PTC Therapeutics price target raised to $81 from $60 at Cantor Fitzgerald » 10:1901/2301/23/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Alethia Young raised her price target for PTC Therapeutics (PTCT) to $81 from $60, while keeping an Overweight rating on the shares. The analyst notes that Roche (RHHBY) has announced that the pivotal FIREFISH study of risdiplam in Type 1 spinal muscular atrophy met the primary endpoint. Young thinks the data is 'highly robust and meaningful for patients with SMA," especially the Type 2 and 3 patients, and adjusted Probably of Success for risdiplam to 100% from 75%. She is confident in a May approval or earlier based on the data generated between FIREFISH and SUNFISH, and thinks that an oral medicine is a game changer in this population taking intrathecal injections. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche.
PTC Therapeutics says pivotal FIREFISH study met primary endpoint » 05:4701/2301/23/20
PTC Therapeutics (PTCT)…
PTC Therapeutics (PTCT) announced positive topline results from part 2 of FIREFISH demonstrating that the study met its primary endpoint of proportion of infants who are sitting without support after 12 months of treatment. The pivotal study assessed the efficacy of risdiplam (RG7916) in infants with type 1 spinal muscular atrophy (SMA), the most severe, infantile onset form of this rare and devastating neuromuscular disease. Risdiplam has been well tolerated and no treatment-related safety findings leading to withdrawal have been observed in any risdiplam trial to date. Data from part 2 of the FIREFISH study will be shared with health authorities globally and will be presented at an upcoming medical congress. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche (RHHBY).
Genentech says risdiplam meets primary endpoint in pivotal FIREFISH study » 05:3401/2301/23/20
Genentech, a member of…
Genentech, a member of the Roche Group, announced positive topline results from the pivotal Part 2 of the FIREFISH study, evaluating risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy, or SMA. The primary outcome measure of the study was the proportion of infants sitting without support for at least five seconds at 12-months of treatment, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development - Third Edition. Safety for risdiplam in the FIREFISH study was consistent with its known safety profile and no new safety signals were identified. To date, more than 400 patients have been treated with risdiplam across all studies, with no treatment-related safety findings leading to study withdrawal in any risdiplam trial.
Cantor specialty pharma analyst to hold an analyst/industry conference call » 09:0101/2101/21/20
IMMU, SGEN, MGNX, PBYI, RHHBY, ARVN
Large Cap & Specialty…
Large Cap & Specialty Pharmaceuticals Analyst Chen, along with Key Opinion Leader Timothy Pluard, Medical Director of Saint Luke's Cancer Institute, discuss the 2020 outlook in breast cancer and potential approvals in TNBC (Triple-Negative Breast Cancer) and HER2+ (Human Epidermal Growth Factor Receptor 2) on an Analyst/Industry conference call to be held on January 27 at 11 am.
Seattle Genetics achieves milestone following EC approval of Roche's Polivy » 08:1101/2101/21/20
Seattle Genetics (SGEN)…
Seattle Genetics (SGEN) announced that it will receive a milestone payment from Roche (RHHBY) triggered by European Commission conditional marketing authorisation for Polivy. Polivy is an antibody-drug conjugate, or ADC, that utilizes Seattle Genetics' technology. It was developed and is commercialized by Roche/Genentech. Polivy was approved in combination with bendamustine plus MabThera for the treatment of adult patients with relapsed or refractory, or R/R, diffuse large B-cell lymphoma, or DLBCL, who are not candidates for a haematopoietic stem cell transplant. Polivy was granted Priority Medicines, or PRIME, designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017.
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PTC Therapeutics shares look 'significantly undervalued,' says Cantor Fitzgerald » 06:4601/1501/15/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Alethia Young reiterates an Overweight rating on PTC Therapeutics with a $60 price target after meeting with management to discuss the company's 2020 priorities. The analyst, while excited about risdiplam, thinks that "significant upside" for the shares will be driven by assets to which investors are paying little attention. PTC's priority remains to generate $1.5B in revenues in 2023, Young tells investors in a research note. At the current $3B market cap, it would suggest that the stock is "significantly undervalued," she adds.
