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Puma Stock Jumps as Biotech Gets Good News From the FDA

Biotech PBYI FDA Puma Biotechnology Biotechnology Pharmaceuticals Cancer Drugs Health Care/Life Sciences Specialized Drugs/Medications Alan Auerbach Auerbach North America United States Regulation/Government Policy Financial Performance Share Price Movement/Disruptions New Products/Services New Product Approvals Corporate/Industrial News Breast Cancer Cancer Political/General News Demographic Health Health Medical Conditions Women's Health Content Types Factiva Filters C&E Exclusion Filter C&E Industry News Filter G/FDA I/BTC I/DRG M/HCR N/CNW N/GEN N/HLT N/PAP N/PBP N/PDT N/PFM R/NME R/US Barrons.com Barrons Blogs CODES_REVIEWED Biotech Health author Josh Nathan-Kazis author|Josh Nathan-Kazis author Josh Nathan-Kazis id Josh Nathan-Kazis name Josh Nathan-Kazis topicid 8583 rank 1 topicid barrons_display_subject BARBIO barrons_display_subject|BARBIO codetype BARRONS_DISPLAY_SUBJECT canbedisplaysubject true value BARBIO source MANUAL status modified name Biotech code BARBIO co usfda 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Biotech Gets Good News From the FDA Puma Stock Jumps as Biotech Gets Good News From the FDA

Regulators will let the biotech company change the label on its breast-cancer drug Nerlynx to include information that could help patients stay on the treatment. Puma Stock Jumps as Biotech Gets Good News From the FDA

Regulators will let the biotech company change the label on its breast-cancer drug Nerlynx to include information that could help patients stay on the treatment. https://www.reuters.com/article/us-otc-puma/in-rare-class-action-trial-jury-finds-puma-biotech-liable-for-fraud-but-puma-claims-victory-idUSKCN1PU2LF https://www.biospace.com/article/releases/fda-grants-orphan-drug-designation-to-puma-biotechnology-s-nerlynx-for-the-treatment-of-breast-cancer-patients-with-brain-metastases/ https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-reduce-risk-breast-cancer-returning mailto:josh.nathan-kazis@barrons.com Puma Stock Jumps as Biotech Gets Good News From the FDA By Josh Nathan-Kazis Pixabay

Puma Biotechnology stock leapt 13% late Wednesday on news that regulators will let the biotech company change the label on its breast-cancer drug Nerlynx to include information that could help patients stay on the treatment.

“We believe FDA approval of the labeling supplement will help us to ensure that physicians and patients are better informed in selecting prophylactic therapy that may improve the tolerability of the drug,” said Puma CEO Alan Auerbach in a statement on Wednesday.

The surge moderated by Thursday morning, with shares up 3.5% in premarket trading.

The approval by the Food and Drug Administration allows Puma (ticker: PBYI) to update the label on Nerlynx, which is used to prevent recurrence of forms of early-stage breast cancer, to include safety information based on a trial that found that prophylactic treatment with certain antidiarrheal drugs reduced the rate at which patients discontinue use of Nerlynx due to diarrhea

The back story. Shares of Puma are down 51.7% so far this year. The company has faced legal issues, namely a securities-fraud class action that ended in February with both sides attempting to claim victory. In September, the FDA granted orphan drug designation to Nerlynx in breast cancer patients with brain metastases. The FDA initially approved Nerlynx in July 2017. It is intended to be taken to reduce the risk of recurrence of certain types of breast cancer after the initial treatment is complete.

What’s new. The new label approval announced Wednesday allows Puma to offer information based on initial results of the antidiarrheal trial on Nerlynx’s label.

The trial found that patients who received prophylactic treatment of loperamide, which is sold as Imodium, along with another drug called budesonide, stopped taking Nerlynx due to diarrhea at lower rate than patients who only used loperamide.

“We are pleased to be able to update the label for NERLYNX to include the data on the use of prophylactic loperamide plus budesonide,” Auerbach said.

Looking ahead. Puma shares face a long road to recovery. The stock is down 77.5% over the past 12 months. It fell 3.5% on Wednesday. It remains to be seen whether the additional labeling could help Nerlynx prescriptions and increase sales.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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