Entrada reports positive Cohort 1 safety data for DMD therapy ENTR-601-45
The company said the Phase 1/2 ELEVATE-45-201 study met its primary safety objective at 5 mg/kg, with Cohort 2 data expected in the first half of 2027.
SEC filing
Latest
Wednesday, October 14
Biodexa hits 100-patient enrollment in Phase 3 FAP trial of eRapa
The company said faster-than-expected PFS event accrual could move up both the futility analysis and database lock for its "Serenta" trial.
SEC filing
The company: Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presen
A record notice: the source is linked, and no summary was written because none passed the fact check.
FDA
FDA expands approval of nogapendekin alfa inbakicept-pmln for bladder cancer
The agency approved the drug, marketed as Anktiva, for use with BCG in adults with BCG-unresponsive non-muscle invasive bladder cancer.
SEC filing, Drugs@FDA, FDA, FDA press release (4)
Coya Therapeutics plans open-label extension of ALS trial, pushes back FTD study start
Coya said it will prioritize COYA 302's ALS program, delaying a planned frontotemporal dementia trial from 2026 into 2027.
SEC filing
Eton licenses LIBERVANT buccal film from Aquestive for U.S. epilepsy market
Eton paid $10 million upfront for exclusive U.S. rights to the diazepam seizure-rescue film, with launch targeted for April 2027 pending final FDA approval.
SEC filing (2)
Ultragenyx agrees to sell rare pediatric priority review voucher for $203 million
The company will transfer a voucher earned from its Sanfilippo syndrome gene therapy approval to an unnamed buyer, pending antitrust clearance.
SEC filing
OneMedNet regains compliance with Nasdaq's minimum bid price rule
Nasdaq notified the company on October 13, 2026 that its stock had met the $1.00 minimum closing bid price requirement for 10 consecutive business days.
SEC filing
Verastem prices $234.7M stock offering, names Bailey CEO, posts VS-7375 data
Verastem priced a public offering expected to net about $234.7 million as it named Michael Bailey CEO and reported new VS-7375 pancreatic, colorectal and lung cancer data.
SEC filing (3)
J&J Innovative Medicine recalls one IMAAVY lot over particulate matter; two trials also update
Vir Biotechnology signs TCE collaboration and license deal with Gilead Sciences
Gilead gets exclusive rights to develop three masked T-cell engager candidates discovered by Vir, with a stock purchase alongside the agreement.
SEC filing
Evotec flags preliminary nine-month 2026 results ahead of market expectations
The company reaffirmed full-year 2026 guidance while reporting preliminary revenue and EBITDA figures for the first nine months that it said topped consensus.
SEC filing
Takeda gets two mesalamine label approvals; psoriatic arthritis trial still not recruiting
Alector reprices employee stock options after board review
Alector's board approved a repricing of underwater employee stock options effective October 13, 2026, setting a new exercise price of $1.87 per share with a one-year retention condition.
SEC filing
Akebia's chief commercial officer resigns, to stay on as consultant
Nicholas Grund will leave his post on November 6, 2026, then advise the company on an hourly basis through April 2027.
SEC filing
MaxCyte raises 2026 revenue guidance on preliminary third-quarter results
The cell-engineering company said third-quarter core business revenue rose 26% year over year, pushing full-year guidance to approximately $34 million.
SEC filing
EMA grants orphan drug status to Quoin's QRX003 for Peeling Skin Syndrome
The October 14, 2026 designation offers Quoin potential market exclusivity in Europe and marks the company's eighth regulatory milestone for the rare-disease drug candidate.
SEC filing
Aptevo to present multispecific CD40 platform data at SITC 2026
Tuesday, October 13
Mirum reports positive Phase 3 EXPAND data for Livmarli in cholestatic liver diseases
Mirum said the study hit its main goal and all five secondary measures, and plans a US filing in the first half of 2027.
SEC filing
iBio highlights NHP data showing IBIO-610 may preserve muscle with GLP-1 therapy
In an eight-week obese primate study, adding IBIO-610 to semaglutide shifted weight loss toward fat over muscle, iBio said October 13, 2026.
SEC filing
FDA approves efficacy supplement for Vifor Fresenius's Velphoro
The FDA cleared a supplemental application for the chewable phosphate binder, classified as an efficacy submission, with a status date of October 13, 2026.
Drugs@FDA
Senti Biosciences adjourns annual meeting to gather more merger votes
The company postponed its October 8 meeting without business and will reconvene October 15 to continue soliciting stockholder support for a merger proposal.
SEC filing
Sanofi terminates phase 2 trial of SAR441566 in Crohn's disease
The trial was stopped for a business decision after enrolling 105 participants, according to the clinical trial registry record last updated October 13, 2026.
ClinicalTrials.gov
Biomea Fusion reports Phase 1 topline data for oral GLP-1 candidate BMF-650
On October 13, 2026, the company disclosed MAD and confinement-cohort results from the GLP-131 study, showing weight loss up to 6.1% and no serious treatment-related adverse events.
SEC filing
Alaunos acquires Velaris Therapeutics, lines up $350 million PIPE financing
The October 13, 2026 merger and private placement bring pulmonary hypertension programs to Alaunos alongside a Fairmount-led investor group.
