On October 30, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported financial results for the third quarter ended September 30, 2018 (Press release, Aduro Biotech, OCT 30, 2018, View Source;p=RssLanding&cat=news&id=2374236 [SID1234530366]). Net loss for the third quarter of 2018 was $23.1 million, or $0.29 per share, and for the nine months ended September 30, 2018 net loss was $69.0 million, or $0.88 per share, compared to net loss of $24.5 million, or $0.33 per share, and net loss of $65.7 million, or $0.92 per share, respectively, for the same periods in 2017.

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Cash, cash equivalents and marketable securities totaled $278.6 million at September 30, 2018, compared to $349.7 million at December 31, 2017.

"Our strong cash position enables us to advance our lead STING agonist, ADU-S100, and novel anti-APRIL antibody, BION-1301, toward maturing data from ongoing clinical studies. We look forward to presenting preliminary data on ADU-S100 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C.," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.

Revenue was $3.1 million for the third quarter of 2018 and $12.3 million for the nine months ended September 30, 2018, compared to $3.8 million and $13.5 million, respectively, for the same periods in 2017. The decrease in revenue for both periods was primarily due to the adoption of the ASC 606 accounting standard on January 1, 2018, which resulted in a change in revenue recognition methodology for our Novartis collaboration revenue.

Research and development expenses were $18.7 million for the third quarter of 2018 and $58.2 million for the nine months ended September 30, 2018, compared to $24.5 million and $66.5 million, respectively, for the same periods in 2017. The decrease in research and development expenses for both periods was primarily due to lower expenses for our antibody programs, including contingent consideration and contract manufacturing related to ADU-1604 and BION-1301, respectively.

General and administrative expenses were $9.1 million for the third quarter of 2018 and $27.0 million for the nine months ended September 30, 2018, compared to $8.5 million and $25.0 million, respectively, for the same periods in 2017. The increase in general and administrative expenses for both periods was primarily due to outside professional services and consulting costs as well as higher stock-based compensation expense.

On October 30, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that the next stage of development for its CD33 ARC (Antibody Radiation Conjugate) Ac-225-Lintuzumab program, after successful completion of the Actimab-A phase 2 trial in Acute Myeloid Leukemia (AML), will incorporate two key initiatives; a pivotal trial pathway for its Actimab-MDS program for Myelodysplastic Syndromes (MDS), and also in two combination trials with Venetoclax for AML (Press release, Actinium Pharmaceuticals, OCT 30, 2018, View Source [SID1234530365]). Actinium’s development strategy for its CD33 program is being informed by: clinical data from 4 trials totaling over 100 patients including the recent Actimab-A Phase 2 trial in AML; positive interactions with the FDA regarding its Actimab-MDS trial; company research findings regarding potential synergy with Venetoclax; support from leading physicians; and attractiveness of the targeted indications given the unmet medical need and potential of its differentiated ARC modality in combination with chemotherapy.

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Actinium highlighted the outcome of its successful discussions with the FDA for the Actimab-MDS program, which resulted in guidance for an accelerated pathway to a pivotal trial after a short dose finding Phase 1 portion. Actinium’s initial proposal to the FDA was to conduct a larger Phase 2 trial prior to a pivotal trial in patients with a TP53 mutation, however, the company was encouraged by the FDA to expand the trial to include all high-risk patients with poor or very poor and complex cytogenetics. The program will use the ARC Ac-225-lintuzumab for targeted conditioning in combination with a reduced intensity dose of fludarabine and melphalan prior to a BMT or Bone Marrow Transplant in patients with high-risk Myelodysplastic Syndrome (MDS).

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "In our studies to date, we’ve seen that Ac-225 – Lintuzumab can achieve remissions with minimal extramedullary toxicities even in patients progressing to AML from MDS. Typically, high-risk MDS patients undergoing a BMT do poorly with standard conditioning resulting in poor outcomes. The goal of the Actimab-MDS program is to use our ARC AC-225 – Lintuzumab to target cells of the myeloid lineage including progenitor cells in combination with reduced intensity conditioning with the goal of achieving improved conditioning and BMT outcomes, as successful BMT is the only potentially curative treatment option for these patients. We are building on the data we already have from our CD33 program and we are excited to have a quicker pathway to a pivotal trial that targets a larger patient population than originally envisaged."

