Going into the second month of this new year, biotech investors have a lot to look forward to. In particular, there are many promising drug candidates awaiting approval from the Food and Drug Administration (FDA), as well as a number of well-established drugs that are on the cusp of receiving expanded approval to treat new conditions.
Although there are quite a few drugs being evaluated in the upcoming weeks, not all of them are a big deal. Here are four of the most noteworthy FDA dates that biotech investors should watch out for in February.
1. Feb. 16: Agile's hormonal contraceptive
First on the list is a once-per-week hormonal contraceptive patch called Twirla being developed by small-cap biotech Agile Therapeutics (NASDAQ:AGRX). An earlier FDA advisory committee gave Twirla its non-binding approval back in fall, an announcement met with much enthusiasm from the company. Although the drug seems to be in a strong position now as it undergoes the agency's full review, Twirla has actually had a tumultuous history with healthcare regulators over the past several years.
The FDA initially rejected Twirla back in February 2013, demanding additional clinical testing from Agile before it would reconsider the drug. Four years later, the biotech gave it another shot, but was rejected a second time by the FDA. The main concerns behind this second rejection included questions about third-party manufacturing issues, as well as some concerns about Agile's phase 3 clinical trial -- specifically the notable withdrawal and dropout rates.
For investors holding out hope in the company, it's been a grueling period. Shares of Agile have lost most of their market value over the past few years. However, anticipation has been building for Feb. 16, when the FDA is expected to rule on the drug for the third time. Although there's a strong correlation between positive advisory committee recommendations and FDA approvals -- with approximately 78% of drug candidates that pass advisory committees winning full approval from the agency -- there's still a possibility that the agency could reject the drug a third time. Investors will have to wait to see whether the third time's truly the charm.
2. Feb. 18: Merck's Keytruda expansion
Merck's (NYSE:MRK) cancer superdrug, Keytruda, is already a blockbuster by any definition of the word. With total revenues for 2019 expected to come in around $10 billion and a 2025 projected revenue of $22.5 billion, Keytruda is well on its way to eclipsing AbbVie's Humira as the best-selling drug on the planet.
The drug is currently approved for a 200 mg dose every three weeks. This month, the agency will review a label expansion for the drug to include a single 400 mg dosing schedule once every six weeks. Patients with a number of conditions -- such as melanoma, gastric cancer, and Hodgkin lymphoma -- will have the option of choosing a six-week schedule if approved by the agency. The idea is that by taking a stronger dose less frequently, patients will be spending less time taking the cancer treatment, which takes 30 minutes per dosing session.
The European Union approved a six-week 400 mg dosing schedule for Keytruda back in March 2019, so it wouldn't be surprising if the FDA follows suit. The agency is expected to come to a decision regarding the 400 mg dosing plan on Feb. 18.
3. Feb. 21: Esperion's cholesterol drug
Esperion Therapeutics (NASDAQ:ESPR) has a much-anticipated LHL ("bad" cholesterol)-lowering drug currently under review by the FDA, with a response expected on Feb. 21. Bempedoic acid is a one-per-day oral treatment that's complimentary with other cholesterol-lowering drugs, giving patients and their physicians another option to choose from.
While there are a handful of drugs out there that already tackle cholesterol -- such as Amarin's recently approved Vascepa -- the sheer size of the cholesterol market makes up for the increased competition. By 2020, the global cholesterol drug market is expected to reach $22.2 billion. The market is large enough that Bempedoic acid could easily carve itself a niche among some patients who respond well to the drug.
4. Feb. 26: Eli Lilly's lung cancer treatment
Eli Lilly (NYSE:LLY) is expecting to hear from the FDA on Feb. 26 regarding Ramucirumab (also known as Cyramza).
The FDA advisory committee will discuss using Cyramza in combination with erlotinib for "first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations." Investors will be paying close attention to how the committee votes. The drug is already approved for treating four cancers, including being used in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy.
Lung cancer comes in two main varieties: small-cell and non-small-cell. Small-cell tends to be the more aggressive type of cancer, with around half the five-year survival rate of non-small-cell patients. However, the market for non-small-cell lung cancer is much larger, accounting for around 85% of all lung cancer cases.
While the global non-small-cell lung cancer market is estimated to come in at $10.5 billion by 2026, there's also plenty of competition already present in this area already. The aforementioned Keytruda is one such drug that's already become a leader in the market.
Editor's note: The information in this article about Cyramza has been updated.