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IMMU

Immunomedics

$14.33

-0.02 (-0.14%)

, RHHBY

Roche

$0.00

(0.00%)

17:23
09/29/19
09/29
17:23
09/29/19
17:23

Immunomedics presents interim data from TROPHY-U-01 open-label Phase 2 trial

Immunomedics (IMMU) presented at the European Society for Medical Oncology Annual Congress interim data from the 100-patient cohort of cisplatin-eligible patients of the company's TROPHY-U-01 open-label Phase 2 study. In this interim report, sacituzumab govitecan produced an overall response rate of 29% in 35 patients with metastatic urothelial cancer who have relapsed or are refractory to immune checkpoint inhibitors and platinum-based chemotherapy. The 29% ORR included two confirmed complete responses, six confirmed partial responses and two additional PRs pending confirmation. At the time of data cutoff on August 5, 2019, eight of ten responders have ongoing response. Median time to onset of response was 1.5 months. For patients with liver metastases, ORR was 25%. Consistent with the company's previous observations, sacituzumab govitecan was well tolerated with a predictable safety profile. In addition, the company announced two clinical collaborations that address continuing unmet needs in breast cancer. The collaboration with Roche (RHHBY) will evaluate the safety and efficacy of the combination of atezolizumab, a programmed cell death ligand 1-blocking checkpoint inhibitor, and sacituzumab govitecan, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC. The open-label, multicenter, randomized Phase 1b/2 study will be conducted as part of MORPHEUS, Roche's novel cancer immunotherapy development platform. Patients with newly-diagnosed mTNBC will be randomized to receive the combination of atezolizumab and sacituzumab govitecan or nab-paclitaxel plus atezolizumab as standard of care. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. Roche will be responsible for conducting the randomized trial. Further, Immunomedics and the GBG Forschungs-GmbH, Neu-Isenburg, Germany, have entered into a collaboration to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response following standard neoadjuvant therapy.

IMMU

Immunomedics

$14.33

-0.02 (-0.14%)

RHHBY

Roche

$0.00

(0.00%)

  • 02

    Oct

  • 04

    Nov

IMMU Immunomedics
$14.33

-0.02 (-0.14%)

08/20/19
CANT
08/20/19
INITIATION
Target $28
CANT
Overweight
Cantor Fitzgerald starts Immunomedics at Overweight, sees approval forthcoming
As previously reported, Cantor Fitzgerald analyst Varun Kumar initiated Immunomedics with an Overweight rating and $28 price target. The current stock price reflects risks around FDA approval in triple-negative breast cancer due to the company receiving a complete response letter earlier this year, though he predicts sacituzumab govitecan will get regulatory approval since he views the issues raised in the CRL as not related to pre/clinical data. He also thinks, based on checks with key opinion leading doctors, that sacituzumab should have strong commercial uptake.
08/20/19
08/20/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Immunomedics (IMMU) initiated with an Overweight at Cantor Fitzgerald. 2. PayPal (PYPL) initiated with a Buy at Rosenblatt while Square (SQ) was initiated with a Neutral. 3. Sunrun (RUN), Vivint Solar (VSLR), and Sunnova Energy (NOVA) initiated with an Overweight at KeyBanc. 4. Spotify (SPOT) initiated with an Equal Weight at Consumer Edge. 5. Silk Road Medical (SILK) initiated with a Buy at Argus. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
09/10/19
PIPR
09/10/19
NO CHANGE
PIPR
Overweight
Safety signals arise for potential Immunomedics competitor, says Piper Jaffray
Daiichi today reported updated Phase I data for its TROP2 antibody drug conjugate DS-1062 in non-small cell lung cancer, and while the drug's efficacy continues to impress, there do appear to be some safety signals popping up, Piper Jaffray analyst Joseph Catanzaro tells investors in a research note. Specifically, dose-limiting toxicities associated with skin rash/stomatitis were reported, which is notable as development of Pfizer's (PFE) TROP2 antibody drug conjugate was discontinued for excess skin rash and mucosa toxicity, adds the analyst. These data may or may not dampen concerns around DS-1062 being a competitive threat to Immunomedics' sacituzumab, says Catanzaro. However, he continues to believe Immunomedics is "very well-positioned" within triple-negative breast cancer and urothelial bladder cancer. The analyst reiterates an Overweight rating on the shares with a $20 price target. Following Daiichi's data, shares of Immunomedics are up 8% to $14.30.
09/10/19
JEFF
09/10/19
NO CHANGE
JEFF
Buy
Immunomedics competitor shows 'impressive' efficacy, AEs cause concern, says Jefferies
Jefferies analyst Chris Howerton says that Immunomedics competitor DS-1062 showed "impressive" efficacy of 70%-plus cORR at RP2D, but he notes that n=7 is "quite small," and baseline characteristics could be different. Importantly, the analyst points out that one patient died of respiratory failure, and four reported potential ILD since data cutoff, including one death. Overall, he does not view DS-1062 as near-term comparable to IMMU-132's current pipeline. Howerton reiterates a Buy rating and $22 price target on Immunomedics' shares.
RHHBY Roche
$0.00

