Oncolytics Biotech announced updated data from Cohort 4 of the GOBLET study showing a median duration of response of approximately 15 months for pelareorep plus atezolizumab in second-line or later squamous cell anal cancer, exceeding the 9.5-month historical benchmark for approved retifanlimab…
Oncolytics Biotech announced updated data from Cohort 4 of its Phase 1/2 GOBLET study showing a median duration of response of approximately 15 months in second-line or later squamous cell anal cancer patients treated with pelareorep plus atezolizumab, compared to 9.5 months for FDA-approved…
William Blair double-downgraded Moderna (MRNA) from Outperform to Market Perform on October 27, 2026, with no price target provided. The firm has a 48% accuracy rate on 330 calls and an average return of 4.2%, placing it below the top-tier firms covering the stock.
GeoVax Labs entered into a $1 million unsecured revolving loan agreement with Bowery Consulting Group, with draws at the lender's sole discretion. Five directors resigned and three lender-nominated directors were appointed, giving the lender effective board control.
Artiva Biotherapeutics is discontinuing all development of its sole pipeline candidate AlloNK (AB-101) after updated longer-term data showed insufficient durability of clinical response and two Grade 5 safety events occurred. The company is reducing its workforce by approximately 94%, has engaged…
CDT entered an evaluation agreement with Manoira Corporation to assess its clinical-stage compounds AZD1656 and AZD5904 for animal health applications, paying a $195,000 fee via 1,347,616 shares at $0.1447 per share. Separately, CDT issued 397,374 shares to a service provider, 437,779 shares to…
60 Degrees Pharmaceuticals reported positive clinical and molecular results from the first five patients to complete treatment with tafenoquine-containing regimens in its expanded access study for relapsing babesiosis in immunosuppressed patients. All five patients showed clinical improvement and…
Enlivex received a Nasdaq delisting notice for failing the $1.00 minimum bid price requirement over 30 consecutive business days. Because a reverse split occurred within the prior 12 months, the company is not eligible for a 180-day cure period.
Actuate Therapeutics priced an underwritten public offering of 30,985,900 shares and warrants at $0.71 per set, expecting gross proceeds of approximately $11.0 million, with potential additional $7.0 million from warrant exercises. The offering represents massive dilution relative to the company's…
CAMP4 Therapeutics received CTA approval from multiple EU countries to initiate its global Phase 1/2 ASCEND trial of CMP-002 for SYNGAP1-related disorder, following prior clearances in the UK, Australia, and Argentina. The company expects to dose the first patient in Q4 2026.
Wave Life Sciences reported Q3 2026 revenue of $13.2M (up 73% YoY from $7.6M) and a GAAP net loss of $61.9M ($-0.30 per share), wider than the $53.9M loss in Q3 2025. The key stock-moving fact is FDA alignment on a registrational pathway for WVE-006 in AATD, including a one-year interim analysis…
Kiniksa reported Q3 2026 ARCALYST net product revenue of $286.0M, up ~58% YoY, and raised full-year 2026 ARCALYST guidance to $1.045B-$1.050B from $980M-$995M. Net income surged to $47.3M from $18.4M a year ago, with cash and investments of $568.8M and no debt.
Kiniksa reported Q3 2026 ARCALYST net product revenue of $286.0M, up ~58% YoY, and raised full-year 2026 ARCALYST revenue guidance to $1.045B-$1.050B from $980M-$995M. Net income was $47.3M ($0.56 diluted EPS) vs $18.4M ($0.23) a year ago, beating the $0.31 consensus on a GAAP basis.
Cellectar Biosciences reported a case study showing a durable complete response lasting over eight years in a heavily pretreated DLBCL patient after a single dose of iopofosine I 131. The company plans to submit findings for publication and is advancing a confirmatory Phase 3 study in Waldenström…
Pharming Group reported strong Q3 2026 results with total revenue up 21% YoY to $117.6M, driven by 58% Joenja growth and 14% RUCONEST growth. Operating profit surged 89% to $29.9M.
IQVIA reported Q3 2026 revenue of $4,428M (up 8.0% YoY) and adjusted diluted EPS of $3.34 (up 11.3% YoY), exceeding consensus estimates of $4.37B and $3.28 respectively. The company raised its full-year 2026 guidance for revenue, Adjusted EBITDA and Adjusted Diluted EPS, citing strong demand…
Repligen reported Q3 2026 revenue of $209.3M, up 11% YoY as reported and 12.5% organic, beating the $206.7M consensus. Adjusted EPS of $0.53 beat the $0.46 consensus.
Repligen reported Q3 2026 adjusted EPS of $0.53, beating the $0.46 consensus by 15.2%, and revenue of $209.3M, above the $206.7M estimate. The company raised FY26 revenue guidance to $844M-$852M (14.5%-15.5% reported growth), driven by organic momentum and the BioLife acquisition.
