Exelixis to Webcast Virtual Fireside Chat as Part of the Guggenheim Healthcare Talks Oncology Day on February 9, 2022

On February 2, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the virtual Guggenheim Healthcare Talks Oncology Day on Wednesday, February 9, 2022 at 1:30pm ET / 10:30am PT (Press release, Exelixis, FEB 2, 2022, View Source [SID1234607623]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for at least 30 days.

Xencor to Present at Upcoming Investor Conferences

On February 2, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate at two upcoming virtual investor conferences (Press release, Xencor, FEB 2, 2022, View Source [SID1234607622]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Guggenheim Healthcare Talks | 2022 Oncology Conference
Presentation Date: Wednesday, February 9, 2022
Presentation Time: 2:00 p.m. EST / 11:00 a.m. PST
11th Annual SVB Leerink Global Healthcare Conference
Presentation Date: Wednesday, February 16, 2022
Presentation Time: 3:40 p.m. EST / 12:40 p.m. PST
Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays will be posted on the Xencor website approximately one hour after the live event and will be available for at least 30 days.

Syros Receives FDA Orphan Drug Designation for Tamibarotene for the Treatment of MDS

On February 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to tamibarotene for the treatment of myelodysplastic syndrome (MDS) (Press release, Syros Pharmaceuticals, FEB 2, 2022, View Source [SID1234607621]). Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with azacitidine in the SELECT-MDS-1 Phase 3 trial for RARA-positive patients with newly diagnosed higher-risk MDS (HR-MDS).

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"The FDA’s orphan drug designation is an important milestone in the development of tamibarotene as a treatment for MDS," said David A. Roth, M.D., Syros’ Chief Medical Officer. "We believe tamibarotene’s novel mechanism of action, promising clinical activity data, oral delivery, and favorable tolerability profile supports a potential new option for the approximately 30% of HR-MDS patients who are RARA-positive. We are focused on developing the first potential therapy for a targeted population in HR-MDS as we continue to advance our ongoing SELECT-MDS-1 pivotal trial."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

The ongoing SELECT-MDS-1 Phase 3 clinical trial is evaluating the safety and efficacy of tamibarotene in combination with azacitidine for RARA-positive patients with newly diagnosed HR-MDS. Data from the pivotal trial are expected in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application filing expected in 2024.

Syros is also evaluating tamibarotene in combination with azacitidine and venetoclax for RARA-positive patients with newly diagnosed unfit acute myeloid leukemia (AML), for which tamibarotene had previously received orphan drug designation. Safety lead-in data from the ongoing SELECT-AML-1 Phase 2 trial is expected in the second half of this year.

Alkermes to Report Fourth Quarter and Year-End 2021 Financial Results on Feb. 16, 2022

On February 2, 2022 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Wednesday, Feb. 16, 2022 to discuss the company’s fourth quarter and year-end 2021 financial results. Management will also discuss financial expectations for 2022 and provide an update on the company (Press release, Alkermes, FEB 2, 2022, View Source [SID1234607620]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

EVERSANA Agencies Win Multiple 2021 PM360 Pharma Choice Awards

On February 2, 2022 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported that both Intouch Group, an EVERSANA company and EVERSANA ENGAGE have been named winners in the 2021 PM360 Pharma Choice Awards (Press release, EVERSANA, FEB 2, 2022, View Source [SID1234607619]).

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Entries from Intouch Group earned gold in the professional campaign category, as well as two silver recognitions in the multichannel and variety categories. EVERSANA ENGAGE earned a silver award for work with Evoke Pharma and the "Spray Your Symptoms Away" campaign which promotes Gimoti (metoclopramide) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

The marketing campaign highlights the novel route administration of GIMOTI to address a problematic disease where oral therapies aren’t properly absorbed due to delayed stomach emptying. It is part of EVERSANA’s integrated suite of outsourced services to commercialize and distribute GIMOTI in the United States.

"It’s tremendous to be recognized by PM360," said Jim Lang, CEO at EVERSANA. "The combined creative team at both Intouch Group and EVERSANA ENGAGE demonstrate the power of our ability to deliver world-class, impactful campaigns that help connect patients with life changing therapies. Congrats to everyone from both teams on this achievement."

PM360 is a leading trade magazine for marketing decision-makers in the pharmaceutical, biotech, medical device, and diagnostics industries. Since 2009, the PM360 Pharma Choice awards have served as the only industry awards to recognize outstanding achievement and creativity in healthcare and life sciences marketing by allowing the industry to choose the winners.

All submissions are placed online, and anyone in the industry can vote for their favorites based on content, format, imagination, influence on the industry, impact on the audience, and overall quality. This year, more than 8,000 votes were cast. Thirty-nine winners across 13 categories are featured in the most recent issue of PM360 magazine.

EVERSANA acquired Intouch Group in December 2021. Agencies from both firms will integrate, as EVERSANA ENGAGE joins forces with the Intouch agency network in 2022.