Merck says Phase 3 KEYNOTE-522 trial met dual primary endpoint » 06:4605/1305/13/21
Merck announced positive…
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Merck call volume above normal and directionally bullish » 13:4505/1005/10/21
Bullish option flow…
Bullish option flow detected in Merck with 20,248 calls trading, 1.5x expected, and implied vol increasing almost 2 points to 19.24%. Jun-21 80 calls and Jun-21 85 calls are the most active options, with total volume in those strikes near 5,700 contracts. The Put/Call Ratio is 0.17. Earnings are expected on July 29th.
ALX Oncology announces first patient dosed in ASPEN-03 phase 2 study of ALX148 » 07:5305/1005/10/21
ALX Oncology (ALXO) in…
ALX Oncology (ALXO) in partnership with Merck (MRK) announced the first patient has been dosed in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma. ASPEN-03 is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 plus pembrolizumab in patients with first line metastatic or unresectable, recurrent PD-L1 positive HNSCC. This study is being conducted in collaboration with Merck and is based upon promising clinical data reported from the ASPEN-01 Phase 1 study, which provided the basis for ALX148's Fast Track designation in HNSCC granted by the U.S. Food and Drug Administration.
Merck declares May 17 as record date for Organon spinoff » 13:0505/0705/07/21
Merck (MRK) announced…
Merck (MRK) announced that its board of directors approved the separation of Organon & Co. (OGN) and declared a special dividend distribution of one-tenth of a share of Organon common stock for every Merck common share outstanding as of the close of business on May 17, the record date for the distribution. The company also announced that the U.S. Securities and Exchange Commission has declared effective the Registration Statement on Form 10 filed by Organon. The Form 10 includes information regarding Organon's business and strategy as well as details on the spinoff, which is expected to be completed on June 2. Merck expects the special dividend of Organon stock will be distributed on June 2. The New York Stock Exchange has authorized the listing of Organon common stock under the symbol "OGN". Organon has been advised that trading in its common stock is expected to begin on a "when issued" basis on May 14, 2021, under the symbol "OGN.WI." "When issued" trading of Organon common stock will continue until Merck pays the special dividend distribution of Organon common stock on June 2, 2021. Organon "when issued" trades are expected to settle after June 2, 2021, with shares of Organon as a standalone company. Beginning on May 14, 2021, and continuing through June 2, 2021, Merck expects that common shares of Merck will trade in two markets on the NYSE: "regular-way" under the symbol "MRK" and in the "ex-distribution" market under the symbol "MRK.WI." Merck shares trading under "MRK" will carry the right to receive shares of Organon through the special dividend distribution. Merck shares trading under "MRK.WI" will not carry the right to receive shares of Organon through the special dividend distribution. Merck shareholders who sell their shares in the "regular-way" market on or before June 2, 2021, will also be selling their entitlement to receive the Organon special dividend distribution of Organon common stock. Merck shareholders are encouraged to consult with their financial advisors regarding the specific consequences of selling Merck common shares on or before June 2, 2021. On June 3, 2021, regular-way trading will commence on the NYSE for Organon under the symbol "OGN" and will continue for Merck under the symbol "MRK." "We are pleased to announce the full details of Organon's spinoff from Merck, commencing later this month. This spinoff will position Organon as a successful, independent, publicly traded company with a compelling portfolio of important medicines, particularly in women's health. Organon will have a significant impact on women's health around the world, providing benefits to patients and shareholders alike," said Rob Davis, president, Merck.
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Fusion Pharmaceuticals announces clinical trial collaboration with Merck » 08:2305/0605/06/21
Fusion Pharmaceuticals (FUSN) announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (MRK) to evaluate Fusion's lead candidate, (FPI-1434), in combination with Merck's anti-PD-1 therapy, KEYTRUDA, in patients with solid tumors expressing insulin-like growth factor 1 receptor. The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.
Merck, Eisai receive FDA priority review for KEYTRUDA plus LENVIMA » 06:4405/0605/06/21
Merck (MRK) and Eisai…
Merck (MRK) and Eisai (ESALY) announced that the U.S. FDA has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications are for the first-line treatment of patients with advanced renal cell carcinoma, based on progression-free survival, overall survival and objective response rate data from the pivotal Phase 3 CLEAR study. The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on PFS, OS and ORR data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial. These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data. The FDA has set Prescription Drug User Fee Act dates, or target action dates, of August 25 and 26, 2021, for the advanced RCC sNDA and sBLA applications, respectively, and September 3, 2021, for the advanced endometrial carcinoma applications.
FDA approves Merck's KEYTRUDA+Trastuzumab in GEJ adenocarcinoma » 16:4605/0505/05/21
The company states:…
The company states: "Merck announced that the FDA has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction, or GEJ, adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This approval is based on data from the ongoing Phase 3 KEYNOTE-811 trial, in which KEYTRUDA in combination with trastuzumab and either 5-fluorouracil plus cisplatin or capecitabine plus oxaliplatin demonstrated a statistically significant objective response rate (ORR) of 74% for patients who received the regimen with KEYTRUDA versus 52% for those who received trastuzumab and chemotherapy alone (pless than0.0001). For patients who received the regimen with KEYTRUDA, the complete response rate was 11% and the partial response rate was 63%. For patients who received trastuzumab and chemotherapy alone, the complete response rate was 3.1% and the partial response rate was 49%."
Merck call volume above normal and directionally bullish » 14:2505/0505/05/21
Bullish option flow…
Bullish option flow detected in Merck with 20,225 calls trading, 1.4x expected, and implied vol increasing over 1 point to 21.31%. May-21 78.5 calls and May-21 77 calls are the most active options, with total volume in those strikes near 4,700 contracts. The Put/Call Ratio is 0.23. Earnings are expected on July 29th.
FDA grants pembrolizumab accelerated approval for HER2-positive gastric cancer » 14:2405/0505/05/21
The Food and Drug…
The Food and Drug Administration announced that it has granted accelerated approval to pembrolizumab, or Keytruda, from Merck in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma. Reference Link
Mereo BioPharma initiated with a Buy at BTIG » 07:1805/0505/05/21
MREO, MRK, RHHBY
BTIG analyst Yun Zhong…
BTIG analyst Yun Zhong initiated coverage of Mereo BioPharma (MREO) with a Buy rating and $10 price target. The stock appears to be "significantly undervalued" given the "abundant" proof-of-concept data that is de-risking its "diversified" pipeline, the analyst tells investors in a research note. Roche (RHHBY) and Merck's (MRK) positive data provide strong validation for Mereo's anti-TIGIT monoclonal antibody given the structural similarity, Zhong adds.