bridgebio pharma announces filing of registration statement for proposed initial public offering

On May 24, 2019 BridgeBio Pharma, Inc., a clinical-stage biopharmaceutical company focused on genetic diseases, reported that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of shares of its common stock (Press release, BridgeBio, MAY 24, 2019, View Source [SID1234576266]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. BridgeBio has applied to list its common stock on the Nasdaq Global Market under the symbol "BBIO."

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, SVB Leerink LLC, KKR Capital Markets LLC, Piper Jaffray & Co., Mizuho Securities USA LLC, BMO Capital Markets Corp. and Raymond James & Associates, Inc. will act as book-running managers for the proposed offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained for free from the offices of J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or by emailing prospectus-eq_fi@jpmchase.com; Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526 or by emailing prospectus-ny@ny.email.gs.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: 1-877-547-6340, or by emailing Prospectus_Department@Jefferies.com; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, telephone: 1-800-808-7525, ext. 6132, or by emailing syndicate@svbleerink.com. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Myovant Sciences Provides Corporate Updates and Reports Financial Results
for Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019

On May 24, 2019 Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, reported corporate updates and reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2019 (Press release, Myovant Sciences, MAY 24, 2019, View Source [SID1234536585]).

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"Earlier this month, Myovant reached a significant milestone with the announcement of positive data from LIBERTY 1, the first of two Phase 3 studies of once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding, which met its primary efficacy endpoint and six key secondary endpoints," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "These positive results bring us one step closer to realizing the potential of relugolix combination as a new treatment option for the millions of women suffering from this debilitating disease. We look forward to reporting data from LIBERTY 2, the second Phase 3 study designed to confirm these results, next quarter and results from our Phase 3 studies in endometriosis and prostate cancer over the next three quarters."
Fourth Fiscal Quarter 2018 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

On May 14, 2019, Myovant announced positive results from the LIBERTY 1 Phase 3 study evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) once daily in women with uterine fibroids and heavy menstrual bleeding. Results from the Phase 3 LIBERTY 2 study are expected in the third quarter of calendar year 2019, and, provided the LIBERTY 2 study is successful, Myovant plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of calendar year 2019.
MVT-602 Clinical Program

Myovant completed a dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a controlled ovarian stimulation protocol. Top-line results are expected to be presented at the European Society of Human Reproduction in Vienna, Austria in June.
Corporate

In the fourth quarter of fiscal year 2018, Myovant issued and sold 1,203,000 common shares for aggregate net proceeds of $26.7 million pursuant to its "at-the-market" equity offering program. In April 2019, Myovant issued and sold an additional 106,494 common shares for aggregate net proceeds of $2.5 million pursuant to the "at-the-market" equity offering program.

Fourth Fiscal Quarter and Full Fiscal Year 2018 Financial Summary
Research and development (R&D) expenses for the quarter ended March 31, 2019, were $59.0 million compared to $40.1 million for the comparable period in 2018. R&D expenses for the fiscal year ended March 31, 2019, were $222.6 million, compared to $116.8 million for the prior fiscal year. The increase for both the quarter and the year primarily reflects the progress of Myovant’s Phase 3 clinical studies of relugolix, as well as additional personnel-related expenses and increased MVT-602 clinical trial expenses.
General and administrative (G&A) expenses for the quarter ended March 31, 2019, were $12.5 million compared to $7.3 million for the comparable period in 2018. G&A expenses for the fiscal year ended March 31, 2019, were $42.2 million, compared to $24.2 million for the prior fiscal year. The increase in G&A expenses for both the quarter and the year primarily reflects increases in personnel-related expenses, professional service fees, share-based compensation expense, and other administrative expenses to support Myovant’s headcount growth and expanding operations.
Interest expense for the quarter ended March 31, 2019, was $3.9 million compared to $1.1 million in the comparable prior year period. Interest expense for the fiscal year ended March 31, 2019, was $8.8 million, compared to $2.0 million for the prior fiscal year. This consists of interest expense related to financing agreements with NovaQuest and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs. The increase for both the quarter and the year was primarily the result of higher outstanding debt balances under the financing agreements as compared to the prior year periods.
Interest income for the quarter and year ended March 31, 2019, was $0.8 million and $0.9 million, respectively. There was no interest income for the quarter and year ended March 31, 2018. During the year ended March 31, 2019, a portion of Myovant’s cash was invested in a combination of money market funds and commercial paper. There were no such investments during the prior year periods.

