As previously reported, CLSA analyst David Li downgraded BeiGene to Outperform from Buy following the news yesterday of Bristol-Myers’ (BMY) proposed acquisition of Celgene (CELG) in a note titled “From friend to foe.” He thinks Celgene is unlikely to continue to cooperate with BeiGene on its PD-1 after the deal goes through and also worries about the three commercialized products licensed from Celgene and about the company selling out of its BeiGene stake, he tells investors. He lowered his price target on BeiGene shares to HK$89.86 from HK$121.34.
Friday, January 4, 2019
Tetraphase initiated at B. Riley FBR
Tetraphase resumed with a Buy at B. Riley FBR. B. Riley FBR analyst David Buck resumed coverage of Tetraphase Pharmaceuticals with a Buy rating and $3 price target.
PierianDx in Pact with Illumina to Support Cancer Research and Diagnostics
PierianDx, a leading clinical genomics informatics company, today announced a strategic, non-exclusive, multi-year partnership with Illumina, Inc.to provide a variant interpretation and reporting solution based on PierianDx’s Clinical Genomics Workspaceplatform and Clinical Genomics Knowledgebase for select Illumina oncology products. Under the agreement, PierianDx and Illumina will offer customers the option of informatics capabilities for Illumina oncology products, including Illumina’s TruSight™ Tumor 170 and TruSight™ Oncology 500, which are currently intended for research use only (RUO). The partnership extends to support Illumina’s future oncology in vitro diagnostic (IVD) offerings. Advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide is a key focus of both parties.
“Accessibility of genomic testing in clinical oncology is critical to realizing the promise of immuno- and targeted therapies and personalized medicine,” stated Rakesh Nagarajan, MD, PhD, Founder and Executive Chairman, PierianDx. “Today, few laboratories have the ability to offer comprehensive tumor profiling because of the complexities associated with validating large NGS assays and interpreting genomic results. This agreement between PierianDx and Illumina has the potential to provide laboratories clinically optimized solutions that may accelerate assay validation and deployment and simplify genomic interpretation.”
“The combination of Illumina’s comprehensive tumor profiling assays with PierianDx’s variant interpretation and reporting solutions will provide customers with a seamless experience,” said Garret Hampton, PhD, Executive Vice President of Clinical Genomics at Illumina.
“PierianDx is thrilled to receive this substantial validation of our genomics Software as a Service (‘SaaS’) platform by a global leader in our space. Our relationship with Illumina will allow us to greatly accelerate our U.S. and international strategic plans as we seek to be the wisdom behind every genomics report,” said Michael L. Sanderson, CEO of PierianDx.
Under the agreement Illumina and its affiliates will be responsible for the distribution of the RUO oncology products and packaged solutions. Laboratories that purchase the RUO products from Illumina will have an option to receive from PierianDx standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories who purchase the bundled RUO oncology product with the PierianDx informatics solution will receive access to PierianDx’s Clinical Genomics Workspace for analysis, interpretation, and reporting of genomic results. Laboratories will also have the opportunity to engage PierianDx for additional services such as genomic interpretation, medical sign-out, and electronic medical record integration.
Adaptive Biotech in Pact with Genentech for Personalized Cancer Therapies
Adaptive Biotechnologies an immune-driven medicine company, today announced that it will enter into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers. The collaboration will combine Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery and immune profiling platform (TruTCR™) to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.
Adaptive offers a pioneering technology platform to rapidly identify T-cell receptors (TCRs) that can most effectively recognize and directly target specific neoantigens, which are proteins generated by tumor-specific mutations not present in normal tissues. Through this partnership, Adaptive will utilize the investigational TCR discovery platform to identify the optimal TCRs to most effectively target each patient’s neoantigens for treatment. Genentech will engineer and manufacture a personalized cellular medicine to deliver to each patient. The goal is to harness the vast majority of therapeutically relevant, patient-specific neoantigens and advance the next generation of cellular therapies in oncology.
“We believe targeting neoantigens could be the most effective approach for harnessing a person’s immune system to fight cancer,” said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. “This partnership, which combines Adaptive’s pioneering platform for identifying T-cell receptors with Genentech’s cancer immunology expertise, has the potential to change the way cancer is treated and bring us one step closer to truly personalized healthcare.”
“Cellular therapy approaches in cancer have been limited by the inability to effectively screen and translate the immune response to patient-specific neoantigens. Accurate recognition of such neoantigens is a major driver in the activity of novel immunotherapies,” added Harlan Robins, Ph.D., head of innovation and co-founder of Adaptive Biotechnologies. “Given Adaptive’s unique ability to read and access the immune system at unprecedented scale and precision, Adaptive and Genentech can potentially jointly develop a patient-specific approach to treating cancer.”
Under the terms of the agreement, Adaptive will receive $300 million in an initial upfront payment and may be eligible to receive more than $2 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. Genentech will have responsibility for clinical, regulatory, and commercialization efforts, and Adaptive will be responsible for patient-specific screening on a global basis.
Adaptive will continue to use its TCR discovery and immune profiling platform to collaborate in the development of cellular therapies in other disease areas, including autoimmune conditions and infectious diseases.
