Fulvestrant

Sermonix Pharmaceuticals to Present Poster on ELAINE-3 Trial in Progress at ASCO 2024

Retrieved on: 
Donnerstag, Mai 30, 2024
McCormick Place, Fulvestrant, Safety, Breast cancer, MBC, Neoplasm, ASCO, ESR1, Society, Mutation, Therapy, Eli Lilly, Quality of life, Pharmaceutical industry

COLUMBUS, Ohio, May 30, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced it will present a poster updating the progress of its Phase 3 ELAINE-3 clinical trial at the annual meeting of the American Society of Clinical Oncology (ASCO).

Key Points: 
  • COLUMBUS, Ohio, May 30, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced it will present a poster updating the progress of its Phase 3 ELAINE-3 clinical trial at the annual meeting of the American Society of Clinical Oncology (ASCO).
  • ASCO 2024 will be held May 31-June 4, 2024, at McCormick Place in Chicago.
  • “Sermonix looks forward to updating our peers at ASCO 2024 about the progress of ELAINE-3, which is actively enrolling in the U.S., Canada, Europe and Israel,” said Dr. David Portman, Sermonix founder and chief executive officer.
  • We are excited to gain a greater understand of lasofoxifene’s potential as ELAINE-3 progresses, and hopefully bring it one important step closer to patients.”

Celcuity Announces Pricing of Underwritten Common Stock Offering

Retrieved on: 
Donnerstag, Mai 30, 2024
Patient, Fulvestrant, CELC, Investment, Suite, Telephone, Sale, Breast cancer, Form, Prospectus, Research, Attention, Vanderbilt Avenue, SVB Securities, Richard Driehaus, State Street, Public expenditure, Clinical trial, Montgomery Street, Security (finance)

MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of an underwritten offering of 3,871,000 shares of its common stock at an offering price of $15.50 per share.

Key Points: 
  • MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of an underwritten offering of 3,871,000 shares of its common stock at an offering price of $15.50 per share.
  • The offering is expected to close on or about May 31, 2024, subject to satisfaction of customary closing conditions.
  • Gross proceeds to Celcuity from the offering are expected to be $60.0 million, before deducting underwriting discounts and commissions and offering expenses.
  • A prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC.

Celcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 Million Debt Financing

Retrieved on: 
Donnerstag, Mai 30, 2024
Ribociclib, Patient, Fulvestrant, CELC, Type, Food, Clinical trial, FDA, PFS, Disease, PIK3CA, Arm, Safety, Breast cancer, RECIST, MD, Letrozole, ABC, Pharmaceutical industry

“We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.

Key Points: 
  • “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.
  • In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%.
  • Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant.
  • At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding.

FDA Grants Priority Review to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Retrieved on: 
Mittwoch, Mai 29, 2024
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, New Drug Application, Patient, Fulvestrant, Progression-free survival, Risk, Food, HER2, Recurrence, ROG, Death, Priority review, Roche, Pharmaceutical industry

“We welcome the FDA’s Priority Review designation for inavolisib, which underscores the urgency to bring this potential best-in-class treatment option to patients as quickly as possible.”

Key Points: 
  • “We welcome the FDA’s Priority Review designation for inavolisib, which underscores the urgency to bring this potential best-in-class treatment option to patients as quickly as possible.”
    The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.
  • Based on the Priority Review designation, the FDA has set a Prescription Drug User Fee Act date of November 27, 2024.
  • Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.
  • We continue to evaluate potential clinical development program expansion opportunities to address patient unmet needs in various tumor types across oncology.

eFFECTOR Therapeutics to Collaborate with the Dana-Farber Cancer Institute on an Investigator-Sponsored Phase 2 Clinical Trial Evaluating Zotatifin as Combination Treatment in ER+ Endometrial Cancer and in Low Grade Serous Ovarian Cancer

Retrieved on: 
Montag, Mai 20, 2024
Patient, Fulvestrant, Hope, Gynecologic Oncology (journal), Ovarian cancer, Panagiotis Konstantinopoulos, Translational research, Therapy, Endometrial cancer, Malignancy, Enzyme inhibitor, Cancer, Harvard Medical School, Letrozole, Division, Associate, IST, DFCI, Breast, Phase II, Female, Pharmaceutical industry

“Endometrial cancer is the most prevalent cancer affecting the female reproductive organs in the United States,” said Dr. Konstantinopoulos.

