On November 10, 2025 Insilico Medicine ("Insilico"), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, reported a research collaboration with Eli Lilly ("Lilly") that the two parties will combine Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development and disease expertise to jointly discover and advance innovative therapies.

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Insilico will utilize its validated Pharma.AI platform and deep drug discovery expertise to generate, design, and optimize candidate compounds against targets defined under the agreement. Insilico is eligible to receive over $100 million including an upfront, milestone payments, and tiered royalties on net sales upon commercialization of any resulting drug products.

"We are delighted to collaborate with Lilly, a global leader in the pharmaceutical industry, renowned for its commitment to medical innovation," said Alex Zhavoronkov, PhD, Founder and Co-CEO of Insilico Medicine. "Lilly has been a valued user of our Pharma.AI software suite, and this expanded collaboration further recognizes Insilico’s AI-driven drug discovery capabilities while strengthening our longstanding partnership. By joining forces, we are accelerating the development of transformative therapies to address urgent patient needs worldwide."

The collaboration represents a further deepening of the partnership between the two companies, which originated with the AI-based software licensing agreement in 2023.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development. While traditional early-stage drug discovery typically requires 3 to 6 years, from 2021 to 2024 Insilico nominated 20 preclinical candidates, achieving an average turnaround – from project initiation to preclinical candidate (PCC) nomination – of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, NOV 10, 2025, View Source;licensing-collaboration-to-advance-ai-driven-drug-discovery-302610234.html [SID1234659741])

On November 10, 2025 Geneseeq Technology Inc., a global precision oncology company, reported its PanTRKareNTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit has received marketing authorization from China’s National Medical Products Administration (NMPA). The assay is approved as a companion diagnostic (CDx) test for Roche’s ROZLYTREK (entrectinib). This milestone marks China’s first next-generation sequencing (NGS)-based pan-solid tumor NGS CDx test, and it is also the first approved assay for detecting NTRK1/2/3 gene fusions.

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Addressing Unmet Clinical Needs: Shedding Light on Rare Mutations

NTRK gene family fusions occur in less than 1% of all solid tumors, but represent one of the most actionable oncogenic alterations across cancer types. Patients harboring these fusions can benefit from TRK inhibitors such as ROZLYTREK. PanTRKare enables accurate, sensitive detection of NTRK1/2/3 fusions across diverse tumor types, bringing precision medicine to patients who harbor this rare but important type of mutations.

Robust Clinical Validation Across 33 Tumor Types and 2,400+ Cases

The PanTRKare kit was rigorously validated through a large-scale multi-center clinical study involving seven leading hospitals, 33 tumor types and more than 2,400 clinical samples. The assay demonstrated high accuracy, sensitivity, reproducibility and broad applicability across a wide spectrum of solid tumors, having successfully detected more than 200 unique NTRK fusion variants in this study. This comprehensive validation establishes PanTRKare as one of the most clinically robust NTRK CDx test globally, ensuring confidence in both routine oncology and translational research settings.

Empowering Targeted Therapies Through Collaborative CDx Development

Clinical bridging studies with ROZLYTREK showed high concordance of testing results, as well as comparable objective response rate (ORR) among NTRK fusion–positive patients. This result underscores the test’s clinical utility and its pivotal role in advancing precision medicine for patients with rare genetic alterations.

"With the NMPA approval of PanTRKare, clinicians across China can now access an accurate, reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies. This milestone reflects Geneseeq’s ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics," said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc.. "Geneseeq will continue to drive innovation across oncology diagnostics through global regulatory collaborations, biopharma partnerships, and patient-centered product development, advancing its mission to make precision medicine accessible to all."

(Press release, Geneseeq, NOV 10, 2025, View Source;chinas-first-ngs-based-pan-solid-tumor-companion-diagnostic-kit-for-ntrk-gene-fusions-302610192.html [SID1234659740])

On November 10, 2025 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported its financial results for fiscal second quarter ended September 30, 2025, and provided a corporate update.

