On November 7, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2017 financial results and provided an update on the company, including its progress with IPI-549, an oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) (Press release, Infinity Pharmaceuticals, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2314924 [SID1234521651]). Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in a four-part Phase 1/1b study in patients with advanced solid tumors. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.

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On November 10, 2017, a late-breaking abstract summarizing data from the recently completed monotherapy dose-escalation component of the study will be presented at the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in National Harbor, MD. The presentation, which will be made during an oral session on new agents, will include an analysis of the safety, activity, pharmacokinetics and pharmacodynamics of IPI-549 in 19 patients who received once daily (QD) doses of IPI-549 ranging from 10 mg to 60 mg. Initial translational data describing how inhibiting PI3K-gamma may elicit an immune response and identifying potential biomarkers of immune response will also be presented. In August, Infinity announced that the company designated the 60 mg QD dose for evaluation in the monotherapy expansion component of the study, which is now under way.

"We are looking forward to sharing the full data from the completed monotherapy dose escalation component of our study later this week at the SITC (Free SITC Whitepaper) Annual Meeting. In addition to reporting on the safety and activity of IPI-549 monotherapy, for the first time we will present initial translational data from patients treated with IPI-549 as a monotherapy that can help us better understand how IPI-549 may activate an immune response," stated Adelene Perkins, Infinity’s chair and chief executive officer. "Patient enrollment in the monotherapy expansion component of the study is progressing very well, and we expect to initiate the combination expansion portion of the study by the end of this year, positioning us for data readouts from the monotherapy expansion cohort as well as data from the combination dose escalation and disease-specific expansion cohorts, all in the first half of 2018."

The Phase 1/1b study of IPI-549 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and activity of IPI-549 as a monotherapy and in combination with the approved dose of Opdivo in approximately 200 patients with advanced solid tumors. The study includes four components: monotherapy dose escalation, combination therapy dose escalation, monotherapy expansion and combination expansion. The combination expansion will include multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. Additionally, the combination expansion component will also evaluate a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy.

Based on progress made during 2017, Infinity expects to achieve the following IPI-549 data milestones in 2018:

Report data from the monotherapy expansion component of the study in the first half of 2018
Report data from the combination dose-escalation component of the study in the first half of 2018
Report initial data from the combination expansion component of the study in the first half of 2018, with more mature data from the combination expansion in the second half of 2018
"We are also focused on maintaining strong fiscal discipline and anticipate that we have cash runway into the first quarter of 2019, allowing us to generate safety and activity data on all four components of our Phase 1/1b study of IPI-549," commented Lawrence Bloch, M.D., J.D., president of Infinity. "We also have the potential to receive a future $22 million payment from Verastem upon the first regulatory approval of duvelisib, which we out-licensed in 2016, that could further strengthen our financial profile."

Recent Corporate Developments

$6.0 million payment received from Verastem: In October, Infinity received a $6.0 million cash payment from Verastem, Inc. The payment was made following the determination that the Phase 3 DUO clinical study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma met certain pre-specified criteria at completion. Infinity out-licensed duvelisib to Verastem in November 2016.

Verastem recently provided guidance that it plans to submit a new drug application for duvelisib in the first quarter of 2018. Infinity is entitled to receive a $22 million payment from Verastem upon the first regulatory approval for duvelisib inside or outside the U.S.
Recent Clinical Developments

IPI-549 selected for an oral presentation at SITC (Free SITC Whitepaper) Annual Meeting: In October, Infinity announced that a late-breaking abstract describing new data for IPI-549 was selected for presentation during an oral session on new agents at the SITC (Free SITC Whitepaper) Annual Meeting. The abstract, "Monotherapy dose escalation clinical and translational data from first-in-human study in advanced solid tumors of IPI-549, an oral, selective, PI3K-gamma inhibitor targeting tumor macrophages" (Abstract O43), will be presented on Friday, November 10, 2017, from 2:15 p.m. – 2:30 p.m. ET. The lead author and presenter is David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. An identically titled accompanying poster will also be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET.

Additionally, a clinical trials in progress poster, "Phase 1/1b, first-in-human study of the PI3K-gamma inhibitor IPI-549 as monotherapy and combined with nivolumab in patients with advanced solid tumors" (Abstract P219), will be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET. The lead author on the poster is Antoni Ribas, M.D., Ph.D., Parker Institute Center Director at the University of California, Los Angeles (UCLA).

