Alkermes reports positive Phase 1b data for ADHD drug ALKS 7290
Alkermes said the orexin 2 receptor agonist showed dose-dependent symptom improvements in adults with ADHD, with a Phase 2 trial now enrolling and data expected in 2027.
SEC filing
Latest
Monday, September 21
Cue Biopharma's 8-K confirms Phase 2 CUE-221 data in chronic hives, outlines next steps
The filing details dose-dependent efficacy across primary and secondary endpoints and lays out plans for a Phase 2b/3 CSU study and a food allergy Phase 2 trial.
SEC filing
Telix Pharmaceuticals to merge with ITM Isotope Technologies Munich in radiopharma deal
Telix will pay ITM shareholders $1.65 billion upfront and up to $700 million more tied to regulatory and sales milestones for cancer drug candidate ITM-11.
SEC filing
Tiziana completes last patient visit in Phase 2a INFORM-MS foralumab trial
The company said database lock is expected within the week, with topline 12-week data from the intranasal foralumab study due in October 2026.
SEC filing
PTC Therapeutics closes acquisition of Sangamo's ST-920 Fabry gene therapy
The one-time AAV gene therapy is headed toward a rolling BLA submission expected to finish in the fourth quarter of 2026.
SEC filing
Electra Therapeutics prices $350 million IPO, sets Nasdaq listing under ETRA
The late-stage biopharma sold 23,333,334 shares at $15.00 each ahead of a September 21, 2026 closing, funding its lead sHLH antibody through a Phase 2/3 registrational trial.
SEC filing (2)
Helus Pharma CEO to join TD Cowen neuropsychiatry summit fireside chat
Michael Halstead will take part in a virtual fireside chat on September 23, 2026 at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit.
SEC filing
Typewriter Therapeutics discloses $56.3 million equity offering in Form D filing
The Cambridge, Massachusetts biotech reported selling the full amount of a private securities offering to six investors, according to an SEC filing.
SEC filing
BioStem Technologies registers $40 million stock facility, files related Form D
BioStem Technologies filed an S-1 covering resale of up to 12,050,000 shares tied to a new equity purchase deal with Roth Principal Investments, alongside a Form D notice of the same offering.
SEC filing (2)
GT Biopharma expands preferred stock offering to $7.75 million with new investor
The company amended its Series M preferred stock and warrant sale to add a new purchaser, raising the deal's aggregate stated value and increasing authorized preferred shares.
SEC filing (2)
Recursion Pharmaceuticals amends Tempus AI data pact and licenses RNA model for oncology
The two companies revised financial terms of their 2023 master agreement and signed a separate two-year license letting Tempus use Recursion's TxFM RNA model in oncology.
SEC filing
CHMP backs two AstraZeneca drugs: Klygefa in gMG, Enhertu in early breast cancer
Both positive opinions came on September 21, 2026, based on Phase III trial data in generalised myasthenia gravis and HER2-positive early breast cancer.
SEC filing (2)
Therapeutic Neuromodulation Systems files Form D for $5 million equity offering
The Louisiana biotechnology company reported $1,709,500 sold toward the offering as of a filing signed September 21, 2026.
SEC filing
Black Hawk discloses missed trust deposits amid pending Vesicor merger
Two extension payments were made after their cure periods lapsed, a breach that could have forced liquidation, but Black Hawk pressed ahead with the Vesicor Therapeutics deal.
SEC filing
Travere Therapeutics names Bradley Campbell CEO as Eric Dube exits
Dube will leave Travere's top job and board seat on December 1, 2026, handing the CEO role to former Amicus Therapeutics chief Bradley Campbell.
SEC filing
University of Zurich registers Phase 2 safusidenib trial in IDH1-mutant grade 3 glioma
Abivax reports H1 2026 results, says NDA filing for obefazimod still on track for Q4
The company details pipeline progress, a completed royalty buy-back, and a cash runway it projects into Q4 2029 after its July offering.
SEC filing
Madrigal registers new Phase 1b trial testing resmetirom in MASH patients with HFpEF
Immuron presents pipeline and financial update at Coffee Microcaps conference
The Australian biopharma outlined FY26 revenue growth, a partnering strategy for two clinical assets, and FDA clearance for an IMM-529 Phase 2 study.
SEC filing
Friday, September 18
FDA approves new efficacy supplement for Eli Lilly's Verzenio
The regulator cleared supplement 22 for the abemaciclib tablet application on September 18, 2026, with updated labeling issued days later.
Drugs@FDA
FDA approves supplemental application for Eli Lilly's Inluriyo
The efficacy supplement for imlunestrant tosylate tablets received FDA approval, with a status date of September 18, 2026.
Drugs@FDA
Lakewood-Amedex updates S-1, adds detail on Nu-3 pipeline and Series C conversion mechanics
The company's September 18, 2026 filing registers 4,512,400 more shares tied to Series C Preferred conversion and details its lead antibiotic candidate's trial progress.