Halozyme CEO says 'tremendous progress repositioning the company' » 08:0601/1401/14/20
HALO, JNJ, RHHBY
"We have made…
"We have made tremendous progress repositioning the company to focus solely on driving the growth and profitability of our ENHANZE business," said Dr. Helen Torley, president and CEO. "Looking ahead, we anticipate a number of value-creating financial and ENHANZE-related milestones will be achieved during 2020." Anticipated 2020 ENHANZE Key Events: U.S. FDA decision on the approval of the Biologics License Application submitted by ENHANZE collaboration partner Janssen Biotech (JNJ) in July 2019 for Daratumumab SC. European Medicines Agency decision on the approval of the extension application submitted by Janssen-Cilag International in July 2019 for Daratumumab SC. Completion in Q1 2020 of regulatory submissions to the FDA and EMA by Roche (RHHBY) seeking approval for the fixed-dose combination of Perjeta and Herceptin utilizing ENHANZE in combination with intravenous chemotherapy. At least 3 new Phase 3 and 1 Phase 2 clinical trial initiations by ENHANZE collaboration partners. Initiation of at least five new Phase 1 clinical trials with partner products utilizing the ENHANZE drug delivery technology.
Roche to price oral SMA drug 'aggressively' to challenge rivals, Reuters reports » 06:1801/1401/14/20
RHHBY, BIIB, NVS
Roche (RHHBY) plans to…
Roche (RHHBY) plans to price its oral spinal muscular atrophy drug risdiplam "aggressively" in order to challenge Biogen's (BIIB) Spinraza and Novartis's (NVS) gene therapy Zolgensma, two of the world's most expensive medicines, Reuters' Robin Respaut reports. Spinraza's list price is $750,000 in the first year, and $375,000 thereafter, while Novartis's gene therapy for the genetic muscle wasting disease lists at $2.1M. The FDA is due to decide on risdiplam by May 24, the report notes. Reference Link
Illumina, Roche announce 15-year collaboration agreement for genomic testing » 11:5801/1301/13/20
Illumina (ILMN) and Roche…
Illumina (ILMN) and Roche (RHHBY) announced a 15-year, non-exclusive collaboration agreement to broaden the adoption of distributable next-generation sequencing-based testing in oncology. As the understanding of genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring. This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of this agreement, Illumina will grant Roche rights to develop and distribute in-vitro diagnostic tests on Illumina's NextSeq 550Dx System, as well as on its future portfolio of diagnostic sequencing systems, including the forthcoming NovaSeqDx. Roche will in turn collaborate with Illumina to complement Illumina's comprehensive pan-cancer assay, TruSight Oncology 500, with new companion diagnostic claims. The financial terms of the deal were not disclosed. Under the IVD terms of the agreement, Roche will develop, manufacture and commercialize AVENIO IVD tests for both tissue and blood for use on Illumina's NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Illumina and Roche will develop tests and pursue CDx claims on TSO 500 for both existing and pipeline oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process, and will continue to manufacture, supply and commercialize TSO 500. Roche will support the development of the claims and regulatory filings.
MRI Interventions obtains $17.5M investment from PTC Therapeutics » 09:3801/1301/13/20
MRI Interventions (MRIC)…
MRI Interventions (MRIC) announced preliminary and unaudited results for the quarter ended December 31, 2019. Additionally, the company announced a $17.5 million strategic investment from PTC Therapeutics, Inc. (PTCT) and Petrichor Healthcare Capital Management. Revenue for the quarter ended December 31, 2019 is expected to be approximately $3.2 million, a new quarterly revenue record and an increase of 43% from $2.3 million in the prior year fourth quarter. For the fiscal year ended December 31, 2019, revenue is expected to be approximately $11.2 million, compared with $7.4 million in 2018, an increase of 53%. These increases resulted in part from the completion of 801 cases utilizing the Company's ClearPoint System or its clinical team's services in 2019, as compared with 670 cases having been completed in 2018. Cash used in operations for the quarter ended December 31, 2019 is expected to improve to approximately $465,000, compared with $600,000 used in the 2018 fourth quarter, and for the fiscal year ended December 31, 2019, is expected to improve to approximately $2.9 million, compared with $4.6 million in 2018. Under the terms of the investment and subject to certain customary closing conditions, PTC will fund a $10.0 million note and Petrichor will fund a $7.5 million note. The Company anticipates that the transaction will close on or before February 29, 2020. The Company intends to use the net proceeds from the sale of the notes to repay in full its existing secured indebtedness, and to fund product commercialization, internal research and development, and general corporate requirements. In addition, the securities purchase agreement provides the Company with the right, but not the obligation, to issue to Petrichor up to an aggregate principal amount of $15M of secured convertible notes within the initial 24 months following the signing of such securities purchase agreement.