PRESS RELEASE AB SCIENCE PATENT FOR MASITINIB IN THE TREATMENT OF SICKLE CELL DISEASE FORMALLY GRANTED IN THE UNITED STATES WITH A PROTECTION UNTIL 2040 THIS DECISION STRENGTHENS MASITINIB’S INTELLECTUAL PROPERTY PORTFOLIO WITH LONG-TERM PROTECTION FOR AN ADDITIONAL INDICATION WITH A HIGH UNMET MEDICAL NEED THE BIOMARKER PHASE 2 IN COOPERATION WITH AP-HP IS FULLY FUNDED Paris, December 22, 2025, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) today announced that the United States Patent Office has fo ...

Core Insights - Corcept Therapeutics' Relacorilant is under FDA review with a PDUFA target date of December 30, 2025, which is crucial for the company's financial strategy to diversify revenue sources beyond Korlym [1] - The outcome of the PDUFA review is critical, as an unfavorable result could significantly impact Corcept's valuation due to the lack of other pre-registration drugs expected to reach approval in the next 3-5 years [1] Clinical & Regulatory Assessment - Relacorilant is a selective glucocorticoid receptor antagonist aimed at managing hypercortisolism in endogenous Cushing's syndrome, with its NDA supported by data from two Phase 3 trials: GRACE and GRADIENT [2] - In the GRACE trial, relacorilant met its primary endpoint, showing that patients switching to placebo had a higher risk of losing hypertension control, while in the GRADIENT trial, it failed to meet its primary endpoint of reducing mean systolic blood pressure [3] - The efficacy of relacorilant may be more pronounced in patients with non-adrenal etiology of endogenous Cushing's syndrome, which constitutes the majority of cases, but the failure in the GRADIENT trial raises concerns about the NDA's approval likelihood [3] Financial Position Outlook - Corcept Therapeutics has a market capitalization of $8.9 billion and maintains a strong liquidity position with no long-term debt, indicating financial stability [4] - The increase in R&D and SG&A expenses is consistent with the company's expanding clinical activities and preparations for the Relacorilant PDUFA event, and is not viewed as alarming [4] - The company's share outstanding remains stable with no imminent dilution expected, largely due to increased revenue from the commercialization of Korlym, which supports pipeline development [5]

Core Insights - The FDA has granted Breakthrough Therapy designation to AstraZeneca and Daiichi Sankyo's Enhertu for expanded use in treating HER2-positive early breast cancer with residual invasive disease [1][2][7] - This marks the tenth Breakthrough Therapy designation for Enhertu, highlighting its potential to transform breast cancer treatment [2] - The designation is based on phase III DESTINY-Breast05 data, which indicates Enhertu may reduce invasive disease recurrence compared to current standard care [3] AstraZeneca's Stock Performance - AstraZeneca's shares have increased by 29.3% over the past six months, outperforming the industry average rise of 26.2% [4] Enhertu's Current Approvals and Developments - Enhertu is approved in over 85 countries for second-line treatment of HER2-positive breast cancer and has additional approvals for lung and gastric cancers [8] - Recently, the FDA approved Enhertu in combination with Roche's Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer based on phase III DESTINY-Breast09 data [9] Partnership and Development Strategy - AstraZeneca and Daiichi Sankyo are jointly responsible for developing and marketing Enhertu globally, except in Japan where Daiichi has exclusive rights [11] - Both companies are pursuing extensive development programs for Enhertu and Datroway across multiple tumor types [11] Recent Study Outcomes - AstraZeneca's phase III LATIFY study, evaluating ceralasertib with Imfinzi in lung cancer, did not meet its primary overall survival goal [12] - The LATIFY study focused on patients without actionable genomic alterations whose disease progressed after prior treatments [13] Imfinzi Sales Performance - Imfinzi generated $4.32 billion in sales during the first nine months of 2025, reflecting a 25% increase driven by demand in lung and liver cancer indications [14]

On Friday, the U.S. Food and Drug Administration (FDA) approved Cytokinetics Incorporated’s (NASDAQ:CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.The full U.S. Prescribing Information for Myqorzo include ...

智通财经APP获悉，周一，Cytokinetics(CYTK.US)大涨超10%，续创年内新高，现报69.34美元。消息面 上，近日，国家药品监督管理局通过优先审评审批程序，批准Cytokinetics, Incorporated申报的1类创新 药阿夫凯泰片(商品名：星舒平)上市，该药用于治疗纽约心脏协会(NYHA)心功能分级II-III级的梗阻性 肥厚型心肌病(HCM)成人患者，以改善运动能力和症状。 ...

