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Zacks News
Biotech Stock Roundup: BMY, GSK, BIIB's Q2 Results, VTVT Down on Setback
by Ekta Bagri
Bristol Myers (BMY) and Biogen (BIIB) are in the spotlight following earnings results and regulatory updates, respectively.
VTv Therapeutics (VTVT) Reports Q3 Loss, Lags Revenue Estimates
by Zacks Equity Research
vTv Therapeutics (VTVT) delivered earnings and revenue surprises of 0% and 100%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Exact Sciences (EXAS) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Exact Sciences (EXAS) delivered earnings and revenue surprises of 23.64% and 4.45%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Acadia Pharmaceuticals (ACAD) Reports Q3 Loss, Misses Revenue Estimates
by Zacks Equity Research
Acadia (ACAD) delivered earnings and revenue surprises of 5.56% and 6.40%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Is Immunocore (IMCR) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Here is how Immunocore Holdings PLC Sponsored ADR (IMCR) and vTv Therapeutics (VTVT) have performed compared to their sector so far this year.
Regeneron (REGN), Sanofi Get Priority Review for Dupixent sBLA
by Zacks Equity Research
The FDA accepts and grants priority review to Regeneron (REGN) and Sanofi's sBLA for Dupixent to treat eosinophilic esophagitis in patients aged 12 years and older. A decision is due on Aug 3, 2022.
Intellia (NTLA) Inks Deal With Kyverna for Autoimmune Diseases
by Zacks Equity Research
Intellia (NTLA) inks a licensing and collaboration deal with Kyverna Therapeutics for developing an allogeneic CAR T-cell therapy for autoimmune diseases.
Genprex's (GNPX) Lead Cancer Drug Gets Second Fast Track Tag
by Zacks Equity Research
The FDA bestows a Fast Track designation to Genprex's (GNPX) Reqorsa in combination with Keytruda for treating patients with non-small cell lung cancer. This is the second Fast Track tag for Reqorsa.
Apellis (APLS) Up More Than 40% in Past 3 Months: Here's Why
by Zacks Equity Research
Approval of Apellis' (APLS) Empaveli for treating paroxysmal nocturnal hemoglobinuria lends a significant boost to the company's growth prospects. The drug's label expansion studies also hold promise.
Kodiak Sciences (KOD) Focuses on Developing Eye Candidate KSI-301
by Zacks Equity Research
Kodiak Sciences (KOD) progresses well with the development of its lead candidate, KSI-301, for treating various retinal vascular diseases. Stiff competition in the target market remains a woe.
Palatin (PTN) Begins Phase III Study For Dry Eye Disease
by Zacks Equity Research
Palatin (PTN) commences the pivotal phase III study evaluating PL9643 for the treatment of dry eye disease. Top-line data from the same is expected in the second half of 2022.
ACADIA (ACAD) Up on Resubmission Plan for Nuplazid sNDA to FDA
by Zacks Equity Research
ACADIA (ACAD) to resubmit sNDA for Nuplazid (pimavanserin) to the FDA for treating hallucinations and delusions associated with dementia focused on Alzheimer's disease psychosis. Shares rise.
Global Blood (GBT) Gets FDA Nod for Oxbryta Label Expansion
by Zacks Equity Research
The FDA approves Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to less the 12 years, and NDA for a pediatric weight-based formulation of the drug.
Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
by Zacks Equity Research
The FDA approves Bristol Myers' (BMY) Orencia in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease. This is the fourth FDA-approved indication for the drug.
Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
by Zacks Equity Research
Alnylam (ALNY) files regulatory applications to the FDA and the EMA, seeking approval for a new indication of Oxlumo for the treatment of advanced primary hyperoxaluria type 1.
Trevena (TRVN) to Begin Clinical Study on Pain Candidate
by Zacks Equity Research
Trevena (TRVN) advances TRV045 into clinical development as a potential treatment for diabetic neuropathic pain. Enrollment in the study is expected to begin in the first quarter of 2022.
Cytokinetics' (CYTK) Aficamten Gets Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy status on Cytokinetics' (CYTK) aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
Intercept (ICPT) Down on Withdrawal of Application for NASH
by Zacks Equity Research
Intercept (ICPT) withdraws its application seeking approval for OCA for the treatment of liver fibrosis due to nonalcoholic steatohepatitis in the EU. Resultantly, the stock declines.
Aytu BioPharma's (AYTU) AR101 Gets FDA's Orphan Drug Status
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Aytu BioPharma's (AYTU) AR101 for the treatment of vascular Ehlers-Danlos Syndrome.
Here's Why vTv Therapeutics (VTVT) is Poised for a Turnaround After Losing 15.2% in 4 Weeks
by Zacks Equity Research
vTv Therapeutics (VTVT) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.
Ultragenyx (RARE) Begins Dosing in Phase I/II Study of UX053
by Zacks Equity Research
Ultragenyx (RARE) doses the first patient in a phase I/II study evaluating its investigational mRNA candidate, UX053, for treating glycogen storage disease type III.
Deciphera (DCPH) to Prioritize Key Pipeline Drugs, Cut Jobs
by Zacks Equity Research
Deciphera (DCPH) announces a corporate restructuring plan to prioritize development of vimseltinib and DCC-3116, streamline commercial operations and reduce workforce by almost 35%. Shares rise.
Blueprint Medicines (BPMC) Set to Acquire Lengo Therapeutics
by Zacks Equity Research
Blueprint Medicines (BPMC) inks an agreement to acquire privately held Lengo Therapeutics. The company is looking to boost its lung cancer portfolio with this acquisition.
BioCryst (BCRX) Begins Enrollment in PNH Study on BCX9930
by Zacks Equity Research
BioCryst (BCRX) starts patient enrollment in the pivotal REDEEM-2 study evaluating BCX9930 for treating patients with paroxysmal nocturnal hemoglobinuria.
Selecta (SELB) Down on FDA's Clinical Hold on Phase I/II Study
by Zacks Equity Research
The FDA issues a clinical hold on Selecta's (SELB) phase I/II study evaluating SEL-302 for the treatment of patients with methylmalonic acidemia. Shares down in after-hours trading.