Sign inThe August 6, 2026 approval covers adults with advanced cutaneous melanoma that progressed on prior anti-PD-1 therapy, based on tumor response data from the IGNYTE trial.
SEC filing
The deal brings Ensysce a Phase 2-stage CRPS therapy with FDA Orphan Drug Designation, funded through a two-tranche private placement.
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An independent monitoring board unanimously backed moving Clearmind Medicine's CMND-100 study into Parts B and C after Part A safety data.
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The $30 million upfront deal, with up to $70 million more tied to sales milestones, adds a second dry eye mechanism alongside Harrow's VEVYE franchise.
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All ten patients receiving tanruprubart showed rapid strength gains within days, and the company still targets a Q4 2026 BLA filing.
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The European Commission extended MenQuadfi's indication to cover infants as young as six weeks against invasive meningococcal disease, expanding on the prior 12-months-and-older approval.
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The exploratory trial was not designed to reach statistical significance, but showed a nominally significant effect in patients with very severe social anxiety.
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The amendment creates a $75 million Revenue Notes series tied to product sales, replacing prior conditional tranches of Initial Notes.
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The company said its trial met prespecified endpoints, with bezisterim showing statistically significant benefits on inflammatory, motor, and non-motor measures versus placebo.
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MBX posted one-year canvuparatide data, early MBX 4291 obesity results, and $418.6 million in cash expected to last into 2029.
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The safety board also cleared a dose escalation in the open-label extension study, as PepGen posted second-quarter 2026 results showing $117.2 million in cash.
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The Q2 2026 filing discloses a $100 million payment due to Eli Lilly in Q3 2026 after BAQSIMI sales crossed a contract threshold, alongside new pipeline detail and an April ipratropium bromide launch.
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Roche published Phase 2b PADOVA data on prasinezumab in The Lancet while Prothena trimmed its 2026 cash forecast after share buybacks.
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Aclaris says cash of $170.6 million plus a recent $40.2 million stock sale should fund operations through the end of 2028 as multiple readouts approach.
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New pricing details show AbbVie's nine-tranche bond sale generated $9.98 billion in gross proceeds and will push total indebtedness to about $80.4 billion.
SEC filing (2)
Xenon reported $1.2 billion in cash and said the FOS filing remains on schedule after a pre-NDA meeting with FDA.
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CytomX said enrollment in its lead ADC's Phase 1 trial is finished and it plans to start a registrational study in the first half of 2027, alongside an expanded Regeneron deal.
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The clinical-stage cardiovascular biotech offered 21,250,000 shares ahead of Nasdaq debut under ticker "BRVE."
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Several OmniAb-derived antibody programs advanced in the quarter, including a Phase 3 start for Johnson & Johnson's ramantamig and new Phase 2b plans for Teva's TEV-'408 in vitiligo.
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The company is reviewing its full-year revenue guidance after strong Amtagvi demand and reported progress across multiple registrational and next-generation TIL trials.
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MetaVia said patients in its Phase 1 Part 3 study of DA-1726 have reached the highest planned dose levels, with 16-week topline data expected in Q4 2026.
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Zymeworks said the FDA's target action date on zanidatamab in gastric cancer falls on August 25, 2026, while the Theravance Biopharma acquisition is still expected to close in the second half of the year.
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Denali posted $3.6 million in net AVLAYAH revenue for Q2 2026, guided to $10-12 million for Q3, and disclosed a delayed DNL593 readout and a discontinued Parkinson's program.
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The company plans a supplemental NDA for aficamten in non-obstructive HCM in the fourth quarter of 2026 after positive Phase 3 topline data.
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Foghorn Therapeutics posted narrower Q2 losses and $167.6 million in cash as its lead SMARCA2 inhibitor advances in Phase 1 dose escalation for NSCLC.
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Collegium posted 6% revenue growth in Q2 2026, but lowered full-year product revenue and adjusted EBITDA guidance due to Nucynta authorized generic pricing.
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Tectonic Therapeutic finished enrolling its Phase 2 APEX trial and cleared a July safety review, with topline data still expected in early Q1 2027.
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AIM ImmunoTech will pay Sterling Pharma Solutions about $1.5 million for Ampligen precursor materials while terminating its at-the-market equity agreement with Maxim Group.
SEC filing (2)
The company will sell up to $200 million in shares through its existing Jefferies agreement, folding in the unsold balance of an earlier $85 million deal.
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Two amendments in July and August 2026 boosted the principal on CDT Equity's convertible note, added a new $200,000 advance, and adjusted conversion terms.
SEC filing (2)
Monte Rosa completed enrollment in its MRT-8102 cardiovascular study, activated two other Phase 2 trials, and said cash on hand should fund operations into 2029.
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The company reported a wider net loss and roughly $1.0 billion in cash while pointing to topline Phase 3 data and a fourth-quarter BLA milestone.
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The company also disclosed a binding MENA licensing term sheet for OCU400 and said cash runway now extends into 2028.
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Lineage highlighted three-year OpRegen data, early COR1 manufacturing progress, and a new scientific advisory board, with cash seen lasting into Q3 2028.
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The FDA identified no major safety or efficacy concerns for ulixacaltamide or relutrigine, with PDUFA dates of January 29, 2027 and December 27, 2026, respectively.
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Aclaris Therapeutics restated its equity sales pact on August 6, 2026, replacing a February 2025 deal that had covered up to $100 million in shares.
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Corbus received FDA clearance to start a registrational study of its cancer drug CRB-701 while posting a wider quarterly net loss.
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Cellectis said its pivotal Phase 2 BALLI-01 trial is advancing with FDA RMAT designation and $169 million in cash to fund operations into Q4 2027.
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The company issued nearly 1,288 preferred shares to Statera and Avenue Venture Opportunities Fund to cover a milestone payment tied to its Toll-like Receptor 5 agonist program.
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An August 6, 2026 8-K details the finalized sales agreement amendment, a new Goodwin Procter legal opinion, and the company's furnished second-quarter financial results.
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The company can now sell Class A common stock through BTIG and Citizens JMP Securities from time to time under a new shelf-based ATM program.
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The company lifted full-year LINZESS, revenue, and EBITDA guidance for a second straight quarter while its confirmatory apraglutide trial begins enrolling patients and it retires $200 million in convertible notes.
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Edgewise plans a Phase 3 HCM trial in Q4 2026 after positive EDG-7500 data, and booked $1.55 billion upfront from its muscular dystrophy business sale to Servier.
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The Phase 2a study will test more frequent VCN-01 dosing in first-line metastatic pancreatic cancer patients, with initial data expected in Q3 2027.
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The company said cash of €252 million should fund operations into the first half of 2029 as it prepares to start two new studies later this year.
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Korro reported $137.9 million in cash and said KRRO-121 remains set to enter the clinic in the second half of 2026 while KRRO-111 advances as a development candidate for AATD.
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