Events, Licensing and Treatment - Drug Discovery Digest

Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.

Drugs

Drugs Clinical Development Therapies Clinical Trials

The future of mental health treatment: Zelquistinel’s role

Drug Target Review

MARCH 17, 2025

Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “We call this phenomenon ‘event-driven pharmacology.”

Treatment

Treatment Licensing Licensing Science

Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

The Pharma Data

JUNE 15, 2025

The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. President and Chief Executive Officer of Intellia Therapeutics.

Treatment

Treatment Therapies Licensing Licensing

Protein degraders: chasing undruggable targets

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Kymera, which hopes to make oral drugs with biologic-like efficacy, released data for KT-621 in June , which showed treatment was well-tolerated in healthy volunteers.

Targeted Protein Degradation

Targeted Protein Degradation Small Molecule Disease Therapies

Viatris Announces Success in Second Pivotal Phase 3 Trial of MR-141 Targeting Presbyopia

The Pharma Data

JUNE 26, 2025

Specifically, the trial measured the percentage of participants who achieved a ≥3-line gain in Early Treatment Diabetic Retinopathy Study (ETDRS) chart readings at 12 hours post-dose on Day 8, while maintaining less than a 5-letter loss in BCDVA from baseline.

Trials

Trials Clinical Trials Treatment Licensing

Otsuka’s Sibeprenlimab Shows Significant Proteinuria Reduction in Phase 3 IgAN Trial

The Pharma Data

JUNE 6, 2025

This outcome suggests sibeprenlimab’s potential to not only delay disease advancement but also improve long-term renal outcomes, addressing a critical unmet need for patients with IgAN, many of whom currently face limited treatment options. Treatment-emergent adverse events (TEAEs) occurred in 76.3% in the placebo group.

Trials

Trials Treatment Therapies FDA

Biogen Launches Phase 3 Trial of Felzartamab for Primary Membranous Nephropathy

The Pharma Data

JULY 2, 2025

Despite its impact, there are currently no FDA-approved therapies for PMN , and treatment options are limited to non-specific and often toxic agents such as chemotherapy or general immunosuppressants. The rights to felzartamab were licensed to Human Immunology Biosciences (HI-Bio) , which Biogen acquired in July 2024. Source link

Trials

Trials Disease FDA Approval Treatment

Takeda to seek approval of new kind of narcolepsy drug after study data

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. The most common adverse events reported were insomnia as well as the sudden urge to urinate. You can unsubscribe at anytime.

Drugs

Drugs Clinical Trials Therapies Licensing

Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

As clinical development progresses, pharmaceutical companies must submit periodic updates to regulatory agencies, reporting on patient safety data, adverse events, and protocol modifications. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.

Drug Development

Drug Development Clinical Trials Compliance Drugs

Fitusiran

New Drug Approvals

APRIL 11, 2025

1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]

Clinical Trials

Clinical Trials FDA FDA Approval Trials

Jazz Pharma Gets EU Nod for Ziihera in Advanced HER2+ Biliary Cancer

The Pharma Data

JULY 2, 2025

This marks a pivotal moment for the treatment of a rare and aggressive group of cancers—including gallbladder cancer (GBC) and cholangiocarcinoma (CCA)—which are often diagnosed at an advanced stage when curative surgical options are no longer feasible. under license from Zymeworks Inc. , formerly BeiGene, Ltd.) the original developer.

Therapies

Therapies Trials Medical Schools Pharmaceuticals

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. You can unsubscribe at anytime. © 2025 TechTarget, Inc. or its subsidiaries.

FDA

FDA Drugs Therapies Science

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

JULY 2, 2025

and Canada, has announced a significant regulatory milestone for its pulmonary arterial hypertension (PAH) treatment, WINREVAIR™ (sotatercept-csrk). Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S.

Trials

Trials FDA Licensing Licensing

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

SugarCone Biotech

JULY 6, 2025

HER3 plays a pivotal role in activating downstream signaling pathways through heterodimerization with other receptors like HER2 and can mediate resistance to therapies targeting EGFR and HER2, making it a compelling target for novel treatments in cancers that rely on oncogenic signaling via those related growth factor receptors.

Drug Development

Drug Development Drugs Clinical Trials Therapies

Vor, with new CEO, changes course to target autoimmune disease

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. You can unsubscribe at anytime. and European drugmakers.

Disease

Disease Licensing Licensing Therapies

Landiolol

New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride.

FDA

FDA Clinical Trials Treatment Trials

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

BioPharma Drive: Drug Pricing

JULY 16, 2025

Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. In response, Sarepta stopped selling the treatment to these older, non-ambulatory patients, who it judges are at higher risk of treatment-induced liver damage.

Therapies

Therapies FDA Clinical Trials Licensing

Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. You can unsubscribe at anytime. No similar major trial has evaluated the new formulations.

Therapies

Therapies FDA Clinical Trials Licensing

Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. You can unsubscribe at anytime. © 2025 TechTarget, Inc. or its subsidiaries.

Drugs

Drugs Licensing Licensing Therapies

FDA to ask Sarepta to stop shipping Duchenne gene therapy

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles. You can unsubscribe at anytime.

Therapies

Therapies FDA Clinical Trials Licensing

Lexeo to help launch spinout around RNA drugs for the heart

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. You can unsubscribe at anytime.

