Deals, pipeline readouts and company news from across biotech and pharma.
The company completed an $86.6 million PIPE and amended its royalty and loan agreements in October, while partner Tanabe Pharma filed for Zynlonta approval in Japan.
The CRO has signed definitive agreements for the Pennsylvania units, with up to $75m in further performance-based payments, through a consortium structure that first takes Frontage private.
The Nasdaq-listed vaping technology company reported a year-on-year revenue decline, citing weaker European sales linked to tighter vaping regulation, while Adjusted EBITDA turned positive.
Tonix says third-quarter TONMYA net sales rose 37% on the prior quarter, while Dr. Reddy's has filed an ANDA with a Paragraph IV certification and the company plans to enforce its patents.
The US cell therapy company's SEC-filed corporate deck sets out its CAR-T candidate across five autoimmune diseases, but the excerpt available contains no new data or dates.
Ionis lowered its full-year Tryngolza outlook, citing slower-than-expected uptake in severe hypertriglyceridemia, while reaffirming other guidance and launching Zanvastro in Alexander disease.
Roivant's fiscal Q2 update covers early sales of FDA-approved LISRAYA, an uveitis filing plan, a positive rheumatoid arthritis readout for IMVT-1402 and a Phase 3 start for mosliciguat.
The US oncology-focused biotech has bought a Phase 2-ready selective JAK1 inhibitor and a preclinical PKCθ programme for undisclosed cash, with no future royalties or milestones owed to Aqilion.
The hybrid pharma-device company's presentation highlights January 2026 FDA approval for re-administration of iDose TR, new Phase 3 non-inferiority analysis and earlier-stage iDose follow-on products.
Anika Therapeutics reported third-quarter revenue of $30.6 million and raised parts of its 2026 guidance, but the FDA told it in October that its Hyalofast cartilage-repair application cannot be approved.
The company reported third-quarter revenue of $1.3 billion and net income of $162 million, and highlighted US approval of mFLUSIVA alongside mixed pipeline news.
The Nasdaq-listed sidewalk and hospital robot company also cut its non-GAAP operating expense outlook and launched a service offering its technology to other robot makers.
NeOnc Technologies posted a Q3 2026 net loss of $4.4M and flagged Phase 2a NEO100 results, FDA feedback on NEO212 and a $15M registered direct offering.
The gene-editing company says it will discontinue clinical development of vispa-cel and CB-011 and is exploring alternatives, including a merger or liquidation, after a difficult financing climate.
The US diagnostics company reported quarterly revenue of $24.0 million, with Diagnostic Testing up 16%, but cited sales force changes, seasonality and delayed development projects.
The aortic disease specialist posted a $7.9M net loss and lower adjusted EBITDA, while preparing a January 2027 US launch of NEXUS.
The SPAC and Brains Bioceutical signed a definitive agreement on 5 November 2026, implying a pre-money equity value of about $750 million, with completion subject to closing conditions.
The shoulder-focused medtech company reported $16.2 million in Q3 net revenue and flagged a new 510(k) clearance, first InSet Go cases, a patent settlement and a distribution partnership.
The single-cell and spatial biology company reported 1% third-quarter revenue growth to $150.7 million and a narrower net loss, while launching a new cloud analysis platform.
Egetis Therapeutics' board has unanimously recommended ANI Pharmaceuticals' SEK 11.25-per-share bid, weeks after the US approval of EMCITATE for MCT8 deficiency.
The protein-sequencing company reported a $22.3 million quarterly net loss, opened Proteus pre-orders and reaffirmed its cash runway into the fourth quarter of 2028.
The medtech group reported $1.9bn in third-quarter sales as advance orders placed ahead of an ERP cutover reversed, while lifting its adjusted EPS outlook to $7.20-$7.30.
The US genetic testing company reported a narrower non-GAAP loss outlook for 2026 and projected year-end cash and investments of about $630 million.
The Zio maker reported third-quarter revenue of $221.6 million, completed its VitalConnect acquisition and filed FDA 510(k) applications for paediatric use of Zio Monitor.
The prostate ablation maker also named Richard Fabian as incoming CEO and guided to at least $25.0 million in full-year revenue.
The infusion-therapy company reported a swing to GAAP profit and a wider gross margin, and expects to finish 2026 toward the high end of its guidance.
The US drugmaker reported higher third-quarter sales and profit, but gross margin fell and epinephrine pre-filled syringe releases slowed following an FDA warning letter at its IMS facility.
The gene therapy and exon-skipping company lifted the low end of its net product revenue guidance by $50m and trimmed expense guidance, with two muscle-disease datasets expected this quarter.
Halozyme reported third-quarter revenue of $493.0m, with royalties of $341.0m, and raised its full-year outlook as ENHANZE partner products continued to drive growth.
ANI Pharmaceuticals has proposed buying Egetis Therapeutics at SEK 11.25 a share, gaining Emcitate, approved in the EU and US for peripheral thyrotoxicosis in MCT8 deficiency.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.