Sanofi

Sanofi engages in the research, production, and distribution of pharmaceutical products. It operates through the following business segments: Pharmaceuticals, Consumer Healthcare, and Vaccines. The Pharmaceuticals segment comprises the commercial operations of the following global franchises: specialty care, diabetes and cardiovascular, established prescription products and generics, and research, development, and production activities. The Consumer Healthcare segment includes the commercial operations for its Consumer Healthcare products. The Vaccines segment consists commercial operations of Sanofi Pasteur. The company was founded in 1973 and is headquartered in Paris, France.

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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.

Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag

Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review granted based on positive results from IMROZ phase 3 study If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for patients with newly diagnosed transplant-ineligible multiple myeloma Pivotal IMROZ phase 3 study results to be featured during oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Paris, May 27, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

Press Release: Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma

Bristol-Myers

A judge in Hawaii on Tuesday ordered Bristol Myers Squibb and Sanofi to pay more than $916 million to the state for failing to warn non-white patients of health risks from its blood thinner Plavix, up from an earlier judgment of $834 million.

Bristol Myers, Sanofi liability in Hawaii Plavix case grows to $916 million

Sanofi (SNY) inks collaboration deal with Formation Bio and OpenAI to build AI-powered software to advance drug development and create new medicines.

Sanofi (SNY) Signs Deal for AI-Powered Drug Development

French drugmaker Sanofi on Tuesday announced it is collaborating with artificial intelligence company OpenAI and Formation Bio to boost its drug development projects through the use of Artificial Intelligence.

Sanofi partners with OpenAI, Formation Bio on AI-driven drug development

Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration Paris, New York, N.Y., and San Francisco, CA, May 21, 2024.

Press Release: Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration

Regeneron Pharmaceuticals

Dupixent ® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD Paris and Tarrytown, N.Y. May 20, 2024.

Press Release: Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Novavax

Hedge fund Shah Capital said on Monday it would withdraw its campaign against the re-election of three directors on Novavax's board, after the COVID-19 vaccine maker struck a licensing deal with Sanofi.

Shah Capital ends campaign against Novavax board after Sanofi deal

Novavax said the deal with Sanofi allows it to remove its "going concern" warning, which it first issued last year due to doubts about staying afloat.

Novavax stock jumps 50% as Sanofi deal kicks off turning point for struggling vaccine maker

Sanofi (SNY) and Regeneron's (REGN) Dupixent is poised to be the first medicine for adolescents with inadequately controlled CRSwNP, if approved by the FDA.

Sanofi (SNY), Regeneron's Dupixent sBLA Gets FDA Priority Tag

Sanofi said the bulk of the investment will double capacity of monoclonal antibody production, which are key in developing an array of pharmaceuticals, at its Vitry-sur-Seine site.

Sanofi to Spend $1 Billion to Boost Drug Production in France

Sanofi on Monday announced it would invest over 1 billion euros ($1.1 billion) to create new medicines and vaccine production capacities at three of its French sites.

Sanofi pledges new 1 bln euros worth of investments in French production sites

Sanofi adds over €1 billion for biomanufacturing to €2.5 billion already committed in major projects in France to support health sovereignty Paris, May 13, 2024. As the largest private contributor to the security and independence of France's health ecosystem, Sanofi today announces an investment of more than €1 billion to create new bioproduction capacity at its sites in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône).

Press Release: Sanofi adds over €1 billion for biomanufacturing to €2.5 billion already committed in major projects in France to support health sovereignty

Novavax announced Q1 2024 results with a beat on EPS and a miss on revenue, causing a surge in premarket trading. Novavax finalized a licensing agreement with Sanofi worth up to $1.2B, boosting its COVID-19 vaccine commercial performance. The Sanofi deal revitalizes the outlook for Novavax, providing immediate cash infusion, long-term revenue streams, and a narrowed focus.

Novavax: Sanofi Partnership Revitalizes My Magnum Opus

Novavax, Inc. (NASDAQ:NVAX) shares surged Friday following the announcement of a significant licensing agreement with Sanofi SA (ADR) (NYSE:SNY), valued at $1.2 billion. The deal encompasses the commercialization of a combined COVID-19 and flu shot, marking a pivotal development in the field of vaccine production.

