American Renal Associates sold for $853M

American Renal Associates to be acquired by Nautic Partners for $11.50 per share

American Renal Associates (ARA) announced that it has entered into a definitive agreement to be acquired by Innovative Renal Care, an affiliate of Nautic Partners, a middle market private equity firm, in an all-cash transaction that values the company at an aggregate enterprise valuation of approximately $853M excluding non-controlling interest.

ARA sold for $11.50 per share

Under the terms of the agreement, ARA shareholders will receive $11.50 per share in cash.

This consideration represents an approximate premium of 66% to the company’s closing price on October 1.

The board of ARA unanimously approved the agreement. The transaction is expected to close in Q1 of 2021, subject to shareholder and regulatory approvals, as well as the satisfaction of customary closing conditions.

Centerbridge Partners has entered into a voting agreement pursuant to which it has agreed to vote in favor of the transaction.

The agreement includes a 40-day “go-shop” period, which permits ARA’s board, with the assistance of independent financial and legal advisors, to actively solicit alternative acquisition proposals from third parties, and potentially enter into negotiations with parties that make alternative acquisition proposals.

The board has appointed a special committee of independent directors to oversee the go-shop process.

ARA will have the right to terminate the agreement with Nautic to enter into a superior proposal subject to the terms and conditions of the agreement.

There can be no assurance that this process will result in a superior proposal, and ARA does not intend to disclose developments with respect to the solicitation process unless and until its special committee or the board makes a determination requiring further disclosure. The period commences on the date of the agreement.

ARA closed at $6.92.

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Watch shares of Mirati Therapeutics

Mirati presents data from sitravatinib in combination with nivolumab trials

Mirati Therapeutics (MRTX) announced the presentation of initial data from its ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in metastatic urothelial cancer patients with documented progression on a platinum-chemotherapy and checkpoint inhibitor.

Mirati is in focus on cancer data, Stockwinners

The data were presented in an oral presentation at the Society of Immunotherapy of Cancer 34th Annual Meeting.

Preliminary results from the ongoing Phase 1 study of neoadjuvant sitravatinib combined with nivolumab in patients with resectable squamous cell carcinoma of the oral cavity, SNOW trial, were also presented in a poster session.

The preliminary data suggest that the combination of neoadjuvant sitravatinib and nivolumab is safe and active in patients with squamous cell carcinoma of the oral cavity who are candidates for resection.

Chart shows Sitravatinib in action, Stockwinners

Tumor reduction was observed in all eight patients who were eligible for evaluation, including one complete pathological response.

All patients received postoperative radiation therapy, and none required postoperative chemotherapy.

With a median follow-up of 31.4 weeks, all patients are alive with no disease recurrence to date.

In most patients, treatment with sitravatinib led to a decrease in myeloid-derived suppressor cells and a shift towards M1-type macrophages in the tumor microenvironment, supporting previous preclinical findings.

“Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases, including TAM family receptors that has the potential to increase responsiveness in patients whose tumors are resistant to checkpoint inhibitors. The initial efficacy data from the Phase 2 clinical trial presented today in patients with checkpoint refractory mUC is promising and extends the clinical benefit data beyond what has already been demonstrated by sitravatinib combined with nivolumab in checkpoint refractory non-small cell lung cancer,” said Charles Baum, M.D., CEO of Mirati.

Sitravatinib offers hope for cancer patients, Stockwinners

“In addition, we are evaluating sitravatinib in patients who have progressed on checkpoint therapy, including those with NSCLC and renal cell cancer, and we continue to expand development efforts of sitravatinib through our collaboration with BeiGene in multiple indications including NSCLC, renal cell cancer, hepatocellular cancer, ovarian cancer, and gastric cancer.”

MRTX closed at $104.78.

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Aveo Pharma. shares tumble following FDA meeting

Aveo Pharmaceuticals provides update after FDA meeting discussing TIVO-3 results

Aveo Pharmaceuticals (AVEO) provided a regulatory update following a meeting with the FDA to discuss results from the August overall survival, or OS, analysis of the TIVO-3 trial and the company’s proposal to proceed with a new drug application, or NDA, for tivozanib. TIVO-3 is the company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, or VEGFR-TKI, to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma, or RCC.

AVEO shares tumble following FDA meeting, Stockwinners

The TIVO-3 trial was designed to address the FDA’s concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the company’s initial RCC pivotal trial, the FDA found that the inconsistent progression free survival, or PFS, and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.

