Target to $90 from $78
Tuesday, January 18, 2022
Kinnate Gets FDA Clearance of Investigational Drug Application for Cancer Therapy
Planned initiation of Phase 1 clinical trial for KIN-3248 in 1H2022
Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, today announced that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation pan-FGFR inhibitor being developed for intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC).
"The IND clearance for KIN-3248 is another important validation of our Kinnate Discovery Engine and an exciting step forward in our mission to deliver new therapies to patients with difficult-to-treat, genomically-defined cancers,” said Nima Farzan, Chief Executive Officer of Kinnate. “By targeting clinically relevant primary FGFR driver alterations and secondary resistance mutations, including FGFR2 and FGFR3 gatekeeper, molecular brake, and activation loop mutations, we believe that KIN-3248 is unique among FGFR inhibitors and has the potential to extend the clinical response of cancer patients with FGFR-altered tumors.”
KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor that has been developed to address both primary FGFR2 and FGFR3 oncogenic alterations and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as ICC and other gastrointestinal cancers. In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.
The Phase 1 trial is expected to initiate in the first half of 2022 and will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-cancer activity of KIN-3248 in FGFR inhibitor naïve and pretreated cancer patients with FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alterations. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC and other selected adult solid tumors.
Oncocyte, Thermo Fisher Agree to Expand Access to Precision Oncology
Collaboration extends global reach for Thermo Fisher’s rapid next-generation sequencing technology
Conference call to be held today at 4:30 pm ET/1:30 pm PT
Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, today announced a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent™ Genexus™ System.* The agreement also grants Oncocyte rights to develop future companion diagnostics on the Genexus System.
Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus* on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic. As an IVD, the >500-gene assay will initially be able to provide physicians with information about patients’ tumors in accordance with established clinical evidence, applicable clinical trials, and future approval may assist with the selection of targeted therapies. Oncocyte will also develop its 27-gene expression DetermaIO™ test as a distributed kit on the Genexus. DetermaIO may predict response to immuno-oncology therapies based on data demonstrating potential pan-cancer utility and improvement over current standard-of-care tests.
“As many as 44% of newly diagnosed cancer patients may be eligible for immuno-oncology therapies, with additional patients potentially benefiting from other precision medicines, yet many patients’ tumors are never sequenced to determine if they may benefit from these targeted treatments,1” said Ron Andrews, President and Chief Executive Officer of Oncocyte. “In order to increase the number of patients benefiting from precision medicine, we need to expand the number of IVDs and develop these tests on instruments that are designed to make sequencing-based testing simple and more accessible. We have developed our Determa menu to ultimately become regulated kits for distribution ex-US on an IVD instrument. Our collaboration with Thermo Fisher using the Genexus System’s end-to-end automation enables that vision.”
Conference Call Information
The Company will host a conference call today, January 18th at 4:30 pm EST / 1:30 pm PST to discuss the agreement. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID: 13726196. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here https://viavid.webcasts.com/starthere.jsp?ei=1523401&tp_key=660b3d209e. The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.
The Company will host a conference call today, January 18th at 4:30 pm EST / 1:30 pm PST to discuss the agreement. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID: 13726196. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here https://viavid.webcasts.com/starthere.jsp?ei=1523401&tp_key=660b3d209e. The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.
NRx: ZYESAMI® (aviptadil) US Expanded Access and Right to Try Programs for Patients with COVID
ZYESAMI® (aviptadil) is currently in a Phase 3 clinical trial being conducted by the National Institutes of Health (NIH)
NRx will continue to provide ZYESAMI to hospitals enrolled in NRx’s Expanded Access Protocol under US Food and Drug Administration guidelines
NRx is also making ZYESAMI available as an investigational medicine under the Federal Right to Try Act1
ZYESAMI is available to patients who have progressed despite treatment with remdesivir and other approved medicines and who are not able to participate in the NIH trial
NRx manufacturing program now supports increases in demand under Expanded Access and Federal Right to Try programs
Xeris Biopharma Reaffirms 2021 Guidance and Provides Business Update
Preliminary 2021 full-year pro forma net sales at high-end of $76-80 million guidance, representing approximately 55% growth from 2020
Year-end 2021 preliminary cash, cash equivalents, and investments of approximately $102 million
20+ million Medicaid lives in IL, TN, PA, OH, and CA have unrestricted access to Gvoke®, effective January 1, 2022
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) ("Xeris" or the "Company"), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced a business update and reaffirmed its 2021 pro forma net sales and year-end cash balance guidance.