Actinium’s two combination trials with Venetoclax, a BCL-2 inhibitor that was jointly developed by AbbVie and Genentech, will leverage Actimab-A’s unique and differentiated mechanism of action to explore synergies between the two agents for patients with relapsed or refractory AML. Venetoclax is an approved drug for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) and a supplemental New Drug Application (NDA) has been submitted to the FDA for patients newly diagnosed with AML. The first proposed study will evaluate Actimab-A in combination with Venetoclax and will be led by Dr. Gary Schiller, Director, Hematology/Stem Cell Transplantation at UCLA Medical center. The second study will evaluate Actimab-A in combination with Venetoclax and hypomethylating agents and will be conducted in collaboration with Dr. Hagop Kantarjian and Dr. Tapan Kadia of the MD Anderson Cancer Center. The company is pursuing these combination trials with Actimab-A and Venetoclax on the basis of internal preclinical studies which have demonstrated a synergistic effect between these two agents that is supported by a mechanistic rational. Specifically, patients with AML have high levels of MCL-1, a protein that mediates resistance to Venetoclax, which is known to be depleted by DNA damage caused by external radiation treatment. Preclinical studies have demonstrated that MCL-1 is effectively depleted by DNA damage caused by external radiation and Actinium believes that Actimab-A’s targeted radiation mechanism will therefore lead to a greater effect of Actimab-A plus Venetoclax, as demonstrated in the Company’s preclinical work.

Dr. Berger added, "Many therapeutic advances in oncology, and also in AML, have been the result of combination therapies. We are excited to be advancing our Actimab-A program in combination with Venetoclax, which has the potential to lead the next evolution of AML therapy, in collaboration with top thought leaders from leading medical institutions. As indicated by our collaborators during the CD33 Update webinar, while results with Venetoclax in patients with AML are encouraging, there remains a high unmet need for durable responses and curative outcomes. We believe Actimab-A can be used in combination with Venetoclax to improve patient outcomes, which is based on a strong scientific rationale supporting the combination as well as preclinical and clinical data. Our proposed trials with these combinations demonstrate the strong investigator interest we have seen for working with Ac-225 – Lintuzumab as an Antibody Radiation Conjugate is a new therapeutic modality for patients with radiation sensitive cancers such as AML, MDS and Multiple Myeloma that has the potential to improve their outcomes."

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "Having a clear and relatively quick pathway to a pivotal trial for Actimab-MDS materially strengthens our targeted conditioning pipeline. It also enhances our outlook for building a business focused on developing and launching multiple products for targeted conditioning prior to BMT or CAR-T that can improve both patient access and outcomes due to their superior safety and efficacy balance compared to non-targeted chemotherapy that is current standard of care. With the solid progress of the Iomab-B Phase 3 trial for BMT, the recent launch of the Iomab-ACT program for CAR-T and the solid impetus for a near-term Actimab-MDS pivotal trial, our pipeline prospects for targeted conditioning have never been better."

Mr. Seth added, "The Actimab-A trial which was recently closed has been a big success as it has provided the foundation for the near-pivotal Actimab-MDS program in an area where there is high unmet need, no competing development programs by other companies and a larger patient population than originally envisaged. Additionally, our combination trials with Venetoclax and Actimab-A are very exciting as we have the opportunity to validate our preclinical research showing superiority of the combination in two highly relevant clinical settings where the unmet medical need continues to be high. Based on these recent developments, our CD33 Program has evolved much beyond the narrow AML focused CD33 programs in the industry due to the versatility of our ARC technology. The ARC approach has allowed us to expand into other radiation sensitive diseases such as multiple myeloma and MDS, and into targeted conditioning using high doses of the ARC as well as therapeutic combinations at lower ARC doses which allow incorporation of targeted radiation as another modality to treat highly radiation sensitive cancers."

