MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3

 Pelabresib and ruxolitinib combination significantly reduced spleen size, with an SVR35 response rate nearly double that of placebo plus ruxolitinib

Showed a strong positive trend in reducing symptom burden and a twofold increase in patients achieving both SVR35 and TSS50 versus placebo plus ruxolitinib

Improved measures of anemia, including higher hemoglobin response rates, fewer patients requiring transfusions and fewer anemia adverse events versus placebo plus ruxolitinib

Improved bone marrow fibrosis by at least one grade in more patients versus placebo plus ruxolitinib

Demonstrated safety results consistent with prior clinical trials, with fewer grade ≥3 adverse events compared with placebo plus ruxolitinib

MorphoSys will host an investor event to review findings on Monday, December 11

MorphoSys will host an in-person investor event to review these detailed findings and address questions with the company’s management team and medical experts, including Professor Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, London, United Kingdom, and Ruben Mesa, M.D., FACP, President and Executive Director, Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center.

The event, taking place on Monday, December 11 at the Hilton San Diego Bayfront Hotel, will start with a networking breakfast at 6:30 a.m. PST and continue with a formal presentation at 7:00 a.m. PST (4:00 p.m. CET / 3:00 p.m. GMT / 10:00 a.m. EST). A webcast will also be available for those not attending ASH 2023 in person.

Webcast participants may pre-register and will receive dial-in details to access the call easily and quickly: https://services.choruscall.it/DiamondPassRegistration/register?confirmationNumber=5982651&linkSecurityString=c1a71840b. Please dial in 10 minutes before the beginning of the conference.

The live webcast (audio and presentation) can be directly accessed via https://media.choruscall.eu/mediaframe/webcast.html?webcastid=q3lG25n3 or via the Investors section under "Events & Conferences" on the MorphoSys website, www.morphosys.com; after the call, a slide-synchronized audio replay of the conference call will be available at the same location.

https://www.businesswire.com/news/home/20231210152441/en/

Schrodinger Data Support Advancement of Treatments for Leukemias

 Schrödinger (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today announced new preclinical data on SGR-1505, its investigational MALT1 inhibitor, and SGR-2921, its investigational CDC7 inhibitor, in a poster session at the American Society of Hematology (ASH) 65th Annual Meeting taking place virtually and in San Diego, California. The preclinical data reported show that both SGR-1505 and SGR-2921 have multiple favorable attributes and the potential for combination activity with standard-of-care agents.

Schrödinger also reported preliminary pharmacodynamic data from the Phase 1 study of SGR-1505 in healthy subjects, which showed that SGR-1505 inhibited cytokine release in human whole blood and demonstrated evidence of MALT1 inhibition in humans. The company will report additional data from the healthy subject study at its Pipeline Day on December 14, 2023.

"The pharmacological data for SGR-1505 and SGR-2921 demonstrate that our development candidates have favorable, differentiated profiles with best-in-class potential," stated Karen Akinsanya, Ph.D., president of R&D therapeutics at Schrödinger. "Our progress within these programs further validates our computational approach to designing therapies with the potential to address the limitations of current treatments. SGR-1505 and SGR-2921 are now being evaluated in Phase 1 clinical studies, and we look forward to seeing these programs advance."

https://finance.yahoo.com/news/schr-dinger-presents-data-supporting-170000067.html

Agios Positive Results from Phase 2 Portion of Pivotal Study in Sickle Cell

 Treatment with Mitapivat Demonstrated Statistically Significant Improvement in Hemoglobin Response Compared to Placebo –

– Improvements Observed in Annualized Rates of Sickle Cell Pain Crises, Markers of Hemolysis and Erythropoiesis in Participants Treated with Mitapivat –

– Agios to Host Live and Webcast Investor Event on Dec. 11, 2023, at 7:00 a.m. Pacific Time –

 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today presented detailed results from the Phase 2 portion of the global RISE UP study of mitapivat in sickle cell disease in an oral presentation (abstract #271) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being hosted Dec. 9-12, 2023, in San Diego.

During the Phase 2 double-blind, placebo-controlled study, treatment with mitapivat demonstrated statistically significant improvement in hemoglobin response across both mitapivat dose levels (50 mg and 100 mg BID), compared to placebo. The safety profile for mitapivat observed in the study was generally consistent with previously reported data in other studies of sickle cell disease and other hemolytic anemias. Improvements were observed in annualized rates of sickle cell pain crises, and markers of hemolysis and erythropoiesis for both mitapivat treatment arms compared to placebo. Improvement in patient-reported fatigue scores was observed with mitapivat 50 mg BID compared to placebo.

