higher Spinraza Dose Meets Goals
by Zacks Equity Research
BIIB's pivotal mid to late-stage study evaluating a higher dosing regimen for Spinraza to treat SMA in infants meets the primary and secondary goals.
Affimed Appoints New CEO, Shares Fall on Leadership Change
by Zacks Equity Research
AFMD appoints Shawn M. Leland as the company's new chief executive officer. Stock falls on the news.
Recursion Stock Down Despite Meeting Goal in Brain Disease Study
by Zacks Equity Research
RXRX plummets on mixed results from the mid-stage study of its lead candidate, REC-994, for treating a rare neurovascular condition.
Corcept Shares Rise More Than 45% in Six Months: Here's Why
by Zacks Equity Research
CORT's Cushing's syndrome drug, Korlym, has been performing well. The NDA for lead candidate, relacorilant, in Cushing's syndrome will be filed shortly.
Amneal Stock Rises 29% in a Month on Upbeat Regulatory Updates
by Zacks Equity Research
AMRX stock gains 29.3% in a month due to the FDA's approval of Parkinson's Disease drug, Crexont.
ALNY Down Despite Positive Data From Heart Disease Drug Study
by Zacks Equity Research
Alnylam presents detailed data from the HELIOS-B study, seeking to expand Amvuttra's label to include the treatment of ATTR amyloidosis with cardiomyopathy.
Krystal Biotech Stock Surges 21.9% in 3 Months: More Room to Grow?
by Zacks Equity Research
KRYS has gained 21.9% in the past three months on strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress.
JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab
by Zacks Equity Research
The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of antibody-positive patients.
Merck Scraps Two Late-Stage Keytruda Studies on Disappointing Data
by Zacks Equity Research
MRK made this decision after an independent committee pointed out that Keytruda did not show improvement in certain types of lung and skin cancers.
EBS Stock Rises on FDA Nod for ACAM2000 in Mpox Indication
by Zacks Equity Research
The FDA approves Emergent BioSolutions' sBLA seeking a label expansion of ACAM2000 for the mpox indication. Stock rises in pre-market trading.
SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA
by Zacks Equity Research
The FDA accepts and grants priority review to SpringWorks' NDA for mirdametinib for treating neurofibromatosis type 1-associated plexiform neurofibromas.
Neurocrine Stock Down 19% on Mixed Schizophrenia Study Results
by Zacks Equity Research
Though data from a mid-stage study shows that treatment with NBIX's schizophrenia drug is effective, results lag behind drugs being developed by its peers.
J&J's Rybrevant Receives EU Approval for Expanded Use in NSCLC
by Zacks Equity Research
The European Commission approves JNJ's Rybrevant in combination with chemotherapy for treating EGFR-mutated NSCLC following failure of prior therapy.
MRK Begins 2nd Phase III Study on Rare Blood Disorder Candidate
by Zacks Equity Research
Merck begins the second phase III study on its LSD1 inhibitor, bomedemstat, for treating certain patients with essential thrombocythemia, a rare blood disorder.
Pfizer Follows Lilly's Example, Unveils DTC Service for Selling Drugs
by Zacks Equity Research
PFE's digital pharmacy aims to provide patients easy access to its medicines for COVID-19, migraine and other conditions.
Addex Stock Soars on Crucial Update From Indivior Research Deal
by Zacks Equity Research
ADXN gains 55% on a crucial update from its GABAB PAM research collaboration with INDV. Both companies pick pre-clinical compounds for IND-enabling studies.
Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review
by Zacks Equity Research
SLNO stock gains 6.3% as FDA accepts regulatory filing for lead candidate, DCCR, to treat hyperphagia associated with PWS under Priority Review.
Ocugen to Begin Phase III Study on Eye Drug in Canada, Stock Up
by Zacks Equity Research
OCGN receives Health Canada's No Objection Letter to begin a phase III study on OCU400 for treating retinitis pigmentosa. Shares rise.