Soaring interest rates have been a disaster for biotech stock prices this year. Luckily, the U.S. Food and Drug Administration (FDA) doesn't take any macroeconomic factors into account when reviewing applications for experimental new drugs.
The outlook for biotech stocks is generally murky, but there is a handful that could soar before the end of the year. All three of these drugmakers have new drug applications in front of the FDA that the regulator is expected to rule on between now and Jan. 6, 2022.
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Blockbuster new drug approvals could send these biotech stocks screaming higher over the next couple of months, but there are no guarantees. Here's what investors should know about the road ahead for all four of these biotech stocks.
Biogen and Eisai
On or before Jan. 06, 2023, Biogen (BIIB 0.23%) and its collaboration partner, Eisai, could earn accelerated approval for a new Alzheimer's disease drug called lecanemab. The partners shocked the medical community in September with top-line pivotal trial results that show treatment with lecanemab significantly slowed cognitive decline for patients with early-stage Alzheimer's disease.
So far, we've seen limited results from the pivotal trial with lecanemab. On Nov. 29, Eisai and Biogen will present more data that could further confirm the exciting top-line results that sent both stocks higher in September.
In 2020, the FDA came under fire for granting accelerated approval to a similar drug from Biogen and Eisai called Aduhelm. Treatment with Aduhelm dramatically reduced amyloid protein fragments in patients' brains and the toxic plaques those fragments form. The partners have had to shelve marketing plans for Aduhelm because clinical trials so far haven't been able to confirm a cognitive benefit.
With the Aduhelm debacle still fresh in everyone's memory, I'll be more than a little surprised if the FDA grants lecanemab an accelerated approval on or before Jan. 6. That's because the application for accelerated approval doesn't incorporate the new phase 3 trial data the partners reported in September.
Gilead Sciences
Long before Gilead Sciences (GILD -0.21%) became famous for its COVID-19-fighting antiviral, Veklury, the company was a pioneer of HIV drugs. By Dec. 27, 2022, we'll know if the company's long-lasting injection, lenacapavir, has a chance at becoming its next blockbuster HIV treatment.
Lenacapavir binds to HIV in a unique way. If approved, it could be the first drug that keeps the virus under wraps with just one treatment every six months. This year, the FDA is expected to approve it for use by treatment-resistant HIV patients. Subsequent label expansions, though, could eventually make it a go-to drug for most members of the HIV-positive community and drive sales past $4 billion annually at its peak.
Earlier this year, the agency swatted down Gilead's first application for lenacapavir, citing a potential interaction between the drug and the glass vials it was stored in. Now that Gilead has swapped out the troublesome glass that hobbled lenacapavir's U.S. application, a positive approval decision looks highly likely. In a pivotal trial supporting its application, the candidate helped 83% of patients with drug-resistant HIV lower their viral load to undetectable levels.
Mirati Therapeutics
Mirati Therapeutics (MRTX) is a clinical-stage biotech developing a lung cancer candidate called adagrasib. This experimental treatment blocks mutated KRAS proteins from causing normal cells to become cancerous.
The FDA is reviewing adagrasib's application and is expected to issue an approval decision by Dec. 14, 2022. If approved, Mirati's candidate will compete with Lumakras, another KRAS inhibitor from Amgen that the FDA approved in 2021.
Lung cancer is the deadliest of all malignancies, and drugs that treat the disease are some of the pharmaceutical industry's top sellers. Lumakras sales soared to an annualized $308 million in the second quarter, and there's a chance that Mirati's drug could prove even more popular.
There are no doubts about Lumakras' ability to shrink tumors or delay disease progression. Unfortunately, Amgen hasn't been able to prove that its drug actually improves patients' chances of long-term survival. Mirati is currently running a trial with adagrasib that's looking for an overall survival benefit. If it finds one, this stock could rocket higher.
