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Zacks News
FDA Grants Orphan Drug Tag to AGIO's Tebapivat for Rare Cancer
by Zacks Equity Research
The FDA bestows an orphan drug designation to Agios' PK activator, tebapivat, for treating myelodysplastic syndromes.
ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down
by Zacks Equity Research
Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.
VRDN Stock Soars as Eye Disorder Study Meets Primary Endpoints
by Zacks Equity Research
The phase III THRIVE study evaluating Viridian's veligrotug for treating active thyroid eye disease meets all primary and secondary endpoints.
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.
MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab
by Zacks Equity Research
The Committee for Medicinal Products for Human Use recommends marketing authorization for Moderna's updated mRNA COVID-19 jab, Spikevax.
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.
Dyne Reports Mixed Data From DMD Study, Key Executives Step Down
by Zacks Equity Research
DYN's shares plummet following mixed data from its ongoing DMD study. Senior executives of the company step down.
Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug
by Zacks Equity Research
DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS II and its subsequent conversion to full approval.
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.
Surging Earnings Estimates Signal Upside for Krystal Biotech (KRYS) Stock
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.
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.
Terns Surges 29.6% in Three Months: Will the Momentum Continue?
by Zacks Equity Research
TERN has outperformed the industry in the past three months on encouraging pipeline progress of its candidates. Positive data on obesity candidates should boost the stock further.
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.
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.
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.
Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated
by Zacks Equity Research
Bristol Myers' (BMY) application to expand Breyanzi's label for the treatment of adult patients with relapsed or refractory follicular lymphoma gets EMA validation.
Kymera (KYMR) to Raise $225 Million Through Offering of Shares
by Zacks Equity Research
Kymera (KYMR) is in the process of selling approximately 2 million shares of common stock at a public offering price of $40.75 per share, along with pre-funded warrants to purchase 3,519,159 shares in the offering.
Gilead (GILD) Obtains FDA Approval for PBC Drug Livdelzi
by Zacks Equity Research
Gilead (GILD) wins FDA nod for seladelpar for the treatment of primary biliary cholangitis (PBC) on an accelerated basis.
Incyte (INCY) Announces Data on Monjuvi, FDA Approval for GVHD Drug
by Zacks Equity Research
Incyte???s (INCY) late-stage study on tafasitamab for patients with relapsed or refractory follicular lymphoma meets its goal. FDA approves axatilimab for the treatment of chronic graft-versus-host disease.