On October 23, 2019 GlaxoSmithKline (LSE/NYSE: GSK) reported that the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either (Press release, GlaxoSmithKline, OCT 23, 2019, View Source [SID1234542453]):

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A deleterious or suspected deleterious BRCA mutation, or
genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
Patient selection is based on an FDA-approved companion diagnostic for Zejula.
This represents the first time a PARP inhibitor has been approved for use in patients beyond those with a BRCA-positive (BRCA+) mutation as monotherapy in the late-line treatment setting. Now women with late-line, HRD-positive (HRD+) disease are eligible to be treated with a PARP inhibitor.

Axel Hoos, MD, PhD, SVP Oncology R&D, GSK, said: "This new indication reinforces our commitment to providing treatment options for more women impacted by ovarian cancer, especially those with high unmet needs. We look forward to continuing our clinical development program of Zejula and understanding its full potential as a treatment for people living with ovarian cancer."

This new indication is based on the QUADRA study, a Phase 2, multi-center, open-label, single-arm clinical study representing a real world, difficult-to-treat patient population with high unmet needs. QUADRA is the largest clinical trial of a PARP inhibitor in women who received three or more treatments for advanced ovarian cancer. The trial enrolled a broad patient population including women with BRCA+ platinum-sensitive, resistant and refractory disease as well as women with HRD+ platinum-sensitive disease.

Clinically meaningful and durable benefit was demonstrated in the FDA-indicated patient population with an objective response rate (ORR) of 24% (95% CI, 16–34). A median duration of response (mDOR) of 8.3 months (95% CI, 6.5–not estimable) was observed.

Additional analyses were conducted in various sub populations where efficacy of Zejula was also demonstrated for patients with tBRCA and GIS; defined as deleterious or suspected deleterious somatic or germline BRCA mutation and genomic instability score (GIS ≥42) as identified with Myriad’s myChoice companion diagnostic test, respectively:

tBRCA+ platinum-sensitive disease, ORR of 39% (95% CI, 17,64);
tBRCA+ platinum-resistant disease, ORR of 29% (95% CI, 11,52);
tBRCA+ platinum-refractory disease, ORR of 19% (95% CI, 4,46); or
non-BRCA mut, GIS-positive, platinum-sensitive disease, ORR of 20% (95% CI, 8,37).
The safety profile was consistent with that seen in the Phase 3 NOVA trial in the recurrent maintenance population. Most common grade ≥3 adverse reactions reported in ≥10% of patients in the QUADRA study included thrombocytopenia (28%), anemia (27%), neutropenia (13%) and nausea (10%).

Dr. Kathleen Moore, Lead Investigator of the QUADRA study; Director, Oklahoma TSET Phase 1 Program; Associate Professor, Section of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma, said: "Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left. It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations."

Ovarian cancer affects nearly 222,000 women in the U.S., and approximately 85% of women with advanced ovarian cancer will see the disease return. With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter. Currently, there are few effective options available for treatment of platinum-resistant/refractory advanced ovarian cancer or HRD+ ovarian cancer in the late-line setting. Zejula received initial FDA approval in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. It is the only oral, once-daily PARP inhibitor.

About QUADRA
QUADRA is a large multi-center, open-label, single-arm, Phase 2 registrational study that evaluated the safety and activity of niraparib in adult patients with relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were treated with three or more previous chemotherapy regimens. Four hundred and sixty-three patients were enrolled and received oral niraparib at a starting dose of 300 mg once daily. Treatment was continued until disease progression. The primary objective was the proportion of patients achieving an investigator-assessed confirmed overall response in patients with HRD+ tumors, including patients with BRCA and without BRCA mutations, sensitive to their last platinum-based therapy. Additional objectives of the study were to evaluate the efficacy of niraparib in the broad late-line ovarian cancer population overall, and in subgroups defined by clinical and molecular biomarkers, such as platinum-sensitivity and BRCA+ and HRD status.

