Fedratinib Hydrochloride

- Awards Dr. Berkowitz an Inducement Grant in accordance with Nasdaq Listing Rule 5635(c)(4) -NEW HAVEN, Conn., March 18, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the appointment of Noah Berkowitz, M.D., Ph.D., to the role of Chief Medical Officer and a member of the Executive Committee reporting to President and Chief Executive Officer John Houston, Ph.D. Effective today, Dr. Berkowitz will lead the ongoing clinical development of Arvinas’ PROTAC® protein degrader programs in oncology and neuroscience. “We are thrilled to have Dr. Berkowitz join Arvinas as we continue advancing multiple programs with the goal of improving the lives of patients with serious diseases,” said John Houston, Ph.D., Chairperson, President and Chief Executive Officer at Arvinas. “Noah’s vision, expertise, and proven track record in designing and launching successful clinical programs across all stages of clinical development complement our rapidly advancing portfolio of novel PROTAC protein degraders. His leadership and experience will be invaluable as we approach our first Phase 3 data readout and continue progressing multiple ongoing and planned clinical-stage programs.” Dr. Berkowitz has more than 20 years of experience in advancing programs through early and late stages of development, with proven ability in leading clinical development, regulatory, and medical affairs. He has led multidisciplinary teams and has extensive knowledge of clinical trial design and execution. Dr. Berkowitz joins Arvinas from Bristol-Myers Squibb (BMS), where he was Senior Vice President, Development Unit Head, Hematology. While at BMS, Dr. Berkowitz’s teams achieved initial or subsequent global indications for Abecma®, Breyanzi®, Reblozyl®, Onureg®, and Inrebic®, managed development life cycles for Revlimid®, Pomalyst®, and Sprycel®, and initiated and/or designed registration trials for iberdomide, mezigdomide, and alnuctamab. Prior to BMS, Dr. Berkowitz held roles of increasing responsibility in the areas of oncology, rare diseases, and hematology at Novartis, most recently as Vice President and Clinical Development Head for Hematology. Dr. Berkowitz earned his M.D. and Ph.D. from Columbia University and trained in medical oncology at the National Cancer Institute. “Arvinas is the leader in targeted protein degradation and is on the cusp of its first pivotal data, an important step in potentially bringing an innovative therapeutic approach to patients with serious diseases,” said Dr. Berkowitz. “Arvinas’ progress over the last several years is impressive and I look forward to working with my colleagues, including the strong leadership team at Arvinas, as we prepare for many important upcoming clinical milestones ahead.” The Company also announced that Ron Peck, M.D., who was Chief Medical Officer since joining Arvinas in mid-2019, will be leaving to pursue other opportunities. “In less than five years, Ron built robust clinical development and medical affairs organizations, enabling the planning and initiation of multiple clinical trials across our oncology and neuroscience portfolios,” continued Dr. Houston. “Under Ron’s leadership and in partnership with Pfizer, vepdegestrant has advanced from the start of Phase 1 to multiple ongoing and planned Phase 3 studies in advanced breast cancer. Ron’s teams also progressed our androgen receptor programs, with ARV-766 moving towards Phase 3 initiation, and initiated human dosing of ARV-102, our neuroscience program targeting LRRK2,” said Dr. Houston. “We thank Ron for his tremendous efforts and take confidence in knowing that Dr. Berkowitz is inheriting a high-performing organization.” In connection with the commencement of Dr. Berkowitz’s employment, Arvinas granted Dr. Berkowitz an option to purchase 93,879 shares of common stock and a restricted stock unit award with respect to 63,452 shares of common stock on March 18, 2024, as an inducement material to entering into employment with Arvinas. The option and restricted stock units were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and not pursuant to Arvinas’ stock incentive plan. The option has a 10-year term and an exercise price of $42.60 per share, which is equal to the closing price per share of Arvinas’ common stock on the grant date. The option vests over four years, with 25% of the original number of shares underlying the option vesting on the one-year anniversary of the date of grant and 1/48th of the original number of shares vesting monthly thereafter, and the restricted stock unit award vests in four equal installments on each one-year anniversary of Dr. Berkowitz’s employment start date until the fourth anniversary of Dr. Berkowitz’s start date, subject to his continued service with Arvinas through the applicable vesting dates.  About ArvinasArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has four investigational clinical-stage programs: vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders. For more information, visit www.arvinas.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements with respect to Arvinas’ development plans; the anticipated data readout for Arvinas’ first Phase 3 clinical trial with vepdegestrant (ARV-471); the potential, pending regulatory approval, for vepdegestrant to address an area of significant unmet need and offer patients an innovative therapeutic approach; and the potential advantages and therapeutic benefits of vepdegestrant (ARV-471). All statements, other than statements of historical facts, contained in this press release, including statements regarding Arvinas’ strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas’ and Pfizer, Inc.’s (“Pfizer”) performance of the respective obligations with respect to Arvinas’ collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant (ARV-471); whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including ARV-766, and including whether Arvinas initiates and completes clinical trials for its product candidates and receive results from its clinical trials on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant (ARV-471), ARV-766 and other product candidates on current timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. Contacts Investors:Jeff Boyle+1 (347) 247-5089Jeff.Boyle@arvinas.com Media:Maurissa Messier+1 (908) 208-9254Maurissa.messier-c@arvinas.com