The company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate.

The August analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio, or HR, of 0.99 at two years from the last patient enrolled in the study.

In the FDA’s preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the company not submit an NDA at this time.

The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the company’s current interim OS results do not abrogate the FDA’s concerns over detriment and that those results may worsen with final analysis at 263 events and that the median OS for tivozanib is worse than that of sorafenib.

In view of the changing first-line treatment landscape as well as the FDA’s continued concerns, the company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC.

At the meeting, the FDA acknowledged AVEO’s responses and reiterated its concerns about the survival information and the totality of data.

The FDA noted that the choice to submit the data is the company’s, and that a discussion with the Oncologic Drug Advisory Committee will likely be required.

The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan, or SAP, with a planned OS update based on the projected number of events at that time.

AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in Q1 of 2020.

AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA.

The FDA and the company agreed that if the final analysis yields an OS HR above 1.00, the company will withdraw its NDA application.

AVEO shares are down 35% to $0.59.

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AVEO Oncology is in focus

AVEO Oncology, EUSA Pharma announce TiNivo combination study opt-in

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AVEO Oncology (AVEO) and EUSA Pharma announced that EUSA Pharma, under its multi-territory licensing agreement with AVEO for FOTIVDA, has opted into the Phase 1/2 TiNivo study.

Under terms of the agreement, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding payment totaling $2M.

EUSA’s decision follows approval in August of tivozanib by the European Commission for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

The TiNivo trial is a Phase 1/2 trial of tivozanib in combination with Bristol-Myers Squibb’s (BMY) OPDIVO, an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.

In June, AVEO announced the advancement of the trial into the Phase 2 expansion portion following successful completion of the Phase 1 dose escalation portion. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities.

The expansion portion of the trial is expected to enroll an additional 20 subjects. Phase 1 results from the ongoing study have been submitted for presentation at a scientific meeting taking place in the fourth quarter. Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $388M in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives.

In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. With European approval, AVEO will be eligible for up to $12M in milestones from EUSA based on reimbursement and regulatory approvals.

In the territories licensed to EUSA, 30% of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.


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FOTIVDA approved in EU for treatment of renal cell carcinoma

AVEO Oncology’s  FOTIVDA approved in EU for treatment of renal cell carcinoma

Stockwinners.com/blog

AVEO Oncology (AVEO) announced that the European Commission has approved FOTIVDA for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC.i EUSA Pharma is the European licensee for tivozanib.

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $394M in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives.

In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories.

European marketing approval for tivozanib triggers a $4M research and development payment from EUSA, and AVEO will also be eligible for up to $12M in additional milestones from EUSA based on reimbursement and regulatory approvals.

In the territories licensed to EUSA, 30% of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin as a sublicensing fee.

In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

See our blog on this stock when AVEO was trading at $0.72. AVEO last traded at $4.17.


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Watch Exelixis!

 Exelixis submits sNDA for CABOMETYX

Exelixis says to present data from cabozanitinib, See Stockwinners.com Market Radar to read more

Exelixis (EXEL) announced it has completed the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for CABOMETYX tablets as a treatment for patients with previously untreated advanced renal cell carcinoma.

The sNDA submission is based on results from the CABOSUN randomized phase 2 trial of #CABOMETYX in patients with previously untreated advanced RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.

#CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program.

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement in progression-free survival compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment.

In June 2017, Exelixis announced that the analysis of the review by a blinded independent radiology review committee confirmed the primary efficacy endpoint results of investigator-assessed PFS from the CABOSUN trial.

CABOMETYX was previously approved by the FDA on April 25, 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

The approval was based on results from the phase 3 METEOR trial, which demonstrated that CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, PFS and objective response rate as compared with everolimus in this patient population.

Bristol -Myers-Squibb

Bristol-Myers Squibb (BMY) reported “mixed” top-line Phase III CheckMate-214 data on 1,070 front-line metastatic renal cell carcinoma patients, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. He continues to expect a front-line renal cell carcinoma supplemental new drug application for Exelixis’ (EXEL) Cabometyx in Q3 with approval next year. Tenthoff anticipates Cabometyx use in front-line RCC expanding the current market opportunity before ultimately showing IO combination benefit. The analyst reiterates an Overweight rating on Exelixis shares with a $29 price target.


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