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Key FDA Decisions Soon on Akebia, Bristol-Myers and Novartis Drugs

Will companies' share prices move on approval or denial?

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Mar 07, 2022
Summary
  • Expected revenues would be biggest boon to Akebia.
  • Others awaiting agency rulings include TG Therapeutics, Marinus and Sol-Gel Technologies.
  • Merck and Roche will be watching judgment on Bristol treatment.
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Do Food and Drug Administration decisions—thumbs up or thumbs down—affect the stock prices of companies seeking drug approvals? We’re likely to find out this month as several key drugs are about to be ruled on. Included in this group are treatments from Akebia Therapeutics Inc. (

AKBA, Financial), Bristol-Myers Squibb Co. (BMY, Financial) and Novartis (NVS, Financial).

Akebia shareholders would welcome any bit of good news given the stock of the Cambridge, Massachusetts-based company is at $2.53, light years away from its all-time high near $30. Akebia expects to hear on March 29 whether the FDA votes yay or nay on vadadustat, which treats the anemia that comes with chronic kidney disease. Analysts at Evaluate think the medication could account for sales of more than $530 million by 2026. That would be a big boost for Akebia given the company’s 2021 revenue totaled $213.6 million, down about 28% from 2020.

Vadadustat should have an advantage over drugs in the same category from AstraZeneca (

AZN, Financial) and FibroGen Inc. (FGEN, Financial), both of which failed approval over safety issues, according to an article in Fierce Pharma. Although vadadustat did not show the same safety problems for kidney patients on dialysis, some have been noted for non-dialysis patients.

Approval of Bristol-Myers’ drug for multiple uses in immune-oncology cases could add $437 million to the company’s top line in 2026, Evaluate reported. The combination of the drug pending approval, relatlimab, with Opdivo held off cancer progression by 10.1 months as opposed to Opdivo by itself, which was effective for just 4.6 months.

The decision on relatlimab, due March 19, will be watched closely by Roche (

RHHBY, Financial) and Merck & Co. Inc. (MRK, Financial), who have drugs in the same category.

A medication with even greater sales potential than the two already named is a prostate cancer therapy from Novartis. Evaluate thinks the drug's sales could reach $851 million by 2026, which would allow the company to start earning a return on the $2.1 billion it paid Endocyte for the prostate cancer medication, an amount analysts thought was too high when the deal was made in 2018.

Novartis is asking for approval to use the drug in the late stages of prostate cancer, with a decision expected during the first half of the year. The company is also testing it as an early-stage treatment.

Other drugs scheduled for a March decision include TG Therapeutics Inc.’s (

TGTX, Financial) combination of Ukoniq and ublituximab, for chronic lymphocytic leukemia. Cantor Fitzgerald analyst Alethia Young projects blockbuster status for the drug if approved, with peak sales reaching $1.6 billion. Marinus Pharmaceuticals Inc.’s (MRNS, Financial) oral version of ganaxolone for epilepsy has an FDA target date of March 20. Sales are projected to be $384 billion in 2026. Sol-Gel Technologies (SLGL, Financial) and Galderma should hear soon on their application for Epsolay for the skin condition rosacea.

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I am/ we are currently short the stocks mentioned. Click for the complete disclosure
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