Key Points: 
  • “Endometrial cancer is the most prevalent cancer affecting the female reproductive organs in the United States,” said Dr. Konstantinopoulos.
  • “While early detection offers hope for successful treatment, patients with recurrent or metastatic disease have limited treatment options.
  • Similarly, low grade serous ovarian cancer has shown sensitivity to combined treatment with aromatase inhibitors and CDK4/6 inhibition, but responding patients eventually develop disease progression.
  • This trial represents a significant step forward in our collective efforts to address the complexities of endometrial cancer and low grade serous ovarian cancer.

Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®)

Retrieved on: 
Donnerstag, Mai 16, 2024
Patient, Progression-free survival, Fulvestrant, DNA, PROTAC, Febrile neutropenia, ARVN, HER2, Neutropenia, Fourth grade, PFS, Chimera, Safety, Cyclin-dependent kinase 4, Breast cancer, Congress, PFE, ESR1, Breast Cancer Research, Sarah Cannon Research Institute, Proteolysis, ESMO, CBR, Mutation, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). After six months of additional follow-up, these data are consistent with data presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2023, and show that vepdegestrant plus palbociclib continue to demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of prior therapy with locally advanced or metastatic ER positive (ER+)/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These updated data were presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress.

Key Points: 
  • These updated data were presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress.
  • “We're encouraged by the clinical activity and safety profile observed with vepdegestrant in combination with palbociclib in patients being treated for advanced ER+/HER2- breast cancer,” said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer at Arvinas.
  • Vepdegestrant is being co-developed by Arvinas and Pfizer and is being evaluated as a monotherapy in the second-line setting in the ongoing Phase 3 VERITAC-2 trial and in the first-line setting in combination with palbociclib in the ongoing study lead-in cohort of the Phase 3 VERITAC-3 trial.
  • The safety profile of vepdegestrant in combination with palbociclib was otherwise consistent with the profile of palbociclib and what has been observed in other clinical trials for vepdegestrant.

Celcuity Inc. Reports First Quarter Financial Results and Provides Corporate Update

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Mittwoch, Mai 15, 2024
Patient, Fulvestrant, CELC, Investment, Disease, PIK3CA, Prostate cancer, GAAP, Research, G&A, Webcast, Pharmaceutical industry

ET

Key Points: 
  • ET
    MINNEAPOLIS, May 15, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the first quarter ended March 31, 2024 and other recent business developments.
  • Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2024, compared to the first quarter ended March 31, 2023.
  • Total operating expenses were $22.5 million for the first quarter of 2024, compared to $12.6 million for the first quarter of 2023.
  • ET today to discuss the first quarter 2024 financial results and provide a corporate update.

FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Retrieved on: 
Dienstag, Mai 21, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Breakthrough therapy, Patient, Fulvestrant, Progression-free survival, PI3K, Risk, Food, Recurrence, ROG, Death, Roche, Pharmaceutical industry

These data reinforce the potential for this inavolisib-based regimen to benefit patients with PIK3CA-mutated locally advanced or metastatic breast cancer.

Key Points: 
  • These data reinforce the potential for this inavolisib-based regimen to benefit patients with PIK3CA-mutated locally advanced or metastatic breast cancer.
  • PIK3CA is one of the most commonly mutated genes in advanced or metastatic breast cancer.
  • Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.
  • We continue to evaluate potential clinical development program expansion opportunities to address patient unmet needs in various tumor types across oncology.

eFFECTOR Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Donnerstag, Mai 9, 2024
PFS, Sale, FDA, Azacitidine, Cancer, Research and development, Investment, ZF, IST, Nausea, Research, Hematology, KICKSTART, Fulvestrant, Insurance, AML, Artificial intelligence, Administration, ZFA, Science, Vomiting, COX, Patient, Fatigue, MNK, Effector, G&A, Assistant, Messenger, Acute myeloid leukemia, Cell, Interval (mathematics), Associate, Therapy, NSCLC, Breast cancer, Anemia, Pharmaceutical industry

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • Research and Development (R&D) Expenses: R&D expenses were $5.3 million for the quarter ended March 31, 2024, compared to $6.6 million for the same quarter of 2023.
  • General and Administrative (G&A) Expenses: G&A expenses were $3.1 million for the quarter ended March 31, 2024, compared to $2.9 million for the same quarter of 2023.
  • G&A expenses included approximately $0.6 million and $0.7 million of non-cash stock compensation expense in the quarters ended March 31, 2024, and 2023, respectively.
  • Other Expense: Other expense was $0.4 million and $0.5 million for the quarters ended March 31, 2024, and 2023, respectively.

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
Mittwoch, Mai 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.