AstraZeneca and Daiichi Sankyo's Enhertu received EU approval as adjuvant monotherapy for HER2-positive early breast cancer patients with residual disease after neoadjuvant therapy, based on the DESTINY-Breast05 Phase III trial showing a 53% reduction in invasive disease recurrence or death versus…
Imunon filed an S-1 registration for a best-efforts offering of up to 20M shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 70M additional shares, representing 350% warrant coverage. The company also disclosed an asset purchase agreement to sell its…
Novartis reported Q3 2026 net sales of USD 14.5 billion (+4% cc) and core operating income of USD 6.0 billion (+10% cc), beating prior guidance. The company raised full-year 2026 core operating income guidance from 'decline low single-digit' to 'in line to grow low single-digit'.
Aclaris Therapeutics reported positive Phase 1b proof-of-concept primary analysis results for its anti-TSLP/IL-4R bispecific antibody ATI-052 in atopic dermatitis and asthma, showing rapid and broad responses with a favorable safety profile. The company also disclosed a preliminary cash balance of…
The SEC declared effective Adial Pharmaceuticals' S-3 registration statement (File No. 333-298636) on October 26, 2026. This allows selling stockholders, primarily former Azora stockholders and PIPE investors, to resell up to 25,148,970 shares of common stock.
The SEC declared effective Lunai Bioworks Inc.'s registration statement on Form S-1 (File No. 333-282898) under the 1933 Act, effective October 26, 2026. This is a micro-cap biotech with a $2M market cap; the effectiveness clears the way for the company to sell securities, likely in a follow-on…
The SEC declared effective Actuate Therapeutics' S-1 registration statement (File No. 333-299332) on October 26, 2026, enabling the company to proceed with its IPO of 40,000,000 shares of common stock and 20,000,000 purchase warrants, plus up to 40,000,000 pre-funded warrants. The company is a…
Aclaris Therapeutics announced positive Phase 1b proof-of-concept results for its bispecific antibody ATI-052 in atopic dermatitis and asthma, showing rapid and durable responses with a favorable safety profile. The company will prioritize Phase 2b development in eosinophilic esophagitis (EoE)…
Pharming reported Q3 2026 total revenue of $117.6M, up 21% YoY and in line with the $117.6M consensus. GAAP diluted EPS was $0.030, above the $0.20 consensus on a different basis; the company uses GAAP EPS as its Street basis.
Lynx1 Capital Management, a 10% owner of Korro Bio, purchased 12,175 shares at $9.68 for $118K in an open-market transaction with no 10b5-1 plan. This follows three additional open-market purchases by the same fund over the prior four days totaling $767K, creating a cluster of insider buying.
Werewolf Therapeutics filed an S-4/A registration statement for a reverse merger with Ambros Therapeutics, where Ambros will become a wholly owned subsidiary of Werewolf and Werewolf will be renamed Ambros Therapeutics. The merger values Ambros at $500 million and Werewolf at $47.5 million, with a…
Skye Bioscience (SKYE) filed a preliminary proxy statement (PREM14A) seeking stockholder approval for its acquisition of Redx Pharma Limited via a UK scheme of arrangement. The transaction values Redx at $161 million and Skye at $14.5 million, with existing Skye stockholders expected to own…
Equillium dosed the first subject in a Phase 1 trial of EQ504, triggering a $20 million milestone closing under its August 2025 private placement. The company issued 14,957,260 shares and 20,130,457 pre-funded warrants at $0.57 per share and $0.5669 per warrant, respectively, for gross proceeds of…
EEME Energy SPV I, LLC and its managing member Majique Ladnier filed an amended Schedule 13D disclosing a maintained 38.3% beneficial ownership stake in XCF Global (SAFX) following the October 16, 2026 closing of the business combination with Southern Energy Renewables. The filing signals…
Traws Pharma filed an S-1 registration statement to register up to 135,135,135 shares of common stock for resale by Roth Principal Investments, LLC under a committed equity facility (Purchase Agreement) entered into on October 23, 2026. The facility allows Traws to sell up to $50 million of newly…
Mirum Pharmaceuticals announced positive Phase 3 PROGRESS Cohort 2 results for ATEBRIOZ (zilurgisertib) in pediatric FOP patients aged 6 to <12 years, showing reduced heterotopic ossification lesion volume and improved joint mobility with statistical significance. The company plans to file a…
Seres Therapeutics CFO Marella Thorell resigned effective November 15, 2026, and will provide advisory services for an orderly transition. No replacement has been named, and the resignation of a key C-suite officer at a micro-cap company with a $21M market cap introduces leadership uncertainty.
Acumen Pharmaceuticals filed a universal shelf registration statement (S-3) on October 26, 2026, registering an unlimited amount of debt securities, common stock, preferred stock, warrants, and units. The filing includes form indentures and warrant agreements but does not specify any immediate…
Prothena director and 10% owner William Scully purchased $819K in open-market shares on October 22, 2026, at $8.19 per share, outside a 10b5-1 plan. This follows his $404K purchase on October 23, bringing his two-day total to $1.22M.