Novavax shares skyrocket after billion-dollar licensing deal with Sanofi

Novavax (NVAX) shares more than doubled in intraday trading Friday after announcing a $1.2 billion deal to license its vaccine technology to French drugmaker Sanofi (SNY).

Novavax Stock Doubles on $1.2B Sanofi Deal for COVID-19, Flu Vaccines

Novavax Inc (NASDAQ:NVAX) stock is up 130% to trade at $10.82 today, by far the best stock on the Nasdaq this morning.

Vaccine Stock Explodes After Sanofi Deal

The two companies will also work on a shot that combines Covid-19 and flu vaccines.

Novavax Gets $1.4 Billion Deal With Sanofi. The Stock Jumps.

Rallybio Corp

Although 5% up over one year, the S&P Biotechnology Select Industry Index is down .22% year-to-date. This seems to be a normalization period.

3 Biotech Stocks to Sell in May Before They Crash & Burn

Novavax (NASDAQ:NVAX) shares rocketed 40% in premarket trading Friday, driven not only by the company's fiscal Q1 2024 earnings report but more significantly, by a crucial multi-billion dollar deal with French pharmaceutical giant Sanofi SA. Despite reporting a first-quarter loss per share of $1.05, wider than the $0.92 anticipated by analysts, and revenue of $93.

Novavax shares jump 40% on $1.2 billion licensing deal with Sanofi despite Q1 losses

Novavax on Friday said it had struck a $1.4 billion deal with Sanofi to commercialize its existing COVID-19 vaccine and develop a new combined jab to inoculate against both the coronavirus and influenza, in a major boost to struggling biotech company.

Novavax shares surge on new $1.4 billion deal with Sanofi

Announces co-exclusive licensing agreement with Sanofi to co-commercialize COVID-19 vaccine, develop novel COVID-19-Influenza combination vaccines and develop multiple new vaccines utilizing Novavax's Matrix-MTM adjuvant This agreement represents a potential multi-billion dollar revenue opportunity for Novavax including : $500 million upfront payment Approximately $70 million equity investment in Novavax Up to $700 million in COVID-19 and combination product near-term milestones, plus ongoing tiered royalties on product sales Up to $200 million in milestones plus royalties for each new vaccine developed utilizing Novavax's Matrix-M TM  adjuvant Announces addition of standalone influenza vaccine to Phase 3 COVID-19-Influenza Combination vaccine trial, which is on-track to initiate second half of 2024, with potential 2026 launch for both candidates Reduced current liabilities by an additional $831 million during Q1 2024 Achieved total revenue in Q1 2024 of $94 million Novavax removes going concern notice Company to host conference call today at 8:30 a.m. ET GAITHERSBURG, Md.

Novavax Reports First Quarter 2024 Financial Results and Operational Highlights

Sanofi on Friday announced it has reached a 'co-exclusive' licensing agreement with Novavax to sell a stand-alone COVID-19 vaccine and develop new flu-COVID-19 combination vaccines.

France's Sanofi in COVID-19 vaccine deal with Novavax - statement

The deal will allow Novavax to lift its "going concern" warning, which it first issued in 2023 due to having "substantial doubt" about its ability to survive.

Novavax signs multibillion-dollar deal with Sanofi to commercialize Covid vaccine, develop combination shots

Agreement provides individuals with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards Provides Novavax with cash and an equity investment totalling approximately $1.2 billion (upfront payment of $500 million and up to $700 million in additional development, regulatory and launch milestones), plus tiered royalties Novavax is entitled to additional launch and sales milestone opportunities of up to $200 million, plus mid-single digit royalties, for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax's Matrix-M™ adjuvant technology Accelerates potential for development of a novel COVID-19-Influenza combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering individuals enhanced convenience and protection GAITHERSBURG, Md. , May 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, has entered into a co-exclusive licensing agreement with Sanofi (Nasdaq: SNY).

Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines

News for Sanofi Stock (SNY)