Sign inInvestigators said 12-week INFORM-MS findings in non-active secondary progressive MS align with longer-term benefits seen in patients treated for up to three years, Tiziana said November 9, 2026.
SEC filing (2)
The company added a Phase 3-ready eosinophilic esophagitis asset and priced a private placement while reporting rising ZEVASKYN treatment volume and a new Medicare payment designation.
SEC filing (3)
Phase 1a results show deep ANGPTL3, triglyceride and LDL-C reductions as the company names a new technical chief and CFO alongside Q3 results.
FDA, SEC filing (3)
New Phase 1/2 results show immunomodulator-free responses sustained at one year in dermatomyositis, lupus nephritis and systemic sclerosis, with a favorable safety profile across 71 patients.
SEC filing (2)
An FDA notice on accelerated approval exists alongside the documented full approval of March 22, 2024, but the earlier action's date is not specified.
FDA (2)
The immunology company will take full ownership of the peptide discovery biotech it had partly invested in, adding macrocyclic peptide capabilities to its antibody platform.
SEC filing
The deal, announced November 9, 2026, adds Exton, Pennsylvania testing sites and could carry up to $75 million more in performance-based payments.
SEC filing
An FDA record shows the agency had previously granted accelerated approval to encorafenib paired with cetuximab and mFOLFOX6 before later converting to traditional approval for BRAF V600E-mutant metastatic colorectal.
FDA (4)
PIKTOR plus paclitaxel showed a 33% confirmed response rate and 7.4-month median PFS in the PIK-201 trial, and Faeth says the results support moving to a registrational study.
SEC filing, FDA (11)
The agency granted traditional approval on April 29, 2024, moving tisotumab vedotin-tftv beyond its earlier accelerated clearance.
FDA (2)
MBX highlighted its pivotal Phase 3 hypoparathyroidism trial dosing and said MBX 4291 obesity data are on track for Q4 2026, with $481.6 million in cash.
FDA, SEC filing (4)
Breyanzi gained accelerated approval for follicular lymphoma on May 15, 2024, two weeks before a full approval for mantle cell lymphoma.
FDA (2)
Biodexa reported 112 of 168 planned participants enrolled in its registrational eRapa trial and said futility analysis could come in early 2027, sooner than expected.
SEC filing (5)
Abeona issued $20 million in stock for the asset and lined up a $30 million PIPE to fund its pipeline and ZEVASKYN commercialization.
SEC filing
The agency's action covers locally advanced or metastatic disease, following an earlier accelerated approval for a pediatric RET-altered population.
FDA (5)
Votes covered a CVP share issuance, warrant repricing, stock plan expansion, a reverse stock split authorization, an ELOC floor price cut, and an adjournment measure.
SEC filing (2)
Ocular reported a September pre-NDA meeting with FDA, a SOL-R primary endpoint moved to Week 40, and cash of $530.6 million as of September 30, 2026.
FDA, ClinicalTrials.gov, SEC filing (8)
The biotech set terms for a combined share and pre-funded warrant sale meant to fund the launch of its newly approved RRP therapy VOCERYQ, with delivery still pending.
FDA, SEC filing (3)
The financing follows positive Phase 1 PBGENE-HBV data and a DMD safety update, with net proceeds meant to fund both programs through key inflection points.
SEC filing (5)
The company reported the patient remains cancer-free, as its Phase III HCC trial continues with survival data running ahead of design assumptions.
SEC filing
The TibuSHIELD study did not meet its primary or key secondary endpoints, and Zura said it is discontinuing development of tibulizumab in the condition.
SEC filing
Neurogene reported Q3 2026 results, kept its Embolden registrational trial readout guidance for the second half of 2027 and said cash lasts into early 2029.
SEC filing (4)
The appointment follows the November 5 firing of David Dodd and the addition of new director Shahin Behroyan, after five directors resigned effective October 23.
SEC filing (2)
Editas said it received ethics and regulatory clearance to begin its Phase 1/2 Strive study of EDIT-401 in Australia, with dosing expected by year-end and initial safety data due in early 2027.
SEC filing
The company also flagged a Phase 3 readout from partner AstraZeneca's rilvegostomig program in H2 2027 and said cash runway extends into 2029.
SEC filing
Tango Therapeutics said its vopimetostat-daraxonrasib combination hit an 82% response rate in pancreatic cancer and reported $977.5 million in cash as of September 30, 2026.
SEC filing (2)
OneMedNet said contracted demand now stands at nearly 14 times full-year 2025 bookings, with about half of 2026 contracts coming from new customers.
SEC filing (2)
The company said additional Stage 1/Phase 2a results for GX-03 showed separation from vehicle, and it now expects its hidradenitis suppurativa trial to start a quarter earlier than planned.
SEC filing
The company named the Oculis Holding chief executive to a Class I board seat effective November 6, 2026, as director Seung Suh Hong plans to step down at year end.
SEC filing
Praxis says PDUFA dates stand for relutrigine on December 27, 2026 and ulixacaltamide HCI on January 29, 2027, with EMERALD topline data expected in Q4 2026.
SEC filing
Kyorin gets exclusive Japanese rights to the ARDS antibody candidate, with Edesa set to collect a $12 million upfront payment plus milestones and royalties.
SEC filing
Tonix Pharmaceuticals reported third-quarter 2026 TONMYA net sales of about $15 million, up 37% from the prior quarter, alongside updates on its MDD, Lyme and transplant programs.
SEC filing
TG Therapeutics lifted full-year 2026 global revenue guidance to about $1 billion and pointed to Phase 3 subcutaneous BRIUMVI data expected around year-end or early 2027.
SEC filing
The company lowered Tryngolza product sales guidance to about $50 million while reporting positive Phase 3 results for sefaxersen and ulefnersen and a first Alexander disease launch.
SEC filing (2)
All 108 participants in the Phase 3 trial of bel-sar have finished treatment, with topline data still expected in the second half of 2027.
SEC filing
The company reported preclinical advances in its IBD and EP300 degrader programs alongside $156.2 million in cash and runway into the second half of 2029.
SEC filing
The November 6, 2026 agreement ties additional funding tranches to progress on Atea's Phase 3 trial of bemnifosbuvir and ruzasvir and other drug milestones.
SEC filing
The company, formerly Adial Pharmaceuticals, reconstituted its board and committees effective November 3, 2026, while also disclosing conversion of preferred stock tied to its Azora acquisition.
SEC filing
The company reports ACR20 response of 92.5% versus 75.6% for placebo at Week 28, with FDA discussions planned for later this year to chart a registrational path.
SEC filing
The November 6, 2026 closing came under a side letter that also extends the purchase agreement's outside date to December 9, 2027.
SEC filing
The company said it now expects to enroll over 500 patients in its Phase 3 kidney disease trial, with topline data still slated for the second quarter of 2027.
SEC filing
The approval covers use after tumor resection in patients with ALK-positive non-small cell lung cancer identified by an FDA-approved test.
FDA
Incyte's Niktimvo cleared for patients after at least two prior lines of systemic therapy failed.
FDA
The approval covers adult patients who have not previously received an ALK-inhibitor.
FDA
The study comparing JDQ443 to docetaxel in KRAS G12C mutant NSCLC was stopped for business reasons after enrolling only 95 of a planned 360 participants.
ClinicalTrials.gov
The agency's approval extends use of lutetium Lu 177 dotatate to adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
FDA
The agency cleared inotuzumab ozogamicin for children 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia on March 6, 2024.
FDA
The agency cleared the PD-L1 blocking antibody for metastatic or locally advanced cutaneous squamous cell carcinoma on December 13, 2024.
FDA