Ribon Therapeutics and Hans Bishop’s Sana Biotechnoloy Officially Launch
The new year brings new beginnings. In the biopharma industry, that means the launch of some new companies taking aim at potentially developing therapies or, even potential cures, for diseases. Two new companies have hit the ground running – Ribon Therapeutics and Sana Biotechnology.
Based in Lexington, Mass., Ribon Therapeutics launched this week with $65 million in a Series B funding round and a focus on developing first-in-class therapeutics targeting novel enzyme families activated under cellular stress conditions. The new company intends to use the proceeds from the financing round to advance its lead programs, including small molecule monoPARP inhibitors, into the clinic.
MonoPARPS are regulators of stress responses that can enable cancer cells to survive, as well as evade detection, Ribon said. Because of new science that has linked the activity of monoPARPS to disease development, the company has developed a technology platform that will harness monoPARPS for the therapeutics. Ribon’s initial focus will be to use this technology in the area of oncology, but the company said the idea is relevant in a number of disease indications, including inflammatory and neurodegenerative diseases. The focus of Ribon’s lead program is on advancing the science of PARP7 inhibitors for the treatment of cancer, beginning with squamous cell carcinoma of the lung.
Ribon will be helmed by Victoria Richon, who will serve as both president and chief executive officer. Prior to helming Ribon, Richon oversaw discovery and preclinical research in oncology at Sanofi. In a statement issued today, Richon said the company will apply its “expertise in drug discovery to develop novel and effective treatments for defined patient populations with limited therapeutic options.”
Financing for Ribon’s Series B was led by the Novartis Venture Fund, with participation from new investors JJDC and Celgene Corporation. It was also supported by The Column Group, Deerfield Management, U.S. Venture Partners, Osage University Partners, Takeda Ventures and Euclidean Capital.
On the other side of the country, Sana Biotechnology launched with a focus on creating and delivering engineered cells as medicines for patients. The Seattle-based company was co-founded by Hans Bishop, the former CEO of Juno Therapeutics. Bishop will serve as executive chairman of the company’s board of directors.
Sana was spun out of Flagship Pioneering and has been supported by investments from ARCH Venture Partners & F-Prime Capital.
In its announcement, Sana said recent advances in science have made it possible to “reprogram cells in the body or replace damaged cells and tissues,” which can create a new class of medicines to treat a broad array of diseases. Sana’s core capabilities are being built around several areas, including “making cells at scale ex vivo to replace any damaged or missing cells in the body; in vivo delivery to specific cell types of any payload – including DNA, RNA, and proteins to reprogram cells; and immunology expertise to hide allogeneic cells.”
Sana Therapeutics will be led by Steve Harr, who is also a co-founder. Harr said that cell and gene engineering provide an opportunity to address the underlying causes of disease and deliver benefits that have not before been possible.
“There are challenges in making and delivering these kinds of medicines to patients, but also the opportunity to treat illnesses that today have few if any, options. Our goal with Sana is to bring together the people, technologies, and resources needed to address these challenges, changing both how we approach treating disease and what we expect as outcomes for patients,” Harr said in a statement.
Bishop said the company launches with a “portfolio of potential medicines and technologies” from scientific innovators that include Flagship Pioneering, Harvard University, the University of California San Francisco and the University of Washington School of Medicine.
AngioDynamics Tops Q2 EPS by 5c, Revenues Beat; Offers FY19 Outlook
AngioDynamics (NASDAQ: ANGO) reported Q2 EPS of $0.22, $0.05 better than the analyst estimate of $0.17. Revenue for the quarter came in at $91.5 million versus the consensus estimate of $89.24 million.
- Net sales of $91.5 million, an increase of 5.5% year over year
- Gross margin expanded 440 basis points year over year to 53.7%
- GAAP EPS of $0.06 per share; adjusted EPS of $0.22 per share
- Cash provided by operations of $13.0 million; capital expenditures of $0.7 million
- Announced the acquisition of RadiaDyne and its proprietary OARtrac® radiation dose monitoring platform to build the Company’s continuum of care within the oncology space
“We are very pleased with our second quarter financial results, which are marked by growth across all of our business segments, expanding gross margins, and improved profitability. Our quarterly performance was positively impacted by our recent acquisitions, validating our portfolio optimization strategy and enhancing our value proposition within oncology. In addition, we continue to make progress toward obtaining a pancreatic cancer indication for NanoKnife and recently received notification from the FDA that NanoKnife will be considered a Category B IDE once we receive approval to begin our DIRECTtm NanoKnife study for Stage III pancreatic cancer,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “We are encouraged by these accomplishments and are well positioned to achieve our financial targets for the full year.”
GUIDANCE:
AngioDynamics sees FY2019 EPS of $0.82-$0.86, versus the consensus of $0.84. AngioDynamics sees FY2019 revenue of $354-359 million, versus the consensus of $356.09 million.
Mersana (MRSN) PT Lowered to $14 at Baird
Baird analyst Michael Ulz lowered the price target on Mersana (NASDAQ: MRSN) to $14.00 (from $20.00) while maintaining a Outperform
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