A Run of FDA Target Dates Fills the Biotech Calendar From Late November to Year End

NEW YORK, Nov. 12, 2026 /CNW/ -- Biotech Today News Commentary - The final weeks of 2026 carry a cluster of U.S. Food and Drug Administration (FDA) target action dates for drugmakers. Five companies that issued quarterly results or pipeline updates between Oct. 29 and Nov. 9 have Prescription Drug User Fee Act (PDUFA) dates on record, according to their own releases, that fall between Nov. 27 and Dec. 27, 2026. The applications cover a form of limb-girdle muscular dystrophy, IgA nephropathy, multiple myeloma, acute pain and SCN2A and SCN8A developmental and epileptic encephalopathies. A PDUFA date is a target date for FDA action on an application. It is not a decision, and the outcome of each review is not known in advance. Active Companies from around the markets with current developments this week include: BridgeBio Pharma, Inc. (NASDAQ: BBIO), Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), Gilead Sciences, Inc. (NASDAQ: GILD), Viatris Inc. (NASDAQ: VTRS), and Praxis Precision Medicines, Inc. (NASDAQ: PRAX).

The dates below are taken from each company's own news releases and filings. BridgeBio and Vertex say their applications are under priority review, and Gilead and Viatris also reported recent FDA approvals for other products in their latest quarterly releases. Each listing gives the application, the target date as the company stated it and the latest results reported alongside it.

The listings run in order of the target dates, from Nov. 27 to Dec. 27, and two of the companies also list 2027 target dates for other candidates.

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BridgeBio Pharma, Inc. (NASDAQ: BBIO)

BridgeBio reported third quarter 2026 results on Oct. 29, with $353.2 million in total third quarter revenues, primarily comprised of $253.2 million of U.S. Attruby (acoramidis) net product revenue. Cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026. "I'm heartened by how consistently the evidence for acoramidis keeps pointing in the same direction," said Neil Kumar, Chief Executive Officer of BridgeBio.

The company said BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) has a November 27, 2026 PDUFA date, with Priority Review. It also listed a February 4, 2027 PDUFA date for oral infigratinib for achondroplasia and a May 8, 2027 PDUFA date for encaleret for autosomal dominant hypocalcemia type 1 (ADH1), each with Priority Review.

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)

Vertex reported third quarter 2026 results in a release furnished to the SEC on Nov. 2, with total revenue up 12% to $3.44 billion compared to the third quarter of 2025. The company raised its full year 2026 total revenue guidance to $13.15 billion to $13.25 billion from $13.1 billion to $13.2 billion previously, and noted that it completed its acquisition of Crinetics Pharmaceuticals in September.

Vertex said the BLA submission for accelerated approval of povetacicept in IgA nephropathy (IgAN) is under priority review by the U.S. FDA, with an assigned PDUFA target action date of November 30, 2026. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines. "Vertex delivered excellent third quarter results marked by strong revenue growth across the increasingly diversified portfolio, continued advancement of the R&D pipeline, and the successful close of the Crinetics Pharmaceuticals acquisition," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex.

Gilead Sciences, Inc. (NASDAQ: GILD)

Gilead reported third quarter 2026 results on Oct. 29, with total product sales up 13% to $8.3 billion and HIV product sales up 18% to $6.2 billion compared to the same period in 2025. The company said it now expects full year 2026 product sales of $31.0 billion to $31.3 billion, compared with $30.1 billion to $30.4 billion previously, and that since its prior quarterly release it received FDA approval for Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) for the treatment of HIV in adults who are virologically suppressed on a stable antiretroviral regimen.

In a Nov. 4 release, Gilead said the Biologics License Application for anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy for relapsed or refractory multiple myeloma, is under review with a PDUFA target date of December 23, 2026. "Gilead delivered an exceptional third quarter, with our strongest year-over-year base business growth in more than a decade, reflecting the strength, breadth and durability of our business," said Daniel O'Day, Gilead's Chairman and Chief Executive Officer.

Viatris Inc. (NASDAQ: VTRS)

Viatris reported third quarter 2026 results on Nov. 5, with total revenues of $3.75 billion, essentially flat on both a reported and operational basis compared to the third quarter of 2025, and raised its 2026 financial guidance midpoints for all metrics. The company said that in October it announced FDA approval of RYZUMVI (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults, and that its agreement to acquire Pacira BioSciences for $36.50 per share in cash is expected to close by the end of November 2026.

In May, Viatris said the FDA accepted for review its New Drug Application for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain, and assigned a PDUFA goal date of Dec. 27, 2026. "Our third-quarter results reflect strong execution and reinforce our confidence in the growth trajectory of our business," said Scott A. Smith, CEO, Viatris.

Praxis Precision Medicines, Inc. (NASDAQ: PRAX)

Praxis provided a corporate update and reported third quarter 2026 results on Nov. 9. The company said the NDA for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) remains under FDA review, with a PDUFA target action date of December 27, 2026, and that the NDA for ulixacaltamide in essential tremor remains under FDA review, with a PDUFA target action date of January 29, 2027.

Praxis said topline results from the EMERALD study of relutrigine in broad DEEs are expected in the fourth quarter of 2026, reported cash and investments of approximately $1.3 billion as of September 30, 2026, and said it will host an Investor Day on November 12, 2026. "We are entering a defining period for Praxis, with two key regulatory milestones ahead and the opportunity to become a commercial CNS company. Our teams are working to bring relutrigine and ulixacaltamide to patients who need new options," said Marcio Souza, President and Chief Executive Officer of Praxis Precision Medicines.

Between Nov. 27 and Dec. 27, five companies have FDA target dates on the calendar, each set out in the companies' own releases. To learn how to read the news and the charts behind stocks like these, get the free Knowledge is Power guide from Stock Preachers at https://biotech-today.com/sp/

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This article is independent news commentary. Biotech Today is wholly owned and operated by Market Equities Limited ("MEL"), a company incorporated under the laws of Ireland. MEL has not been paid by any company mentioned in this article. MEL and its owners, operators, directors, and affiliates do not currently own any shares of the companies mentioned in this article, but reserve the right to, and will, buy and sell shares of those companies at any time without further notice. PDUFA dates, product information, company figures and quotes are as stated in each company's own news releases and SEC filings dated May 18, 2026 through Nov. 9, 2026; a PDUFA date is a target action date and not an FDA decision. No intraday or closing market prices are cited in this article. Information is drawn from company news releases and filings, government and industry data, published reporting and third-party data believed to be reliable, but its accuracy is not guaranteed. Investing in securities carries risk, including the loss of some or all of your investment. This document is governed by the laws of Ireland.

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