On October 6, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, reported that it will host its second R&D Day on Tuesday, October 12, 2021, at 8:30 a.m. ET (Press release, BridgeBio, OCT 6, 2021, View Source [SID1234590858]).

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BridgeBio founder and CEO Neil Kumar, Ph.D., will present and be joined by Richard Scheller, Ph.D., chairman of R&D at BridgeBio; Charles Homcy, M.D., chairman of pharmaceuticals at BridgeBio; and Uma Sinha, Ph.D., chief scientific officer at BridgeBio, along with senior scientists and physicians leading BridgeBio’s drug discovery and development programs. BridgeBio has 14 programs that are being advanced in the clinic or commercial setting with 30+ programs total in its pipeline for patients living with genetic diseases and genetically-driven cancers.

BridgeBio will unveil new programs, share new information about its pipeline and discuss how it is broadening the scope of its R&D engine. It will also cover the company’s most significant near-term catalysts with a focus on the upcoming topline results for acoramidis, BridgeBio’s investigational therapy for transthyretin (TTR) amyloidosis (ATTR). ATTR is a rare heart condition with a progressive and debilitating impact on quality of life likely affecting more than 400,000 patients worldwide.

Topline results from Part A are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. If the change from baseline in 6MWD in Part A is highly statistically significant, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the U.S. Food and Drug Administration.

The R&D Day program importantly and additionally will highlight BridgeBio’s broader efforts in cardiorenal, progress in its KRAS portfolio, and advancements in its previously disclosed early-stage Mendelian programs. The Company will also be unveiling new programs in gene therapy.

Agenda:

Welcome and introduction – Grace Rauh, vice president of marketing and communications, BridgeBio Pharma
Genetic basis of disease – Richard Scheller, Ph.D., chairman of R&D, BridgeBio Pharma
BridgeBio’s endless summer – Neil Kumar, Ph.D., founder and CEO, BridgeBio Pharma
Precision cardiorenal introduction – Cameron Turtle, D.Phil., chief strategy officer, BridgeBio Pharma
Acoramidis: TTR stabilizer for ATTR – Jonathan Fox, M.D., Ph.D., chief medical officer, BridgeBio Cardiorenal
Encaleret: Calcium sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1) – Mary Scott Roberts, M.D., senior director of clinical development, BridgeBio Cardiorenal
Gene therapy platform – Eric David, M.D., J.D., CEO, BridgeBio Gene Therapy
Mendelian programs: Primary hyperoxaluria type 1 (PH1), limb-girdle muscular dystrophy type 2i (LGMD2i), recessive dystrophic epidermolysis bullosa (rDEB) – Uma Sinha, Ph.D., chief scientific officer, BridgeBio Pharma
Precision oncology programs: KRAS, SHP2 – Eli Wallace, Ph.D., chief scientific officer, BridgeBio Oncology
BridgeBioX – Charles Homcy, M.D., chairman of pharmaceuticals, BridgeBio Pharma
Q&A
The event will be webcast, with a link available in the event calendar on BridgeBio’s investor website, View Source A replay of the webcast will be available for one year following the event.

To register for BridgeBio’s R&D Day, please sign up here. To view the agenda and speaker profiles visit our R&D Day webpage. Attendees must register and watch the webcast to participate in the Q&A sessions.

On October 6, 2021 NextEra Energy, Inc. (NYSE: NEE) reported that it plans to report third-quarter 2021 financial results before the opening of the New York Stock Exchange on Wednesday, Oct. 20, 2021, in a news release to be posted on the company’s website at www.NextEraEnergy.com/FinancialResults (Press release, Nextera, OCT 6, 2021, View Source [SID1234590875]). The company will issue an advisory news release over PR Newswire the morning of Oct. 20, with a link to the financial results news release on the company’s website. As previously communicated, the company will make available its financial results only on its website.

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Jim Robo, chairman and chief executive officer of NextEra Energy, Rebecca Kujawa, executive vice president, finance and chief financial officer of NextEra Energy, and other members of the company’s senior management team will discuss the company’s third-quarter 2021 financial results during an investor presentation to be webcast live, beginning at 9 a.m. ET on Oct. 20. Results for NextEra Energy Partners, LP (NYSE: NEP) also will be discussed during the same investor presentation.

