BridgeBio PharmaNASDAQ: BBIO

BridgeBio announced the FDA approval of Attruby (acoramidis) for the treatment of patients with ATTR-CM. The label looks clean and it includes all the relevant clinical data. Attruby's approval also triggers a $500 million milestone payment to BridgeBio under the royalty-backed deal it signed earlier this year and removes a regulatory and funding overhang on the stock.

The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.

- Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes

- In Cohort 5 of PROPEL 2, daily oral treatment of infigratinib at 0.25mg/kg resulted in statistically significant and sustained increases in annualized height velocity (AHV), with a mean change from baseline of +2.50cm/year at Month 18 (P=0.001)

- Case study co-authored by members of BridgeBio senior management and BridgeBio co-founder and MIT professor, Andrew W. Lo, Ph.D.

Upcoming Food and Drug Administration decisions could push these stocks through the roof.

PALO ALTO, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced today that outcomes data through 42 months from the ongoing long-term open-label extension of ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be shared in a featured science oral presentation at the American Heart Association (AHA) Scientific Sessions, taking place in Chicago, Illinois on November 16 – 18, 2024. In addition to the presentation, BridgeBio was selected to share three posters in moderated poster sessions on ATTR-CM.

- Acoramidis treatment led to a highly significant reduction in all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared with placebo

Investors are optimistic that small- and mid-cap stocks will rally this year after a tough 2023, as attention shifts from the AI-focused Magnificent Seven.