SEC filing
SPRAVATO label update approved; J&J vision, hip, and lumateperone trials advance
Adial holds 2026 annual meeting, adjourns vote on four proposals pending Nasdaq approval
Stockholders approved eight of twelve agenda items on September 17, 2026, but the company put off votes on four proposals until October 1 while it awaits Nasdaq's response on a listing application.
SEC filing
CDT Equity issues $2,126,250 convertible note to J.J. Astor & Co.
The note, secured by company assets, converts at 70% of a trailing VWAP with a $0.05 floor price, and carries warrants for 3,468,500 shares.
SEC filing
Corvus registers Phase 1b trial of soquelitinib in hidradenitis suppurativa
Lexaria Bioscience reports Form D covering warrant exercise proceeds
The Kelowna-based biotechnology company disclosed $113,492 in proceeds from a warrant inducement arrangement in a Form D filed with the SEC.
SEC filing
AIMEDBIO registers Phase I trial of BI 4060107 with Boehringer Ingelheim as collaborator
BioStem Technologies enters $40 million committed equity facility with Roth
The Pompano Beach regenerative medicine company can sell shares to Roth Principal Investments over time, subject to a registration statement and price conditions.
SEC filing
Vicora, Inc. reports Form D for $2.5 million private offering
The Buffalo, New York biotechnology company disclosed a securities sale with $2.3 million already raised from 59 investors as of the September 18, 2026 filing date.
SEC filing
Halozyme prices upsized $1.3 billion convertible notes offering due 2033
The company raised the deal from an original $1.05 billion and gave initial purchasers an option for $200 million more, with proceeds set to fund capped calls and repurchase older notes.
SEC filing
Lilly's orforglipron posts Phase 3 diabetes results; six new trials registered
Roche posts HCC trial results, registers five new studies across cancer, MS, flu, COPD
FibroBiologics CSO buys $0.5 million in stock in private placement
Chief Scientific Officer Hamid Khoja purchased shares and warrants at market price, closing September 15, 2026.
SEC filing (2)
Nasus Pharma files to sell up to $8.5 million in shares via ATM offering
The Israeli intranasal drug developer set terms with BTIG on September 18, 2026, for stock sales tied to its epinephrine program NS002.
SEC filing
Upstream Bio posts VIBRANT Phase 2 results for verekitug in nasal polyps
Regeneron's EYLEA HD posts Phase 3b safety results; dupilumab keloid study completes
GSK's IPF drug GSK3915393 fails Phase 2 on futility; expanded access opens for velzatinib in GIST
BlossomHill reports Q2 2026 results, FDA Fast Track for lung cancer drug BH-30643
The company disclosed Fast Track designation for its lead EGFR inhibitor and set an end-of-phase-1 FDA meeting for later in 2026, alongside cash from its August IPO.
SEC filing
Thursday, September 17
Indivior declares $8.13 per share special dividend tied to Supernus merger closing
The dividend will only be paid if Indivior's pending merger with Supernus Pharmaceuticals closes, expected on or about November 2, 2026.
SEC filing
Aethlon Medical to merge with North Immunology in reverse merger backing IL-13 x IL-18 bispecific
The all-stock deal pairs Aethlon with private biotech North Immunology and an oversubscribed $180 million private placement to fund development of NOR-101 in atopic dermatitis.
SEC filing
NeOnc CEO buys more stock after positive NEO100 Phase 2a data
Amir Heshmatpour purchased 35,000 additional NeOnc shares on September 15, 2026, bringing his and CMO Thomas Chen's combined open-market purchases to about $629,000 since August's trial results.
SEC filing
Aquestive resubmits FDA application for Anaphylm epinephrine film
The company said new human factors and pharmacokinetic data address the FDA's prior Complete Response Letter for the needle-free anaphylaxis treatment.
SEC filing
FDA grants full approval to Ultragenyx gene therapy FAYUVI for Sanfilippo syndrome Type A
Ultragenyx said the approval, announced September 17, 2026, covers pediatric patients with MPS IIIA and comes with a Priority Review Voucher.
SEC filing
Anteris Technologies grants contingent options and PSUs to executives, options to McDonnell
The board approved equity awards for CEO Wayne Paterson, David St Denis and Matthew McDonnell on September 12, 2026, with most grants pending stockholder approval.
SEC filing
SurgiBox Inc discloses $486,000 raised in Regulation D offering
The Cambridge, Massachusetts biotechnology company reported a $3,000,000 target offering with 9 investors participating as of the filing date.
SEC filing
TuHURA Biosciences adopts inducement equity plan, adds detail in amended filing
The board reserved 5,000,000 shares for new-hire equity awards, and a follow-up filing clarifies vesting, pricing and disclosure terms.
SEC filing (2)
Calidi Biotherapeutics prices $1.2 million stock offering at $1.17 per share
The San Diego biotech will sell 1,025,640 shares directly to investors, with delivery expected September 21, 2026, as it flags going-concern doubt.
SEC filing
Tempest secures option to license Senlang's CD7 lentiviral in vivo CAR-T platform
The option, signed September 14, 2026, covers a BCMA/GPRC5D dual-targeting candidate now in Phase 1 for relapsed/refractory multiple myeloma.
SEC filing (2)