"In addition," said Mr. Seth, "from a strategic perspective, the Actimab-MDS targeted conditioning trial strengthens our go-it-alone outlook. However, the other CD33 program developments including combination trials increase its attractiveness to potential collaborators and are expected to provide our company with attractive optionality going forward, as the period between now and 2019 are expected to yield several valuable clinical milestones and data readouts. We look forward to providing updates as value in this program continues to build.".

On October 30, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its third quarter 2018 financial and operating results after the close of U.S. financial markets on Monday, November 5, 2018 (Press release, Alder Biopharmaceuticals, OCT 30, 2018, https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-third-0 [SID1234530364]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

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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 9574606. The webcast can be accessed from the Events & Presentations page of the Investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for at least 30 days.

On October 30, 2018 Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2018. Net loss was $1.3 million, or $0.11 per share (Press release, Pain Therapeutics, OCT 30, 2018, View Source [SID1234530363]). This compared to a net loss of $2.6 million, or $0.40 per share, for the same period in the prior year. Cash and cash equivalents were $20.4 million as of September 30, 2018, including net proceeds of approximately $12.3 million from common stock offerings during the quarter. The Company has no debt.

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"We are quite excited to advance our drug candidate for Alzheimer’s disease into a Phase IIa study," said Remi Barbier, President and CEO of Pain Therapeutics. "It helps that the science program stands up to rigorous, peer-reviewed evaluation, as evidenced by recently announced NIH grants, representing up to $6.7 million of non-dilutive financing."

Financial Highlights for Third Quarter 2018

Net loss was $1.3 million compared to $2.6 million for the same period in the prior year, representing a 51% decrease. Net loss per share was $0.11 compared to $0.40 for the same period in the prior year.
Cash and cash equivalents were $20.4 million as of September 30, 2018, compared to $9.6 million as of June 30, 2018. Cash and cash equivalents at September 30, 2018 included $10.3 million of net proceeds raised through a sale of common stock and issuance of warrants and $2.0 million of net proceeds raised through our At-The-Market common stock offerings. We have no debt outstanding.
We received research grant funding reimbursements of $1.1 million from the National Institutes of Health ("NIH") and recorded this as a reduction in research and development expenses ("R&D"). This compared to $0.8 million of NIH grant receipts received for the same period in the prior year.
R&D expenses were $0.4 million. This compared to $1.6 million for the same period in the prior year, representing a 73% decrease. R&D expenses included non-cash stock related compensation costs of $0.2 million, compared to $0.3 million for same period in the prior year.
General and administrative ("G&A") expenses were $0.8 million. This compared to $1.0 million for the same period in the prior year, representing a 13% decrease. G&A expenses included non-cash stock-related compensation costs of $0.3 million, compared to $0.4 million for the same period in the prior year.
On August 17, 2018, we announced the closing of a registered direct offering of 8,860,778 shares of our common stock and issuance of warrants. Total net proceeds from the offering were approximately $10.3 million.
In August and in October 2018, we announced that the NIH had awarded us research grants to support a Phase II program with PTI-125, our drug candidate to treat Alzheimer’s disease. Collectively, these two NIH grants represent up to $6.7 million of non-dilutive financing.
Third Quarter Developments

Our lead drug candidate has historically been REMOXY, a proprietary abuse-deterrent, extended-release form of oxycodone to treat severe chronic pain. On August 3, 2018, we received a Complete Response Letter ("CRL") from the Food and Drug Administration ("FDA") for our New Drug Application ("NDA") for REMOXY, stating that the data submitted in the NDA does not support the conclusion that the benefits of REMOXY outweigh the risks.

Based on data, we disagree with the FDA’s actions around REMOXY. Consequently, a formal dispute may arise between ourselves and the FDA. The FDA has in-place an administrative process to resolve complex scientific/medical disputes, which is called a Formal Dispute Resolution ("FDR"). Pending further discussions with the FDA, we may or may not chose to appeal the REMOXY CRL through an FDR or take other measures. If we appeal there can be no assurance that such appeal will satisfactorily resolve any scientific/medical disputes between ourselves and the FDA.

If we do not prevail in an FDR, or if we chose not to pursue an FDR, we may immediately cease development of REMOXY.

