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Zacks News
RARE Submits BLA to the FDA for Sanfilippo Syndrome Gene Therapy
by Zacks Equity Research
Ultragenyx submits a BLA to the FDA seeking the accelerated approval of UX111 for patients with Sanfilippo syndrome type A in the United States.
VRTX Down as Non-Opioid Drug Shows Similar Pain Reduction as Placebo
by Zacks Equity Research
Vertex announces data from a phase II study evaluating its NaV1.8 pain signal inhibitor, suzetrigine, for treating painful lumbosacral radiculopathy. Shares down.
LLY Stock Up as FDA Removes Mounjaro, Zepbound From Shortage List
by Zacks Equity Research
Eli Lilly stock gains as the FDA removes tirzepatide drugs from the drug shortage list following a thorough reevaluation.
MRK's Pivotal Study on Two-Drug, Once-Daily HIV Pill Meets Goals
by Zacks Equity Research
Merck posts positive data from two phase III studies evaluating a two-drug, single-tablet regimen of doravirine/islatravir in adults with HIV-1 infection.
Roche's Prasinezumab Misses Goal in Parkinson's Disease Study
by Zacks Equity Research
The phase IIb PADOVA study, evaluating Roche's prasinezumab in people with early-stage Parkinson's disease, misses the primary endpoint.
KRYS Reports Upbeat Initial Data From Lung Cancer Study of KB707
by Zacks Equity Research
Krystal Biotech reports initial data from a phase I/II study showing therapeutic benefit in NSCLC patients treated with its immunotherapy candidate, KB707.
SRPT Finishes Enrolment in Late-Stage Study for Rare Muscular Disorder
by Zacks Equity Research
The phase III EMERGENE study evaluates Sarepta's experimental gene therapy for an ultra-rare form of muscle disorder for which there is no treatment beyond symptom management.
REGN's Eylea HD Shows Non-Inferiority to Eylea in Eye Disease Study
by Zacks Equity Research
Regeneron's phase III study evaluating Eylea HD against stand-of-care Eylea treatment meets the primary endpoint of non-inferior visual gain in RVO patients.
GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung Cancer
by Zacks Equity Research
Gilead announces that the FDA grants a second Breakthrough Therapy designation to Trodelvy for the extensive-stage small cell lung cancer indication.
NVO to Invest $1.2B in New Rare Disease Drugs Facility in Denmark
by Zacks Equity Research
Novo Nordisk is set to invest $1.2 billion for a new facility in Odense, Denmark, to produce various product types for rare diseases, including haemophilia.
EWTX Stock Rises on Upbeat Data From Rare Muscular Disorder Study
by Zacks Equity Research
Data from a mid-stage study show that treatment with Edgewise's experimental drug reduces levels of a biomarker related to skeletal muscle damage.
Merck Ends Development of Two Experimental Cancer Drugs
by Zacks Equity Research
MRK's decision to discontinue the development of two cancer drugs follows a series of setbacks in multiple late-stage studies.
FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC
by Zacks Equity Research
The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR-mutated non-small cell lung cancer.
4 Solid Net Profit Margin Stocks to Boost Portfolio Returns
by Anirudha Bhagat
Here, we present four stocks, CSTL, QFIN, ESEA and STRA, with solid net profit margins that can contribute toward making a strong portfolio.
CHMP Endorses Merck's Kidney Cancer Drug for Two Indications
by Zacks Equity Research
The CHMP's opinion is based on positive results from two late-stage studies on MRK's Welireg in two indications associated with renal cell carcinoma.
EDIT Stock Falls on Decision to End Reni-Cel Studies, Cut Workforce
by Zacks Equity Research
Editas stock falls as it ends development of reni-cel for SCD and TDT following failed attempts to find a commercial partner. It plans to cut workforce by 65%.
Wall Street Analysts Believe Castle Biosciences (CSTL) Could Rally 42.02%: Here's is How to Trade
by Zacks Equity Research
The average of price targets set by Wall Street analysts indicates a potential upside of 42% in Castle Biosciences (CSTL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
ABBV to Acquire Nimble Therapeutics to Strengthen Immunology Pipeline
by Zacks Equity Research
AbbVie is set to acquire privately held biotech, Nimble Therapeutics, for $200 million to strengthen its immunology pipeline.
KRYS Stock Down on Initial Clinical Updates on KB407 & KB408
by Zacks Equity Research
Krystal Biotech posts initial clinical updates on its two pipeline candidates, KB407 and KB408, which are being developed to treat rare respiratory diseases.
SNY's Tolebrutinib Gets FDA Breakthrough Therapy Tag for nrSPMS
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to Sanofi's tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis.
NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD
by Zacks Equity Research
Novo Nordisk's diabetes drug, Ozempic, receives positive CHMP opinion in the EU for expanded use in T2D and CKD patients.
Here's Why Q32 Bio Stock Hit a New Record Low on Wednesday
by Zacks Equity Research
Shares of QTTB fall after its experimental autoimmune disease drug failed to meet the primary endpoint in a mid-stage study for eczema.
CORT's Dazucorilant Fails to Meet Goal in Neurologic Disorder Study
by Zacks Equity Research
The phase II DAZALS study evaluating Corcept's dazucorilant in patients with amyotrophic lateral sclerosis fails to meet the primary goal.
AnaptysBio Stock Down as Eczema Study Fails to Meet Goals
by Zacks Equity Research
Phase IIb study on ANAB's ANB032 for atopic dermatitis fails to meet goals. The company decides to discontinue any further investment in the candidate.
Here's Why Agios Stock Plummeted More Than 20% on Monday
by Zacks Equity Research
The fall in AGIO stock comes after reports of an unexpected side effect linked to its sole-marketed drug Pyrukynd in thalassemia patients.