The listen-only webcast will be available on NextEra Energy’s website by accessing the following link: www.NextEraEnergy.com/FinancialResults. The financial results news release and the slides accompanying the presentation may be downloaded at www.NextEraEnergy.com/FinancialResults, beginning at 7:30 a.m. ET on the day of the webcast. A replay will be available for 90 days by accessing the same link as listed above.

On October 6, 2021 Race Oncology ("Race") reported that it has been issued a new patent (US 11,135,201) from the United States Patent and Trademarks Office (USPTO) for its cancer drug, Zantrene (bisantrene dihydrochloride) (Press release, Race Oncology, OCT 6, 2021, View Source [SID1234591004]).

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This is Race’s fifth patent granted for Zantrene in the United States. "This latest US patent provides Race with additional protection around the use, formulation and compositions of Zantrene (and related chemical structures) that improve the therapeutic benefit of Zantrene", said Race’s CEO & Managing Director, Phillip Lynch.

The new patent builds on Race’s existing Zantrene patents granted in the USA in 2018 (US 9,993,460 and US 9,974,774), 2019 (US 10,500,192) and in 2020 (US 10,548,876), further strengthening Race’s IP position for Zantrene.

The patent further expands Race’s IP portfolio in the therapeutic utility of Zantrene (and related chemical structures), in particular – for methods, formulations and compositions that improve the therapeutic efficacy of Zantrene and reduce side effects.

On October 6, 2021 Cothera Bioscience Inc. and Adastra Pharmaceuticals Inc., private biopharmaceutical companies focused on the development of first-in-class therapeutics for the treatment of cancer, reported a definitive agreement under which Cothera has acquired zotiraciclib (ZTR), an oral kinase inhibitor that readily crosses the blood brain barrier and possesses a unique mechanism of action of Myc depletion via the inhibition of cyclin-dependent kinase 9 (CDK9) (Press release, Cothera Bioscience, OCT 6, 2021, View Source [SID1234627381]). Financial terms of the asset purchase were not disclosed.

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In June 2021, the results of the zotiraciclib Phase 1b clinical trial were published in Clinical Cancer Research. The conclusion of the Phase 1b trial found that Zotiraciclib combined with temozolomide (TMZ) is safe in patients with recurrent high-grade astrocytomas.

After the conclusion of the trial a successful Type B meeting with the U.S. Food and Drug Administration Division of Oncology (D02) was held. The transition of ZTR from Adastra to Cothera enables the execution of clinical development plans built on input from the FDA meeting, as well as insight from global neuro-oncology thought-leaders and clinical investigators.

"The acquisition of zotiraciclib fits nicely into the Cothera portfolio of differentiated drug candidates synergistically aligning to our current research efforts to address cancers driven by the Myc oncogene," said Alex Wu, Ph.D., President and Chief Executive Officer and Founder of Cothera. "Importantly, zotiraciclib adds to the Cothera portfolio of therapeutics that hold promise for cancer patients around the world."

Scott Megaffin, Chief Executive Officer of Adastra, said, "I want to thank all the physicians and dedicated healthcare providers who have put forward relentless effort on behalf of their patients as the Adastra team transitions zotiraciclib into Cothera."

Vernon Jiang, Ph.D., Executive Vice President and Co-Founder of Cothera, added, "We are grateful to Adastra for its important work with physicians within neuro-oncology. Cothera is enthusiastic to build upon these relationships, as we believe highly in the promise of zotiraciclib in high-grade gliomas and pediatric mid-line gliomas such as Diffuse Intrinsic Pointe Glioma (DIPG).

On October 6, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, and a company it founded, Caelum Biosciences, Inc. ("Caelum"), a biotechnology company developing treatments for rare and life-threatening diseases with two ongoing Phase 3 clinical trials, reported the closing of AstraZeneca’s acquisition of Caelum, pursuant to the Development, Option and Stock Purchase Agreement in place between Fortress, Caelum, AstraZeneca’s Alexion and the other parties thereto (as amended, the "DOSPA") (Press release, Caelum Biosciences, OCT 6, 2021, View Source [SID1234590859]).

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AstraZeneca acquired Caelum for the agreed option exercise price of approximately $150 million. Distributions will be made to all existing Caelum stockholders. The agreement also provides for additional potential payments to Caelum stockholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones.

Fortress is eligible to receive approximately 43 percent of all proceeds from the transaction.