fast Track Designation was granted for BB-301 following U.S. Food and Drug Administration (FDA) review of positive interim clinical study results and proprietary Responder Analysis planned for use in pivotal study for BB-301
Positive interim clinical study results from the Phase 1b/2a trial of BB-301, showed a 100% responder rate, with all six patients in Cohort 1 meeting the formal statistical criteria for response to BB-301
First patient of Cohort 2 successfully treated... Read more
Data from Phase 2 BESTOW trial demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus
Data supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection
Strengthened balance sheet with $57.5 million financing to advance transplantation programs IRVINE, Calif., Nov. 14, 2025 (GLOBE... Read more
Clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next generation GnRH antagonist, are steadily advancing PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 14, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, announced today its financial and operating... Read more
MIRAMAR, Fla., Nov. 14, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2025.
The Company anticipates dosing the first patient in... Read more
- Each shareholder is estimated to receive US$1.82 per share plus one CVR per common share -
- Transaction expected to close in the first quarter of 2026 -
- Additional portfolio monetization efforts continue -
- Company reports 3Q 2025 financial results -
- $112.6 million in cash and cash equivalents and marketable securities as of September 30, 2025, as compared to $109.5 million at June 30, 2025 - CAMBRIDGE, Mass. & MONTREAL / Nov 14, 2025 / Business Wire... Read more
NEW YORK, Nov. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update.
"We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn, designed to generate confirmatory data to support a potential BLA... Read more
Third Quarter Highlighted by Initiation of Phase 3 Study of PF614, Underscoring Progress Toward Market Readiness and Commitment to Novel Opioid Solutions
Further Program Advancement Supported by Preferred Stock Financing SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation severe pain therapeutics designed to minimize abuse and... Read more
SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended September 30, 2025 (the "third quarter").
"We are focused on capitalizing and advancing our... Read more
Dermata announced a strategic pivot to develop and commercialize over-the-counter (OTC) skin care treatments
Dermata plans to launch its first OTC product, a once weekly acne kit with its Spongilla technology, in the middle of 2026 SAN DIEGO, CALIFORNIA / ACCESS Newswire / November 14, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today highlighted recent corporate progress... Read more
FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study
EB613 Phase 2 Data Demonstrating Consistent Efficacy across Younger Post-Menopausal Women with Osteoporosis and its Impact on Trabecular and Cortical Bone Indices, Highlighted at NAMS and ASBMR
Next-Generation EB613 Remains on Track for Phase 1 Initiation in Late 2025
Pre-Clinical Data for Oral OXM in Obesity and Oral GLP-2 in Short Bowel Syndrome in Collaboration with OPKO Presented... Read more
In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request. CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation ne... Read more
FOSTER CITY, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that members of senior management will be presenting at the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 4:30 p.m. GMT.
A live webcast of the presentation will be available on the investor relations page of the Terns Pharmaceuticals website at ht... Read more
Company reports $14.3 million in revenue in Q3’25, consisting of $3.6 million in YCANTH® revenue and $10.7 million of license and collaboration revenue
Reports positive feedback from the FDA and alignment regarding the study design of a Phase 3 program for VP-315 in basal cell carcinoma; Company presented new data on VP-315 at the recent Society for Immunotherapy of Cancer conference
Received positive feedback from European Medicines Agency that supports a Marketing... Read more
Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib,... Read more
BRISBANE, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated diseases of the body, brain, and eye, today announced the closing of its previously announced underwritten public offering of 29,423,075 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase... Read more
BOSTON and ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the quarter ended September 30, 2025 and highlighted recent developments.
“During our third quarter of 2025, we continued to position... Read more
CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD).
As previously disclosed, the ELEVIDYS label now includes several key updates, including: A boxed warning for the risk of acute serious liver injury... Read more
LEXINGTON, Mass., Nov. 14, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced that Curis will report emavusertib and BTKi clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations and preclinical data on emavusertib in an oral presentation at the 30th Annual Meeting of the Society for... Read more
Received FDA Fast Track designation for stenoparib in advanced ovarian cancer
Reported landmark median overall survival now exceeding 25 months in ongoing Phase 2 trial
Advanced DRP® platform through new licensing agreement TARPON SPRINGS, Fla., November 14, 2025 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual... Read more
Three clinical trial readouts for FB102 expected in 2026, including phase 2 in celiac disease and phase 1b in both vitiligo and alopecia areata DALLAS / Nov 14, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its third quarter 2025 financial results and provided a business update.