The Myriad myChoice companion diagnostic test was utilized during this clinical trial and has been approved by the FDA as the companion diagnostic test to determine HRD+ status as either tBRCA and/or a genomic instability score (GIS ≥42). GIS is an algorithmic measurement of Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST).

Information about Myriad myChoice companion diagnostic is available at Myriad.com.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the front-line, approximately 85% of patients will experience disease recurrence. Once the disease recurs, its considered incurable with time to each future recurrence getting shorter. Late-line treatment options for women with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10% when treated with chemotherapy.

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development program by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial as monotherapy maintenance treatment in patients with first-line ovarian cancer (PRIMA), data from this study were recently presented at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), a Phase 3 study as a first-line triplet maintenance treatment in ovarian cancer (FIRST), and a Phase 2 study of niraparib combined with bevacizumab maintenance treatment in advanced ovarian cancer (OVARIO).

Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (TOPACIO). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

Important Safety Information

Zejula may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with Zejula. MDS or AML may lead to death.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with Zejula. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

Weakness
Feeling tired
Weight loss
Frequent infections
Fever
Shortness of breath
Blood in urine or stool
Bruising or bleeding more easily
Uncommonly, fever associated with low white blood cells is observed during treatment with Zejula.

Your doctor will do blood tests to check your blood cell counts before treatment with Zejula. You will be tested weekly for the first month of treatment with Zejula, monthly for the next 11 months of treatment, and from time to time afterward.

High blood pressure is common during treatment with Zejula, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with Zejula.

Before starting to take Zejula, tell your doctor about all of your medical conditions, including if you:

Have heart problems
Have high blood pressure
Are pregnant or plan to become pregnant. Zejula may harm an unborn baby and may cause loss of pregnancy (miscarriage)
If you are able to become pregnant, you should use effective birth control (contraception) during treatment with Zejula and for 6 months after taking the last dose of Zejula
If you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with Zejula
You should tell your doctor right away if you become pregnant
Are breastfeeding or plan to breastfeed
Zejula may harm your baby. You should not breastfeed your baby during treatment with Zejula and for 1 month after taking the last dose of Zejula
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Zejula include the following:

Heart not beating regularly
Nausea
Constipation
Vomiting
Pain in the stomach area
Mouth sores
Diarrhea
Indigestion or heartburn
Dry mouth
Tiredness
Loss of appetite
Urinary tract infection
Shortness of breath
Cough
Rash
Changes in liver function or other blood tests
Pain in your joints, muscles, and back
Headache
Dizziness
Change in the way food tastes
Trouble sleeping
Anxiety
Sore throat
Changes in the amount or color of your urine
If you have certain side effects, then your doctor may change your dose of Zejula, temporarily stop, or permanently stop treatment with Zejula.

These are not all the possible side effects of Zejula. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For full prescribing information visit www.zejula.com/prescribing-information.

myChoice companion diagnostic is a registered trademark of Myriad.

About GSK Oncology
GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On October 23, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) reported financial results for the third quarter ended September 30, 2019 (Press release, BioMarin, OCT 23, 2019, View Source [SID1234542437]).

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Total Net Product Revenues for the third of quarter 2019 increased to $450.9 million, compared to $386.3 million for the third quarter of 2018. The increase in Net Product Revenues was attributed to the following:

Vimizim Net Product Revenues increased by $40.2 million, or 33%, driven primarily by increased sales volume driven by government orders in certain Middle Eastern countries, a large order from Brazil as well as smaller orders from other Latin American countries;

Palynziq Net Product Revenues increased by $20.0 million, driven by a combination of revenue from patients achieving maintenance dosing and new patients initiating therapy in the U.S. Palynziq received approval from the U.S. Food and Drug Administration (FDA) in May 2018 and launched in the third quarter of that year. Palynziq received European Medicines Agency (EMA) approval in May 2019 and commercial sales in Europe are expected to commence in the fourth quarter of 2019;

Brineura Net Product Revenues increased by $9.9 million, or 100%, due in large part by growth in the number of patients across all regions; and

Kuvan Net Product Revenues increased by $7.3 million, or 6%, primarily driven by an increase in the number of patients in North America; partially offset by