SEC filing (2)
CervoMed reports early NfL drop in Phase 2a nfvPPA trial of neflamapimod
The company presented 12-week biomarker data at ISFTD 2026, with 24-week results due in November and clinical data expected in early 2027.
SEC filing
Regentis reports surgeon interest in GelrinC at ICRS Summit in Portugal
The Israeli regenerative medicine company said European clinical sites for its CE Mark-approved cartilage implant are also feeding into an ongoing U.S. FDA pivotal trial.
SEC filing
RedHill Biopharma raises ATM capacity to $2.59 million under Form F-3 limit
The October 13, 2026 prospectus supplement lets RedHill sell additional ADSs up to $2,587,409, within a $2,637,099 Form F-3 ceiling.
SEC filing
SAB Biotherapeutics gets FDA Fast Track for T1D therapy SAB-142
The designation applies to SAB-142 in new-onset Stage 3 type 1 diabetes, as the company's Phase 2b and investigator-led Phase 3 studies continue.
SEC filing
Oncolytics details GOBLET readout timing; SystImmune starts Phase 3 ADC trial in urothelial cancer
AstraZeneca pediatric NEXIUM trial for erosive esophagitis listed as completed
Merck adds Paul J. Diaz to board of directors
Merck announced on Oct. 13, 2026 that Cressey & Company managing partner Paul J. Diaz will join its board effective Nov. 1, 2026, expanding the board to 14 members.
SEC filing
Nurix reports Q3 2026 results as bexobrutideg enters Phase 3 and NX-2127 is dropped
Nurix dosed its first patient in a registrational Phase 3 CLL trial for bexobrutideg, discontinued NX-2127, and ended the quarter with $1.1 billion in cash after closing its Roche collaboration.
SEC filing
CDT Equity issues $6.75 million convertible note to J.J. Astor & Co.
The Nasdaq-listed company will repay the note in 24 weekly installments while directing most at-the-market proceeds toward the debt.
SEC filing
FibroBiologics' Form D confirms Peak One debenture as Rule 506(b) offering, fully sold
A new SEC Form D shows the $1.2 million convertible debenture and share issuance to Peak One was sold entirely to one investor under Rule 506(b).
SEC filing (2)
Axelyf discloses $2.7 million equity offering in SEC Form D filing
The Chestnut Hill, Massachusetts biotechnology company reported sales of about $2.63 million toward a $2.7 million target, with eight investors participating.
SEC filing
FDA accepts BridgeBio's NDA for oral infigratinib in achondroplasia, grants priority review
The PDUFA target action date is February 4, 2027, for a drug BridgeBio says would be the first oral therapy for children with the condition if approved.
SEC filing
J&J reports Q3 2026 results, raises full-year sales and EPS guidance
Johnson & Johnson posted 5.9% reported sales growth to $25.4 billion and raised its 2026 outlook, citing regulatory and clinical progress across its portfolio.
SEC filing
EpiVario files Form D for $500,000 debt offering
The Philadelphia pharmaceutical company has sold $185,000 of a planned $500,000 note offering to nine investors as of October 13, 2026.
SEC filing
ADC Therapeutics restructures finances with $86.6 million private placement
The company amended its HealthCare Royalty agreement and loan terms while raising new equity, extending its expected cash runway into 2029.
SEC filing
Revolution Medicines draws $250M loan tranche after FDA approves RASONQUE
The FDA approval of daraxonrasib for pancreatic cancer triggered a $250 million Royalty Pharma loan draw, while the company passed on a separate $250 million royalty sale option.
SEC filing
Tempest Therapeutics files Form D for $7.5 million private placement
Tempest Therapeutics raised $7.5 million through pre-funded warrants and common stock purchase warrants in an offering first sold September 15, 2026.
SEC filing
Gasherbrum Bio registers Phase 1 hepatic impairment study for aleniglipron
MetaVia names Sarah Browne, M.D. as Chief Medical Officer
The appointment, effective October 12, 2026, comes ahead of fourth-quarter topline data expected from Part 3 of the Phase 1 trial of DA-1726.
SEC filing
ImmuCell reports 46% jump in third-quarter 2026 product sales
Preliminary figures show total sales of $8.0 million for the quarter ended September 30, 2026, with growth broad-based across the company's calf health product lines.
SEC filing
Zoetis appoints Iris Knobloch to board, expanding it to 13 members
The animal health company named Knobloch a director effective December 1, 2026, days after declaring its fourth-quarter dividend of $0.53 per share.
SEC filing (2)
Harmony Biosciences names Peter Anastasiou CEO, succeeding Jeffrey Dayno
Harmony's board set a leadership transition effective January 1, 2027, while reaffirming 2026 WAKIX revenue guidance and a pipeline data readout.
SEC filing
Boehringer Ingelheim registers Phase Ib/II trial testing obrixtamig plus pumitamig in SCLC
BioHarvest says Olive Cell asset is commercial-ready, opens CDMO licensing
The company reported completion of manufacturing scale-up and a self-affirmed GRAS process for its olive-derived Verbascoside composition, citing preclinical liver data.
SEC filing
SS Innovations issues $21.025 million convertible note to institutional investor
The Florida-based company closed a secured convertible note deal on October 9, 2026, raising $20 million in net purchase price under terms disclosed in a new SEC filing.
SEC filing