Infinity will host a reception for investors and analysts on Friday, November 10, 2017, from 6:00 a.m. to 8:00 a.m. ET to discuss the clinical development of IPI-549, including a review of data from the ongoing clinical study. The presentation portion of the reception will be webcast live beginning at 6:30 a.m. ET. The webcast and accompanying slides will be available in the "investors/media" section of the company’s website, www.infi.com. A replay of the event will also be available.
Expanded clinical collaboration with Bristol-Myers Squibb: In September, Infinity announced that it expanded its existing clinical collaboration with Bristol-Myers Squibb evaluating IPI-549 in combination with Opdivo to include patients with TNBC who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. The TNBC cohort will be part of the combination expansion component of the Phase 1/1b study.
Phase 1/1b study of IPI-549 advancing: The company is continuing to advance the Phase 1/1b study of IPI-549 both as a monotherapy and in combination with Opdivo in patients with solid tumors. Infinity has completed an evaluation of escalating monotherapy doses of IPI-549 ranging from 10 mg QD to 60 mg QD and selected the 60 mg dose for evaluation in the monotherapy expansion component of the study. Dose escalation evaluating IPI-549 40 mg QD in combination with Opdivo is ongoing, and Infinity expects to initiate the combination expansion component of the study by the end of 2017.
Third Quarter 2017 Financial Results

At September 30, 2017, Infinity had total cash, cash equivalents and available-for-sale securities of $55.6 million, compared to $66.2 million at June 30, 2017. The September 30, 2017 cash and investments balance excludes the $6.0 million payment from Verastem, which Infinity received in October 2017.
Revenue for the third quarter of 2017 was $6.0 million, all of which related to the amounts due from Verastem for the DUO study meeting the pre-specified criteria at completion. Infinity did not record any revenue during the third quarter of 2016.
Research and development (R&D) expense for the third quarter of 2017 was $9.3 million, compared to $12.8 million for the same period in 2016. The decrease in R&D expense was related to the company’s 2016 restructuring activities, partially offset by the $6.0 million convertible note issued to Takeda in exchange for eliminating Infinity’s royalty obligation to Takeda for selective inhibitors of PI3K gamma, including IPI-549.
General and administrative (G&A) expense was $4.5 million for the third quarter of 2017 compared to $7.1 million for the same period in 2016. The decrease in G&A expense was primarily due to the company’s 2016 restructuring activities.
Net loss for the third quarter of 2017 was $7.1 million, or a basic and diluted loss per common share of $0.14, compared to net loss of $19.5 million, or a basic and diluted loss per common share of $0.39, for the third quarter of 2016.
Cash and Investments Outlook

Infinity’s 2017 financial outlook remains as follows:

Net loss: Infinity expects net loss for 2017 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2017 with a cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million.
Based on its current operational plans, Infinity expects that its cash, cash equivalents and available-for-sale securities at September 30, 2017, will be adequate to satisfy the company’s capital needs into the first quarter of 2019. The company’s financial outlook excludes additional funding or business development activities.

Conference Call Information
Infinity will host a conference call today, November 7, 2017, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 97100725. An archived version of the webcast will be available on Infinity’s website for 60 days.

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin by the end of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion component will now also add a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 7, 2017 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported financial results for the third quarter and nine months ended September 30, 2017 (Press release, Rigel, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2315079 [SID1234521689]).

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Recent Achievements

On October 2, 2017, Rigel announced that the U.S. Food and Drug Administration (FDA) is not currently planning on holding an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in adult patients with chronic or persistent immune thrombocytopenia (ITP).
Rigel recently completed enrollment of Stage 1 of its Phase 2 study of fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia (AIHA). On a top-line, preliminary basis, the Phase 2 study achieved the pre-specified primary efficacy endpoint for Stage 1. Given this achievement, Rigel is preparing to begin enrollment of Stage 2 of this study.
Rigel announced the closing of a public offering of common stock in October, with proceeds of $69,730,250, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Rigel.
"Our NDA review is progressing smoothly," said Raul Rodriguez, president and chief executive officer of Rigel. "As we prepare for an FDA decision, we are simultaneously implementing our commercial plan for a potential launch of fostamatinib in ITP, as well as continuing our clinical studies of fostamatinib in other disorders."

For the third quarter of 2017, Rigel reported a net loss of $17.7 million, or $0.14 per basic and diluted share, compared to a net loss of $22.6 million, or $0.24 per basic and diluted share, in the same period of 2016.

