Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to great, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
In simpler terms, these updates within the industry have the potential to make or break biopharma companies.
Here, 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates for the rest of March. We have added some color, a recent trading history and a consensus analyst price target.
It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and some can be disasters if a company is deeply financed.
As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Arena Pharmaceuticals Inc. (NASDAQ: ARNA) is expected to release Phase 2 data for etrasimod in the treatment of ulcerative colitis sometime later this month. Etrasimod has other indications for primary biliary cholangitis and pyoderma gangrenosum, and Arena will report data later this year.
Shares of Arena closed out the week at $31.51 apiece, with a consensus analyst price target of $51.57 and a 52-week trading range of $11.30 to $44.50.
Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY) announced this past week that additional results from its APOLLO Phase 3 study of patisiran, an investigational therapeutic for the treatment of hereditary ATTR amyloidosis, which will be presented at the 16th International Symposium on Amyloidosis being held March 26 to 29, 2018, in Kumamoto, Japan.
Additionally, new data from the Phase 1 trial of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic for the treatment of ATTR amyloidosis, will also be presented at that time.
Shares of Alnylam were last seen trading at $145.06, in a 52-week range of $46.90 to $152.75.
The International Liver Congress is releasing abstracts on March 28. However, the event actually will take place in Paris, France, between April 11 and 15. Among the big movers that we could see from this group could be Madrigal Pharmaceuticals Inc. (NASDAQ: MDGL), Arbutus Biopharma Corp. (NASDAQ: ABUS), Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) and Spring Bank Pharmaceuticals Inc. (NASDAQ: SBPH).
ImmunoGen Inc. (NASDAQ: IMGN) will present updated dose-escalation findings from the Forward II mirvetuximab plus Keytruda combination cohort at the Society of Gynecologic Oncology annual meeting between March 24 and 27. This will be Phase 1 data for the treatment of ovarian cancer and relapsed endometrial cancer.
Shares of ImmunoGen ended the week at $12.22. The consensus price target is $11.43, and the 52-week range is $2.84 to $12.38.
Amgen Inc. (NASDAQ: AMGN) has a PDUFA target action date for Blincyto set for March 29. Blincyto works to treat minimal residual disease in patients with acute lymphoblastic leukemia.
Amgen shares closed at $185.08 on Friday, with a consensus analyst target of $195.67 and a 52-week range of $152.16 to $201.23.