10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Agios Pharmaceuticals, NOV 6, 2015, View Source [SID:1234508084])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Ariad, NOV 6, 2015, View Source [SID:1234508085])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Stemline Therapeutics Reports Third Quarter 2015 Financial Results

On November 6, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended September 30, 2015 (Press release, Stemline Therapeutics, NOV 6, 2015, View Source [SID:1234508095]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "During the third quarter, we made significant progress on many fronts as we continue to advance our clinical programs forward. We are actively enrolling patients, and opening additional sites, in the expansion stage of our ongoing SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm, BPDCN. We look forward to sharing clinical updates from both the lead-in and initial expansion stages of this trial at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting this December, and on into next year."

Dr. Bergstein continued, "We remain focused on the BPDCN indication while continuing to pursue expansion opportunities for SL-401 in additional malignancies. We have single agent trials currently open in several indications and we anticipate combination studies coming on-line as well. We are also continuing to develop our other pipeline candidates, SL-701 and SL-801, and look forward to treating our first patient with SL-801, our novel XPO1 inhibitor, early next year. With a strong cash position and multiple ongoing programs advancing across a range of indications of unmet medical need, we remain focused on achieving our objective of building a leading commercial stage biopharmaceutical company."

Third Quarter 2015 Financial Results Review

Stemline ended the third quarter of 2015 with $104.0 million in cash, cash equivalents and investments, as compared to $58.6 million as of December 31, 2014. In the first quarter of 2015, the Company completed an equity offering raising $68.6 million in gross cash proceeds on the sale of 4.4 million common shares.

For the third quarter of 2015, Stemline had a net loss of $9.2 million, or $0.53 per share, compared with a net loss of $6.9 million, or $0.53 per share, for the same period in 2014.

Research and development expenses were $7.3 million for the third quarter of 2015, which reflects an increase of $2.3 million compared with $5.0 million for the third quarter of 2014. The higher expenses during the third quarter were primarily attributable to the ramp up of SL-401 and SL-701 clinical activities. Also, we incurred costs relating to SL-801 IND-enabling studies.

General and administrative expenses were $2.2 million for the third quarter of 2015, which reflects an increase of $0.2 million compared with $2.0 million for the third quarter of 2014. The higher costs were primarily attributable to an increase in non-cash stock based compensation expense relating to employees.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Dyax, NOV 6, 2015, View Source [SID:1234508086])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


TESARO Announces Data Presentations for Niraparib at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On November 6, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of three posters describing niraparib at the 2015 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), November 5-9, 2015, in Boston, Massachusetts (Press release, TESARO, NOV 6, 2015, View Source [SID:1234508096]). The posters describe the homologous recombination deficiency (HRD) analysis being performed on tumor samples from the ongoing Phase 3 NOVA trial of niraparib in patients with ovarian cancer, in addition to preclinical data demonstrating that niraparib crosses the blood brain barrier in animal models and highlighting potential genetic markers of resistance in animal models of small cell lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are executing a very comprehensive development program for niraparib, and believe that the emerging profile of this promising candidate warrants expansion to a variety of tumor types, as a monotherapy and in combination with immuno-oncology and other targeted agents," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We are very optimistic about the potential of niraparib for patients with ovarian, breast and other cancers, and we look forward to initiating several new trials in the coming months."

Presentation Details:

Sunday, November 8, 2015, 12:30 PM to 3:30 PM
Homologous recombination deficiency of high grade serous ovarian tumors from the NOVA Phase III clinical study
Abstract: C53, Location: Session C, Hall C-D

Saturday, November 7, 2015, 12:30 PM to 3:30 PM
The PARP inhibitor, niraparib, crosses the blood brain barrier in rodents and is efficacious in a BRCA2-mutant intracranial tumor model
Abstract: B168, Location: Session B, Hall C-D

Saturday, November 7, 2015, 12:30 PM to 3:30 PM
A mouse avatar tumor maintenance study identified a subset of SCLC patient-derived tumor xenograft models sensitive to the PARP inhibitor niraparib
Abstract: B169, Location: Session B, Hall C-D

About Niraparib

Niraparib is an orally active and potent poly (ADP-ribose) polymerase, or PARP, inhibitor. A Phase 1/2 monotherapy study of niraparib has been completed in more than 100 patients with advanced solid tumors. Two Phase 3 trials are currently ongoing to evaluate a single oral dose of niraparib for patients with ovarian cancer and for patients with BRCA-positive breast cancer.