Contract revenues from collaborations of $900,000 in the third quarter of 2017 were related to a payment received from a license agreement with a third party. Contract revenues from collaborations of $3.8 million in the third quarter of 2016 represent the remaining amortization of the $30.0 million upfront payment which was fully amortized in September 2016, pursuant to Rigel’s collaboration and license agreement with Bristol-Myers Squibb.

Rigel reported total costs and expenses of $18.8 million in the third quarter of 2017, compared to $26.5 million for the same period in 2016. The decrease in costs and expenses was primarily due to the decreases in personnel costs as a result of the reduction in workforce in September 2016 and the completion of the pivotal Phase 3 clinical trials in ITP in 2016, partially offset by the increase in costs related to the preparation for the potential commercial launch of fostamatinib in ITP.

For the nine months ended September 30, 2017, Rigel reported a net loss of $52.1 million, or $0.43 per basic and diluted share, compared to a net loss of $53.6 million, or $0.58 per basic and diluted share, for the same period of 2016.

As of September 30, 2017, Rigel had cash, cash equivalents and short-term investments of $68.1 million, compared to $74.8 million as of December 31, 2016. In October 2017, Rigel completed an underwritten public offering in which it received proceeds of approximately $65.3 million, net of underwriting discounts and commissions and estimated offering expenses. Rigel expects that its cash, cash equivalents and short-term investments will be sufficient to support its current and projected funding requirements, including the potential U.S. commercial launch, through at least the next 12 months. Rigel continues to evaluate ex-U.S. partnerships for fostamatinib and other partnering opportunities across its pipeline.

Corporate Update
Rigel continues to execute on its commercial readiness plan to support the potential commercial launch of fostamatinib in 2018. This includes the hiring of key personnel across several functions such as marketing, sales, market access, business operations and medical affairs.

Portfolio Update
TAVALISSE (fostamatinib disodium) in ITP
During the Mid-Cycle Communication teleconference, the FDA confirmed that it was not currently planning to hold an ODAC meeting to discuss the NDA for fostamatinib in patients with chronic or persistent ITP. The FDA indicated that the review of fostamatinib is proceeding according to the standard internal review timeline as described in the Guidance on Good Review Management Principles and Practices for Prescription Drug User Fee Act (PDUFA) Products. Under the PDUFA, the action date for the FDA to complete its review will be April 17, 2018.

Update on Fostamatinib in Autoimmune Hemolytic Anemia (AIHA)
The Phase 2, open-label, multi-center, Simon two-stage study of fostamatinib for the treatment of warm AIHA recently completed enrollment of Stage 1. The study is evaluating the safety and efficacy of fostamatinib, at 150mg BID (twice daily), in patients with warm AIHA who have previously received at least one treatment for this disease, but did not have a meaningful benefit and are still anemic.

Stage 1 of the 12-week study enrolled 17 patients. As of September 30, 2017, four patients responded during the 12-week evaluation period and an additional two patients met the response criteria in the extension study after 12 weeks of dosing, for a response rate of 35% (6/17) on fostamatinib (these data are preliminary and require further verification). A response was defined as achieving a hemoglobin level of greater than 10 g/dl and at least a 2 g/dl increase from baseline. The safety profile was consistent with the existing fostamatinib safety database.

Fostamatinib in IgA Nephropathy (IgAN)
Rigel has completed enrollment of the second cohort in its Phase 2 study of fostamatinib in IgAN. Similar to the first cohort, which reported results in January 2017, the study will evaluate the efficacy, safety, and tolerability of fostamatinib as measured by change in proteinuria, renal function, and histology (comparing the pre- and post-study renal biopsies). However, the second cohort evaluates a higher dose of fostamatinib, 150mg BID, while the first cohort evaluated 100mg BID. The primary efficacy endpoint is the mean change of proteinuria from baseline at 24 weeks.

Additional Product Development
During the second quarter of 2017, Rigel selected a molecule from its IRAK program for preclinical development. The molecule is differentiated in that it inhibits both the IRAK 1 and IRAK 4 signaling pathways, with potential to treat autoimmune and inflammatory diseases such as lupus, gout, psoriatic arthritis and multiple sclerosis. The company expects to initiate clinical trials in 2018.

About ITP
ITP affects approximately 65,000 adult primary patients in the US. In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising, bleeding and fatigue. People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies and as a result, there remains a significant medical need for additional treatment options for patients with chronic ITP.

