On October 14, 2019 BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, reported that it was unable to come to an agreement with the Special Committee formed by its subsidiary Eidos Therapeutics (NASDAQ: EIDX), a clinical-stage biopharmaceutical company developing AG10 for the treatment of transthyretin amyloidosis (ATTR), to acquire the outstanding common stock of Eidos that BridgeBio does not already own (approximately 34% of Eidos’s outstanding shares) (Press release, BridgeBio, OCT 14, 2019, View Source [SID1234576262]).

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Subsequent to an initial offer of 1.3 BridgeBio shares for each Eidos share, the offer was raised twice, resulting in a final offer equivalent to 1.5 BridgeBio shares for each Eidos share with an option for Eidos shareholders to receive a portion of that consideration in cash. Eidos shareholders were to have three options to receive their consideration: all-stock, mixed consideration of cash and stock, or all-cash subject to proration such that the cash portion of the transaction would not exceed approximately $110 million. The cash consideration was to have been funded by BridgeBio with the use of acquisition financing, and was therefore to have had a neutral-to-positive impact upon BridgeBio’s runway post-close.

"We appreciate the hard work of the Eidos Special Committee in evaluating our proposal," said Brian Stephenson, Ph.D., CFA, chief financial officer of BridgeBio. "At BridgeBio, we work hard to balance opportunities for doubling down on attractive pipeline programs with preserving our ability to pursue a diversified pipeline, as the latter characteristic is valued deeply by many of our investors. We continue to believe strongly in AG10, of which we retain approximately 66% ownership, but we feel that beyond our final offer there are superior ways for us to deploy capital, both in and outside of our pipeline, to generate benefits for patients and returns for our investors. Going forward, we will continue to focus on creating value for patients and investors alike by efficiently allocating capital to high-return genetic disease projects where the science supports advancing therapeutic candidates as rapidly as possible."

"With this process now behind us, we will return to operating BridgeBio and Eidos as two companies that share the sole focus of bringing important medicines to patients with genetic disease," said Neil Kumar, Ph.D., founder and chief executive officer of BridgeBio and chief executive officer of Eidos. "BridgeBio will continue to empower Eidos with critical leadership and infrastructure across the commercial, clinical operations, and executive functions, while Eidos will remain laser-focused on getting AG10, our potentially best-in-class stabilizer for ATTR-CM, to patients. I thank the Special Committee for its hard work and look forward to continuing our efforts around the Phase 3 trial for AG10 and the analysis of data from our Phase 2 Open Label Extension. Eidos and AG10 are a significant part of who we are at BridgeBio, having been part of our plan since we founded the company. We remain incredibly excited about the program and its potential for patients with ATTR cardiomyopathy."

On October 14, 2019 ImaginAb, Inc., a leading clinical-stage immuno-oncology imaging company, reported the signing of a multi-party collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN), Pfizer Inc. (NYSE: PFE) and Takeda Pharmaceutical Company Limited (Takeda) focused on furthering the clinical development of ImaginAb’s CD8 ImmunoPET technology (Press release, ImaginAb, OCT 14, 2019, View Source [SID1234554042]). Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

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Under the terms of the agreement, the collaborators will help guide a current ImaginAb-sponsored clinical trial that aims to evaluate the utility and value of CD8 ImmunoPET in immuno-oncology drug development. In return, the collaborators will gain early access to clinical and imaging data and collectively contribute to the post-trial data analysis.

Commenting on the agreement, Ian Wilson, Chief Executive Officer of ImaginAb, said: "One of our key objectives is to streamline the clinical development of next-generation cancer immunotherapies so that ultimately cancer patients have access to the best possible treatments. We believe that working with global leaders in immuno-oncology will help us further develop CD8 ImmunoPET as a pharmacodynamic marker for use in drug development and, in the future, as a diagnostic and predictive test for use in hospitals."