Naglazyme Net Product Revenues decreased by $8.7 million, or 8%, primarily due to decreased sales volume driven by government ordering patterns from certain Latin American and European countries; and

Aldurazyme Net Product Revenues decreased $4.8 million, due to the timing of customer acceptance for product shipped to Genzyme in the third quarter for which no revenue was recognized as of September 30, 2019.
The increase in GAAP Net Income for the third quarter of 2019, compared to GAAP Net Loss the same period in 2018 was primarily due to the following:

increased gross profits of $51.3 million driven by increased product sales;

increased tax benefit, which is primarily attributed to quarterly fluctuations in the mix and timing of our profits and losses on a territorial basis and reversals of certain tax reserves that were no longer required, partially offset by

higher selling, general and administrative (SG&A) expense related to pre-commercialization activities for valoctocogene roxaparvovec, support of the EU commercial launch and continued U.S. expansion of Palynziq, and increased general and administrative expense primarily attributed to personnel-related costs resulting from increased headcount to support our growth; and

higher research and development (R&D) expense related to preclinical activities for BMN 307 and clinical activities for the Company’s vosoritide and valoctocogene roxaparvovec development programs, partially offset by decreased R&D expense related to Palynziq for which we began capitalizing manufacturing costs upon FDA approval in May 2018, and a decrease in tralesinidase alfa clinical manufacturing costs. R&D expenses in the quarter were consistent with 2019 guidance despite the acceleration of the valoctocogene roxaparvovec development program and subsequent activities implemented to pursue an expedited regulatory path forward.

Key Program Highlights

•
Valoctocogene roxaparvovec gene therapy for hemophilia A: The European Medicines Agency (EMA) recently granted BioMarin’s request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A. Accelerated assessment reduces the time-frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a Marketing Authorization Application (MAA) for an Advanced Therapy Medicinal Product (ATMP). Applications are eligible for accelerated assessment if the CHMP and CAT decide the product is of major interest for public health, particularly from the point of view of therapeutic innovation. Evaluating a MAA under the EMA centralized procedure can take up to 210 days, not counting clock stops when applicants are requested to provide additional information. On request, the CHMP and CAT can reduce the time-frame to 150 days if the applicant provides sufficient justification for an accelerated assessment. The decision to grant accelerated assessment has no impact on the eventual CHMP and CAT opinion on whether a marketing authorization should be granted.

On July 8, the Company announced that based on recent meetings with health authorities in the U.S. and Europe, it plans to submit marketing applications to both the FDA and the EMA in the fourth quarter of 2019 for valoctocogene roxaparvovec with the 6e13 vg/kg dose. The submissions will be based on the recently completed Phase 3 interim analysis and the updated three-year Phase 1/2 data of patients treated with valoctocogene roxaparvovec. Both submissions are expected to represent the first time a gene therapy product for any type of hemophilia indication will be reviewed for marketing authorization by health authorities.

Enrollment in the GENEr8-1 Phase 3 study is expected to be complete by R&D Day with 52-week results from the 130 subjects expected at the end of 2020. Although the trial is open label, BioMarin has implemented a data access plan designed to significantly mirror a blinded trial. This restricts the release of any ongoing data to a small group of medical personnel monitoring and managing the trial, and then, only to the extent necessary to perform their monitoring responsibilities.

The Company has chosen to cease development of the 4e13 vg/kg dose of valoctocogene roxaparvovec given the overwhelming preference by patients to be treated with the 6e13 vg/kg dose.

BioMarin intends to provide a 4 year update with the 6e13 vg/kg dose subjects and a 3 year update with the 4e13 vg/kg dose subjects from the ongoing Phase 2 study in mid-2020.