Agios will host a live investor event on Dec. 11, 2023, at 7:00 a.m. PT in San Diego to review key oral and poster presentations from this year’s ASH meeting, including the detailed RISE UP Phase 2 results. The event will be webcast live and can be accessed under “Events & Presentations” in the Investors and Media section of the company's website at www.agios.com. The archived webcast will be available on the company's website beginning approximately two hours after the event.

https://finance.yahoo.com/news/agios-presents-positive-results-phase-000000424.html

Incyte and Syndax Additional Data from Positive Trial in Chronic Graft-Versus-Host Disease

 Trial met its primary endpoint across all dose cohorts with 74% of patients at the 0.3 mg/kg dose achieving a complete or partial response within the first six months of treatment - Data are featured in the Plenary Scientific Session at the 65th American Society of Hematology Annual Meeting 2023 - Incyte and its partner Syndax expect to file a Biologics License Application (BLA) for axatilimab by year-end 2023

Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced the full results from the pivotal Phase 2 AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with refractory chronic graft-versus-host disease (GVHD) who had received at least two prior lines of systemic therapy. These data are featured today in the Plenary Scientific Session (Abstract #1) at the 65th American Society of Hematology Annual Meeting 2023 (ASH 2023), held December 9-12, 2023, in San Diego and virtually.

https://www.marketscreener.com/quote/stock/INCYTE-CORPORATION-9675/news/Incyte-and-Syndax-Present-Additional-Data-from-Positive-AGAVE-201-Trial-at-ASH-Plenary-Session-Showi-45537990/

Astellas' VEOZA OKd by EC for Treatment of Vasomotor Symptoms in Menopause

 First-in-class treatment option reduces number and intensity of hot flashes and night sweats 

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 

VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.

Before menopause, there is a balance between estrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates the brain's temperature control center. As the body goes through menopause, estrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in the temperature control center, fezolinetant reduces the number and intensity of hot flashes and night sweats.

This approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 across Europe, the U.S. and Canada. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause and were published in The Lancet and The Journal of Clinical Endocrinology & Metabolism, respectively.7,8 Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.9

The EC marketing authorization for fezolinetant is applicable in the European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein.10 Fezolinetant was also approved in Switzerland on December 4, 2023.

Astellas has already reflected the impact from this matter in its financial forecast of the current fiscal year ending March 31, 2024.

https://www.marketscreener.com/quote/stock/ASTELLAS-PHARMA-INC-120791908/news/Astellas-VEOZA-fezolinetant-Approved-by-European-Commission-for-Treatment-of-Vasomotor-Symptom-45538048/

'CDC director urges Americans to mask-up again'

 The CDC has issued a fresh call for Americans to mask-up this holiday season — despite mounting evidence they don't protect against respiratory viruses. The new advice came via a video posted to the CDC's Twitter (X) account, where the agency's director Dr Mandy Cohen warned about the rise of several respiratory infections and gave advice on how Americans can protect themselves. She urged people to get their latest Covid, flu and RSV vaccines, adding: 'Use additional layers of protection like avoiding people who are sick, washing your hands, improving ventilation and — wearing a mask.'

https://www.msn.com/en-us/travel/tripideas/cdc-director-urges-americans-to-mask-up-again/ss-AA1ldDk6

Cigna Ditches Mega-Merger Plans With Humana, Opts for Stock Buybacks

 Healthcare and insurance provider Cigna Group has ditched its proposed merger with health insurer Humana, according to sources from the Wall Street Journal. Initially reported on Nov. 29 by WSJ, this merger, valued at around $140 billion, would have resulted in a health insurance giant challenging the market dominance of UnitedHealth Group. 

Sources said Cigna and Humana hit roadblocks when the two companies could not agree on price and other financial terms. Cigna will now focus on acquiring smaller companies in the same industry and repurchasing upwards of $10 billion of stock. 

Cigna maintains its confidence in the benefits of a potential merger with Humana, citing that a possible merger would have improved consumer access to healthcare and reduced expenses, according to sources. 

The sources said the deal would have been possible on the regulatory side despite the Biden administration's tough stance on mergers and acquisitions.

However, an S&P Global Market Intelligence report pointed out the merger would have "likely faced regulatory scrutiny" due to an "overlap between the two companies' Medicare Advantage businesses." 

Hartmut Schneider, vice chair of the antitrust and competition practice at law firm WilmerHale, told S&P Global that any merger between the two companies would have to occur in an antitrust enforcement landscape currently undergoing a "seismic shift."

"At least in public communications, [the antitrust agencies] have given up on what used to be a pretty widely held consensus that a lot of mergers are either benign or pro-competitive and only a small number raise problems," Schneider said, adding, "The tone at the moment seems to be that pretty much every merger is potentially a problem."

As of the Friday cash close in US markets, Cigna had a market capitalization of $75.5 billion, and Humana's was $59.3 billion. 

Was the potential merger between Cigna and Humana ever likely to succeed?

https://www.zerohedge.com/markets/Cigna-ditches-mega-merger-plans-humana