On January 5, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported a business update for 2022 (Press release, Eagle Pharmaceuticals, JAN 5, 2022, View Source [SID1234598213]):

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Near-Term Business Highlights:

Vasopressin: The Company will begin shipping its recently approved vasopressin product on Monday, January 17, 2022, with 180 days of marketing exclusivity. This is an important product for Eagle, as Vasostrict U.S. sales totaled $890 million for the LTM ended September 30, 2021.
PEMFEXY: On February 1, 2022, the Company will launch PEMFEXY, a ready-to-use liquid with a unique J-code. Eagle has been building inventory and believes this is a significant opportunity, as the Alimta U.S. market totaled $1.2 billion for the LTM ended September 30, 2021.
TREAKISYM: Eagle’s bendamustine franchise continues to grow, including the launch of the TREAKISYM ready-to-dilute ("RTD") formulation in Japan in the first quarter of 2021. Together with a potential approval of the rapid infusion ("RI") (50ml) liquid formulation, this could generate approximately $20 million of combined royalty and milestone revenue in 2022.
Fulvestrant: Based on discussions with the U.S. Food and Drug Administration ("FDA"), the Company will commence human pilot studies of its fulvestrant product candidate for the treatment of HR+/HER- advanced breast cancer shortly.
Landiolol: The Company is on track to submit a new drug application ("NDA") in the first half of 2022, seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
CAL02: The Company is preparing to begin clinical trials for CAL02, a novel approach to the treatment of severe bacterial pneumonia, later this year.
"Our business is off to a very strong start this year. With our launch of vasopressin now and PEMFEXY on February 1, we believe that our products will do very well. We are advancing our other pipeline products as we expect to submit an NDA for Landiolol in the first half of this year and to begin our clinical studies for CAL02 later this year. We are also pleased to be moving forward with our fulvestrant product and expect to begin our next clinical studies soon," stated Scott Tarriff, President and Chief Executive Officer of Eagle.

"Importantly, our already-strong balance sheet and cash position will benefit from the two launches and position us well to deploy our cash strategically through additional in-licensing opportunities, as well as potential acquisitions of companies or products," concluded Tarriff.

On January 5, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, reported that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright Virtual BioConnect 2022 Conference being held January 10-13, 2022 (Press release, Dynavax Technologies, JAN 5, 2022, View Source [SID1234598212]).

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The on demand presentation will be available, beginning Monday, January 10, 2022 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

On January 5, 2022 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported that Dr. Jeremy Bender, chief executive officer, will present virtually during the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11 at 10:30 a.m. ET (Press release, Day One, JAN 5, 2022, View Source [SID1234598211]).

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A live audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website. An archived replay of the webcast will be available for 30 days following the live presentation.

On January 5, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12th at 3:00 p.m. ET (Press release, CytomX Therapeutics, JAN 5, 2022, View Source [SID1234598210]).

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available for 30 days following the event. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

On January 5, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that provided 2021 year-end updates and corporate guidance for 2022 (Press release, Cogent Biosciences, JAN 5, 2022, View Source [SID1234598209]).

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"I am proud of the substantial progress the Cogent team made in 2021. In addition to achieving our key corporate milestones of initiating three late-stage clinical trials of bezuclastinib, our highly potent and selective KIT mutant inhibitor, we also formed the Cogent Research Team which is focused on building a portfolio of best-in-class small molecules for patients with significant unmet medical need," said Andrew Robbins, President and CEO of Cogent Biosciences. "In 2022, we will advance the APEX, SUMMIT and PEAK clinical trials, with preliminary clinical data expected from APEX in the first half of 2022. In addition, we look forward to moving into our new research headquarters in Boulder and to sharing more details about the impressive research pipeline the Cogent Research Team has created in a very short period of time."

Key Highlights

Bezuclastinib now under investigation in three late-stage clinical trials
APEX clinical trial in patients with Advanced Systemic Mastocytosis (AdvSM): In mid-2021, Cogent initiated APEX, a Phase 2 clinical study of bezuclastinib in patients with AdvSM. APEX is an open-label, global, multicenter study evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. We expect to report preliminary clinical data at a scientific conference during the first half of 2022, including safety and tolerability data as well as bezuclastinib’s impact on serum tryptase levels, a validated biomarker of mast cell activity. Learn more about the APEX trial at cogentclinicaltrials.com/apex/.
SUMMIT clinical trial in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM): In the fall of 2021, Cogent initiated SUMMIT, a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM). Learn more about the SUMMIT trial at cogentclinicaltrials.com/summit/.
PEAK clinical trial in patients with Gastrointestinal Stromal Tumors (GIST): During the fourth quarter of 2021, Cogent initiated PEAK, a randomized, open-label, global Phase 3 clinical trial. The PEAK study is designed to explore the efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.

Preclinical data highlights bezuclastinib as potent KIT inhibitor with minimal CNS activity and PDGFR inhibition
During the third quarter of 2021, Cogent presented preclinical data providing further evidence of bezuclastinib as a differentiated, potent, and selective KIT mutant inhibitor with minimal brain penetration that avoids targeting PDGFR isoforms. These data were presented in a virtual poster at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper).

Cogent Research Team created to generate robust pipeline of potential best-in-class molecules
Cogent Research Team: During the second quarter of 2021, the company announced the formation of its Cogent Research Team, a highly-experienced, Boulder-based discovery and research team focused on pioneering best-in-class, small molecule therapeutics to expand Cogent’s pipeline.
The Cogent Research Team is led by John Robinson, PhD, and already has grown to over 35 employees. This spring, the team will move into its newly-built, state-of-the-art research facility in Boulder.
Cogent Scientific Advisory Board: In mid-2021, the company formed the Cogent Scientific Advisory Board, which is comprised of world-class experts involved in the discovery and development of novel therapeutics for patients with genetically driven diseases. This group has been brought together to provide external perspective for the Cogent Research Team as it develops a robust portfolio of novel, small molecule discovery programs designed to address significant patient unmet needs.
R&D Investor Event: In April 2022, Cogent will host an R&D investor event to introduce the Cogent Research Team, outline its strategy and focus to create best-in-class small molecules, highlight additional preclinical data demonstrating the potential differentiated profile for bezuclastinib and present early data from its growing pipeline of novel, small molecule targeted therapy programs.