Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced new Phase 3 data for molnupiravir, an oral COVID-19 antiviral. This data will be presented at the ASTMH 2021 Annual Meeting from Nov. 17-21, including interim results from the MOVe-OUT trial. The trial showed positive efficacy, reducing hospitalization or death risk by approximately 50% in high-risk patients. Merck has produced 10 million courses of molnupiravir by the end of 2021 and plans for 20 million in 2022, focusing on global access.

Merck (NYSE: MRK) has launched the VICTOR trial, a pivotal Phase 3 study of VERQUVO (vericiguat) aimed at treating adults with chronic heart failure and reduced ejection fraction. This randomized, placebo-controlled trial will enroll approximately 6,000 participants globally, focusing on patients with an ejection fraction of 40% or less who have not experienced a recent worsening heart failure event. The primary efficacy endpoint is the time to cardiovascular death or heart failure hospitalization. The trial is expected to conclude in 39 months and follows the successful VICTORIA study.

Organon reported Q3 2021 revenue of $1,600 million, down 1% from Q3 2020. Net income was $323 million or $1.27 per diluted share, a 42% decline year-over-year. Adjusted EBITDA fell 15% to $636 million, with a margin of 39.8%. The company affirmed its financial guidance and announced a quarterly dividend of $0.28 per share. Notably, Women’s Health revenue dropped 10%, while Biosimilars rose 41%. Organon is actively expanding through acquisitions and maintaining strong cash flow with $1,008 million in cash, despite high debt levels.

Organon (NYSE: OGN) has announced its acquisition of Forendo Pharma, a clinical-stage company focusing on innovative treatments for women’s health. The deal includes a $75 million upfront payment, with additional potential payments totaling up to $954 million based on milestones. Forendo's lead candidate, FOR-6219, is a novel oral HSD17B1 inhibitor for treating endometriosis and is entering Phase 2 clinical trials. This acquisition aligns with Organon’s commitment to addressing significant unmet needs in women's health, including conditions like endometriosis and polycystic ovarian syndrome (PCOS).

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced an agreement with the Japanese government to purchase approximately 1.6 million courses of molnupiravir, an oral antiviral for COVID-19, pending regulatory approval. The deal is valued at around $1.2 billion. Merck anticipates producing 10 million treatment courses by the end of 2021 and at least 20 million in 2022. The company has initiated various global supply agreements and aims to broaden access to molnupiravir through tiered pricing and licensing for generic versions.

Avoro Capital Advisors owns approximately 7% of Acceleron Pharma Inc. (XLRN) and opposes Merck's ($MRK) $180 per share tender offer. Avoro believes that now is not the right time to sell, citing expected significant value from upcoming STELLAR Phase 3 trial data within a year. They argue the offer undervalues Acceleron based on higher precedents and criticize the board for a flawed sale process with limited buyer outreach. Avoro is prepared to support Acceleron as an independent entity and will not tender its shares.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced that the U.S. government will purchase an additional 1.4 million courses of molnupiravir, bringing the total commitment to approximately 3.1 million courses for around $2.2 billion. This procurement is contingent on Emergency Use Authorization (EUA) or FDA approval for molnupiravir, an oral antiviral treatment for COVID-19. Merck has been producing the drug at risk, expecting to deliver 10 million courses by year-end 2021, with capabilities to produce at least 20 million in 2022.

Merck has received antitrust clearance for its acquisition of Acceleron Pharma Inc. from competition authorities in Germany and Austria. The acquisition involves a cash tender offer of $180 per share, as announced on October 12, 2021. This step fulfills one of the necessary conditions for the tender offer's completion. The tender offer is set to expire on November 18, 2021, unless extended. The acquisition is anticipated to close in Q4 2021, pending other conditions detailed in the SEC filings.

Acceleron Pharma reported Q3 2021 revenue of $34.2 million, including $32.0 million in royalty revenue from REBLOZYL, up from $25.6 million last quarter. Merck agreed to acquire Acceleron for $180 per share, valuing the deal at approximately $11.5 billion, expected to close in Q4. The company has several ongoing Phase 3 trials for its therapies, including sotatercept for pulmonary hypertension and ACE-1334 for systemic sclerosis-associated lung disease. Cash reserves stand at $652.5 million.