#AGIO

Agios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio Growth Agios (Nasdaq: AGIO) outlined 2026 strategic priorities focused on commercializing AQVESME (mitapivat) in thalassemia and advancing a pipeline of rare-disease programs.Key points: AQVESME received U.S. FDA approval in December 2025 for anemia in adults with alpha- or beta-thalassemia and is expected to be available in the U.S. in late January 2026 after REMS implementation. Agios plans a pre-sNDA FDA meeting for mitapivat in sickle cell disease in Q1 2026 with a planned U.S. regulatory submission to follow. Multiple topline readouts are expected across 2026 for tebapivat, AG-236, and AG-181. The company projects a clear path to profitability and cites potential for over $1 billion in peak global sales from its PK activation franchise.

2 months ago

#AGIO Agios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio Growth

www.stocktitan.net/news/AGIO/agios-outlines...

0 0 0 0

U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia Agios (Nasdaq: AGIO) announced U.S. FDA approval of AQVESME™ (mitapivat) for treatment of anemia in adults with alpha- or beta-thalassemia, covering both non-transfusion-dependent and transfusion-dependent patients.The approval is based on the randomized ENERGIZE and ENERGIZE-T Phase 3 trials (total 452 patients) that met primary and key secondary endpoints, showing improvements in hemoglobin, fatigue, and transfusion burden. AQVESME will be available in the U.S. in late January 2026 after implementation of an FDA REMS requiring liver tests and education. Five patients experienced adverse reactions suggestive of hepatocellular injury, with two hospitalizations; liver tests improved after discontinuation.

2 months ago

#AGIO U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

www.stocktitan.net/news/AGIO/u-s-fda-approv...

0 0 0 0

Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia Agios (Nasdaq: AGIO) announced that the U.S. FDA has not issued a regulatory decision on the supplemental NDA for mitapivat in adult non‑transfusion‑dependent and transfusion‑dependent alpha‑ or beta‑thalassemia; the application remains under active review.The FDA's PDUFA goal date was December 7, 2025. Agios said the agency has not requested, and the company has not submitted, any new efficacy or safety data, and that the companies are collaborating to finalize labeling and REMS materials. The FDA has not provided a timeline for its decision and Agios continues to work expeditiously to conclude the review.

3 months ago

#AGIO Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia

www.stocktitan.net/news/AGIO/agios-provides...

0 0 0 0

InsiderFinance

@insiderfinance.com

3 months ago

🚨 Institutions #optionsvolume surge detected! PM Top Momentum Activity from 🔥 INSIDERFINANCE.COM

🚨 Institutions #optionsvolume surge detected!

PM Top Momentum Activity from 🔥 INSIDERFINANCE.COM 🔥
1. #Z 30.7x
2. #AMGN 26.0x
3. #AGIO 23.3x
4. #ARWR 22.4x
5. #NOW 15.4x

#OptionFlow #OptionsTrading #Trading

0 0 0 0

Option Mike

@optionmike.bsky.social

3 months ago

Good Morning!

Futures up!

#NVDA many pt raised $320 high at Melius

#MU pt raised $275 from $245 @ UBS
#IONQ int Neutral @ JPM pt $47
#XYZ pt raised $100 @ Mizuho
#SNDK pt raised $300 from $270 @ BOFA
#NDAQ u/g Overweight @ MS pt $110 from $97
#JACK pt cut $16 from $21 @ Cowen
#AGIO pt cut

0 0 0 0

Small Cap Strategist

@smcapstrategist.bsky.social

3 months ago

Most Searched, Wednesday November 19, 2025 – Crystal Equity Research

Most searched small-cap stocks, Wed Nov 19th - #LAC #KZIA #RXRX #QUBT #SGML #SGML #SEMR #EOSE #NUVB #OLMA #DNN #AGIO #PLUG #SGBX #ONDS #IQ #EVH #CEP #CAAS #BORR #AMLX - More: crystalequityresearch.com/most-searche... - #smallcap

0 0 0 0

3 months ago

#AGIO Agios Announces Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell Disease

www.stocktitan.net/news/AGIO/agios-announce...

0 0 0 0

Agios Reports Third Quarter 2025 Financial Results and Provides Business Update $12.9 million in third quarter PYRUKYND ® (mitapivat) net revenues PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025 CHMP adopted positive opinion for PYRUKYND in thalassemia; EC decision expected by early 2026 RISE UP Phase 3 trial topline results in sickle cell

4 months ago

#AGIO Agios Reports Third Quarter 2025 Financial Results and Provides Business Update

www.stocktitan.net/news/AGIO/agios-reports-...

0 0 0 0

Yuki-daisuke

@yuki-daikun.bsky.social

4 months ago

大船駅ルミネウィング7階にある、AGIO ナトゥーラルミネ大船店にて。
この日は有給休暇でランチ。
トマトソースとバジルのスパゲッティ(大盛り)のランチセットと豪華にしました。サラダとコーヒー付き。ここのイタリアンは本当に美味しいです。
ごちそうさまでした。
#大船
 #ルミネ
 #AGIO

3 0 0 0

Pomerantz Law Firm Launches Investigation for Agios Pharmaceuticals Investors Amid FDA Drug Review Delay The Pomerantz Law Firm is probing claims from investors of Agios Pharmaceuticals in light of FDA review delays that impacted stock prices significantly.

5 months ago

Pomerantz Law Firm Launches Investigation for Agios Pharmaceuticals Investors Amid FDA Drug Review Delay #USA #New_York #Pomerantz_Law_Firm #Agio #Agios_Pharmaceuticals

0 0 0 0

Bedrijfsrekenen.nl

@bedrijfsrekenen.bsky.social

5 months ago

Woordzoeker Boekhoudtermen oplossen.

