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News of Note - February 24, 2023

BULL BEAR BRES|NAHAN

Friday, February 24, 2023

18:36



We’ve, just about, survived another week folks..


😊


Br. -john



 


*PRESS RELEASES*



SAN FP | SNY

Sanofi


ALTUVIIIO™ approved by the U.S. FDA: this positive event triggers impairment reversal, positively impacting 2022 IFRS net income; no change on business net income (non-IFRS)


Sanofi, together with its subsidiaries, engages in the research, development, manufacture, and marketing of therapeutic solutions in the United States, Europe, and internationally. -CapIQ



PFE & BNTX

Pfizer & BioNTech


Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster


Pfizer Inc. discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. -CapIQ


BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. -CapIQ



SAN FP | SNY

Sanofi


New Phase 3 data presented at WORLDSymposium™ reinforce Nexviazyme® (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease


Sanofi, together with its subsidiaries, engages in the research, development, manufacture, and marketing of therapeutic solutions in the United States, Europe, and internationally. -CapIQ



4568 JT & AZN LN | AZN SS | AZN

Daiichi Sankyo & AstraZeneca


Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens


ENHERTU® Approved in China for Patients with HER2 Positive Metastatic Breast Cancer Treated with One or More Prior AntiHER2-Based Regimens


Daiichi Sankyo Company, Limited, a pharmaceutical company, manufactures and sells pharmaceutical products worldwide. - CapIQ


AstraZeneca PLC, a biopharmaceutical company, focuses on the discovery, development, manufacturing, and commercialization of prescription medicines. -CapIQ



MRK

Merck


Merck and Ridgeback Provide Update on EU Marketing Authorization Application for LAGEVRIO™ (Molnupiravir)


Merck & Co., Inc. operates as a healthcare company worldwide. It operates through two segments, Pharmaceutical and Animal Health. -CapIQ



IIA AV & SPI AV

IMMOFINANZ & S IMMO


IMMOFINANZ: Letter of intent to sell Vienna office properties to S IMMO signed


IMMOFINANZ AG acquires, develops, owns, rents, and manages properties primarily in Austria, Germany, Poland, the Czech Republic, Hungary, Romania, Slovakia, and the Adriatic region. - CapIQ


S IMMO AG is a real estate investment company with its head office in Vienna. - CapIQ



SAABB SS

Saab


Receives Orders for Defence Equipment

The total order value is approximately SEK 8 billion with deliveries planned 2023–2026


Saab AB (publ) provides products, services, and solutions for the military defense, aerospace, and civil security markets worldwide.EKTAB SS



Elekta


Release/ Report

https://storage.mfn.se/fa1fc860-c15c-4b1c-8423-5123f4a8ddaa/elekta-q3-report-22-23.pdf


Webcast

https://elekta-qreports.creo.se/230224


Hub

https://ir.elekta.com/investors/reports-presentations/


Elekta AB (publ), a medical technology company, provides clinical solutions for treating cancer and brain disorders worldwide. -CaqIQ



AGIO

Agios


Reports Fourth Quarter and Full Year 2022 Financial Results


Agios Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery and development of medicines in the field of cellular metabolism and adjacent areas of biology. -CapIQ



NKTR

Nektar Therapeutics


FAIL


Announces Phase 2 Topline Data for Rezpegaldesleukin in Patients with Systemic Lupus Erythematosus


Nektar Therapeutics, a biopharmaceutical company, focuses on discovering and developing medicines in areas of unmet medical need in the United States and internationally. -CapIQ



SOBI SS & SAN FP | SNY

Sobi & Sanofi


FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A


FDA approves once-weekly ALTUVIIIO™, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection


Swedish Orphan Biovitrum AB (publ), an integrated biotechnology company, researches, develops, manufactures, and sells pharmaceuticals in the therapeutic areas of haematology, immunology, and genetic and metabolic diseases in Europe, North America, and internationally. -CapIQ


Sanofi, together with its subsidiaries, engages in the research, development, manufacture, and marketing of therapeutic solutions in the United States, Europe, and internationally. It operates through three segments: Pharmaceuticals, Vaccines, and Consumer Healthcare. -CapIQ



BWXT

BWX Technologies


Release

http://investors.bwxt.com/news-events/News/news-details/2023/BWX-Technologies-Reports-Fourth-Quarter-and-Full-Year-2022-Results-Initiates-2023-Guidance-and-Increases-Quarterly-Cash-Dividend/default.aspx


Presentation

http://s2.q4cdn.com/477932843/files/doc_financials/2022/q4/4Q22-earnings-presentation-final.pdf


Webcast

https://events.q4inc.com/attendee/587387303


BWX Technologies, Inc. manufactures and sells nuclear components in the United States, Canada, and internationally. – CapIQ



PRTA

Prothena


Reports Fourth Quarter and Full Year 2022 Financial Results, and Provides Financial Guidance and Business Highlights


Prothena Corporation plc, a late-stage clinical company, focuses on discovery and development of novel therapies for life-threatening diseases in the United States. - CapIQ



PEUG FP & FII FP

Peugeot Invest & LISI


To take part in the reorganisation of LISI’s ownership structure

  • After these transactions, Peugeot Invest may no longer own any CID shares, and it may become LISI’s second-largest shareholder with a stake of up to 16.0%.

