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Zacks News
FDA Panel to Review Perrigo's (PRGO) OTC Birth Control Pill
by Zacks Equity Research
The FDA schedules a joint advisory committee meeting in November 2022 to review Perrigo's (PRGO) regulatory filing for the first-ever over-the-counter birth control pill.
Sarepta (SRPT) Stock Up 76.8% in Three Months: Here's Why
by Zacks Equity Research
Sarepta Therapeutics (SRPT) is progressing with the development of its pipeline, which focuses on treating DMD. It expects to initiate a BLA filing for its DMD gene therapy by year-end
Revance (RVNC) Gets FDA Nod for Anti-Wrinkle Product, Stock Up
by Zacks Equity Research
FDA approves Revance Therapeutics' (RVNC) Daxxify as a long-acting neuromodulator with a strong label that includes 36-week efficacy data from the SAKURA clinical program.
Amylyx (AMLX) Up 51% After FDA Committee Endorses ALS Drug
by Zacks Equity Research
The FDA's PCNSDAC recommends granting marketing approval to Amylyx's (AMLX) oral drug, which slows the progression of ALS.
Pfizer (PFE) Streptococcus Jab Gets FDA's Breakthrough Tag
by Zacks Equity Research
Pfizer (PFE) gets Breakthrough Therapy Designation for GBS vaccine candidate, GBS6, based on an interim analysis of a phase II study.
GSK's NDA for Daprodustat to be Reviewed by an FDA Panel
by Zacks Equity Research
GSK's regulatory applications for daprodustat are based on data from the ASCEND phase III program, consisting of five studies.
Clinical Hold on Sarepta's (SRPT) DMD Candidate Lifted by FDA
by Zacks Equity Research
The FDA lifts the clinical hold placed on Sarepta's (SRPT) next-generation DMD candidate, SRP-5051, being evaluated in the ongoing phase II MOMENTUM study.
AstraZeneca (AZN) Imfinzi Gets FDA Nod for Biliary Tract Cancer
by Zacks Equity Research
AstraZeneca's (AZN) Imfinzi plus chemotherapy becomes the first immunotherapy combination to get approval in the United States to treat advanced biliary tract cancer
CRISPR Therapeutics' (CRSP) Pipeline Development Fuels Growth
by Zacks Equity Research
While CRISPR Therapeutics' (CRSP) lead candidate is still a couple of years away from commercialization, it is highly dependent on collaboration revenues to fund its ongoing pipeline.
Vertex (VRTX) CF Drug Gets FDA Expanded Label for Toddlers
by Zacks Equity Research
Following FDA approval for label expansion, Vertex Pharmaceuticals' (VRTX) Orkambi is now approved for treating cystic fibrosis in children aged one year and older.
AstraZeneca (AZN) Evusheld Gets Japan Nod as COVID Treatment
by Zacks Equity Research
AstraZeneca's (AZN) Evusheld gets approval in Japan for treating COVID-19. This is the first global approval for Evusheld as a COVID-19 treatment.
Sanofi (SNY) Hemophilia A Drug BLA Gets FDA Priority Tag
by Zacks Equity Research
Sanofi's (SNY) BLA filing for efanesoctocog alfa was based on data from the XTEND-1 pivotal phase III study.
Moderna (MRNA) Sues Pfizer and BioNTech Over COVID Jab
by Zacks Equity Research
Moderna (MRNA) sues Pfizer and BioNTech, alleging that Comirnaty infringes on patents that Moderna filed from 2010 to 2016 related to its mRNA technology.
Erytech (ERYP) Stops Developing Drug in Leukemia, Down 19.6%
by Zacks Equity Research
After evaluating the FDA's feedback, Erytech Pharma (ERYP) halts developing its lead candidate in leukemia. It is also looking for strategic partnerships to leverage its proprietary platform.
Iovance (IOVA) Starts Rolling BLA With FDA for Melanoma Therapy
by Zacks Equity Research
Iovance (IOVA) starts a rolling BLA submission with the FDA seeking approval for its lead pipeline candidate in advanced melanoma patients. The filing is expected to be completed by fourth-quarter 2022.
AbbVie (ABBV), J&J's Imbruvica Gets FDA Nod for cGVHD in Kids
by Zacks Equity Research
AbbVie (ABBV) and J&J's (JNJ) Imbruvica gets FDA nod for label expansion to treat pediatric patients with chronic graft versus host disease. It is also the first BTK inhibitor approved for use in pediatric patients
BioMarin's (BMRN) Hemophilia Gene Therapy Gets Nod in EU
by Zacks Equity Research
BioMarin's (BMRN) Roctavian is the first gene therapy to get approval for hemophilia A in the European Union. The therapy has also been granted a 10-year market exclusivity.
Wall Street Analysts Predict a 108% Upside in Morphic Holding, Inc. (MORF): Here's What You Should Know
by Zacks Equity Research
The average of price targets set by Wall Street analysts indicates a potential upside of 107.9% in Morphic Holding, Inc. (MORF). 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.
The Zacks Analyst Blog Highlights Pfizer, BioNTech, Moderna and Morphic
by Zacks Equity Research
Pfizer, BioNTech, Moderna and Morphic are included in this Analyst Blog.
Pfizer (PFE), BioNTech Post Data on COVID Jab for Kids Under 5
by Zacks Equity Research
Pfizer (PFE) and BioNTech (BNTX) report updated data, showing that their three-dose COVID-19 vaccine is 73.2% effective in children under five years.
Moderna (MRNA) Seeks FDA Nod for Omicron-Based COVID Jab
by Zacks Equity Research
Moderna's (MRNA) bivalent COVID-19 booster vaccine, mRNA-1273.222, is designed to target the Omicron BA.4 and BA.5 subvariants. The vaccine has been developed specifically for the U.S. market.
Moderna (MRNA) to Supply Omicron-based COVID Jab in Canada
by Zacks Equity Research
Moderna's (MRNA) Omicron-specific bivalent vaccine booster is yet to be approved by Canadian health authorities. The government seeks to purchase 12 million doses of the same in 2022.
Jazz (JAZZ) Starts Study on Epidiolex for a Fourth Indication
by Zacks Equity Research
Jazz Pharmaceuticals (JAZZ) initiates a two-part pivotal late-stage study evaluating its epilepsy drug, Epidiolex, in children and adolescents suffering from epilepsy with Myoclonic-Atonic Seizures (EMAS).
I-Mab (IMAB) Down After Partner AbbVie Revises Partnership Deal
by Zacks Equity Research
I-Mab's (IMAB) partner AbbVie decides to stop early-stage development of an anti-CD47 antibody therapy targeting multiple cancer indications. IMAB intends to support the candidate's development.
J&J (JNJ) to Stop Selling Talc-based Baby Powder From 2023
by Zacks Equity Research
J&J (JNJ) will stop selling its talcum-based baby powder globally from next year. Though reports claim that the use of the talc causes cancer, JNJ maintains its stance that this product is safe.