Month: December 2025

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 …

Alnylam Pharmaceuticals Announces Partial Repurchase of 1% Convertible Senior Notes Due 2027

Alnylam Pharmaceuticals Yesterday, December 11, 2025, Alnylam Pharmaceuticals, Inc. (ALNY) announced that it has entered into separate, privately negotiated repurchase agreements with certain holders of its 1.00% Convertible Senior Notes due 2027 (the “Notes”) to repurchase for cash (the “Repurchases”) approximately $34.4 million aggregate principal amount of the Notes for a total repurchase cost (including accrued and unpaid interest) of approximately $51.9 million . . …

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.
Praxis Precision Medicines Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen In Early Onset SCN2A Developmental and Epileptic Encephalopathy

Praxis Precision Medicines Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen In Early Onset SCN2A Developmental and Epileptic Encephalopathy

Praxis Precision Medicines Praxis Precision Medicines (PRAX) - a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, announced the completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) and agreement to immediately convert the EMBRAVE3 . . . This content is for paid subscribers. Please click here to …

About Time to Remember, and Today and Many Days Before

About Time to Remember A few days ago, Governor Ron DeSantis eliminated property taxes for property owners in Florida. The value of Structure Therapeutics’ (GPCR) increased and its stocks surged on positive phase 2b results for the obesity drug Aleniglipron. The company reported positive 36‑week topline results . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Ionis receives U.S. FDA Breakthrough Therapy Designation for Zilganersen for Alexander Disease

Ionis Pharmaceuticals On December 2, 2025 - Ionis Pharmaceuticals (IONS) announced that the FDA has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare, progressive and often fatal neurological condition. Over time, it can lead to loss of mobility and independence, along with difficulties walking, speaking, swallowing and breathing. There are currently no . . . This content is …

Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting

Harmony Biosciences Epilepsy News and the Treatment of Dravet Syndrome   Harmony Biosciences Holdings, Inc. (HRMY), announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA. The ARGUS trial is currently enrolling, and …

Roche: FDA Clearance with CLIA Waiver and CE Mark for its First Point-of-Care Test for Diagnosing Bordetella Infections, Including Whooping Cough

Roche in the NEWS Basel, December 2, 2025 - Roche (RHHBY) announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification. The . . . This content is for paid subscribers. Please …

A Question And An Answer

Question & Answer About Cogen Biosciences Question From Mel Nashef   Q: On November 24, 2025, you posted news about a biotech company called Cogent Biosciences (COGT). In it you wrote that the firm has positive data from Phase 3 PEAK Trial in combination of its drug . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Eli Lilly Lowers the Price of Zepbound® (tirzepatide) Single-Dose Vials

Lilly in the NEWS INDIANAPOLIS, December 1, 2025, Eli Lilly and Company (LLY) today announced Zepbound® (tirzepatide) single-dose vials will now be available at lower prices on LillyDirect, the company’s digital healthcare platform. This update builds on Lilly’s ongoing efforts to lower out-of-pocket costs for people living with obesity in the United States. Last month, Lilly announced lower prices for Zepbound multi-dose pens, subject to approval by …