“We continue to make excellent progress... Read more
Phase 1 trial evaluating GTB-3650 TriKE® for relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues to actively enroll with the next update anticipated in Q1 2026
GTB-5550 TriKE® IND submission for B7H3-expressing solid tumors expected in late December 2025 or January 2026 SAN FRANCISCO, CALIFORNIA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on... Read more
SHELTON, CONNECTICUT / ACCESS Newswire / November 14, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it will be presenting today, Friday, November 14th, at 11:25am ET at the Pharma Partnering Summit 2025 held at the Hilton Boston Logan Airport in Boston, MA.
Event Information: Event NanoViricides Presentation at the... Read more
GLEN ALLEN, Va., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the third quarter of 2025.
Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We continue to achieve meaningful milestones... Read more
Total net revenue increased 20.5% to $17.6 million for third quarter of 2025 compared to the third quarter of 2024
Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28 million at closing and is eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl)
Dotinurad, a next-generation URAT1 inhibitor, is advancing in two Phase... Read more
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the Company will participate in a fireside chat at the Stephens Annual Investment Conference at 11:00 a.m. ET (10:00 a.m. CT) on Thursday, November 20, 2025.
A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at:... Read more
Topline data from Phase 3 (IOB-013) clinical trial in advanced melanoma presented at ESMO; data highlights improvements in PFS achieved in overall population and across virtually all subgroups, although statistical significance on the PFS primary endpoint was narrowly missed
Meeting scheduled with FDA in December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in patients with advanced melanoma
Pre-clinical data for additional... Read more
NORCROSS, Ga., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and nine months ended September 30, 2025.
“The new NAVIGATE data presented at AASLD further strengthen the clinical and mechanistic profile of belapectin. We continue to see encouraging consistency across key biomarkers—including... Read more
Received FDA IND clearance to evaluate CDI-988 as both norovirus preventive and treatment
Expects to initiate CDI-988 Phase 1b norovirus challenge study in Q1 2026
Granted NIH SBIR award to advance influenza A/B replication inhibitor program BOTHELL, Wash., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September 30, 2025, and provides updates... Read more
Initiated development of a second CAPTN-3 tri-specific antibody targeting TROP2
Manufacturing milestone achieved for IM1240, the first tri-specific 5T4-targeting antibody from the CAPTN-3 platform
Cash position of $10.5 million as of September 30, 2025, with an anticipated cash runway into the first half of 2027, supporting the development of our CAPTN-3 technology platform through significant milestones REHOVOT, Israel, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Purple... Read more
Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
Demonstrated continued best-in-disease durability and tolerability in BOND-003 Cohort C with robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with HR NMIBC unresponsive to Bacillus Calmette Guerin (BCG)
Completed enrollment of PIVOT-006,... Read more
BOSTON, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the third quarter 2025.
On October 30, 2025, the Company announced that its Board of Directors determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue... Read more
Company plans to request re-examination after CHMP opinion feedback following its oral explanation
FDA advises Company to meet and discuss Company’s Alzheimer's Disease clinical trial results NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, ne... Read more
New clinical data show durable remissions and long-tail survivors including >2-year complete remissions in chemotherapy- and checkpoint-refractory cancers
GVHD trial launching through non-dilutive funding from NIH- and philanthropic grants
Launching Phase 2+ trial in severe pulmonary disease in US population with FDA-validated endpoints
Added national leaders in pulmonary medicine, trauma, and biodefense join MiNK management (Dr. Hammond) and Board (Dr. Holcomb)... Read more
Recommendation based on breadth of clinical evidence demonstrating significant HAE attack rate reduction with DAWNZERA
European Commission decision expected in Q1 2026 CARLSBAD, Calif. / Nov 14, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of DAWNZERA™ (donidalorsen)... Read more
Commercially Launched ORLYNVAH™ in the United States in August 2025
Extended Cash Runway into Q2 2026
Company to host conference call today at 8:30amET DUBLIN, Ireland and CHICAGO, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company or Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported... Read more
APOLLO study showed encouraging overall responses and favorable safety profile in relapsed/refractory B-cell lymphoma
MT-601 demonstrated 66% objective response rate with 50% complete response in relapsed Non-Hodgkin lymphoma (NHL) patients in the ongoing APOLLO study
First patient treated in Off-the-Shelf program (RAPID study) investigating MAR-T cells in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
cGMP manufacturing collaboration... Read more
Day One Biopharmaceuticals, Inc. to Acquire Mersana Therapeutics, Inc.
