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Zacks News
Biotech Stock Roundup: KYMR, IDYA, QURE Soar on Study Data, HLVX Tanks on Study Failure
by Zacks Equity Research
IDEAYA Biosciences (IDYA) and uniQure N.V. (QURE) are in the spotlight following positive pipeline updates.
Kymera's (KYMR) Partner SNY to Expand Ongoing HS and AD Studies
by Zacks Equity Research
Kymera (KYMR) announces expansion plans of ongoing mid-stage studies on KT-474 (SAR444656) by partner Sanofi.
The Zacks Analyst Blog Highlights Eli Lilly, Sanofi Merck, AstraZeneca's and Roche
by Zacks Equity Research
Eli Lilly, Sanofi Merck, AstraZeneca's and Roche are included in this Analyst Blog.
Pharma Stock Roundup: FDA Nod to LLY's Kisunla, SNY's Dupixent Gets EU Nod for COPD
by Kinjel Shah
Eli Lilly (LLY) wins FDA approval for its Alzheimer's disease drug, Kisunla. (donanemab). Sanofi (SNY) and Regeneron's Dupixent gets approval for COPD in Europe.
Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi get approval for their blockbuster drug Dupixent for the chronic obstructive pulmonary disease indication in the EU.
Regeneron (REGN) Gets Positive CHMP Opinion for Lymphoma Drug
by Zacks Equity Research
Regeneron (REGN) gets positive CHMP recommendation for odronextamab for the treatment of adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma.
AbbVie's (ABBV) Celsius Therapeutics Deal to Boost IBD Presence
by Zacks Equity Research
AbbVie's (ABBV) acquisition of Celsius Therapeutics is set to add the latter's lead pipeline candidate, CEL383, a potential first-in-class TREM1 inhibitor, to ABBV's pipeline.
Denali (DNLI) Outperforms Industry in 3 Months: Here's Why
by Zacks Equity Research
Denali (DNLI) gains 11.9% in three months on positive updates on its candidates.
Novavax (NVAX) Seeks Nod for Updated COVID-19 Jab in Europe
by Zacks Equity Research
Novavax (NVAX) seeks marketing authorization in the European Union for an updated version of its COVID-19 vaccine, which has been formulated to target the JN.1 variant.
AbbVie's (ABBV) Skyrizi Gets FDA Nod for Ulcerative Colitis
by Zacks Equity Research
AbbVie's (ABBV) Skyrizi is now approved for four indications across immune-mediated inflammatory diseases.
Regeneron (REGN) Outperforms Industry YTD: What Lies Ahead?
by Zacks Equity Research
Regeneron (REGN) maintains momentum on the back of Dupixent profits and efforts to develop oncology portfolio despite near-term challenges.
Novavax (NVAX) Seeks FDA Nod for Updated COVID-19 Vaccine
by Zacks Equity Research
Novavax (NVAX) seeks FDA???s approval to update its COVID-19 vaccine for the 2024-2025 fall season against current circulating strains, including KP.2 and KP.3.
AbbVie (ABBV) Buys Global Rights to Novel IBD Candidate
by Zacks Equity Research
AbbVie (ABBV) signs an exclusive global licensing deal with the Chinese company FutureGen to develop FG-M701, a next-generation TL1A antibody, for IBD indications.
Regeneron (REGN), SNY Win FDA Nod for Kevzara Label Expansion
by Zacks Equity Research
The FDA approves label expansion of Regeneron (REGN) and Sanofi's Kevzara for the treatment of polyarticular juvenile idiopathic arthritis.
Denali's (DNLI) Candidate Selected for FDA's START Pilot Program
by Zacks Equity Research
Denali's (DNLI) DNL126, an investigational enzyme replacement therapy, gets selected for the START Pilot Program, intended to accelerate the development of rare disease therapies.
TEVA Stock Rises 135% in a Year: What's Driving the Recovery?
by Zacks Equity Research
TEVA expects its newer drugs, Austedo, Uzedy and Ajovy, as well as a stable generics business, to help revive top-line growth in future quarters.
GSK Stock Dips on Delaware Court Ruling for Zantac Litigation
by Zacks Equity Research
GSK shares decline more than 7% in pre-market trading on Monday in response to an unfavorable ruling by a state court in Delaware in the Zantac litigation.
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
by Zacks Equity Research
Per the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication constitutes a major amendment to its previously-submitted data. A final decision is expected by Sep 27.
Pharma Stock Roundup: JNJ, MRK M&A Deals, SNY, RHHBY Drugs' Priority Review & More
by Kinjel Shah
J&J (JNJ) and Merck (MRK) announce the acquisitions of private biotechs. The FDA grants Priority Review tags to Sanofi's (SNY) and Roche's (RHHBY) regulatory applications.
J&J (JNJ) to Buy Rights to Novel Atopic Dermatitis Candidate
by Zacks Equity Research
J&J (JNJ) is set to acquire Yellow Jersey Therapeutics, which holds NM26 rights, from Numab's shareholder, for a purchase price of $1.25 billion in cash.
Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
by Zacks Equity Research
The FDA grants priority review to Sanofi's (SNY) sBLA for the Sarclisa combination regimen for transplant-ineligible newly diagnosed multiple myeloma. A decision is due on Sep 27, 2024.
AstraZeneca (AZN) Plans to Generate $80B in Revenues by 2030
by Zacks Equity Research
AstraZeneca (AZN) targets $80 billion in total revenues by 2030. It expects to launch 20 new medicines.
Sanofi (SNY) Signs Deal for AI-Powered Drug Development
by Zacks Equity Research
Sanofi (SNY) inks collaboration deal with Formation Bio and OpenAI to build AI-powered software to advance drug development and create new medicines.
Why Novavax (NVAX) Stock Price Appreciated 14% on Monday
by Zacks Equity Research
Novavax (NVAX) surges after one of its top shareholders drops a proxy campaign against the company. This withdrawal is in sync with the company???s recently signed multi-billion-dollar deal with Sanofi.
The Zacks Analyst Blog Highlights Novavax, Sanofi, Fulcrum Therapeutics, Moderna and Bristol Myers
by Zacks Equity Research
Novavax, Sanofi, Fulcrum Therapeutics, Moderna and Bristol Myers are included in this Analyst Blog.