Core Insights - The European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa for the treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, addressing a significant unmet medical need in a rare respiratory condition [1][2][3] Group 1: Efdoralprin Alfa Overview - Efdoralprin alfa (SAR447537, formerly INBRX-101) is an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein aimed at treating AATD emphysema [1][4] - The drug has shown superiority over standard plasma-derived therapy in adults with AATD in the global phase 2 ElevAATe study, meeting all primary and key secondary endpoints [2][4] - Efdoralprin alfa has also received fast track and orphan drug designations from the US FDA, indicating its potential significance in treating AATD [3][4] Group 2: Alpha-1 Antitrypsin Deficiency (AATD) - AATD is a rare inherited disorder characterized by low or absent levels of AAT, leading to progressive lung and liver tissue damage [5] - Approximately 235,000 individuals globally are affected by AATD, with nearly 100,000 in the US, and about 90% of these cases remain undiagnosed [5] Group 3: Sanofi's Commitment - Sanofi is dedicated to developing treatments for rare diseases, as evidenced by the recent orphan designation for efdoralprin alfa [7] - The company emphasizes its commitment to improving lives through innovative research and development in the biopharma sector [6]

Piper Sandler sets a price target of $142 for NASDAQ:ABVX, indicating a potential increase of 27.95%.The "Strong Buy" rating is driven by positive phase 3 ABTECT induction data for obefazimod, highlighting its potential in the ulcerative colitis therapy market.Abivax plans significant milestones in 2026, including filing for New Drug Application (NDA) and Marketing Authorization Application (MAA) if trials remain positive.Abivax SA (NASDAQ:ABVX) is a biopharmaceutical company focused on developing therapies ...

Core Insights - GSK plc announced FDA approval for Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older [1][9]. Clinical Trial Results - The FDA approval is based on the SWIFT-1 and SWIFT-2 phase III trials, where depemokimab showed a 58% and 48% reduction in annualized asthma exacerbations compared to placebo over 52 weeks [2]. - A pooled analysis indicated a 72% reduction in clinically significant exacerbations requiring hospitalization or emergency department visits for depemokimab compared to placebo [3]. Treatment Benefits - Depemokimab offers sustained protection from exacerbations with only two doses per year, potentially redefining patient care for severe asthma [4]. - The treatment is well-tolerated, with side effects similar to those of placebo [3]. Market Context - Approximately 2 million Americans suffer from severe asthma, with half experiencing frequent exacerbations that lead to increased healthcare costs [5]. - Currently, only 20% of eligible patients in the US receive biologics, indicating a significant unmet need in the market [5]. Future Prospects - Depemokimab has received a positive opinion from the CHMP in Europe, with an approval decision expected in Q1 2026, and is under review in other regions including China and Japan [7]. - GSK is expanding its pipeline for depemokimab to include other diseases with type 2 inflammation, such as chronic rhinosinusitis and chronic obstructive pulmonary disease (COPD) [18].

Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company focusing on autoimmune diseases, oncology, and pain management.H.C. Wainwright set a price target of $135 for NKTR, indicating a potential price increase of approximately 164%.Recent Phase 2b REZOLVE-AA trial results for rezpegaldesleukin showed significant potential in treating severe-to-very-severe alopecia areata.Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company focused on developing innovative medicines in areas of high un ...

Core Insights - Harbour BioMed has entered a multi-year global strategic collaboration with Bristol Myers Squibb to develop next-generation multi-specific antibodies [1][2] - The agreement includes potential payments totaling $90 million and up to $1.035 billion in development and commercial milestones, along with tiered royalties [2] Company Overview - Harbour BioMed is a global biopharmaceutical company focused on discovering and developing novel antibody therapeutics in immunology and oncology [4] - The company aims to build a robust portfolio through internal R&D, collaborations, and selective acquisitions [4] Technology and Innovation - The proprietary Harbour Mice technology platform generates fully human monoclonal antibodies in various formats, enhancing the therapeutic potential of biologics [5] - The HCAb-based immune cell engagers (HBICE) technology allows for tumor-killing effects that traditional therapies cannot achieve, making the antibody discovery engine unique and efficient [5] Strategic Collaboration - The collaboration with Bristol Myers Squibb is expected to leverage Harbour BioMed's technology and development capabilities, particularly in conducting early clinical trials in China [3]

— First-in-human trial of candidate from the next-generation ATTC platform — — Simultaneous China and global clinical development strategy to expedite development process — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy Conjugate (“ATTC”) comprising a highl ...

Today, Dec. 16, 2025, Pfizer's shrinking COVID cash flows could mean little growth next year as M&A bets will take time to deliver. NYSE : PFEPfizerToday's Change( -3.40 %) $ -0.90Current Price$ 25.53Key Data PointsMarket Cap$150BDay's Range$ 24.92 - $ 26.5052wk Range$ 20.91 - $ 27.69Volume112MAvg Vol68MGross Margin69.12 %Dividend Yield6.51 %Pfizer (PFE 3.40%), which develops and sells biopharmaceutical products worldwide, closed today's session (Dec. 16) at $25.53, down 3.41%. Trading volume reached 108.1 ...

® SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology today announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and the Phase 1/2 trial evaluating patients with checkpoint ...

CHICAGO, IL, Dec. 16, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,233,488 shares of common stock at a purchase price of $1.224 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered toge ...

SOUTH SAN FRANCISCO, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that members of its leadership team will participate in a presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 5:15 p.m. PT. A live webcast of the presentation will be accessible on the “Events” page of the BBOT website at https://investors.bbot ...