RNA

RNA Drugs Therapies Licensing

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

BioPharma Drive: Drug Pricing

JULY 30, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs

Drugs Clinical Trials FDA Therapies

Organon drug for endometriosis falls short in mid-stage study

BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

Clinical Trials

Clinical Trials Drugs Therapies Licensing

Merck to buy Verona and its lung drug in $10B deal

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

Clinical Trials Drugs Therapies Licensing

FDA takes major step to ease access to CAR-T therapy

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment.

Therapies

Therapies FDA Treatment Licensing

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

Vaccine

Vaccine FDA Therapies Licensing

Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP

BioPharma Drive: Drug Pricing

AUGUST 11, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Sponsored Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP Published Aug. You can unsubscribe at anytime. © 2025 TechTarget, Inc.

Marketing

Marketing Pharmacy Therapies Clinical Trials

The rise of GLP-1 drugs: Transforming weight loss treatment

BioPharma Drive: Drug Pricing

JUNE 23, 2025

This shift raises ethical questions around prioritizing supply for diabetes patients versus those seeking treatment for obesity or cosmetic weight loss. You can unsubscribe at anytime. The balance is complex, as obesity carries its own serious health risks. TechTarget, Inc.s registered office is 275 Grove St. Newton, MA 02466.

Treatment

Treatment Drugs Therapies FDA

Replimune drug rejected by FDA; Omega raises $647M biotech fund

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously. and Europe.

FDA

FDA Specialty Pharmacies Drugs Therapies

Sanofi to acquire vaccine biotech in billion-dollar deal

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 You can unsubscribe at anytime. © 2025 TechTarget, Inc.

Vaccine

Vaccine Clinical Trials FDA Therapies

OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

JUNE 12, 2024

Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

FDA

FDA Regulations Treatment Licensing

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

ACEP Applauds Removal of X-waiver, Expanding Medication-assisted Treatment for Opioid Use Disorder

The Pharma Data

JANUARY 14, 2021

Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.

Treatment

Treatment Licensing Licensing Hospitals

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

Licensing

Licensing Licensing Vaccine FDA Approval

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. About GDA-201.

Licensing

Licensing Licensing Clinical Trials FDA

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

FDA Approval

FDA Approval Treatment FDA Clinical Trials

Burning Rock Announces an Exclusive in-Licensing of a Risk Stratification Test for Early Stage Lung-Cancer Patients from Oncocyte in China

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

Licensing

Licensing Licensing Pharmaceutical Companies Treatment

Identify and Validate Innovative Peptides for the Treatment of Obesity

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

Treatment

Treatment Bioinformatics Clinical Development Therapies

Dragonfly Therapeutics and Bristol Myers Squibb Announce Exclusive Global License for Dragonfly’s IL-12 Investigational Immunotherapy Program

The Pharma Data

AUGUST 17, 2020

DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About DF6002. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies.

Licensing

Licensing Licensing Production Clinical Trials

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Biohaven Forward-looking statements.

Small Molecule

Small Molecule Licensing Licensing Treatment

Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression

The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

Treatment

Treatment Trials Clinical Trials Therapies

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine

The Pharma Data

DECEMBER 30, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

Trials

Trials Treatment Clinical Trials Therapies

Passage Bio Receives FDA Clearance of IND Application for Lead Gene Therapy Candidate PBGM01 for Treatment of Infantile GM1 Gangliosidosis

The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). chief medical officer of Passage Bio. About PBGM01.

Therapies

Therapies FDA Treatment Clinical Trials

Actithera draws new investors to radiopharma drug pitch

The future of mental health treatment: Zelquistinel’s role

Trending Sources

Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

Protein degraders: chasing undruggable targets

Viatris Announces Success in Second Pivotal Phase 3 Trial of MR-141 Targeting Presbyopia

Otsuka’s Sibeprenlimab Shows Significant Proteinuria Reduction in Phase 3 IgAN Trial

Biogen Launches Phase 3 Trial of Felzartamab for Primary Membranous Nephropathy

Takeda to seek approval of new kind of narcolepsy drug after study data

Navigating Regulatory Hurdles in Drug Development

Fitusiran

Jazz Pharma Gets EU Nod for Ziihera in Advanced HER2+ Biliary Cancer

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

Vor, with new CEO, changes course to target autoimmune disease

Landiolol

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

Panel urges FDA to remove warnings on hormonal menopause therapy

Soleno sales of new Prader-Willi drug rise faster than expected

FDA to ask Sarepta to stop shipping Duchenne gene therapy

Lexeo to help launch spinout around RNA drugs for the heart

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

Organon drug for endometriosis falls short in mid-stage study

Merck to buy Verona and its lung drug in $10B deal

FDA takes major step to ease access to CAR-T therapy

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP

The rise of GLP-1 drugs: Transforming weight loss treatment

Replimune drug rejected by FDA; Omega raises $647M biotech fund

Sanofi to acquire vaccine biotech in billion-dollar deal

OTC Hearing Aids: “Nothing to See Here” Says GAO Report

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

ACEP Applauds Removal of X-waiver, Expanding Medication-assisted Treatment for Opioid Use Disorder

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

Burning Rock Announces an Exclusive in-Licensing of a Risk Stratification Test for Early Stage Lung-Cancer Patients from Oncocyte in China

Identify and Validate Innovative Peptides for the Treatment of Obesity

Dragonfly Therapeutics and Bristol Myers Squibb Announce Exclusive Global License for Dragonfly’s IL-12 Investigational Immunotherapy Program

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine

Passage Bio Receives FDA Clearance of IND Application for Lead Gene Therapy Candidate PBGM01 for Treatment of Infantile GM1 Gangliosidosis

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