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"Over the past year, we have made steady progress deploying LungFit PH to hospitals across the U.S. and establishing a global distribution network. As the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use, LungFit PH is delivering meaningful workflow and efficiency benefits for clinicians and hospital administrators. With the recent capital infusion, we plan to accelerate commercial execution and advance regulatory initiatives, including select international submissions and our second-generation LungFit PH. We also welcome Beyond Air Board member Bob Goodman as Interim Chief Commercial Officer to lead our commercial strategy and team transitioning from David Webster, who leaves us with our gratitude. Bob brings decades of commercial leadership across medtech and pharma, including senior roles at BioTelemetry and Philips Healthcare, and will oversee U.S. and international commercial strategy, team expansion, and channel optimization," said Steve Lisi, Chairman and Chief Executive Officer.

We are gearing up for regulatory approvals outside the US as well as the anticipated FDA approval of our second generation LungFit PH and subsequent launch before the end of calendar 2026, subject to regulatory review and clearance," concluded Mr. Lisi.

Commercial Execution, Recent Highlights and Upcoming Milestones

LungFit PH Commercial Execution
Revenue increased 128% to $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year. Growth was driven by increased demand for LungFit PH through U.S. commercial activities.
International revenue continues to build momentum, driven by recent regulatory approvals in select markets. During the quarter, the Company expanded its global LungFit PH distribution network, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 35 countries, representing a combined population of 2.8 billion people.
Appointed Robert (Bob) Goodman interim Chief Commercial Officer following the departure of David Webster. Robert, who joined the Board of Beyond Air in June 2025, has held key leadership roles at a range of high-performing organizations, including BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His career spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success.
U.S. Patent and Trademark Office granted a patent allowance for a design patent covering the second-generation LungFit PH through 2040.
Achieves certification to demonstrate conformity of its Quality Management System with the regulatory requirements of all MDSAP participating countries, that include Australia, Brazil, Canada, European Union, Japan and United States.
The Beyond Air team will be attending the AARC Annual Congress, which is taking place December 6th to 8th in Phoenix, AZ.
Pending Regulatory Milestones
PMA supplement for the second-generation LungFit PH submitted to U.S. FDA in June 2025.
International submissions for LungFit PH remain on track with local partners.

Beyond Cancer – Solid Tumor Program – clinical stage development of an intratumoral ultra-high concentration Nitric Oxide (UNO) technology as a gas delivery of NO at high concentrations to tumors to induce an immune response.

Clinical Development Execution
Phase 1a trial (monotherapy) – Part A of the trial evaluating UNO therapy in 10 subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
Latest results to date from the Phase 1a trial show median overall survival (mOS) has not yet been achieved, with median survival expected to exceed 23 months.
Phase 1b trial (combination therapy) – Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in subjects with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment.

NeuroNOS – Autism Spectrum Disorder (ASD) Program – developing neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder ("ASD") and other neurological conditions.

U.S. FDA granted Orphan Drug Designation to its investigational therapy, BA-101, for the treatment of Glioblastoma (GBM). The Company is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 toward first-in-human studies.
U.S. FDA granted Orphan Drug Designation to BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with ASD. The Company is in preclinical development and expects to progress to a Phase 1 first-in-human clinical trial by the end of 2026, which could provide data in 2027.

Financing & Liquidity

Closed a promissory note and equity line of credit for up to $32 million with Streeterville Capital, LLC. The agreement provides Beyond Air with a debt agreement for $12.0 million, which does not require any payment for the first year, as well as an equity line of credit for up to $20 million, which is subject to an effective registration statement and other customary conditions. This infusion of new capital equates to a September 30, 2025 proforma cash, cash equivalents, restricted cash and marketable securities balance of $22.9 million, which is expected to provide runway into calendar 2027.

Financial Results for the Fiscal Quarter Ended September 30, 2025
Revenues for the fiscal quarter ended September 30, 2025 increased 128% to $1.8 million, compared with $0.8 million for the fiscal quarter ended September 30, 2024. Gross loss of $0.3 million was recognized for the quarter ended September 30, 2025, compared with a gross loss of $1.1 million for the quarter ended September 30, 2024. The decrease in gross loss was primarily attributed to sales growth, partially offset by one-time costs required to upgrade the Company’s existing fleet of devices and provisions for excess inventory.

Research and development expenses for the fiscal quarter ended September 30, 2025 were $2.5 million compared with $4.6 million for the fiscal quarter ended September 30, 2024. The decrease of $2.1 million was primarily attributed to a decrease in salaries, stock-based compensation costs and a reduction in Gen II device development costs.

