Agios Pharmaceuticals Inc (NASDAQ:AGIO) outlined key 2017 milestones in conjunction with its presentation at the 35th Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will outline important milestones as Agios evolves into a commercial stage company, including potential launches for enasidenib and AG-120 in R/R AML, pivotal development for its second wholly owned asset, AG-348 in pyruvate kinase (PK) deficiency, and an investigational new drug (IND) application submission for the company’s next development candidate, focused on MTAP deleted cancers.
“This is the year Agios will evolve into a commercial-stage organization with the anticipated launch of enasidenib for patients with R/R AML, followed by the NDA submission of AG-120 and AG-348 preparing to enter a pivotal trial in PK deficiency,” said David Schenkein, M.D., chief executive officer of Agios. “We believe these milestones will enable us to achieve our vision of delivering important medicines with the potential to transform patients’ lives. Additionally, our robust research engine continues to be highly productive with an IND submission for the company’s sixth development candidate in eight years anticipated by the end of 2017.”
The company expects to achieve the following key milestones by the end of 2017:
- Potential approval of enasidenib in the United States for IDH2m positive R/R AML in collaboration with Celgene.
- Submit a new drug application (NDA) to the U.S. FDA for AG-120 by the end of 2017. AG-120 is a wholly owned, first-in-class, oral, selective, potent inhibitor of IDH1m, in IDH1m positive R/R AML.
- Initiate a global, registration-enabling Phase 3 study combining AG-120 and VIDAZA in frontline AML patients with an IDH1 mutation ineligible for intensive chemotherapy in the first half of 2017.
- Finalize design and operational activities for a global pivotal trial of AG-348 to initiate in the first half of 2018. AG-348 is a wholly owned, first-in-class, oral activator of both wild-type (normal) and mutated pyruvate kinase-R (PKR) enzymes, in PK deficiency.
- File an IND application for the MTAP pathway development candidate by the end of 2017.
The company also provided an update on the following 2016 milestones achieved in December:
- Supported Celgene’s submission of an NDA for enasidenib in IDH2m positive R/R AML.
- Initiated a global, registration-enabling randomized Phase 3 trial for AG-120 in IDH1m positive cholangiocarcinoma. The FDA also granted AG-120 Fast Track Designation for the treatment of patients with previously treated, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation.
- Selected a development candidate focused on the MTAP pathway to enter IND-enabling studies.
2016 Year-End Cash and Guidance
Agios ended 2016 with approximately $574 million of cash, cash equivalents and marketable securities. Based on its current operating plans, the company expects that its existing cash, cash equivalents and marketable securities as of December 31, 2016, together with anticipated interest income, and anticipated expense reimbursements under its collaboration agreements with Celgene, but excluding any additional program-specific milestone payments from Celgene, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2018. (Original Source)
Shares of Agios Pharmaceuticals are currently rising 3.22% to $47.50, or up $1.48 in pre-market trading Monday. AGIO has a 1-year high of $67.74 and a 1-year low of $33.50. The stock’s 50-day moving average is $50.67 and its 200-day moving average is $47.73.
On the ratings front, Agios Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on January 3, Oppenheimer analyst Leah R. Cann reiterated a Hold rating on AGIO. Separately, on December 16, Leerink Swann’s Michael Schmidt reiterated a Hold rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Leah R. Cann and Michael Schmidt have a yearly average loss of -2.0% and a return of 18.2% respectively. Cann has a success rate of 22% and is ranked #3150 out of 4350 analysts, while Schmidt has a success rate of 59% and is ranked #120.
Sentiment on the street is mostly bullish on AGIO stock. Out of 6 analysts who cover the stock, 4 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $58.50, which implies an upside of 23% from current levels.
Agios Pharmaceuticals, Inc. is a biopharmaceutical company which engages in applying scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders of metabolism. Its products include IDH1 AND IDH2, PKR, II D-2 hydroxyglutaric aciduria, AG-221 and AG-120.