Company Overview - ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma treatments, offering allergy immunotherapy and related products and services [2] - The company is headquartered in Hørsholm, Denmark, and employs approximately 2,800 people worldwide [2] Financial Calendar - The financial calendar for ALK includes key dates such as: - 23 January 2026: Silent period begins - 20 February 2026: Annual report for 2025 is scheduled for release - 16 March 2026 at 4:00 p.m.: Annual General Meeting [4] - Additional reporting dates include: - 5 May 2026: Three-month interim report (Q1) for 2026 - 20 August 2026: Six-month interim report (Q2) for 2026 - 18 November 2026: Nine-month interim report (Q3) for 2026 [5] AGM Participation - Written requests for specific business transactions to be included in the AGM agenda must be received by the company by 30 January 2026 [1]

Drugmaker Cipla has launched Afrezza (insulin human) inhalation powder, the company said, about a year after the product got regulatory approval in India. The company has the exclusive distribution and marketing rights of Afrezza, a rapid-acting orally-inhaled insulin, which offers a needle-free alternative to injectable insulin therapy, it said, without disclosing its pricing. Afrezza from US’ MannKind Corporation dissolves rapidly upon oral inhalation and begins lowering blood glucose within approximately ...

Market Performance - U.S. stocks traded higher, with the Nasdaq Composite gaining over 100 points on Monday [1] - The Dow increased by 0.18% to 48,222.17, the NASDAQ rose by 0.56% to 23,439.24, and the S&P 500 climbed 0.45% to 6,864.96 [1] Sector Performance - Energy shares rose by 1.3% on Monday [1] - Utilities stocks fell by 0.5% during the same trading session [1] Commodity Prices - Oil prices increased by 2.2% to $57.75 [4] - Gold prices rose by 1.7% to $4,463.30 [4] - Silver prices went up by 2.5% to $69.150, while copper prices fell by 0.1% to $5.5085 [4] European Market Trends - European shares were lower, with the eurozone's STOXX 600 declining by 0.3% [5] - Spain's IBEX 35 Index fell by 0.2%, London's FTSE 100 decreased by 0.5%, Germany's DAX 40 dropped by 0.3%, and France's CAC 40 fell by 0.5% [5] Asian Market Trends - Asian markets closed higher, with Japan's Nikkei 225 gaining 1.81%, Hong Kong's Hang Seng rising by 0.43%, China's Shanghai Composite increasing by 0.69%, and India's BSE Sensex up by 0.75% [6] Notable Stock Movements - Haoxin Holdings Limited (NASDAQ:HXHX) shares surged by 118% to $0.7513 [8] - Sidus Space, Inc. (NASDAQ:SIDU) shares increased by 78% to $2.0650 after receiving a contract from the Missile Defense Agency [8] - Jyong Biotech Ltd. (NASDAQ:MENS) shares rose by 36% to $4.32 [8] - Luminar Technologies, Inc. (NASDAQ:LAZR) shares dropped by 60% to $0.2396 after announcing voluntary Chapter 11 proceedings [8] - EUDA Health Holdings Limited (NASDAQ:EUDA) shares fell by 25% to $2.09 following a strategic technology integration announcement [8] - Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) shares decreased by 20% to $1.74 due to a self tender offer announcement [8]

Core Points - Cytokinetics held a conference call to discuss the FDA approval of MYQORZO [1] Group 1 - The conference call was led by Diane Weiser, the Senior Vice President of Corporate Affairs at Cytokinetics [1]

Core Insights - The Trump administration has signed drug-pricing agreements with several large-cap drugmakers to lower drug prices in the U.S. [1] - The agreements require drugmakers to reduce prescription drug prices to match those in comparable developed countries, supporting the Most Favored Nation (MFN) pricing proposal [2] - Drugmakers will receive a three-year exemption from import tariffs on pharmaceutical ingredients in exchange for expanding domestic manufacturing operations [3] - Some companies will donate active pharmaceutical ingredients (APIs) to a government stockpile to ensure supply chain resilience during emergencies [4] - The Trump administration has now reached deals with 14 out of 17 targeted drug manufacturers, with three companies still in discussions [5] Industry Impact - The agreements address major concerns regarding drug pricing and tariffs, improving investor outlook for the pharmaceutical sector [6] - The deals are seen as a turning point that could alleviate regulatory and pricing pressures on the industry [7] - The latest agreements involve nine major drugmakers, joining others like Pfizer and AstraZeneca who signed similar deals earlier [8]