On October 2, 2018, we announced a strategic reorganization to align Company resources on advancing our drug and diagnostic pipeline in Alzheimer’s disease. On October 4, 2018, we provided details of our neuroprotection program during a conference call and presentation.

On October 11, 2018, we announced the appointment of Mr. Eric Schoen as Chief Financial Officer, effective on or before November 7, 2018.
About the Neuroprotection Program
Our lead drug candidate, PTI-125, is a small molecule with a unique mechanism of action for treating Alzheimer’s disease ("AD"). We expect to initiate a Phase IIa study with PTI-125 in AD in Q4 2018.

The underlying science for PTI-125 is published in prestigious peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, and Neuroimmunology and Neuroinflammation, and benefits from several peer-reviewed research grant awards from the NIH.

We are also developing a blood-based test, called PTI-125Dx, to detect whether a person has Alzheimer’s disease, possibly years before any symptoms appear. An early diagnosis of AD could optimize treatment options and empower physicians and patients to slow or halt the disease.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with AD may be unable to carry out even the simplest tasks. There is a profound and timely need to develop new drugs for Alzheimer’s. Currently, there are no drug therapies to halt Alzheimer’s, much less reverse its course

On October 30, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, Blueprint Medicines, OCT 30, 2018, View Source;q=View Source;source=gmail&ust=1541070221980000&usg=AFQjCNEV72tiQ5N9U9Dom5ERVILd_aDycQ [SID1234530361]).

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"Our third quarter and recent accomplishments represent tremendous progress across our portfolio, marked by the receipt of positive regulatory feedback from the FDA for avapritinib and BLU-667 and the presentation of new data across our clinical- and research-stage pipeline," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "As we prepare to enter a critical year, we are now accelerating our efforts with a focus on executing five registration-enabling studies across seven patient populations, building a global commercial enterprise to deliver medicines to patients and investing in the next generation of precision therapies."

Clinical Programs:

Avapritinib: Systemic Mastocytosis (SM)

Blueprint Medicines announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to avapritinib for the treatment of patients with advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.
Blueprint Medicines announced that it has screened the first patient in PATHFINDER, its registration-enabling, open-label, single-arm Phase 2 clinical trial in patients with advanced SM. Blueprint Medicines expects to initiate PIONEER, its registration-enabling, randomized, placebo-controlled Phase 2 clinical trial in patients with indolent and smoldering SM, by the end of 2018.
Blueprint Medicines announced that the European Medicines Agency has granted orphan drug designation to avapritinib for the treatment of mastocytosis.
Enrollment in the expansion portion of the Phase 1 EXPLORER clinical trial for advanced SM is ongoing. Blueprint Medicines plans to present data from this trial at the 60thAmerican Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018.
Avapritinib: Gastrointestinal Stromal Tumors (GIST)

Blueprint Medicines continues to evaluate avapritinib in its Phase 1 NAVIGATOR clinical trial and will present updated data across multiple patient populations, including PDGFRA-driven GIST, third-line or later GIST, and second-line GIST, at the 2018 Connective Tissue Oncology Society (CTOS) Annual Meeting on November 15, 2018. Based on data from this trial, Blueprint Medicines plans to submit a new drug application (NDA) to the FDA for avapritinib for the treatment of patients with PDGFRα Exon 18 mutant GIST and fourth-line GIST in the first half of 2019.
BLU-667: RET-Altered Solid Tumors