Fijn even #financieel #puzzelen met de #woordzoeker #boekhoudtermen? Vind de #woorden #journaalpost #crediteren #passiva #inkomen #saldo #kruisposten #agio #tekort #reserves #kapitaal #jaarrekening #ratio #kasgeld #balans bedrijfsrekenen.nl/puzzels/boek... Online oplossing met JavaScript kan later

0 0 0 0

Rieco

@rieco.bsky.social

5 months ago

2025/10/04 Lunch
#AGIO
#マーケットレストランAGIO

0 0 0 0

NetrioNow: Revolutionizing Managed Services with AI and Automation Netrio launches NetrioNow, an AI-powered platform that transforms managed services, enhancing customer experience and efficiency in IT operations.

5 months ago

NetrioNow: Revolutionizing Managed Services with AI and Automation #United_States #Minneapolis #NETRIO #Agio #NetrioNow

0 0 0 0

Pomerantz Law Firm Launches Investigation into Agios Pharmaceuticals Amid Stock Price Concerns Pomerantz LLP is investigating potential securities fraud claims on behalf of Agios Pharmaceuticals investors after significant stock drops following FDA news.

5 months ago

Pomerantz Law Firm Launches Investigation into Agios Pharmaceuticals Amid Stock Price Concerns #USA #New_York #Pomerantz_LLP #Agio #Agios_Pharmaceuticals

0 0 0 0

InsiderFinance

@insiderfinance.com

6 months ago

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily averag

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily average with strong consensus on direction.

AM Algo #TradeIdea from 🔥 INSIDERFINANCE.COM 🔥
#BRBR, #AGIO, #EAT, #SGHC, #NI

#OptionFlow #OptionsTrading #Trading

0 0 0 0

InsiderFinance

@insiderfinance.com

6 months ago

🚨 Institutions #optionsvolume surge detected! AM Top Momentum Activity from 🔥 INSIDERFINANCE.COM

🚨 Institutions #optionsvolume surge detected!

AM Top Momentum Activity from 🔥 INSIDERFINANCE.COM 🔥
1. #AEO 6.1x
2. #BRBR 3.9x
3. #AGIO 3.9x
4. #NEON 3.0x
5. #PYPL 2.9x

#OptionFlow #OptionsTrading #Trading

0 0 0 0

FDA Extends Review of First Oral Treatment for Thalassemia: Agios' PYRUKYND Decision Set for December FDA extends PYRUKYND review to Dec 7, 2025 following REMS submission for hepatocellular injury risk. Drug targets both transfusion-dependent and non-dependent thalassemia patients.

6 months ago

#AGIO Agios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia

www.stocktitan.net/news/AGIO/agios-provides...

0 0 0 0

Agios’ PYRUKYND® (mitapivat) Approved for Adults with Thalassemia in Saudi Arabia Agios Pharmaceuticals (Nasdaq: AGIO) has achieved a significant milestone as its drug PYRUKYND® (mitapivat) received approval from the Saudi Food and Drug Authority (SFDA) for treating adult patients with thalassemia. This marks the first regulatory approval for PYRUKYND in thalassemia globally.The approval, evaluated under SFDA's Breakthrough Medicines Program, is based on results from the ENERGIZE and ENERGIZE-T Phase 3 trials. The drug is approved for both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia patients. Agios has partnered with NewBridge Pharmaceuticals to manage PYRUKYND commercialization in the Gulf Region.Additional regulatory applications for PYRUKYND in thalassemia are under review in the U.S. (PDUFA date: September 7, 2025), United Arab Emirates, and European Union.

7 months ago

#AGIO Agios’ PYRUKYND® (mitapivat) Approved for Adults with Thalassemia in Saudi Arabia

www.stocktitan.net/news/AGIO/agios-pyrukynd...

0 0 0 0

Agios Reports Strong Q2 Growth: PYRUKYND Sales Surge 45% as Critical FDA Decision Approaches Q2 earnings show 45% revenue growth, $1.3B cash position, and imminent FDA decision for thalassemia treatment. Key pipeline updates revealed. Get full insights.

7 months ago

#AGIO Agios Reports Second Quarter 2025 Financial Results and Provides Business Update

www.stocktitan.net/news/AGIO/agios-reports-...

0 0 0 0

Netrio Enhances Cybersecurity and Gen AI Services with Agio Acquisition Netrio has acquired Agio, a leader in managed IT and cybersecurity services, expanding their capabilities in financial services and AI-powered solutions.

9 months ago

Netrio Enhances Cybersecurity and Gen AI Services with Agio Acquisition #United_States #New_York #Cybersecurity #NETRIO #Agio

0 0 0 0

BotDeLaChatte

@lebotdelachatte.bsky.social

11 months ago

Agio de la chatte

L'agio est la majoration d'un prix par rapport à la valeur nominale d'un actif, souvent utilisée dans le contexte financier pour désigner le coût d'une opération de change ou de prêt. #Agio #Majoration #Finance #Actif #Coût

0 0 0 0

Agios Delivers Record PYRUKYND Growth as FDA Decision Looms: Q4 Earnings Deep Dive Agios reports 20% QoQ PYRUKYND revenue growth to $10.7M, maintains $1.5B cash position. FDA decision for thalassemia indication expected September 2025.

1 year ago

#AGIO Agios Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

www.stocktitan.net/news/AGIO/agios-reports-...

0 0 0 0