Drug News Update: 02 Feb 2025

Here is your life science and drug development newsletter, sharing updates on clinical data and regulators decisions in January 2025.

Of note, in January, semaglutide received an approval in another indication that the cardio-metabolic therapeutic area, a new anti-pain drug ( was approved, the first since long time, and Esketamine indication was extended to major depressive disorder by the FDA.

Intriguing Science

NASA’s OSIRIS-REx mission returned samples from asteroid Bennu, revealing building blocks for life: the 5 nucleobases and 14/20 amino acids. The samples contain both left- and right-handed amino acids, suggesting a more complex origin of life. Find more on this article from Nature.

European Medicine Agency

The EMA’s Committee for Medicinal Products for Human Use (CHMP) held its monthly meeting from January 27-30. Below are the key takeaways:

1. Capvaxive (pneumococcal polysaccharide conjugate vaccine [21-valent], Merck) received a recommendation for marketing authorization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae bacteria in adults.
2. Datroway (datopotamab deruxtecan, Daiichi Sankyo) received a positive opinion for the treatment of breast cancer.
3. Tivdak (tisotumab vedotin, Pfizer) received a positive opinion for the treatment of recurrent or metastatic cervical cancer.
4. Vimkunya (chikungunya vaccine [recombinant, adsorbed], Bavarian Nordic) received a recommendation for marketing authorization to protect individuals aged 12 years and older against disease caused by the Chikungunya virus.

The CHMP adopted positive opinions for three biosimilar medicines:

1. Dyrupeg (pegfilgrastim, CuraTeQ Biologics, biosimilar of Neulasta), intended to shorten the duration of neutropenia and help prevent febrile neutropenia after chemotherapy
2. Pavblu (aflibercept, Amgen) and its duplicate Skojoy (aflibercept, Amgen), indicated for the treatment of neovascular age-related macular degeneration and visual impairment related to various conditions. CHMP meeting highlights.

US Food and Drug Administration (FDA)

The FDA approved the following NDA/BLAs in January 2025:

1. Omvoh (mirikizumab-mrkz, Eli Lilly) was approved for a label expansion to treat moderately to severely active Crohn’s disease in adults. Eli Lilly press release.
2. Calquence (acalabrutinib, AstraZeneca) was approved for use in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. AstraZeneca press release.
3. Lumakras (sotorasib, Amgen) was approved in combination with Vectibix (panitumumab, Amgen) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). Amgen press release.
4. Datroway (datopotamab deruxtecan-dlnk, Daiichi Sankyo) was approved for adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer. FDA press release.
5. Journavx (suzetrigine, Vertex Pharmaceuticals) was approved for the treatment of adults with moderate-to-severe acute pain. Vertex press release.
6. Spravato (esketamine, Johnson & Johnson) was approved as a monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. J&J press release.
7. Leqembi (lecanemab-irmb, Biogen) intravenous (IV) maintenance dosing was approved for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. Biogen press release.
8. Symbravo (meloxicam and rizatriptan, Axsome Therapeutics) was approved for the acute treatment of migraine, with or without aura, in adults. Axsome press release.
9. Ozempic (semaglutide, Novo Nordisk) was approved to reduce the risk of kidney disease progression, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). Novo Nordisk press release.
10. Enhertu (trastuzumab deruxtecan, AstraZeneca) was approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low, or HER2-ultralow breast cancer. AstraZeneca press release.

The FDA rejected the Biologics License Application (BLA) for Ebvallo (tabelecleucel, Atara Biotherapeutics) as a monotherapy for treating adult and pediatric patients (two years and older) with Epstein-Barr virus-positive post-transplant lymphoproliferative disease. The Complete Response Letter (CRL) cited issues observed during a pre-approval inspection of a third-party manufacturing facility. Atara Biotherapeutics press release.

Additionally, the FDA has mandated a Guillain-Barré Syndrome (GBS) warning in the prescribing information for the RSV vaccines Abrysvo (Pfizer) and Arexvy (GSK). FDA press release.

New data from clinical trials (Phase 2, Phase 3)

Here are the latest updates on Phase 2 and Phase 3 clinical trials, including published data from January 2025:

1. Akero Therapeutics shared positive data from the Phase 2b study of efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Akero press release.
2. ITM Isotope Technologies announced positive results from its Phase 3 trial of ITM-11 (n.c.a. 177Lu-edotreotide) in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM press release.
3. Roche reported positive results from the Phase 3 study investigating Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant for patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant, locally advanced, or metastatic breast cancer. Roche press release.
4. Valneva shared positive results for its Phase 2 trial evaluating its single-shot chikungunya vaccine, IXCHIQ, in children. Valneva press release.
5. Tris Pharma announced positive results from its Phase 3 trial evaluating cebranopadol for the treatment of moderate-to-severe acute pain in patients following abdominoplasty surgery. Tris Pharma press release.
6. Shionogi announced that its Phase 2 study of S-337395 in healthy adults who were actively inoculated with RSV has achieved its primary endpoint. Shionogi press release.
7. Pfizer shared positive results from the Phase 3 trial evaluating Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Pfizer press release.
8. Bayer announced that its Phase 3 study of elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with or at high risk of breast cancer met all primary and secondary endpoints. Bayer press release.
9. Metsera shared positive data from the Phase 2a trial of MET-097i in participants with obesity and overweight who did not have Type 2 diabetes. Metsera press release.
10. Denali Therapeutics announced that the Phase 2/3 trial evaluating DNL343 for the treatment of amyotrophic lateral sclerosis (ALS) did not meet the primary endpoint. Denali press release.
11. Boehringer Ingelheim announced that the Phase 3 trial of iclepertin for the treatment of adults with schizophrenia did not meet the primary or key secondary endpoints. Boehringer Ingelheim press release.
12. Pfizer reported positive results from its Phase 3 trial evaluating sasanlimab in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Pfizer press release.
13. Johnson & Johnson shared positive data from the Phase 3 study of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. J&J press release.
14. MaaT Pharma announced that the Phase 3 study of MaaT013 in acute Graft-versus-Host disease met its primary endpoint. MaaT Pharma press release.
15. Vistagen shared positive results from the Phase 2A study of PH284 in cancer cachexia. Vistagen press release.
16. Sling Therapeutics announced positive data from the Phase 2b/3 LIDS trial of linsitinib in patients with active, moderate to severe thyroid eye disease (TED). Sling press release.
17. Alentis Therapeutics shared positive results from two Phase 2 trials of lixudebart (ALE.F02) to reverse organ fibrosis. Alentis press release.