Blueprint Medicines recently received written feedback from the FDA supporting expedited development of BLU-667 and plans to submit an NDA for BLU-667 in the first half of 2020 based on additional data from the ongoing Phase 1 ARROW trial. Based on the feedback from the FDA, Blueprint Medicines currently expects the NDA submission will be for separate potential indications: (1) patients with RET-fusion positive NSCLC and papillary thyroid cancer (PTC) who have progressed following prior systemic therapy and (2) patients with RET-mutant medullary thyroid cancer (MTC) who have progressed following treatment with a tyrosine kinase inhibitor.
In October 2018, Blueprint Medicines presented updated data from its ongoing Phase 1 ARROW clinical trial of BLU-667 in patients with MTC and PTC at the 88th Annual Meeting of the American Thyroid Association. The data showed that BLU-667 is highly active and well-tolerated in these patient populations, with increased activity observed at higher dose levels and longer treatment durations. Ninety percent of evaluable patients with MTC and PTC experienced radiographic tumor reductions, regardless of RET alteration or prior multi-kinase inhibitor therapy. The response rate was 62 percent in patients with MTC in the 300 and 400 milligram once daily dose groups who were treated for at least 24 weeks. The data also showed that BLU-667 was well-tolerated, and most adverse events reported by investigators were Grade 1. Read the full data here.
In September 2018, Blueprint Medicines presented two clinical case studies demonstrating proof-of-concept for BLU-667 in combination with Tagrisso (osimertinib) in patients with treatment-resistant, EGFR-mutant NSCLC harboring an acquired RET fusion. The data showed that the combination of BLU-667 and osimertinib overcame resistance to standard therapy, and both patients achieved a partial response with a 78 percent reduction in target tumors per RECIST version 1.1. In these two patients, the combination was well-tolerated, and all reported adverse events were Grade 1 or 2. Read the full data here.
BLU-554: Hepatocellular Carcinoma (HCC)

In September 2018, Blueprint Medicines and its partner, CStone Pharmaceuticals, submitted an investigational new drug (IND) application for BLU-554 to Chinese health authorities. Subject to approval of the IND application, the companies plan to expand Blueprint Medicines’ ongoing Phase 1 clinical trial of BLU-554 as a monotherapy for the treatment of advanced HCC to include clinical sites in Mainland China. Additionally, the companies plan to initiate a proof-of-concept clinical trial evaluating BLU-554 in combination with CS1001, a clinical-stage anti-PD-L1 immunotherapy, in 2019.
Research Programs:

BLU-782: Fibrodysplasia Ossificans Progressiva (FOP)

In September 2018, Blueprint Medicines presented preclinical proof-of-concept data for BLU-782, an investigational precision therapy specifically designed to target the underlying cause of FOP, at the 2018 American Society for Bone and Mineral Research Annual Meeting. The data showed that BLU-782 prevented injury- and surgery-induced heterotrophic ossification, reduced edema and restored healthy tissue response to muscle injury in a well-characterized FOP mouse model. Read the full data here.
Blueprint Medicines expects to submit an IND application to the FDA for BLU-782 by the end of 2018, and subject to review of the IND application, plans to initiate a Phase 1 clinical trial in healthy volunteers in the first quarter of 2019. Upon completion of the Phase 1 clinical trial, Blueprint Medicines plans to advance BLU-782 into a registration-enabling Phase 2 clinical trial in patients with FOP.
Corporate:

In October 2018, Blueprint Medicines announced the expansion of its leadership team with the appointment of Christina Rossi as Chief Commercial Officer. Blueprint Medicines also announced the appointment of Paul Beresford as General Manager, International.
Third Quarter Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $559.6 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment achieved under the Roche collaboration in June 2018.
Collaboration Revenues: Collaboration revenues were $1.1 million for the third quarter of 2018, as compared to $8.1 million for the third quarter of 2017. This decrease was primarily due to the termination of the Alexion agreement in 2017.
R&D Expenses: Research and development expenses were $64.6 million for the third quarter of 2018, as compared to $39.3 million for the third quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $4.8 million in stock-based compensation expenses for the third quarter of 2018.
G&A Expenses: General and administrative expenses were $12.0 million for the third quarter of 2018, as compared to $7.4 million for the third quarter of 2017. This increase was primarily due to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.6 million in stock-based compensation expenses for the third quarter of 2018.
Net Loss: Net loss was $72.7 million for the third quarter of 2018, or a net loss per share of $1.66, as compared to a net loss of $37.7 million for the third quarter of 2017, or a net loss per share of $0.96.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Earnings Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 626-8618 (domestic) or (531) 289-2784 (international) and referring to conference ID 7598866. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

CTOS Conference Call Information:

Blueprint Medicines will host a live conference call and webcast to discuss data being presented at the 2018 CTOS Annual Meeting on November 15th at 7:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 3479587. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.