Major Biopharma Catalysts and FDA Events to Look For in March

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Companies in the biotech and pharmaceutical industries are subject to a sizable amount of risk with regards to their drug candidates passing clinical trials and gaining regulatory approval. But with the risk of failure, which can spell disaster for a stock, comes great reward as well. Some companies can see massive upside just from winning a single midstage trial or even achieving as much as a Fast Track designation from the U.S. Food and Drug Administration (FDA).

In simpler terms, these updates within the industry have the potential to make or break biopharma companies.

Here 24/7 Wall St. includes a calendar of a few of the biggest companies expecting clinical trial and FDA updates in the month 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 outside and internal factors, or some of these dates may have changed already. Some of these date 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.

Insmed Inc. (NASDAQ: INSM) is expecting a New Drug Application (NDA) submission for its ALIS before the end of March. ALIS is a formulation of amikacin that is in late-stage clinical development for adult patients with treatment-refractory nontuberculous mycobacterial lung disease caused by mycobacterium avium complex. JMP Securities believes that there is a good chance the FDA will accept the filing for accelerated approval.

Shares of Insmed closed out the week at $24.29, with a consensus analyst price target of $38.11 and a 52-week trading range of $11.49 to $33.94.

Savara Inc. (NASDAQ: SVRA) is presenting Phase 2 Aironite data for HFpEF on March 11 at the American College of Cardiology. The study is being conducted by the Mayo Clinic with additional National Institutes of Health funding. Savara will provide study drug and nebulizers for the study, but no direct financial support. If the results are favorable, this could warrant a deal with a strategic partner.

Shares of Savara ended the week at $11.28, with a consensus price target of $25.75 and a 52-week range of $4.60 to $17.19.

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).

AnaptysBio Inc. (NASDAQ: ANAB) is expecting top-line data from its Phase 2 study of ANB020 in severe adult peanut allergies sometime in the month of March. One other thing to look out for is Aimmune Therapeutics Inc. (NASDAQ: AIMT), which on March 4 is presenting data for its Phase 3 Palisade trial for treating peanut allergies as well.

Shares of AnaptysBio closed the week at $128.55, with a consensus price target of $137.68 and a 52-week range of $18.15 to $134.00.

Aimmune shares were last seen at $34.07. The stock has a 52-week range of $15.97 to $42.00 and a consensus price target of $60.13.

Amgen Inc. (NASDAQ: AMGN) has a few things in the works for the month of March. First, the Oncologic Drugs Advisory Committee of the FDA will review data supporting the Blincyto (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia at a meeting on March 7. The firm also has a PDUFA target action date for Blincyto set for March 29.

Shares of Amgen closed on Friday at $185.08, with a consensus analyst target of $195.67 and a 52-week range of $152.16 to $201.23.

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 closed out the week at $11.32. The consensus price target is $11.43, and the 52-week range is $2.84 to $12.05.