Agreement provides for upfront consideration of $25.00 per share in cash, plus potential contingent value rights cash payments of up to an aggregate of $30.25 per share, for aggregate deal value of up to approximately $285 million
Closing is expected to occur by the end of January 2026 CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage... Read more
Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA)
Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection... Read more
Appointed Mark Nawacki, seasoned M&A expert, co-founder, president & former CEO of Searchlight Pharma, to Board of Directors
Completed IND submission to the U.S. FDA and global regulatory filings to advance a Phase 2 clinical trial of SAT-3247 in children with Duchenne muscular dystrophy (DMD)
Dosed first patient in open-label, long-term follow-up study (LT-001) of SAT-3247 in adults with DMD
Ended the third quarter of 2025 with cash balance of $48.2 million... Read more
SAN DIEGO, Nov. 14, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the third quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials.
Recent Corporate... Read more
TORONTO, ONTARIO, Nov. 14, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (TSX: CSCI) (FINRA: CSCIF) (“COSCIENS” or the “Company”), a life science company focused on natural ingredients and pharmaceutical solutions, announced today that Peter H. Puccetti, CFA, Chairman of the Company’s board of directors (the “Board”), has been appointed Interim Chief Executive Officer, effective immediately. Peter succeeds Anna Biehn, who has stepped down as Chief Executive... Read more
RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) (“Fennec” or the “Company”), a specialty pharmaceutical company, today announced that it intends to engage in a non-brokered offering of its common shares in Canada, at a price of US$7.50 per share, with certain of its existing institutional shareholders, for aggregate gross proceeds of up to US$5,025,000. The offering is expected to close on November... Read more
Reported positive interim data from NGN-401 Phase 1/2 gene therapy trial for Rett syndrome demonstrating multidomain, durable gains, with 35 total developmental milestones/skills acquired across eight participants
First participant dosed in Embolden™ registrational trial of NGN-401 for Rett syndrome, with complete enrollment expected in three to six months
Strong cash position provides runway through first quarter of 2028 NEW YORK / Nov 13, 2025 / Business Wire /... Read more
The 52-week symptom data reported for Cohort 6 patients is consistent with the long-term durability data previously reported from Cohort 5; Cohorts 5 & 6 are the only groups to reach 52 weeks thus far.
In Cohort 6, a durable clinical symptom response was observed 52 weeks after a single administration of EP-104GI.
All 3 patients in Cohort 6 maintained a clinical benefit and 2 out of 3 patients remain in clinical remission 52 weeks after treatment of EoE with EP... Read more
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the quarter ended September 30, 2025, and highlighted recent achievements.
“As we continue to advance our pipeline, we are entering an important period for Alumis. Our teams have been working diligently, and we... Read more
Conference Call Today at 4:30 p.m. ET SEATTLE / Nov 13, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2025, which include: Net loss for the third quarter of 2025 was $30.9 million, or $0.47 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024. For the nine months ended September 30, 2025,... Read more
Announced completion of dose exploration portion of ORIC-944 Phase 1b clinical trial and presented data that continues to demonstrate potential best-in-class efficacy and safety
Bolstered leadership team with the appointment of Kevin Brodbeck, PhD, as Chief Technical Officer to further support ORIC’s transition to potential late-stage development
Cash and investments of approximately $413 million expected to provide runway into 2H 2028 and beyond anticipated primary... Read more
PALO ALTO, Calif., Nov. 13, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the third quarter ended September 30, 2025.
"Kodiak Sciences has entered a period of strong, sustained momentum driven by compelling clinical data, accelerated execution and growing external enthusiasm...across all three of our late-stage programs," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sc... Read more
Efficacy data remain consistent with prior disclosure and continue to demonstrate broad and deep PSA responses, with 55% PSA50 response rate and 20% PSA90 response rate
Rapid and deep ctDNA reductions were observed in 76% of patients and ctDNA clearance was observed in 59% of patients, underscoring potential for long-term treatment and survival benefit
PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and at comparable rates in combination... Read more
Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025
Spero’s development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 4Q 2025
Company expects current cash and cash equivalents to fund operations into 2028 CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics,... Read more
