Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced FDA approval for KEYTRUDA, its anti-PD-1 therapy, as the first immunotherapy for adjuvant treatment in patients with intermediate-high or high-risk renal cell carcinoma (RCC) post-nephrectomy. This approval is based on the Phase 3 KEYNOTE-564 trial, showing a 32% reduction in disease recurrence or death risk compared to placebo (HR=0.68). While KEYTRUDA presents a promising new treatment option, it also comes with potential severe immune-mediated adverse reactions.

Avoro Capital Advisors, a major shareholder in Acceleron Pharma Inc. (XLRN), owning approximately 7%, expressed strong opposition to Merck's (MRK) tender offer of $180 per share. The firm criticized the transaction as poorly timed and undervaluing Acceleron, stating it believes significant shareholder value will emerge post results from the pivotal STELLAR phase 3 trial. Avoro emphasized its commitment to a standalone Acceleron, suggesting alternative financing methods if needed and urging other shareholders not to tender their shares, potentially indicating strong discontent among investors.

Merck (NYSE: MRK) has announced the expiration of the waiting period under the Hart-Scott-Rodino Act concerning its acquisition of Acceleron Pharma Inc. (NASDAQ: XLRN). The cash tender offer for Acceleron's outstanding shares at $180 each has been extended to November 19, 2021. Approximately 11,980,722 shares, or 19.6% of Acceleron’s outstanding shares, were tendered by November 16, 2021. The acquisition is anticipated to close in Q4 2021, pending fulfillment of other conditions outlined in the previously filed SEC tender offer statement.

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.