  • Peugeot Invest would retain at least one seat on LISI’s Board of Directors provided that it owns more than 5% of its capital.

Peugeot Invest Société anonyme operates as an investment company. - CapIQ


Lisi S.A. provides assembly and component solutions for the aerospace, automotive, and medical industries in France and internationally. - CapIQ



MRK GY

Merck KGaA


Highlights New Four-Year Efficacy and Safety Data for Investigational BTK Inhibitor, Evobrutinib, in RMS

  • Data from the ongoing Phase II extension showed treatment benefits of evobrutinib were maintained over four years and remained consistent with the efficacy and safety profile seen in earlier data

  • Evobrutinib is an investigational highly-selective, oral, CNS-penetrant BTK inhibitor with the potential to become a safe and highly efficacious treatment option for people living with RMS

MERCK Kommanditgesellschaft auf Aktien operates in the healthcare, life science, and electronics sectors worldwide. – CapIQ



NUE

Nucor


Provides One-Year Update on New West Virginia Sheet Mill


Nucor Corporation manufactures and sells steel and steel products. - CapIQ



BPMC – ROG SW | RO SW | RHHBY

Blueprint Medicines – Roche


Should nix any thoughts of Roche taking out BPMC anytime soon..


To Regain Global Rights to GAVRETO® (pralsetinib)

  • Following a decision by Roche to discontinue the collaboration agreement between the companies for GAVRETO for strategic reasons

  • Since the initiation of the collaboration with Roche in July 2020, Blueprint Medicines has benefited from approximately $1 billion between upfront and milestone payments and from cost-sharing the commercialization and development of GAVRETO.

  • The company anticipates no impact to its 2023 revenue guidance, which includes $40 million to $50 million in collaboration revenues from existing collaborations, or its anticipated operating expenses in 2023.

Blueprint Medicines Corporation, a precision therapy company, develops medicines for genomically defined cancers and blood disorders in the United States and internationally. - CapIQ



EWTX

Edgewise Therapeutics


Reports Fourth Quarter And Full Year 2022 Financial Results And Recent Business Highlights


Edgewise Therapeutics, Inc., a biopharmaceutical company, develops small molecule therapies for musculoskeletal diseases. -CapIQ



MDGL

Madrigal Pharmaceuticals


Provides Corporate Updates and Reports 2022 Fourth Quarter and Full Year Financial Results


Madrigal Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of therapeutic candidates for the treatment of cardiovascular, metabolic, and liver diseases. - CapIQ



ALNY

Alnylam Pharmaceuticals


Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Period Activity


Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, focuses on discovering, developing, and commercializing novel therapeutics based on ribonucleic acid interference. – CapIQ



RNA

Avidity Biosciences


Announces Arthur A. Levin to Join Board of Directors and Transition to Distinguished Scientist and Strategic Leader


Avidity Biosciences, Inc., a biopharmaceutical company, engages in the development of oligonucleotide-based therapies. -CapIQ



ARVN

Arvinas


Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update


Arvinas, Inc., a clinical-stage biopharmaceutical company, engages in the discovery, development, and commercialization of therapies to degrade disease-causing proteins. - CapIQ



CCCC

C4 Therapeutics


Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights


C4 Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops novel therapeutic candidates to degrade disease-causing proteins for the treatment of cancer, neurodegenerative conditions, and other diseases. - CapIQ



KYMR

Kymera Therapeutics


Announces Fourth Quarter and Full Year 2022 Financial Results and Provides a Business Update


Kymera Therapeutics, Inc., a biopharmaceutical company, focuses on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system. - CapIQ



ABBV

AbbVie and Capsida Biotherapeutics


Expand Strategic Collaboration to Develop Targeted Genetic Medicines for Eye Diseases with High Unmet Need


AbbVie Inc. discovers, develops, manufactures, and sells pharmaceuticals worldwide. -CapIQ




 


*ARTICLES, ETC.*




Evaluate


Spotlight – Cystic fibrosis developers take a deep breath

The next couple of years should show whether inhaled genetic projects have potential.


Nektar’s next cytokine hope follows bempe towards the bin


Conditions are ripe for reverse mergers

  • Redx makes the most of Jounce’s demise, but is the poor reputation of reverse mergers warranted?

Sickle cell pipeline gets edited down


Astra buys itself a second shot at the Claudin18.2 goal



Bloomberg


Euro-Zone Core Inflation at Record Set to Embolden ECB Hawks

  • January underlying price gauge revised up to 5.3% from 5.2%

  • ECB very likely to lift deposit rate to 3% in March as planned



Stat


The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

  • Historically, the FDA’s regulation of these tools has been minimal.

  • The FDA’s final guidance followed two rounds of draft documents that were opened for comment, which is an unusual step for the agency.

  • It’s unclear when or whether FDA will target companies with products on the market that fall under the definition of devices, but never received FDA approval or clearance.



Science News


The James Webb telescope found six galaxies that may be too hefty for their age

  • The masses of the galaxies raise questions about how they got so big so fast



Nature


Delivering on the promise of protein degraders



Reuters


First Zantac cancer risk trial in Calif. postponed five months


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