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

The five applications span muscular dystrophy, kidney disease, cancer, acute pain and developmental epilepsies; review outcomes remain unknown.

Rhea-AI Summary

BridgeBio Pharma (BBIO) has a November 27, 2026 FDA target action date for BBP-418, opening a five-company year-end review calendar. The application covers limb-girdle muscular dystrophy type 2I/R9 and has priority review.

Vertex Pharmaceuticals (VRTX) has a November 30 target for povetacicept in IgA nephropathy, also under priority review. Gilead Sciences (GILD) has a December 23 target for anito-cel in relapsed or refractory multiple myeloma. Viatris (VTRS) has a December 27 goal for fast-acting meloxicam in moderate-to-severe acute pain. Praxis Precision Medicines (PRAX) has a December 27 target for relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies.

These are FDA action targets, not approval decisions. Recent updates also included raised 2026 outlooks at Vertex, Gilead and Viatris, alongside additional regulatory milestones in 2027.

11 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 9 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointVertex third-quarter 2026 revenue rose 12% to $3.44 billion versus third-quarter 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Vertex raised 2026 revenue guidance to $13.15–$13.25 billion from $13.1–$13.2 billion.
• Moderate pointVertex completed its Crinetics Pharmaceuticals acquisition in September 2026.
• Moderate pointGilead third-quarter 2026 product sales rose 13% to $8.3 billion versus the same period in 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Gilead raised expected 2026 product sales to $31.0–$31.3 billion from $30.1–$30.4 billion.
• Moderate pointGilead received Bixlenvo FDA approval for HIV in adults virologically suppressed on a stable antiretroviral regimen.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Viatris raised its 2026 financial guidance midpoints for all metrics.
• Moderate pointViatris announced RYZUMVI FDA approval in October for presbyopia in adults.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Viatris agreed to acquire Pacira BioSciences, with closing expected by the end of November 2026.

2 minor points

• Minor pointGilead third-quarter 2026 HIV product sales rose 18% to $6.2 billion versus the same period in 2025.
• Minor point. Forward-looking: it has not happened yet and may not happen.Praxis expects fourth-quarter 2026 topline results from EMERALD, studying relutrigine in broad developmental and epileptic encephalopathies.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Viatris Pacira acquisition requires $36.50 per share in cash.
• Minor pointBridgeBio BBP-418 remains pending FDA action, with priority review and a November 27, 2026 target.
• Minor pointBridgeBio infigratinib for achondroplasia has a pending February 4, 2027 FDA target, with priority review.
• Minor pointBridgeBio encaleret for autosomal dominant hypocalcemia type 1 has a pending May 8, 2027 FDA target, with priority review.
• Minor pointVertex povetacicept accelerated-approval application remains under priority review, targeting November 30, 2026 FDA action.

4 minor points

• Minor pointGilead anito-cel remains under FDA review, with a December 23, 2026 target date.
• Minor pointViatris fast-acting meloxicam application remains pending FDA action, with a December 27, 2026 goal date.
• Minor pointPraxis relutrigine remains under FDA review, with a December 27, 2026 target action date.
• Minor pointPraxis ulixacaltamide for essential tremor remains under FDA review, with a January 29, 2027 target.

Key Figures

Companies with PDUFA dates: 5 companies Anito-cel PDUFA target date: Dec. 23, 2026

Companies with PDUFA dates

5 companies

Target dates on record from Nov. 27 to Dec. 27, 2026

Anito-cel PDUFA target date

Dec. 23, 2026

Gilead application for relapsed or refractory multiple myeloma under review

Historical Context

1 past event · Latest: Nov 04

1 event

1. Nov 04

   FDA application update

   24h Move

   +4.2%

   Reported anito-cel follow-up context and the same December 23 FDA target date.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pdufa, biologics license application, new drug application, car t-cell therapy

4 terms

pdufa regulatory

"Prescription Drug User Fee Act (PDUFA) dates on record"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

biologics license application regulatory

"the Biologics License Application for anitocabtagene autoleucel"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

new drug application regulatory

"the New Drug Application for MR-107A-02"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

car t-cell therapy medical

"an investigational CAR T-cell therapy for relapsed or refractory multiple myeloma"

Car T-cell therapy is a medical treatment that uses a patient’s own immune cells, modified in a lab to better recognize and attack cancer cells. It is considered a breakthrough because it offers potentially long-lasting effects for certain types of cancer. For investors, its development and approval can signal advances in healthcare innovation and potential growth opportunities in the biotech sector.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

NEW YORK, Nov. 12, 2026 /PRNewswire/ -- 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.

Biotech headlines move fast, and the chart shows how a stock responds to them. Our sister site, Stock Preachers, offers Knowledge is Power, a free 27-page guide in 10 chapters that teaches reading the news and reading the chart in plain English, along with The Roadmap every Monday, Wednesday and Friday. Get the free guide here.

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/

Contact Information:
biotech-today.com
Media Contact: info@biotech-today.com 

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is not a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances.

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.

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/a-run-of-fda-target-dates-fills-the-biotech-calendar-from-late-november-to-year-end-302937803.html

SOURCE Biotech Today

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Do the FDA target dates for BBIO, VRTX, GILD, VTRS and PRAX mean their drugs are approved?

No. A Prescription Drug User Fee Act (PDUFA) date is a target for FDA action on an application, not an approval decision. The outcomes of these reviews are not known in advance.

What revenue and cash figures did BridgeBio report alongside its BBP-418 update?

BridgeBio reported $353.2 million in third-quarter 2026 total revenues, primarily comprising $253.2 million of U.S. Attruby net product revenue. Cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026.

How much cash and investments did Praxis report with its regulatory update?

Praxis reported approximately $1.3 billion in cash and investments as of September 30, 2026.

How did Viatris revenue perform ahead of its acute-pain FDA target date?

Viatris reported $3.75 billion in third-quarter 2026 revenue, essentially flat on both a reported and operational basis compared with the third quarter of 2025.