Roche update supports Ionis' 'high risk' HTTRx 'having a shot,' says Stifel » 10:0402/2802/28/20
Stifel analyst Paul…
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Immunomedics reports Q4 EPS (50c), consensus (46c) » 16:0202/2702/27/20
Reports Q4 revenue $295K…
Reports Q4 revenue $295K consensus $430K. "We are pleased to have submitted our Biologics License Application (BLA) in late November - our top priority for 2019," said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. "While we are working closely with the FDA to facilitate their review of our BLA, we continued to execute against key initiatives across our commercial, clinical, and manufacturing operations. Our commercial team has been actively preparing for launch readiness, and, as we wait for an FDA decision, we are well positioned to commercialize sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) on or before the June 2, 2020 PDUFA goal date. In addition, our main goals for 2020 include maximizing the global commercial potential of sacituzumab govitecan, while accelerating its development as a single agent and in combination with checkpoint inhibitors across a number of clinical settings to meet our commitment to help transform the lives of people with hard-to-treat cancers worldwide."
Puma Biotechnology announces FDA approval of neratinib with capecitabine sNDA » 08:1302/2602/26/20
Puma Biotechnology announced that the FDA approved a supplemental new drug application, or sNDA, for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.
MacroGenics price target lowered to $15 from $18 at Citi » 06:5102/2602/26/20
Citi analyst Yigal…
Citi analyst Yigal Nochomovitz lowered the firm's price target on MacroGenics to $15 from $18 and keeps a Buy rating on the shares. MacroGenics remains under pressure from uncertainty surrounding the company's late-stage pipeline, Nochomovitz tells investors in a research note. While margetuximab's Biologics License Application acceptance was expected, uncertainty on its commercial prospects remain, says the analyst. Nochomovitz, however, believes multiple readouts from the early-stage pipeline should help the stock work in 2020.
MacroGenics expects to be able to fund operations into 2021 » 16:0602/2502/25/20
MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, combined with anticipated and potential collaboration payments, will enable it to fund its operations into 2021, assuming the company's programs and collaborations advance as currently contemplated. Through the prioritization of programs and ongoing realignment of its resources, MacroGenics is focused on extending its cash runway into 2022.
Spring Bank, Roche announces collaboration to evaluate SB 11285 w/ atezolizumab » 08:2202/2502/25/20
Spring Bank Pharmaceuticals, Inc. (SBPH) announced a new clinical collaboration with Roche (RHHBY), to explore the co-administration of SB 11285, Spring Bank's intravenously-administered STING agonist with Roche's PD-L1 checkpoint inhibitor atezolizumab in patients with advanced solid tumors. During the fourth quarter of 2019, Spring Bank dosed the first patient in the monotherapy dose escalation component of the intravenously-administered SB 11285 Phase 1a trial. This monotherapy dose escalation component will be followed by a combination dose escalation of IV SB 11285 with a checkpoint inhibitor and with atezolizumab as an additional arm added to the combination dose escalation segment of the Phase 1a trial. By the end of 2020, Spring Bank plans to generate sufficient data from its Phase 1a/1b IV STING agonist program to enable advancement into a Phase 2 clinical trial. As noted above, Phase 1a of the IV SB 11285 Phase 1 trial is a dose-escalation study with monotherapy followed by combination with one or more checkpoint inhibitors and is designed to determine a recommended Phase 2 dose. Phase 1b of the trial will explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in selected tumor types. The trial is being conducted at multiple sites in the United States.
Bicycle Therapeutics announces collaboration with Genentech » 07:0102/2502/25/20
Bicycle Therapeutics (BCYC) announced that it has entered into a strategic collaboration agreement with Genentech, a member of the Roche Group (RHHBY), to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. Under the terms of the agreement, Genentech and Bicycle will collaborate on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Bicycle will be responsible for discovery research and early pre-clinical development up to candidate selection, and Genentech will be responsible for further development and commercialization upon the selection of candidates. None of Bicycle's wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration. Bicycle will receive a $30M upfront payment. The upfront payment and potential discovery, development, regulatory and commercial-based milestone payments could total up to $1.7B. Bicycle will also be eligible to receive tiered royalties on Bicycle-based medicines commercialized by Genentech.
Halozyme announces FDA acceptance of BLA for FDC of Perjeta, Herceptin » 05:2002/2502/25/20
Halozyme Therapeutics (HALO) announced that the FDA has accepted a Biologics License Application, or BLA, from Genentech, a member of the Roche Group (RHHBY), for the fixed-dose combination of Perjeta and Herceptin for subcutaneous administration using Halozyme's ENHANZE drug delivery technology in combination with intravenous chemotherapy for the treatment of eligible patients with HER2-positive breast cancer. The BLA submission is based on positive results from the global Phase III FeDeriCa study conducted by Genentech, which demonstrated non-inferior levels of Perjeta in the blood and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.
Genentech announces FDA acceptance of BLA for FDC of Perjeta, Herceptin » 05:1402/2502/25/20
Genentech, a member of…
Genentech, a member of the Roche Group, announced that the FDA has accepted the company's Biologics License Application, or BLA, for the fixed-dose combination, or FDC, of Perjeta and Herceptin with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the Phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.
Epizyme, Blueprint among cancer companies that fit M&A criteria, says Jefferies » 08:3902/2402/24/20
EPZM, BPMC, DCPH, MTRX, IMMU, KPTI, AGIO
Jefferies analysts Michael Yee and Andrew Tsai noted that of the 66 standalone small-to-mid cap companies with an approved oncology drug in the last decade, 22 of those, or 61%, were ultimately acquired. Within that context, they noted that Epizyme (EPZM), Blueprint Medicines (BPMC), Deciphera (DCPH), Matrix Service (MRTX) and Immunomedics (IMMU) are some of the oncology companies that continue to fit the M&A criteria they examined. The analysts also noted that the M&A rate is over 55% for standalone oncology SMIDs with an approved oral, small molecule, adding that it is possible Epizyme, Blueprint, Karyopharm (KPTI) and Agios Pharmaceuticals (AGIO) could be attractive M&A candidates since they have maintained sole U.S. rights. Yee and Tsai additionally noted that with 22 cancer IPOs in 2019 that the M&A "pool is being replenished."