EMA validates MAA for Pfizer and Valneva's Lyme disease vaccine candidate
The agency will now formally review PF-07307405, backed by Phase 3 VALOR trial results showing more than 70% efficacy.
SEC filing
Latest
Friday, August 14
Quantum BioPharma gets FDA nod to start Lucid-MS Phase 2 trial in progressive MS
The company reported Q2 2026 results alongside FDA clearance to advance its lead MS candidate into a randomized, placebo-controlled trial.
SEC filing
iSpecimen settles WestPark dispute, signs $2M IR consulting deal
Two 8-K filings show iSpecimen resolved an underwriter arbitration for $97,500 and separately agreed to pay an investor relations firm $2 million for a three-month campaign.
SEC filing (2)
Novo Nordisk posts results for two semaglutide trials, opens new NNC0487-0111 study
Lilly posts orforglipron Phase 3 results; adds new early-phase studies
Outlook Therapeutics prices $55 million stock and warrant offering
The company plans to use proceeds along with existing cash to launch LYTENAVA in the US, where it holds a going concern warning and about $11.2 million in cash as of June 30, 2026.
SEC filing (2)
NewAmsterdam Pharma names new accounting officer, details COO exit terms
The company appointed Robert W. Gunning as principal accounting officer while finalizing separation and advisory terms for former COO Douglas Kling.
SEC filing (2)
Citius Pharmaceuticals reports fiscal Q3 2026 results as LYMPHIR launch continues
The company reported $7.1 million in nine-month LYMPHIR revenue and $17 million in cash, while citing early-stage data expanding the drug's potential use beyond cutaneous T-cell lymphoma.
SEC filing
Traws Pharma preps revised toxicology data for MHRA resubmission by Q3 2026
The company plans to resubmit an updated toxicology package for tivoxavir marboxil after MHRA feedback, aiming to support a Phase 2a influenza Challenge study.
SEC filing
Replimune's TUDRIQEV wins FDA accelerated approval, launch set within 60 days
Replimune reports fiscal Q1 2027 results alongside the melanoma therapy's approval, a new commercial chief, and a completed $150 million financing.
SEC filing
LeonaBio reports Q2 2026 results, enrollment nears completion for ELAINE-3 trial
The company said it has enrolled 495 of an expected 600 patients in its Phase 3 lasofoxifene trial, with cash down to $51.1 million.
SEC filing
HCW Biologics reports Q2 2026 results, alopecia data and going concern doubt
The company said preliminary Phase 1 data show SALT score improvements for HCW9302 in alopecia areata, with full data expected in Q4 2026, while flagging substantial doubt about its ability to continue as a going.
SEC filing
OPKO Health amends note agreement, issues $125 million in additional senior secured notes
The notes, tied to EirGen Pharma's mazdutide royalty interest from Eli Lilly, mature in 2044 and carry a SOFR-plus-7.5% rate with a 4% floor.
SEC filing
Innate Pharma to hold conference call August 14, 2026
The company announced a call and webcast on August 14, 2026 featuring its CEO, COO, CFO, and IR head.
SEC filing
Quince Therapeutics reports Q2 2026 results after closing Orphai acquisition
The company folded in Orphai's inhaled rapamycin program LAM-001 and raised $115 million as it advances trials in three pulmonary diseases.
SEC filing
Heron Therapeutics extends tax benefit preservation plan to 2029
The company amended its shareholder rights plan on August 13, 2026, pushing the expiration date back three years.
SEC filing
TuHURA reports Q2 2026 results, outlines second-half milestones for AML and MCC programs
TuHURA said it filed an IND for its VISTA-inhibiting antibody TBS-2025 and expects to start a Phase 1b/2 AML trial in the second half of 2026, while citing a $50 million credit facility for its cash runway.
SEC filing
Skye Bioscience and Redx Pharma to merge, form Fibrx Therapeutics with $125M financing
The combined company will focus on Redx's fibrosis pipeline, led by RXC008 for fibrostenotic Crohn's disease, with Phase 2 data expected in H2 2028.
SEC filing
Incyte-linked filings this week: FIGHT-302 results posted, new academic pancreatic trial listed
InflaRx registers up to $65 million in ordinary shares for at-the-market sales
The prospectus supplement, filed August 14, 2026, expands an existing sales agreement with Leerink Partners and details InflaRx's cash position and izicopan development plans.
SEC filing
Insmed registers Phase 1 trial testing INS1033 in healthy volunteers
Outlook Therapeutics details LYTENAVA US launch prep in Q3 FY2026 update
The company said it is readying a U.S. launch of FDA-approved wet AMD drug LYTENAVA by year-end 2026, reporting $11.2 million in cash plus a subsequent $51.1 million offering.
SEC filing (2)
Pfizer posts hemophilia results, opens eczema Phase 3, ends two skin studies early
Olaparib Phase 2 results posted; three diabetes labels updated; new myeloma CAR-T trial recruits
Amneal clears five FDA supplements: REMS update on buprenorphine/naloxone leads week
Thursday, August 13
Cellectar reports Q2 2026 results, advances Phase 3 WM trial toward mid-2027 filing
The company started site activation for a confirmatory Phase 3 study of iopofosine I 131 as it targets an accelerated approval submission and reported $34.0 million in cash.