Palynziq for PKU: Palynziq, an injection to reduce blood Phe concentrations in adult patients with PKU, was added to BioMarin’s commercial product portfolio upon its U.S. approval May 2018. As of September 30, 2019, 670 patients were on reimbursed Palynziq, with an additional 153 naïve patients enrolled and awaiting their first treatment with commercial Palynziq. Of the 670 patients on therapy at the end of the third quarter, 528 were formerly naïve patients and 142 had transitioned from clinical studies. Of the 125 PKU clinics in the U.S., 97 unique clinics had at least one complete patient enrollment in the REMS program as of September 30, 2019.
On May 6, 2019, the European Commission (EC) granted marketing authorization for Palynziq at doses of up to 60 milligrams once daily, to reduce blood Phe concentrations in patients with PKU aged 16 and older, who have inadequate blood Phe control (blood Phe levels greater than 600 micromol/L) despite prior management with available treatment options. The Company is in the process of securing reimbursement on a country-by-country basis across the European Union and anticipates meaningful revenue contributions from this region in 2020.

Vosoritide for children with achondroplasia: The vosoritide development program includes four distinct areas of focus to support global approval, including a large contemporaneous natural history study which is underway. The global Phase 3 study is a randomized, double-blind placebo-controlled study of vosoritide in approximately 110 children with achondroplasia between the ages of 5 to 14 years. Data from this study is expected by year-end 2019.
The Company plans to share 54-month results from the ongoing Phase 2 study with vosoritide in children ages 5 to 14 years at the upcoming R&D Day planned for November 14. These data are expected to corroborate maintenance of effect at the time of anticipated marketing application submissions.

The fourth component of the Company’s global development program with vosoritide, includes a large Phase 2 study in infants and young children (newborn to 60 months old) with achondroplasia, to determine the impact of treatment in this age group. Three cohorts, segmented by age, are at various stages of enrollment in this study. Cohort 1 includes children ages 24 to 60 months old and has completed enrollment. Cohort 2 includes children ages 6 to 24 months old and will complete enrollment by year-end. Cohort 3, includes children ages 0 to 6 months old and began enrolling earlier this month.

BMN 307 gene therapy product candidate for phenylketonuria (PKU): On October 21, 2019, BioMarin was granted Orphan drug designation from the FDA for BMN 307 for the treatment of phenylketonuria. On September 26, 2019, the Company submitted a CTA with the medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K.
Preclinical data with BMN 307 demonstrated a lifetime Phe correction sustained at 80 weeks in mouse models. BMN 307 is an AAV vector containing the DNA sequence that codes for the phenylalanine hydroxylase enzyme that is deficient in people with PKU. Product to support clinical evaluation is being produced at BioMarin’s gene therapy manufacturing facility, where valoctocogene roxaparvovec is currently made, using a commercial scale manufacturing process to facilitate rapid clinical development.

Tralesinidase alfa (formerly referred to as BMN 250) for Mucopolysaccharidosis IIIB (MPS IIIB) or Sanfilippo Syndrome, Type B: On October 23, 2019, the Company announced that it had entered into a licensing agreement with Allievex Corp. (Allievex) for tralesinidase alfa, an investigational Enzyme Replacement Therapy (ERT) for MPS IIIB or Sanfilippo Syndrome Type B. Under the terms of the agreement, Allievex will receive a worldwide, exclusive license to tralesinidase alfa. BioMarin is entitled to receive a minority equity stake in Allievex, milestone payments if certain development, regulatory and sales milestones are met by Allievex and royalties on net sales of tralesinidase alfa. Upon closing of the transaction, Allievex will assume all financial obligations associated with the development and commercialization of tralesinidase alfa other than certain continued manufacturing activities that will be paid by BioMarin. BioMarin will transfer all tralesinidase alfa-related clinical and regulatory activity and responsibilities to Allievex during a transition period following closing of the transaction. Tralesinidase alfa is currently being evaluated in ongoing natural history and clinical trials.

R&D Day to be held in New York November 14, 2019: The Company plans to hold an investor event to discuss potential new product candidates, vosoritide, valoctocogene roxaparvovec status and other general corporate updates. Please email [email protected] for more information.
BioMarin will host a conference call and webcast to discuss third quarter 2019 financial results today, Wednesday, October 23, 2019 at 4:30 p.m. ET. This event can be accessed on the investor section of the BioMarin website at www.biomarin.com.
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Conference ID: 6989536

Conference ID: 6989536

On October 23, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that Christopher Haqq M.D., Ph.D. has joined Elicio as Executive Vice President, Head of Research and Development, and Chief Medical Officer (Press release, Elicio Therapeutics, OCT 23, 2019, View Source [SID1234542438]).

