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Zacks News
Akebia (AKBA) Up as Vafseo Gets FDA Nod for Anemia Due to CKD
by Zacks Equity Research
Akebia (AKBA) gains during premarket hours on Mar 28 as its key product Vafseo (vadadustat) tablets receive FDA's approval for the treatment of anemia due to chronic kidney disease.
Stoke Therapeutics (STOK) Up on Upbeat Dravet Syndrome Study Data
by Zacks Equity Research
Stoke Therapeutics (STOK) gains on meaningful clinical data from STK-001 studies for the treatment of Dravet syndrome.
Cardiff (CRDF) Stock Rallies 194% in a Month: Here's Why
by Zacks Equity Research
Cardiff (CRDF) surges 194% in the past month, driven by investors' optimism regarding the potential of its investigational candidate, onvansertib, to treat first-line patients with RAS-mutated mCRC.
Crinetics (CRNX) Up as Second Acromegaly Study Meets Goals
by Zacks Equity Research
Crinetics (CRNX) stock rises after achieving goals in the second late-stage study evaluating paltusotine in patients with acromegaly who are treatment-naive or not currently receiving medical therapy.
Hoth Therapeutics (HOTH) Up on Upbeat Alzheimer's Drug Data
by Zacks Equity Research
Hoth Therapeutics (HOTH) rises on encouraging pre-clinical data demonstrating cognitive benefits of its novel therapeutic candidate, HT-ALZ, in the treatment of Alzheimer's disease.
Fennec (FENC) Signs Licensing Deal With Norgine, Stock Up
by Zacks Equity Research
Fennec (FENC) signs a licensing deal with Nordine, granting the latter rights to Pedmarqsi in the EU, Australia and New Zealand to treat cisplatin-induced hearing loss. The stock rises 11.4%.
Journey Medical (DERM) Up as FDA Accepts Skin Disease Drug NDA
by Zacks Equity Research
Journey Medical (DERM) stock rises as the FDA accepts its regulatory filing for review seeking approval for DFD-29 to treat inflammatory lesions and erythema of rosacea in adults.
Aquestive (AQST) Up as Anaphylm Pivotal Study Meets Goals
by Zacks Equity Research
Aquestive's (AQST) stock rises after meeting primary and secondary goals in the pivotal study of Anaphylm Sublingual Film to treat severe allergic reactions, including anaphylaxis.
Mirum's (MIRM) Livmarli Receives FDA Nod for Expanded Use
by Zacks Equity Research
Mirum's (MIRM) Livmarli gets FDA approval for label expansion to include the treatment of cholestatic pruritus in patients aged five years and older with PFIC.
Geron (GERN) Gets ODAC Votes for Blood Disorder Drug, Shares Up
by Zacks Equity Research
Geron's (GERN) pipeline candidate, imetelstat, gets FDA Committee backing for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes.
AstraZeneca (AZN) to Acquire Amolyt Pharma for $1.05 Billion
by Zacks Equity Research
AstraZeneca (AZN) enters into an agreement to acquire Amolyt Pharma to strengthen its rare disease pipeline by adding the latter's late-stage hypoparathyroidism treatment candidate, eneboparatide.
Pacira's (PCRX) Knee Osteoarthritis Drug Gets FDA's RMAT Tag
by Zacks Equity Research
Pacira (PCRX) receives the FDA's RMAT designation for its gene-therapy product candidate, PCRX-201, which is currently being developed in an early-stage study to treat osteoarthritis of the knee.
NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up
by Zacks Equity Research
NewAmsterdam (NAMS) gains on the initiation of a phase III study evaluating fixed-dose combination of obicetrapib and ezetimibe in patients with HeFH and/or ASCVD.
Applied Therapeutics (APLT) Surges 124% in a Month: Here's Why
by Zacks Equity Research
Applied Therapeutics (APLT) surges 124% in a month due to encouraging updates from two separate developmental programs for govorestat to treat different rare neurological indications.
Incyte (INCY) Posts Positive Results on Opzelura From HS Study
by Zacks Equity Research
Incyte's (INCY) Opzelura leads to a significantly greater reduction in abscess and inflammatory nodule (AN) count in HS patients.
Regeneron (REGN) Gets FDA Nod for Praluent Label Extension
by Zacks Equity Research
Regeneron (REGN) obtains FDA approval for Praluent as an adjunct to diet and other LDL-C, lowering therapies to include pediatric patients aged eight and older with HeFH.
Acadia (ACAD) Down as Schizophrenia Study on Nuplazid Fails
by Zacks Equity Research
Acadia (ACAD) tumbles after its late-stage study on pimavanserin to treat negative symptoms of schizophrenia fails to achieve the primary goal with statistical significance.
Novo Nordisk's (NVO) Wegovy Gets FDA Nod to Reduce Heart Risk
by Zacks Equity Research
Novo Nordisk (NVO) announces FDA approval of its application seeking label expansion for Wegovy to reduce the risks of major adverse cardiovascular events.
Iterum (ITRM) Plans Early Submission of UTI Drug NDA, Stock Up
by Zacks Equity Research
Iterum (ITRM) stock rises as the company gears up to submit a regulatory application to the FDA seeking approval for oral sulopenem to treat adult women with uUTIs ahead of schedule.
FibroGen (FGEN) Q3 Earnings: Taking a Look at Key Metrics Versus Estimates
by Zacks Equity Research
The headline numbers for FibroGen (FGEN) give insight into how the company performed in the quarter ended September 2023, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.
Biotech Stock Roundup: FGEN Down on Study Failure, BMY Drug's Label Expansion & More
by Zacks Equity Research
Regulatory updates from Fibrogen (FGEN) and Bristol Myers (BMY) are in focus in the biotech sector.
FibroGen (FGEN) Fails to Meet Goals in DMD Study, Stock Down 23%
by Zacks Equity Research
FibroGen (FGEN) falls 22.7% as its late-stage study of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy fails to meet the primary endpoint.
Down -46.88% in 4 Weeks, Here's Why FibroGen (FGEN) Looks Ripe for a Turnaround
by Zacks Equity Research
The heavy selling pressure might have exhausted for FibroGen (FGEN) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
FibroGen (FGEN) Q2 Earnings: Taking a Look at Key Metrics Versus Estimates
by Zacks Equity Research
The headline numbers for FibroGen (FGEN) give insight into how the company performed in the quarter ended June 2023, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.
FibroGen (FGEN) Reports Q2 Loss, Tops Revenue Estimates
by Zacks Equity Research
FibroGen (FGEN) delivered earnings and revenue surprises of 9.72% and 29.72%, respectively, for the quarter ended June 2023. Do the numbers hold clues to what lies ahead for the stock?