Sign inThe 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 amendment creates a $75 million Revenue Notes series tied to product sales, replacing prior conditional tranches of Initial Notes.
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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.
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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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The clinical-stage cardiovascular biotech offered 21,250,000 shares ahead of Nasdaq debut under ticker "BRVE."
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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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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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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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The agency's records show a submission status date of August 5, 2026, with an approval letter dated August 6, 2026.
Drugs@FDA
Zevra posted $39.7 million in net revenue for the quarter, said arimoclomol prescriptions in the U.S. keep rising, and is seeking a fresh EU regulatory review while advancing its celiprolol trial.
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IST net product sales rose 46% year over year in the quarter as Innoviva signed an antibiotic licensing pact with Dr. Reddy's and stood up a new long-acting oral drug delivery subsidiary.
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Black Diamond said no patients developed new brain metastases in a Phase 2 lung cancer trial and it will seek FDA feedback on pivotal development in the fourth quarter of 2026.
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The animal health company reported second quarter revenue of $1,368 million and raised its full-year guidance while accelerating debt paydown targets.
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Fanapt sales rose 23%, BYSANTI is set to launch in the second half of 2026, and Vanda expects Phase III data on three programs before 2027.
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Three universities commissioned NSF-backed cloud labs while MIT separately won a state grant, as Ginkgo posted lower revenue and wider losses.
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Interim gene therapy data and a $10 million Alnylam payment accompany fourth-quarter 2026 regulatory update plans for both lead programs.
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The company said it submitted new drug applications for ralinepag tablets in PAH and Nebulized Tyvaso in IPF, with more filings and organ program milestones expected by year end.
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Seres said 80% of patients in an MSK-run trial of SER-155 hit the day-15 response endpoint, while the company works to fund its allo-HCT and IBD programs.
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The contract research firm posted a GAAP loss per share in the second quarter but lifted its full-year revenue and non-GAAP EPS outlook after book-to-bill improved.
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The company reiterated its merger with Treeline Biosciences is progressing toward a stockholder vote and expected close before year-end 2026, while withdrawing full-year revenue guidance.
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Perrigo reported declines in net sales and adjusted profit for the quarter ended June 27, 2026, and said it still expects full-year results to improve in the second half.
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Vafseo revenue rose to $21.3 million as Akebia started a Phase 2 basket trial in three rare kidney diseases and cited positive interim safety data from the VOICE trial.
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The aesthetics company posted 21% revenue growth for the second quarter, expanded its injectable portfolio with new licensing deals, and reaffirmed 2028 targets.
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The company reported 17.3 month median overall survival in a first-line pancreatic cancer study and said its Phase 3 trial has begun dosing patients, with cash extending into 2029.
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The company reported 36-week SIGNAL-AA Part B results in alopecia areata and said cash plus a $200 million offering should fund operations through Phase 3 topline data.
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Compass says its rolling NDA submission for COMP360 in treatment-resistant depression is on track for completion in the fourth quarter, with a possible launch in the first half of 2027.
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The company sold 3,125,000 shares at $96.00 apiece and expects roughly $327.1 million in net proceeds after underwriters' full option exercise.
SEC filing (3)
Arcus added three new clinical collaborations for its HIF-2α inhibitor casdatifan and said cash runway extends to at least the second half of 2028.
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Entrada says ELEVATE-44-201 Cohort 1 open-label data are due by year-end 2026 and Cohort 2 enrollment is complete, while cash runway extends into Q3 2027.
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BioCryst posted $218.3 million in total revenue and raised full-year revenue guidance as it finished enrollment in its pivotal navenibart study and began pediatric ORLADEYO pellet shipments.
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ADMA reiterated full-year 2026 guidance and said its SG-001 preclinical program remains on track for a pre-IND meeting package submission to the FDA by year-end.
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The company formerly known as Applied DNA Sciences received a Nasdaq delisting determination over the $1.00 bid price rule and is seeking review while its shares trade on OTCQB.
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The company reported second-quarter ACV growth of 27% and lifted its full-year drug discovery revenue guidance after an Ajax Therapeutics milestone payment.
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The injectables CDMO reported a second-quarter net loss of $6.2 million as revenue fell 6.2%, while pointing to a growing pipeline of new contract wins.
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Coherus said LOQTORZI revenue rose 15% sequentially as it pointed to October for more mature clinical data on its CCR8 antibody in head and neck cancer.
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The company priced a $2.0 million equity unit offering at $0.75 alongside a $3.5 million convertible note follow-on from institutional investors, both dated August 4, 2026.
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UroGen reported second-quarter ZUSDURI sales up 73% from the prior quarter and outlined next steps for UGN-103, UGN-104 and UGN-501, alongside a Teva patent settlement on JELMYTO.
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The reagent maker reported second quarter 2026 revenue of $12.2 million, up 18%, and lifted its full-year revenue outlook to $45-47 million.
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Faster-than-planned enrollment in the STAT6 degrader's Phase 2b trial pulls the readout forward to year-end 2026 and sets up an earlier Phase 3 start.
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The company said it plans to start the Phase 3 ENABLE-2 trial in the second half of 2026 after positive Phase 1 results and FDA discussions.
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The company reported enrollment in two Phase 3 focal seizure trials, a bipolar mania readout expected in October, and $436.1 million in cash as of June 30.
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