Chris Arendt, Head of the Oncology Drug Discovery Unit at Takeda, said: "We are excited to participate in this pre-competitive alliance, which brings together a rich network of expertise and resources to develop and evaluate an imaging tracer for CD8+ T cells. The ability to track, both spatially and temporally, immune responses associated with novel immuno-oncology therapies and relate these to anti-tumor responses in patients has the potential to deepen our understanding of the cancer immunity cycle and how it can be leveraged for curative intent, which is the primary focus of our oncology research efforts at Takeda."

On October 14, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, November 4, 2019 (Press release, Neurocrine Biosciences, OCT 14, 2019, View Source [SID1234540996]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 800-894-5910 (US) or 785-424-1052 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On October 14, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported the Company will release its third quarter 2019 earnings results on Wednesday, October 30, 2019 after the close of the market (Press release, NuVasive, OCT 14, 2019, View Source [SID1234540995]).

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NuVasive will hold a conference call on Wednesday, October 30, 2019, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the third quarter 2019. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through November 29, 2019. In addition, a telephone replay of the call will be available until November 6, 2019. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13695343.

On October 14, 2019 Servier and its partner Taiho Oncology, Inc. (US), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), reported that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF (trifluridine/tipiracil) in adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, platinum, and either a taxane and/or irinotecan-containing regimen, and if appropriate, HER2/neu-targeted therapy, were published in the October issue of JAMA Oncology (Press release, Servier, OCT 14, 2019, View Source [SID1234540994]).1

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In the preplanned subgroup analysis, 221 of 507 patients with mGC or GEJ adenocarcinoma with prior gastrectomy were enrolled and randomized to receive LONSURF (n=147) or placebo (n=74) on days 1-5 and 8-12 of each 28-day treatment cycle. Results showed that treatment with LONSURF was tolerable and prolonged survival versus placebo by 6 months vs 3.4 months [95% CI, 0.57 (0.41-0.79)]. Further, the overall safety profile of the drug, including the incidence of severe AEs in this heavily pretreated patient population, was similar in patients with or without gastrectomy.

"For patients with metastatic gastric cancer and gastroesophageal junction adenocarcinoma, nearly half will undergo a gastrectomy and often these patients are likely to have more complications compared to those who do not have one. Therefore this data is critical in demonstrating the safety and efficacy for a large sub-population of patients, who in Europe, may have limited treatment options," said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).

"Patients with metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, have a high unmet medical need when the current standard of care no longer works. We are pleased with the results from this subgroup analysis that strongly suggest the same efficacy and tolerability for LONSURF in this group of patients regardless of previous gastrectomy," said Patrick Therasse, MD, PhD, Head of Servier Research and Development Oncology.

Data from the subgroup analysis were previously announced at an oral presentation during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, US.

In the EU LONSURF is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. It has recently been accepted by the European Commission as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

#ENDS#

About TAGS

TAGS (TAS-102 Gastric Study) is a Taiho-sponsored, global, randomized, double-blind, placebo controlled, Phase III study evaluating the efficacy and safety of LONSURF in 507 adult patients with previously treated mGC or mGEJ adenocarcinoma. The primary endpoint was OS, and key secondary endpoints included PFS, safety and tolerability, as well as quality of life. LONSURF demonstrated statistically significant improvements in OS and PFS compared with placebo. The median OS improved from 3.6 months with placebo to 5.7 months with LONSURF, HR 0.69 (95% confidence interval [CI], 0·56-0·85; P=0.00058).

For more information on TAGS, please visit www.ClinicalTrials.gov ( View Source ). The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Gastric Cancer

Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and colorectal cancer), with an estimated 780,000 deaths annually.2　

When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body, this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.3

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2/neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, there are neither approved nor standard third-line treatments in the EU.

About LONSURF4

LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, LONSURF is indicated in monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. As of October 2019, LONSURF is approved as a treatment for advanced mCRC in 74 countries and regions. LONSURF was approved as a treatment for mGC/mGEJC in the United States in February 2019, in Japan in August 2019 and in the EU in September 2019.

LONSURF was discovered and developed by Taiho Pharmaceutical. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia.