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Zacks News
Analysts Estimate Applied Genetic Technologies (AGTC) to Report a Decline in Earnings: What to Look Out for
by Zacks Equity Research
Applied Genetic Technologies (AGTC) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Analysts Estimate Applied Genetic Technologies (AGTC) to Report a Decline in Earnings: What to Look Out for
by Zacks Equity Research
Applied Genetic Technologies (AGTC) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Alexion (ALXN) Q2 Earnings Beat Estimates, Guidance Raised
by Zacks Equity Research
Alexion (ALXN) beats both earnings and sales estimates in the second quarter of 2019 and raises 2019 guidance.
Horizon's NDA for Procysbi New Dosage Form Accepted by FDA
by Zacks Equity Research
The FDA accepts Horizon Therapeutics' (HZNP) NDA for Procysbi (Cysteamine Bitartrate) delayed-release oral granules in packets.
Horizon Therapeutics Files BLA to FDA for Eye Disease Drug
by Zacks Equity Research
Horizon Therapeutics (HZNP) files a BLA for teprotumumab to the FDA for the treatment of active thyroid eye disease.
Mirati Inks Deal with Novartis to Evaluate Tumor Candidate
by Zacks Equity Research
Mirati (MRTX) inks a clinical collaboration with Novartis to evaluate the combination of the former's MRTX849 and the latter's SHP2 inhibitor, TNO155, in patients with advanced solid tumors.
Kadmon Initiates Dosing in Study for Systemic Sclerosis Drug
by Zacks Equity Research
Kadmon (KDMN) doses first patient in a phase II study of KD025 for the treatment of diffuse cutaneous systemic sclerosis (SSc).
ObsEva Ends Recruitment in Second Uterine Fibroids Study
by Zacks Equity Research
ObsEva (OBSV) completes patient recruitment in the second pivotal phase III study evaluating linzagolix for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids.
Catalyst Pharma Focuses on Firdapse Launch & Label Expansion
by Zacks Equity Research
Catalyst Pharmaceuticals (CPRX) intends to launch Firdapse and expand the label of the same.
Novavax (NVAX) Seeks Accelerated Approval Pathway for NanoFlu
by Zacks Equity Research
Novavax (NVAX) seeks to use accelerated approval pathway for its influenza vaccine candidate, NanoFlu, in the United States.
Alnylam Presents New Data for RNAi Therapeutic Onpattro
by Zacks Equity Research
Alnylam (ALNY) announces new results from the Global Open-Label Extension study of Onpattro at the 2019 Peripheral Nerve Society (PNS) Annual Meeting.
Epizyme Announces Positive Interim Data on Lead Candidate
by Zacks Equity Research
Epizyme (EPZM) announces positive interim data from an ongoing phase II study of its lead candidate, tazemetostat.
AMAG's Vyleesi Gets FDA NOD for Women with Low Sexual Desire
by Zacks Equity Research
AMAG Pharmaceuticals (AMAG) announces that the FDA has approved Vyleesi to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women.
Ultragenyx & Arcturus Therapeutics Expand Existing Agreement
by Zacks Equity Research
Ultragenyx (RARE) and Arcturus Therapeutics expand their existing collaboration to discover and develop mRNA, DNA and siRNA therapeutics for up to 12 rare disease targets.
Alexion's (ALXN) PNH Drug Ultomiris Shows Long-Term Efficacy
by Zacks Equity Research
Alexion (ALXN) reports positive data on Ultomiris in adult patients with paroxysmal nocturnal hemoglobinuria.
Dr. Reddy's Inks Deal to Sell Neurology Branded Products
by Zacks Equity Research
Dr. Reddy's (RDY) announced that it has entered a definitive asset purchase agreement with Upsher-Smith Laboratories, LLC to sell its neurology branded products.
Catalyst Pharma Files Lawsuit Against FDA Approval of Ruzurgi
by Zacks Equity Research
Catalyst Pharma (CPRX) files lawsuit against FDA's approval of Jacobus Pharmaceutical Co's drug, Ruzurgi, for the treatment of LEMS in pediatric patients.
Alkermes Initiates Monothearpy Expansion Phase of ALKS 4230
by Zacks Equity Research
Alkermes (ALKS) initiates monotherapy expansion phase of ALKS 4230 to treat patients with renal cell carcinoma or melanoma.
Is Applied Genetic Technologies (AGTC) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Is (AGTC) Outperforming Other Medical Stocks This Year?
Novavax' Shares Drop as FDA Advises Another Study for Resvax
by Zacks Equity Research
FDA recommends Novavax (NVAX) to conduct additional phase III study for its respiratory syncytial virus (RSV) vaccine candidate for infants, ResVax.
bluebird's Zynteglo Gets EU Conditional Marketing Approval
by Zacks Equity Research
bluebird bio (BLUE) announces that the EC has granted conditional marketing authorization to Zynteglo, its first gene therapy, for patients aged 12 years or older with TDT, who do not have a specific genotype.
Alnylam Initiates Phase I Study on Hypertension Candidate
by Zacks Equity Research
Alnylam (ALNY) initiates phase I study on ALN-AGT, an investigational RNAi therapeutic targeting angiotensinogen for the treatment of hypertension in high unmet need populations.
Mallinckrodt to Spin Off Specialty Generics Unit, Shares Down
by Zacks Equity Research
Mallinckrodt (MNK) will spin-off its Specialty Generics business to its shareholders.
Epizyme (EPZM) Shares Surge More Than 100% YTD: Here's Why?
by Zacks Equity Research
Epizyme's (EPZM) share price soars more than 100% year to date. The company is progressing well with its pipeline candidate, Tazmetostat.
Dynavax (DVAX) to Cut Jobs and Focus on Vaccine Business
by Zacks Equity Research
Dynavax (DVAX) announces restructuring measures to focus on vaccine business. The CEO of the company will retire on Aug 1, 2019.