SEC filing
Voyager Therapeutics registers Phase 1 dose-escalation trial of VY1706 in early Alzheimer's disease
Aposture Surgical Corp discloses $150,000 SAFE offering in SEC Form D
The Philadelphia biotech, formerly BioSpine Corp, reported $87,000 raised toward the target as of a first sale date of August 7, 2026.
SEC filing
Adial Pharmaceuticals plans CEO and CFO transition tied to 2026 annual meeting vote
The company said it expects to swap out its top executives and reshape its board if stockholders approve certain proposals at the September 17, 2026 meeting.
SEC filing
Curis prices $5.6 million offering of stock, pre-funded and common warrants
The company plans to use the proceeds for research and development and general corporate purposes as it flags substantial doubt about its ability to continue as a going concern.
SEC filing (2)
Abcuro discloses Form D for equity offering worth up to $176.5 million
The Newton, Massachusetts biotechnology company reported $39.4 million sold as of a first sale date of August 7, 2026, with 23 investors participating.
SEC filing
NeOnc reports Phase 2a NEO100-01 met primary endpoint in recurrent IDH1 mutant glioma
In an August 12, 2026 investor call, NeOnc said NEO100 hit its PFS6 benchmark and reported a 26.1-month median overall survival in recurrent high-grade glioma patients.
SEC filing
Auron Therapeutics files Form D for $12 million debt offering
The Wellesley, Massachusetts biotechnology company reported $7,118,141 already sold toward the offering, with 14 investors participating as of the filing date.
SEC filing
Capricor gives update on Deramiocel BLA after adcomm setback, reports Q2 2026 results
Capricor said it continues to work with FDA on the Deramiocel BLA following a negative advisory committee vote, as HOPE-3 data appear in The Lancet and cash falls to $238 million.
SEC filing
EyeCBetter registers trial testing non-contact eye pressure device against gold standard tonometer
NeuroSense CEO updates shareholders on PARAGON financing, Canada filing, Nasdaq issue
The company said it is still working to fund its Phase 3 ALS trial while preparing a Canadian drug submission and addressing a Nasdaq bid price deficiency.
SEC filing
Archean Sciences files Form D for SAFE offering of indefinite size
The Champaign, Illinois biotechnology company reported $385,000 raised from eight investors under a Regulation D exemption.
SEC filing
Chung Shan Medical University registers trial on slow-paced breathing in heart failure patients
Fate Therapeutics doses first lupus nephritis patient in Phase 2 FT819 trial, clears FT839 IND
The company reported second-quarter 2026 results alongside pipeline updates across three CAR T-cell candidates and cash runway extending into 2028.
SEC filing
Rani Therapeutics reports Q2 2026 results, advances RT-114 oral GLP-1/GLP-2 program
Rani dosed the first participants in an expanded RT-114 cohort, posted early Phase 1a data topping subcutaneous exposure, and said cash covers operations at least through 2027.
SEC filing
Siriraj glaucoma survey completes in Bangkok; BASIC-S vascular pilot not yet recruiting in Ontario
4DMT reports Q2 2026 results, completes enrollment for second wet AMD Phase 3 trial
4D Molecular Therapeutics said enrollment finished for 4FRONT-2 and reported new credit facility and cash position as of August 13, 2026.
SEC filing
New observational study registered on NT-proBNP monitoring in acute heart failure
Assembly Biosciences registers Phase 2 trial of ABI-6250 for chronic hepatitis D
Dogwood reports Q2 2026 results as Halneuron Phase 2b nears fall readout
Dogwood Therapeutics said its 217-patient Halneuron Phase 2b trial in chemotherapy-induced neuropathic pain remains on track for top-line data in fall 2026, with cash of $9.6 million.
SEC filing
ARS Pharma narrows commercial focus for neffy, sees CSU data in Q1 2027
The company reported $26.2 million in Q2 2026 neffy revenue, named a new commercial chief, and pointed to interim urticaria trial data expected in early 2027.
SEC filing
Invivyd completes enrollment in two VYD2311 pivotal trials, reports Q2 2026 results
LIBERTY is fully dosed with data due late Q3 2026, while DECLARATION enrollment is complete with data planned later in Q3 2026, as PEMGARDA revenue grew 21%.
SEC filing
CorMedix reports Q2 2026 results, flags REZZAYO filing and DefenCath supply deal
CorMedix expects to submit an sNDA for expanded REZZAYO use in Q3 2026 and signed a new dialysis supply agreement, while maintaining full-year revenue guidance.
SEC filing
Gossamer reports Q2 2026 results, reacquires seralutinib rights from Chiesi
Gossamer says it remains on track to file its seralutinib NDA in PAH in September 2026 after a Pre-NDA meeting with the FDA, while reporting $57.0 million in cash as of June 30, 2026.
SEC filing
Inhibrx reports Q2 2026 results, sets Q3 PFS readout for INBRX-106
The company also drew $100 million more from Oxford Finance and got FDA filing acceptance for its ozekibart BLA in chondrosarcoma with an April 2027 goal date.
SEC filing