Core Insights - PolyPid Ltd. has appointed Brooke Story as Chairman of the Board of Directors, effective December 11, 2025, which is seen as a pivotal moment for the company [1][2] - Ms. Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD and Medtronic, and her expertise is expected to enhance PolyPid's strategic and commercial capabilities [2][3] - The company is preparing for the New Drug Application (NDA) submission of its lead product candidate, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [5] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release of therapeutics [5] - The company has a pipeline that includes innovative solutions in oncology, obesity, and diabetes, indicating a broad scope of potential market applications [5] Leadership and Strategy - Brooke Story's appointment is anticipated to support the transformation of PolyPid's clinical success into commercial reality, particularly in the area of surgical infection prevention [2][4] - Ms. Story's previous roles include overseeing global strategy and P&L for BD's Surgery business, which aligns with PolyPid's goals in the surgical market [2][3]

BRISBANE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that Dr. Jeremy Bender, chief executive officer, will present during the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 5:15 p.m. Pacific Time / 8:15 p.m. Eastern Time. A live audio webcast of the ...

Key Takeaways Earnings yield highlights stocks generating strong profits relative to price.The screen targets earnings yield above 10%, forward EPS growth, solid liquidity, and stocks priced above $5.Upcoming jobs, inflation and retail sales reports to shape rate-cut expectations and broader market direction.Markets ended yesterday slightly lower as pressure continued on some of the biggest names tied to the artificial intelligence (AI) trade. After a strong run, investors are starting to question whether A ...

Supports Development of Phospholipid Radioconjugate (PRC) CLR-225 for the Treatment of Solid TumorsFLORHAM PARK, N.J. and LANSING, Mich., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced a multi-year supply agreement with Ionetix Corporation, a leading cyclotron technology innovator and full-service radioisotope manufacturer, for two crit ...

VANCOUVER, Wash. and NEW YORK, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative AI, today announced the company will be participating in the upcoming 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Absci management is scheduled to present on Wednesday, January 14th at 3:45 p.m. Pacific Time (6:45 p.m. Eastern Time). Interested parties may access a live and archived webcast of ...

Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026 Topline results on track for the second quarter of 2026 SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment ...

Core Insights - The FDA has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, highlighting its potential to address a significant unmet medical need [1][2][3] - Palvella Therapeutics plans to initiate a Phase 2 trial for QTORIN™ rapamycin in the second half of 2026, following discussions with the FDA [1][4] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate targeting microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [5] Industry Context - Angiokeratomas are chronic skin lesions with no FDA-approved therapies, affecting an estimated 50,000 diagnosed patients in the U.S. [1][2] - The FDA's Fast Track program aims to expedite the development and review of drugs for serious conditions, facilitating earlier access for patients [3]

Core Insights - The FDA has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, highlighting its potential to address a significant unmet medical need [1][2][3] - Palvella Therapeutics plans to initiate a Phase 2 trial for QTORIN™ rapamycin in the second half of 2026, following discussions with the FDA [1][4] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate targeting microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [5][6] Industry Context - Angiokeratomas are chronic skin lesions with no FDA-approved therapies, affecting an estimated 50,000 diagnosed patients in the U.S. [1][2] - The FDA's Fast Track program aims to expedite the development and review of drugs for serious conditions, facilitating earlier access for patients [3]

Core Insights - Royalty Pharma has acquired a royalty interest in Nuvalent's neladalkib and zidesamtinib for up to $315 million [1][4] - Neladalkib and zidesamtinib are next-generation tyrosine kinase inhibitors (TKIs) targeting specific mutations in non-small cell lung cancer (NSCLC) [2] - Positive pivotal results for neladalkib have been reported, showing durable activity and a well-tolerated safety profile [3] Transaction Details - The acquisition includes a low-single digit royalty on worldwide net sales of both therapies, expected to last until approximately 2041 to 2042 [4] - The total investment for the royalty interest is capped at $315 million [4] Product Development Status - Neladalkib is in a Phase 3 study for TKI-naïve patients, while zidesamtinib is under FDA review with an action date of September 18, 2026 [3] - Analyst consensus projects sales of neladalkib to reach approximately $3.5 billion and zidesamtinib to reach approximately $1.9 billion by 2035 [3] Company Background - Royalty Pharma is the largest buyer of biopharmaceutical royalties and funds innovation across the biopharmaceutical industry [6] - The company has a diverse portfolio that includes royalties on over 35 commercial products and 20 development-stage candidates [6]

SAN FRANCISCO and BOSTON, Dec. 16, 2025 (GLOBE NEWSWIRE) -- SandboxAQ and MapLight Therapeutics, Inc. (Nasdaq: MPLT) announced today that the companies have entered into a strategic collaboration to discover and develop potential first-in-class therapies targeting a novel G protein-coupled receptor (GPCR) for the treatment of central nervous system (CNS) disorders. Under the terms of the agreement, SandboxAQ received an upfront payment and will be eligible to receive additional preclinical, development, reg ...