Senti Biosciences completed its merger with a Celadon Partners affiliate, divesting its operating subsidiary (Midco/Opco) and its lead asset SENTI-202. Public stockholders received no upfront cash; instead they received contingent value rights (CVRs) with an aggregate cap of $60M tied to SENTI-202…
Tempest Therapeutics' 2026 definitive proxy statement schedules a November 9, 2026 annual meeting with four proposals: election of Class II directors (Yee, Richey), ratification of Ernst & Young as auditor, approval of potential stock issuance exceeding 20% of outstanding shares under the Lincoln…
XCF Global (SAFX) is holding a special meeting on November 9, 2026 to approve a reverse stock split (1-for-2 to 1-for-50) to regain compliance with Nasdaq's $1.00 minimum bid price requirement by the December 7, 2026 deadline, and to authorize an adjournment if needed. The filing follows the…
Jazz Pharmaceuticals filed an 8-K estimating a pre-tax charge of approximately $755 million for acquired IPR&D expense related to the Actio Biosciences acquisition, which will reduce GAAP and non-GAAP adjusted EPS by about $11.00 in Q3 2026. No current-quarter earnings results or guidance were…
Ascendis Pharma announced pooled data from Phase 2 and Phase 3 trials showing TransCon PTH (palopegteriparatide) provided early, sustained, and clinically meaningful improvements in kidney function in adults with hypoparathyroidism over up to 5 years, with statistically significant eGFR increases…
SciSparc entered into an inducement letter with L.I.A Pure Capital to exercise warrants for 405,728 shares at a reduced price of $1.0 per share (down from $4.929), raising approximately $405,728 in gross proceeds. The exercise is dilutive, adding ~20% to the current share count of 2,057,719, but…
GSK announced positive Phase III data for Ris-Rez (risvutatug rezetecan) in relapsed osteosarcoma from the ARTEMIS-011 trial in China, showing a 67% reduction in risk of progression or death vs chemotherapy. The results support a regulatory submission in China and inform GSK's global development…
Akebia Therapeutics announced positive VOICE trial data for Vafseo (vadadustat) presented at ASN Kidney Week, showing statistically significant reduction in the primary composite endpoint of all-cause mortality and hospitalization versus ESA, driven by a 10% lower hospitalization rate. The data supports vadadustat's potential to become a new standard of care, but the company faces a Nasdaq deficiency notice for non-compliance with the minimum bid price requirement.
Longeveron announced updated results from its Phase 2b ELPIS II trial of laromestrocel in HLHS. The trial missed the primary endpoint (RVEF change at 12 months), but a pre-specified secondary endpoint (MACE) showed statistical significance favoring laromestrocel (8 vs 1 events, p=0.043). The company plans to request an FDA meeting to discuss next steps.
Braskem filed a 6-K disclosing confidential restructuring proposals exchanged with bondholders in its out-of-court reorganization (EJ Plan). Neither the company's proposal (Oct 23) nor the investors' counterproposal (Oct 24) has been accepted, and no agreement has been reached. A key milestone deadline has been extended to October 30, 2026. The filing also includes management projections showing negative unrestricted cash balances through 2034 under the status quo.
TScan Therapeutics is holding a special meeting on November 20, 2026, to seek stockholder approval for a reverse stock split (ratio between 1:2 and 1:50) to regain compliance with Nasdaq's $1.00 minimum bid price requirement after receiving a deficiency notice on August 27, 2026. The stock closed at $0.2379 on October 12, 2026, and failure to regain compliance could lead to delisting. The board also seeks approval to adjourn the meeting if needed to solicit additional votes.
Oruka Therapeutics announced positive Week 16 results from its Phase 2b EVERLAST-B trial of ORKA-001 in moderate-to-severe plaque psoriasis. The high-dose (600 mg) group achieved 61% PASI 100 and 86% PASI 90, consistent with prior EVERLAST-A results, with a favorable safety profile. The company plans to initiate Phase 3 trials in the first half of 2027 and has a cash runway of $1.1 billion through a BLA filing.
Xencor presented updated Phase 1 results for XmAb819 (ENPP3 x CD3 bispecific) in advanced ccRCC at ESMO 2026, showing a 45.5% confirmed ORR at the proposed 400 mcg/kg IV RP3D, with an 82% 6-month PFS estimate and median PFS not reached. The company selected 400 mcg/kg as the proposed IV RP3D, plans an End of Phase 1 meeting with the FDA in 1H2027 to discuss a potential accelerated approval pathway, and targets initiation of a registration-enabling study by YE2027. Cash runway was extended to 2029. No current-quarter financial results were released; the filing is a clinical data update.