About AIHA
AIHA is a rare, serious blood disorder where the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the US and can be a severe, debilitating anemia. To date, there are no FDA approved disease-targeted therapies for AIHA, despite the tremendous medical need that exists for these patients as disease relapse is common. Instead, physicians generally treat acute and chronic cases of the disorder with corticosteroids, IV immunoglobulin infusion, other immuno-suppressants, or splenectomy (surgical removal of the spleen).

About IgAN
IgAN (also known as Berger’s disease) is a chronic autoimmune disease associated with inflammation in the kidneys that diminishes their ability to filter blood. It is the most common primary glomerular disease affecting an estimated 82,500 to 165,000 cases in the US, with a higher prevalence in Asia. For as many as 25 percent of those living with IgAN, the disease results in end-stage renal failure requiring dialysis or kidney transplantation. Other than angiotensin blockade (primarily for blood-pressure control), there are no disease-targeted therapies for IgAN.

Conference Call and Webcast Today at 5:00PM Eastern Time
Rigel will hold a live conference call and webcast today at 5:00pm Eastern Time (2:00pm Pacific Time).

Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 4894258. The conference call will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

On November 7, 2017 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, reported financial results for the third quarter ended September 30, 2017, and provided a corporate update (Press release, Alder Biopharmaceuticals, NOV 7, 2017, View Source [SID1234521711]).

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"In the third quarter, we continued to showcase the positive results of eptinezumab, our lead pivotal-stage product candidate for the prevention of migraine, and recently had seven presentations at the 18th Congress of the International Headache Society," said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. "We are encouraged by the migraine community’s excitement regarding eptinezumab’s unique clinical profile, including migraine prevention as early as Day 1 and >75% responder rates achieved by month one and sustained for three months from one administration. As the first-to-market anti-CGRP infusion therapy, we are confident that eptinezumab can address a distinct market segment of five million of the most severe episodic and chronic patients who are heavily impacted by migraine. Importantly, we remain on track to announce top-line data our PROMISE 2 Phase 3 pivotal trial in the first half of 2018 and complete our planned BLA submission in the second half of 2018. We look forward to delivering on our mission to transform the treatment of migraine and creating long-term value for our shareholders."

Recent Corporate Highlights

•
Completed patient enrollment in PROMISE 2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 2), the Company’s ongoing Phase 3 pivotal trial evaluating the safety and efficacy of eptinezumab administered via infusion once every three months in approximately 1,050 patients with chronic migraine.

•
Delivered seven presentations at the 18th Congress of the International Headache Society (IHC) in Vancouver, Canada in September 2017 providing clinical data and analyses for eptinezumab, including additional Phase 3 data from the PROMISE 1 Phase 3 pivotal trial and analyses of Alder’s Phase 2b clinical trial. The data presented further supported eptinezumab’s clinical profile as a potential first-of-its-kind, highly differentiated infusion therapy to prevent migraine.

Upcoming Milestones

•
Report top-line data from the PROMISE 2 pivotal trial in the first half of 2018.

•
Submit the BLA for eptinezumab with the U.S. Food and Drug Administration (FDA) in the second half of 2018.

Third Quarter 2017 Financial Results

Research and development expenses for the quarter ended September 30, 2017 totaled $52.2 million, compared to $29.5 million for the same period in 2016. This increase over the same period last year reflects the company’s commitment to advancing the pivotal-stage eptinezumab program and commercialization preparations.

General and administrative expenses for the quarter ended September 30, 2017 totaled $8.2 million, compared to $6.2 million for the same period in 2016. The increases in spending were primarily due to an increase in stock-based compensation expense and salaries due to headcount growth, and an increase in professional fees and other administrative costs primarily to support commercial readiness activities.

Net loss for the quarter ended September 30, 2017 totaled $59.6 million, or $0.92 per share, compared to net loss of $35.1, or $0.70 per share, on a fully-diluted basis, for the same period in 2016.

Cash, cash equivalents, short-term investments and restricted cash totaled $340.9 million as of September 30, 2017, compared to $224.5 million as of June 30, 2017.

Financial Outlook

Alder estimates its available cash and cash equivalents and short-term investments, will be sufficient to meet the company’s projected operating requirements through late 2018/early 2019 and enable the Company to achieve the planned BLA submission for eptinezumab and other key eptinezumab activities.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 4399736. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for 30 days.

Verastem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Verastem, 2017, NOV 7, 2017, View Source [SID1234521639]).

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Galectin Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Galectin Therapeutics, 2017, NOV 7, 2017, View Source [SID1234521695]).

Schedule your 30 min Free 1stOncology Demo!
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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

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