Category: Today’s Highlights

Two Companies: 1. FDA Extended Review for Eli Lilly’s Oral Obesity Drug, Orforglipron. 2. Wall Street is Bullish on Spyre Therapeutics

Eli Lilly   The FDA extended its review for Eli Lilly (LLY) oral obesity drug, orforglipron, pushing the target decision date to April 10, 2026, from earlier expectations of late March, despite it receiving a Commissioner's National Priority Voucher for faster . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease

Anavex Life Sciences Corp Today, January 13, 2026, Anavex Life Sciences Corp. (AVXL) announced its participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer’s disease (AD) across real‑world clinical settings. The multi-year program is funded by the . . . This content is for paid subscribers. Please click here …

AbbVie and RemeGen Announce Exclusive Licensing Agreement to Develop A Novel Bispecific Antibody for Advanced Solid Tumors

AbbVie and RemeGen Announce Licensing Agreement Today, January 12, 2026,  - AbbVie (ABBV) and RemeGen announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy . . . This content is for paid subscribers. Please click here to subscribe or …
Insmed Inc Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

Insmed Inc Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

Insmed Inc Insmed Inc is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Insmed is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory …
Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline

Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline

Rapport Therapeutics in the NEWS Today, January 07, 2026, Rapport Therapeutics, Inc. (RAPP) announced plans to initiate its Phase 3 program for RAP-219 in FOS in the second quarter of 2026 and expand its epilepsy portfolio with a new program in PGTCS. Additionally, the Company announced progress across its pipeline, including . . . This content is for paid subscribers. Please click here to subscribe or …

Novo Nordisk Files for FDA Approval of CagriSema, the First Once-Weekly Combination of GLP‑1 and Amylin Analogues for Weight Management

Novo Nordisk PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Dec. 18, 2025 /PRNewswire/ -- Today, Novo Nordisk (NVO) announced the submission of a New Drug Application (NDA) to the U.S. FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain . . . This content is for paid subscribers. Please click here to …

Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors

Immunome Inc Immunome, Inc. (IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today the firm announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), in patients with progressing desmoid tumors. The trial met its primary . . . This content is for paid subscribers. Please click here to …

Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Phase 2 Trial Setmelanotide Demonstrating Positive Efficacy Signal in Prader-Willi Syndrome

Rhythm Pharmaceuticals Today, Rhythm Pharmaceuticals, Inc. (RYTM), announced positive preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS). The firm also announced plans to advance setmelanotide into a Phase 3 registrational trial in PWS, pending successful completion of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Cidara Therapeutics Provides Corporate Update and Reports Q3 2025 Results

Cidara Therapeutics Q3 Financial Results SAN DIEGO, November 06, 2025, Cidara Therapeutics, Inc. (CDTX) reported financial results for the third quarter ended September 30, 2025, and provided recent business updates. From Cidara Therapeutics Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, said, “With our Phase 3 ANCHOR study now over 50 percent enrolled, we expect to achieve target enrollment . . . This …

Knowing What Cidara Therapeutics is Doing for the Seasonal Flu

Cidara Therapeutics Cidara Therapeutics (CDTX) is using its proprietary Cloud break® platform to develop novel drug-Fc conjugate (DFC) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In . . . This content …

BridgeBio Pharma Reported Positive Phase 3 Results from FORTIFY the Phase 3 Pivotal Study of BBP-418 in People with Limb-Girdle Muscular Dystrophy Type 2I/R9

BridgeBio Pharma BridgeBio Pharma, Inc. is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. The Company was founded in 2015. Its team of experienced drug discoverers, developers and innovators is committed to applying advances in genetic medicine …

Why GRAL is Moving UP More Than Usual Today

Samsung and GRAIL Announce Strategic Collaboration  to Bring GRAIL’s Galleri® Multi-Cancer Early Detection Test to Asia Today, October 16, 2025, Samsung C&T (SCT), Samsung Electronics (SEC), and GRAIL, Inc. (GRAL) announced signing a binding Letter of Intent for a strategic collaboration to bring GRAIL’s GalleriⓇ multi-cancer early detection (MCED) test to . . . This content is for paid subscribers. Please click here to subscribe or …

U.S. FDA Lifts Clinical Hold on NUZ-001, Neurizon® Lead Investigational Therapy for ALS  

Neurizon Therapeutics in the NEWS Today October 6, 2025, from Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), and U.S (ECQO.F), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the U.S. FDA has lifted the clinical hold on its lead investigational drug, NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS …

Eli Lilly’s Oral GLP-1, Orforglipron, is Superior to Oral Semaglutide in Head-to-Head Trial

Eli Lilly Eli Lilly and Company (LLY) today September 17, announced positive topline results from ACHIEVE-3, Phase 3 clinical trial evaluating the safety and efficacy of orforglipron compared to oral semaglutide, administered according to approved label instructions in 1,698 adults with type 2 diabetes inadequately controlled with metformin. The 52-week trial compared orforglipron (12 mg and 36 mg) to oral . . . This content is …

Alkermes: Detailed Positive Results from Vibrance-1 Phase 2 Study of Alixorexton in Patients with Narcolepsy Type 1 at World Sleep Congress 2025

Alkermes in the NEWS Today, Alkermes Inc., (ALKS) announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, (formerly ALKS 2680), is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 . . . This content is for paid subscribers. Please …