(0.00%)

07/23/19
JPMS
07/23/19
NO CHANGE
JPMS
Neutral
Competition questions for Biogen, Ions' Spinraza not dissipating soon, says JPMorgan
Following Biogen's (BIIB) quarterly results, JPMorgan analyst Jessica Fye notes that while there seems to be limited second quarter impact to the company's and partner Ions Pharmaceuticals' (IONS) Spinraza from Novartis' (NVS) Zolgensma international revenues were down quarter over quarter for a variety of reasons despite double-digit patient growth. Overall, the analyst maintains her view that Roche (RHHBY) and PTC Therapeutics' (PTCT) Risdiplam represents a key potential competitive threat to Spinraza given the convenience of oral dosing and with filing for Risdiplam anticipated in the second half of 2019, in addition to Zolgensma's launch, Fye does not see questions related to competition for Spinraza dissipating anytime soon. The analyst reiterates a Neutral rating on Ions Pharmaceuticals' shares.
07/26/19
UBSW
07/26/19
UPGRADE
UBSW
Buy
Roche upgraded to Buy from Neutral at UBS
UBS analyst Michael Leuchten upgraded Roche to Buy from Neutral and raised his price target for the shares to CHF 300 from CHF 270. The company's legacy portfolio, built around Herceptin and Rituxan, is showing greater resilience while its "credible" neuroscience pipeline is taking shape, Leuchten tells investors in a research note. As such, he now sees Roche's business model as less challenged.
09/13/19
DBAB
09/13/19
NO CHANGE
DBAB
Hold
Novartis' ofatumumab to be 'strong' competitor to Roche drug, says Deutsche Bank
Deutsche Bank analyst Richard Parkes tells investors in a research note after attending the ECTRIMS conference in Stockholm that data from Novartis' (NVS) ASCLEPIOS trials suggests ofatumumab will be a "strong" competitor for Roche's (RHHBY) Ocrevus in relapsing/remitting multiple sclerosis. Parkes says he expects physicians to view the drugs as having broadly comparable and highly compelling efficacy, with ofatumumab's at-home dosing an attractive option for some patients, suggesting meaningful upside potential to his current 2024E ofatumumab sales of $1.1B and possible risks to his forecasts for Roche's Ocrevus. According to physician feedback, Parkes says the drugs are likely to share a rapidly growing market. Parkes maintains a Hold rating and 90 CHF price target on Novartis shares.
09/23/19
GUGG
09/23/19
UPGRADE
Target $403
GUGG
Buy
Guggenheim upgrades Regeneron to Buy, says sentiment too negative
As previously reported, Guggenheim upgraded Regeneron (REGN) to Buy from Neutral as analyst Yatin Suneja noted that Eylea has maintained its dominance in the branded anti-VEGF retinal disease market despite "stiff branded competition" from Roche's (RHHBY) Lucentis and off-label use of Roche's Avastin. Eylea's expansion into new indications has resulted in a diversified business and defensible market position, argued Suneja, who also believes the Street is substantially under-appreciating the market opportunity for Dupixent, which is expected to drive significant leverage in the Sanofi (SNY) antibody collaboration that recently became profitable. Suneja raised the price target on Regeneron shares to $403 from $355.

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EOG

EOG Resources

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PEP

PepsiCo

$136.25

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Keurig Dr Pepper

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LNDC

Landec

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LAC

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ARQL

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SON

Sonoco

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AZN

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