"We are proud to have ended 2021 on a strong note with continued growth of Gvoke and Keveyis®, delivering net sales at the upper end of our guidance range, over $100 million of cash, cash equivalents, and investments on the balance sheet, and the approval of our third commercial product, Recorlev®. 2022 is off to a good start with an additional $30 million from the recent capital raise on our balance sheet and the near-term launch of Recorlev," said Paul R. Edick, Chairman and CEO of Xeris Biopharma.
"Since the launch of Gvoke, we have persistently worked to make Gvoke accessible for as many people with diabetes as possible. There are over 6.8 million people with diabetes on insulin at risk of a severe hypoglycemic event, and we think every one of them should have access to a ready-to-use product such as Gvoke. We are very pleased that a growing number of Medicaid lives now have unrestricted access to Gvoke," said Mr. Edick.
https://finance.yahoo.com/news/xeris-biopharma-reaffirms-2021-guidance-120000596.html
bluebird Provides Update on FDA Review Timelines
bluebird bio, Inc. (NASDAQ: BLUE) today announced that the US Food and Drug Administration (FDA) has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD). The revised PDUFA goal dates for beti-cel and eli-cel are August 19, 2022 and September 16, 2022, respectively.
The FDA extended the PDUFA goal dates for beti-cel and eli-cel to allow time to review additional clinical information previously submitted by the company in response to FDA information requests as part of its ongoing reviews. The information was deemed a major amendment. The extension of the FDA review timeline does not relate to new safety events for either beti-cel or eli-cel.
bluebird’s BLA submission for beti-cel for adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions was accepted by the FDA for priority review in November 2021. The FDA accepted the BLA for eli-cel for patients with cerebral adrenoleukodystrophy (CALD) under the age of 18 for priority review in December 2021. If approved, beti-cel and eli-cel would be the first lentiviral vector gene therapies for patients with severe genetic diseases in the United States.
"Gene therapies are complex, potentially transformative treatment options for those living with severe genetic diseases, and we all share a responsibility to be diligent for patients as we progress this novel field," said Andrew Obenshain, CEO, bluebird bio. "We look forward to continuing to work with the FDA on its ongoing reviews of beti-cel and eli-cel, and to bringing these therapies to patients with beta-thalassemia and cerebral adrenoleukodystrophy in the US later this year."
Bausch Eyes Refinance of Credit Agreement And Conditional Redemption Of Existing Notes in IPO
Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") announced today that it is seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur only upon completion of the initial public offering (IPO) of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing"). At the time of the Bausch + Lomb IPO, Bausch + Lomb will initially remain a "restricted" subsidiary subject to the terms of the Credit Agreement covenants, but the Credit Agreement Refinancing is expected to permit Bausch Health to designate Bausch + Lomb as an "unrestricted" subsidiary outside the terms of the Credit Agreement covenants upon achievement of a 7.6x pro forma "Total Leverage Ratio." The Credit Agreement Refinancing is designed to facilitate the separation and distribution of Bausch + Lomb.
The Company also intends, subject to market conditions, to issue approximately $1.0 billion of secured debt securities (the "New Debt Securities"). The proceeds of the New Term B Loans and the offering of the New Debt Securities, along with proceeds from the Bausch + Lomb IPO and from the repayment of an intercompany note owed by Bausch + Lomb (which is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the redemption in full of our outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund a partial redemption of our outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025" and, collectively with the 9.000% Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.
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