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"Chris is an accomplished physician-scientist who brings to Elicio over 20 years of translational drug development and leadership in large and small biotechnology companies across T cell immunotherapy, biologic, and small molecule modalities," commented Elicio CEO Robert Connelly. "We expect Chris’ knowledge of the impact of T-cell expansion, persistence and trafficking in immuno-oncology will dovetail with the unique lymph node targeting ability of Elicio’s Amphiphile platform."

Before joining Elicio, Dr. Haqq was the first employee and Chief Medical Officer of Atara Biotherapeutics, and later its Chief Scientific Officer, where he was the architect for an innovative pipeline including EBV specific T-cell product candidates for oncology and autoimmune disease, and a next generation off the shelf CAR-T cells for solid tumors. Earlier at Cougar Biotechnology and Janssen, Dr. Haqq was the lead clinician for a pivotal prostate cancer study leading to market approval for Zytiga (abiraterone acetate) and he led early development studies at Amgen.

Dr. Haqq has served as medical monitor for numerous oncology clinical trials working closely with global regulatory agencies. His teams have made successful filings for investigational new drug applications, breakthrough therapy, priority medicines, special protocol assessments and marketing approval and he has authored multiple patents and publications. Dr. Haqq initially practiced as a medical oncologist and led a translational science laboratory as an Assistant Professor in the Division of Hematology/Oncology at the University of California, San Francisco following post-graduate training as an Intern and Resident in Internal Medicine, Fellow in Medical Oncology and Fellow in Molecular Medicine. Dr. Haqq completed his M.D. and Ph.D. in Genetics at Harvard Medical School and his undergraduate training at Stanford University and the University of British Columbia.

"I am excited to lead Elicio’s strong R&D team during the transition from the lab bench to the bedside for its promising lymph node targeted immunotherapies where preclinical monotherapy and CAR-T combination show unique potential," said Dr. Haqq. "And as my family has experienced the unmet need for an effective mKRAS therapy, I am looking forward to evaluate ELI-002’s safety and efficacy in mKRAS bearing pancreatic, colorectal and lung cancers."

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On October 23, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract containing data from the Company’s Phase 2 clinical trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) has been selected for oral presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which will be held October 26-30, 2019 at the Hynes Convention Center in Boston (Press release, Kura Oncology, OCT 23, 2019, View Source [SID1234542439]).

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Nearly 500 abstracts were considered for this year’s program and just 10 were selected as short-talks by the Scientific Committee Cochairs. As a result of the selection, the previously announced poster presentation related to the Phase 2 clinical trial of tipifarnib in HRAS mutant HNSCC has been rescheduled to take place following the oral presentation. Details of the oral and poster presentations, entitled "Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations" (abstract A087), are as follows:

Oral Presentation
Session Title: Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers
Session Date: Tuesday, October 29, 2019
Session Start Time: 11:50 a.m. ET
Session End Time: 12:30 p.m. ET
Location: Level 3 – Ballroom AB

Poster Presentation
Session Title: Poster Session C: Clinical Trials 2
Session Date: Tuesday, October 29, 2019
Session Start Time: 12:30 p.m. ET
Session End Time: 4:00 p.m. ET
Location: Level 2 – Hall D

The data are embargoed until the beginning of the Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers session at 11:50 a.m. ET on Tuesday, October 29, 2019. A copy of the oral and poster presentations will be available at www.kuraoncology.com following presentation at the meeting.

On October 23, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Wednesday, November 6, 2019 following release of its third quarter 2019 financial results (Press release, Puma Biotechnology, OCT 23, 2019, https://investor.pumabiotechnology.com/press-release/featured-release/puma-biotechnology-host-conference-call-discuss-third-quarter-financi [SID1234542440]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.