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  CEPI’s founding CEO set to lead public health charity Wellcome Wellcome  U.K.-based public health charity Wellcome has not shied away from its ambitious goal of donating 16 billion pounds sterling by 2032. Now, the organization will have a new chief to oversee the mission.  The nonprofit has named John-Arne Røttingen as its CEO, plucking the public health diplomat and former NGO executive to help steer the multibillion-dollar fund. Røttingen is currently the ambassador for global health in Norway’s Ministry of Foreign Affairs. He was previously the founding head of the Center for Epidemic Preparedness and Innovation (CEPI), which Wellcome helped launched in 2017, and CEO of the Research Council of Norway.  The organization has dipped its toe in an array of public-health-adjacent work, from launching new initiatives like CEPI to directly funding clinical development. Earlier this year, it joined the Bill & Melinda Gates Foundation to pour $550 million toward a phase 3 trial for GSK’s TB vaccine. The organization also helped fund the establishment of the AMR Action Fund, which has been tasked with tackling antimicrobial resistance and advancing new antibacterials. Source Fresh off IPO, Neumora names new R&D chief Neumora Neuroscience-focused biotech Neumora has seen its spotlight brighten in recent weeks since joining a select few companies to plunge into the public markets this year. That makes the company’s most recent hire even more important. Robert Lenz, M.D., Ph.D., is joining the company from Amgen, where he lead all global development for the Southern California pharma. He was there for nearly 11 years, leading development for a number of franchises including neurology, inflammation and nephrology. Neumora touted Lenz’s experience launching more than 130 trials and recruiting some 53,000 patients.  Neumora received a $100 million equity investment from Amgen back in 2021 and received global exclusive rights to a couple of programs for neurodegenerative diseases. Neumora recently jumped onto Wall Street, aiming to raise $250 million with shares at $17 per share. But it's been a tough first month, with prices down 40% to $9.64 per share. Release Poseida’s newly named cell therapy president to take CEO reins  Poseida Therapeutics Well, that was a quick promotion! Kristin Yarema, Ph.D., was hired by Poseida in April as president of cell therapy and now is moving up to the tippy top of the company. The company announced this week that she’ll be the new CEO, with current boss Mark Gergen moving to executive chairman. In a statement, he said the point of the leadership swap was “to set the Company up for success in its next phase of growth.”  Yarema was previously the chief commercial officer of Atara Biotherapeutics, which became the first company to have a marketed off-the-shelf cell therapy. The treatment was approved in Europe in late December as a treatment for patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease who had tried at least one prior treatment. She held a number of commercial roles at Amgen before that, including as VP and head of global product strategy and commercial innovation in hematology-oncology.  Gergen joined Poseida in 2018, first as CFO and chief business officer, before shedding the CFO title for president. He became CEO in February 2022 and tacked on board chair duties a year later. Yarema is set to officially take over at the start of 2024. Release > Elicio Therapeutics has “terminated without cause” Chief Business Officer Annette Matthies, Ph.D. Matthies joined the company in early 2021 to lead all business and corporate development efforts, overseeing Elicio when it snagged a ticket to the public markets via a reverse merger with Angion Biomedica this January. Release > After nabbing FDA approval for its heart drug Inpefa, Lexicon Pharmaceuticals has signed on Tom Garner as SVP and chief commercial officer. Garner joins from Bristol Myers Squibb, where he spent 21 years and most recently served as SVP and head of the company's U.S. Cardiovascular & Established Brands business unit. Fierce Pharma > Dyadic International has selected Doug Pace as the biotech’s EVP of business development. Before joining the microbial platform company, Pace has decades of experience across Pfizer and Novartis. Release > Arvin Yang, M.D., Ph.D., has departed his chief medical officer position at Mersana Therapeutics for the same title at Pheon Therapeutics. Before Mersana, Yang spent over a decade at Bristol Myers Squibb, where he helped drive the approvals of nivolumab, ipilimumab, fedratinib and luspatercept. Release > Blue Water Biotech is shaking things up, selecting Neil Campbell to lead as president and CEO while appointing Bruce Harmon as chief financial officer as Jon Garfield exits the company. Before joining Blue Water Biotech, Campbell was president and CEO of Marizyme, while Harmon served as an independent consultant and an outsourced CFO for multiple public companies. Release > As Federation Bio folds, Kanvas Biosciences has snapped up two of the biotech’s assets and Chief Scientific Officer Lee Swem, Ph.D., to lead program development. Swem now serves as Kanvas’ chief development officer. Fierce Biotech > Ashvattha Therapeutics has appointed Sakura Minami, Ph.D., as VP of translational medicine and nonclinical development and Sarah Thayer as head of clinical operations. Minami previously served as Alkahest’s senior director of research, nonclinical development and translational medicine, while Thayer most recently served as VP and head of clinical operations for ReCode Therapeutics. Release > Lixte Biotechnology Holdings’ founder and executive chair John Kovach, M.D., has passed away at age 87. Kovach founded the company in 2005 and served as CEO until Sept. 26 of this year, when Bas van der Baan took the title. Release > Medicenna Therapeutics has chosen Humphrey Gardner, M.D., to serve as the immunotherapy company’s chief medical officer. Most recently, Gardner served as Harbour BioMed’s CMO and has held past leadership roles at Stingthera, Roivant Sciences, Evelo Biosciences, AstraZeneca, Novartis and Biogen. Release > Neil McFarlane is taking the top spot at Zevra Therapeutics, succeeding Christal Mickle, who has been serving as interim CEO and president since June and will continue in her role as chief development officer. As for McFarlane, he recently served as CEO of Adamas Pharmaceuticals until its acquisition by Supernus Pharmaceuticals in November 2021. Release > Sibylla Biotech has selected Sonia Poli, Ph.D., to serve as chief scientific officer. For the last three years, Poli served as life cycle leader for AC Immune’s collaboration with Eli Lilly on a Tau morphomer program. Release > VarmX has chosen Chief Scientific Officer Jeffrey Lawson, M.D., Ph.D., to helm the company, taking over for Jan Öhrström, M.D., who will continue as chair of the board. Before joining VarmX in March, he served as Humacyte’s president and CEO. Release