Net loss for the quarter ended March 31, 2019, was $75.0 million, compared to $48.3 million for the comparable period in 2018. Net loss for the fiscal year ended March 31, 2019, was $273.6 million, compared to $143.3 million for the prior fiscal year. On a per common share basis, net loss was $1.07 and $0.81 for the quarters ended March 31, 2019, and 2018, respectively, and $4.09 and $2.41 for the fiscal years ended March 31, 2019 and 2018, respectively. The increases in the net loss and net loss per common share for both the quarter and the year were driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled $156.1 million as of March 31, 2019. Currently, an additional $10.4 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.
About Relugolix
Relugolix is a once daily oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids. Myovant is studying relugolix combination therapy (relugolix 40 mg plus 1.0 mg estradiol with 0.5 mg norethindrone acetate) in two Phase 3 clinical studies (LIBERTY 1 and LIBERTY 2) in women with uterine fibroids and heavy menstrual bleeding, and in two Phase 3 clinical studies (SPIRIT 1 and SPIRIT 2) in women with endometriosis-associated pain. Myovant is studying whether the combination optimizes estradiol levels to maximize the benefit of relugolix on symptoms of uterine fibroids and endometriosis, while maintaining bone health and mitigating other side effects from a low-estrogen state such as vasomotor symptoms. Relugolix monotherapy, 120 mg once daily, is also being evaluated in the Phase 3 HERO study in men with advanced prostate cancer.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in the controlled ovarian stimulation setting has been completed. This study is intended to provide information for dose selection for a study of MVT-602 in infertile women seeking pregnancy.

Allergan Announces Updated Presentation Time at the Bernstein Strategic Decisions Conference

On May 24, 2019 Allergan plc (NYSE: AGN) reported that Chairman and CEO Brent Saunders will participate in a fireside chat at the Bernstein 35th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 24, 2019, View Source [SID1234536584]). The presentation will begin at 4:00 p.m. Eastern Time on Thursday, May 30, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: View Source;

An archived version will be available within approximately one hour of the live presentation and can be accessed at the same location for 180 days.

FDA approves Novartis Piqray® – the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer

On May 24, 2019 Novartis reported the US Food and Drug Administration (FDA) has approved Piqray (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen1 (Press release, Novartis, MAY 24, 2019, View Source;the-first-and-only-treatment-specifically-for-patients-with-a-pik3ca-mutation-in-hrher2–advanced-breast-cancer-300856766.html [SID1234536581]).

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Experience the interactive Multichannel News Release here: View Source

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation8,10. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis11,12. Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer.

"The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation. We are proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," said Susanne Schaffert, PhD, CEO, Novartis Oncology. "We are grateful to our researchers’ bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone."

FDA approval is based on results of the Phase III trial, SOLAR-1, that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation (median PFS 11.0 months vs 5.7 months; HR=0.65, 95% CI: 0.50-0.85; p<0.001)2. Piqray provided consistent PFS results across pre-specified subgroups, including among patients previously treated with a CDK4/6 inhibitor2,3.

Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002)2,3. Piqray and its associated companion diagnostic test from QIAGEN N.V. was the first combination product approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program.

"Today’s approval is expected to change the way we practice medicine in advanced breast cancer. For the first time, physicians can test for PIK3CA biomarkers and develop a treatment plan based on the genomic profile of a patient’s cancer," said Fabrice André, MD, PhD, research director and head of INSERM Unit U981, professor in the Department of Medical Oncology at Institut Gustave Roussy in Villejuif, France, and global SOLAR-1 principal investigator. "In the SOLAR-1 Phase III trial, alpelisib plus fulvestrant nearly doubled median PFS and more than doubled overall response rate in patients with a PIK3CA mutation, offering them new hope for longer life without progression."

Patients with HR+/HER2- advanced breast cancer can be selected for treatment with Piqray based on the presence of PIK3CA mutations. Concurrent with the approval of Piqray, the therascreen* PIK3CA companion diagnostic test from QIAGEN was also approved by the FDA and is now available for patient testing.

"If you are facing a complex disease like metastatic breast cancer, you want to follow a path that is specific to your type of disease," said Shirley Mertz, President, Metastatic Breast Cancer Network. "Finding the right treatment team and getting the right tests, like testing for the PIK3CA mutation, will help your healthcare team identify accurate, precise treatment options for your disease."

Novartis is committed to providing patients with access to medicines, as well as resources and support to address a range of needs. The Novartis Oncology Patient Support Program is available to help guide eligible patients through the various aspects of getting started on treatment, from providing educational information to helping them understand their insurance coverage and identify potential financial assistance options. For more information, patients and healthcare professionals can call 1-800-282-7630.

Full prescribing information for Piqray can be found at View Source

About Piqray (alpelisib)
Piqray is a kinase inhibitor approved in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after endocrine-based regimen1.

Approximately 40% of HR+ advanced breast cancer patients have a mutation that may activate the PI3K-alpha isoform, called PIK3CA mutations5,6,7,8. These mutations are associated with resistance to endocrine therapy, disease progression and a poor prognosis11,12. Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations.

About SOLAR-1
SOLAR-1 is a global, Phase III randomized, double-blind, placebo-controlled trial studying Piqray in combination with fulvestrant for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor1,2,3. SOLAR-1 is the pivotal Phase III trial that supported this approval.

The trial randomized 572 patients. Patients were allocated based on central tumor tissue assessment to either a PIK3CA-mutated cohort (n=341) or a PIK3CA non-mutated cohort (n=231). Within each cohort, patients were randomized in a 1:1 ratio to receive continuous oral treatment with Piqray (300 mg once daily) plus fulvestrant (500 mg every 28 days + Cycle 1 Day 15) or placebo plus fulvestrant. Stratification was based on visceral metastases and prior CDK4/6 inhibitor treatment1,2,3. Patients and investigators are blinded to PIK3CA mutation status and treatment.

The primary endpoint is local investigator assessed PFS using RECIST 1.1 for patients with a PIK3CA mutation. The key secondary endpoint is overall survival, and additional secondary endpoints include, but are not limited to, overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutated cohort, safety and tolerability1,2,3. SOLAR-1 is ongoing to assess overall survival and other secondary endpoints.

About Novartis in Advanced Breast Cancer
For more than 30 years, Novartis has been tackling breast cancer with superior science, great collaboration and a passion for transforming patient care. With one of the most diverse breast cancer pipelines and one of the largest numbers of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.

Indication
PIQRAY (alpelisib) tablets is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause and men who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and whose disease has progressed on or after endocrine therapy. Your health care provider will test your cancer for an abnormal "PIK3CA" gene to make sure that PIQRAY is right for you. It is not known if PIQRAY is safe and effective in children.

Important Safety Information
Patients should not take PIQRAY if they have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.

PIQRAY may cause serious side effects. PIQRAY can cause severe allergic reactions. Patients should tell their health care provider or get medical help right away if they have trouble breathing, flushing, rash, fever, or fast heart rate during treatment with PIQRAY. PIQRAY can cause severe skin reactions. Patients should tell their health care provider or get medical help right away if they get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever. PIQRAY can cause high blood sugar levels (hyperglycemia). Hyperglycemia is common with PIQRAY and can be severe. Health care providers will monitor patients’ blood sugar levels before they start and during treatment with PIQRAY. Health care providers may monitor patients’ blood sugar levels more often if they have a history of Type 2 diabetes. Patients should tell their health care provider right away if they develop symptoms of hyperglycemia, including excessive thirst, dry mouth, urinate more often than usual or have a higher amount of urine than normal, or increased appetite with weight loss. PIQRAY can cause lung problems (pneumonitis). Patients should tell their health care provider right away if they develop new or worsening symptoms of lung problems, including shortness of breath or trouble breathing, cough, or chest pain. Diarrhea is common with PIQRAY and can be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney problems. Patients who develop diarrhea during treatment with PIQRAY should tell their health care provider right away.

Before taking PIQRAY, patients should tell their health care provider if they have a history of diabetes, skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling, are pregnant, or plan to become pregnant as PIQRAY can harm their unborn baby. Females who are able to become pregnant should use effective birth control during treatment with PIQRAY and for 1 week after the last dose. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose. Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with PIQRAY and for 1 week after the last dose. Patients should also read the Full Prescribing Information of fulvestrant for important pregnancy, contraception, infertility, and lactation information.

Patients should tell their health care provider all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

The most common side effects of PIQRAY when used with fulvestrant are rash, nausea, tiredness and weakness, decreased appetite, mouth sores, vomiting, weight loss, hair loss, and changes in certain blood tests.

QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

On May 24, 2019 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the immediate launch of its therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis (Press release, Qiagen, MAY 24, 2019, View Source [SID1234536580]).

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The therascreen PIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use in any cancer indication for detection of activating mutations in the PIK3CA gene. It is also the first FDA approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive (HR+) advanced or metastatic breast cancer patients. The real-time qualitative PCR kit is processed on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions. The test leverages QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

QIAGEN’s therascreen PIK3CA Kit was co-developed in collaboration with Novartis and co-approved with PIQRAY (alpelisib) by the FDA. The Novartis drug is indicated in combination with fulvestrant for the treatment of postmenopausal women and men ,with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Further detail about the Kit is available at www.qiagen.com/PIK3CA.