Selling, general and administrative expenses for the quarters ended September 30, 2025 and September 30, 2024 were $4.9 million and $7.2 million, respectively. The decrease of $2.3 million was primarily attributed to a reduction in salaries and stock-based compensation costs.

Other expense for the quarter ended September 30, 2025 was $0.6 million compared with other expense of $1.2 million for the quarter ended September 30, 2024. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt.

Net loss attributed to common stockholders of Beyond Air, Inc. for the quarter ended September 30, 2025 was ($7.9) million or a loss of ($1.25) per share, basic and diluted, compared to a net loss attributed to common stockholders of Beyond Air, Inc. for the fiscal quarter ended September 30, 2024 of ($13.4) million or a loss of ($5.67) per share, basic and diluted.

Net cash burn in the fiscal quarter ended September 30, 2025 was $4.7 million.

As of September 30, 2025, the Company reported cash, cash equivalents, and marketable securities of $10.7 million, and total long-term debt outstanding was $10.1 million. An additional $2.1 million related to an insider loan was recorded as long term liabilities pending finalization of terms. Synthetic royalty related debt repayment does not begin until October 2026. Subsequent to the end of the quarter, the Company secured up to $32 million in capital through a new promissory note and equity line of credit. The new $12 million note bears a 15% interest rate and matures in 24 months, with no payments due during the first 12 months.

Financial Guidance for Fiscal Year 2026
The Company updated its revenue guidance to $8 to $10 million for the fiscal year ending March 31, 2026.

Conference Call & Webcast
Monday, November 10th @ 4:30 PM ET
Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13756730
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

(Press release, Beyond Air, NOV 10, 2025, View Source [SID1234659739])

On November 10, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the Piper Sandler 37th Annual Healthcare Conference, which is scheduled to take place December 2 – 4, 2025, in New York, NY.

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Details of the presentation appears below:

Conference: Piper Sandler 37th Annual Healthcare Conference
Date: Tuesday, December 2, 2025
Time: 1:00pm EST
Location: New York, NY
Format: Fireside Chat

In addition to the presentation, company management will be available to participate in one-on-one meetings with investors who are registered attendees of the conference. A webcast of the event will be available on the Investor’s section of the company’s website at www.atyrpharma.com. Following the event, a replay of the presentation will be available on the aTyr website for at least 90 days. For more information, contact [email protected].

(Press release, aTyr Pharma, NOV 10, 2025, View Source [SID1234659738])

On November 10, 2025 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Biohaven remains energized and focused on our mission to advance innovative medicines to patients who are waiting every day for new treatments. Our pipeline consists of multiple novel approaches for unmet medical needs and has the potential to deliver paradigm shifting treatments for conditions such as epilepsy, autoimmune disease, obesity, depression and cancer. We are particularly excited about the continued progress across our key programs and clinical-stage assets including: MoDE and TRAP degrader programs, where our two lead assets, BHV-1300 and BHV-1400, show compelling evidence to change the treatment paradigm in immune-mediated diseases; opakalim, a novel Kv7 ion channel activator, for the treatment of epilepsy and depression; and taldefgrobep alfa, myostatin-activin targeting therapy for obesity and SMA."

Dr. Coric continued, "Our late-stage clinical programs are poised to transform their respective treatment paradigms, given their novel mechanistic foundations and the body of clinical and non-clinical data generated to date. Our redirected approach to ‘right-sizing’ innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business. With this thoughtful approach to rebalancing our portfolio, we believe Biohaven remains well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we remain unwaveringly committed to delivering on our promise to advance our programs for patients, families, and shareholders in the balance of the year and in the years ahead. We will also continue to provide updates on any progress determining a path forward in SCA."

Third Quarter 2025 and Recent Business Updates

Initiated strategic cost optimization efforts across portfolio to focus forward-looking spend on three value-driving, late-stage clinical programs that will prioritize resources:
Opakalim, Kv7 ion channel activator, in pivotal studies for focal epilepsy and depression;
Lead TRAP and MoDE extracellular degraders for IgA nephropathy (BHV-1400) and Graves’ disease (BHV-1300);
Taldefgrobep alfa, myostatin-activin pathway inhibitor, for obesity and spinal muscular atrophy.
Restructuring of business priorities and optimizing resource allocation may result in either pause, delay or halting of non-priority programs.
The cost optimization efforts are expected to achieve an approximately 60% reduction in annual direct R&D spend (which excludes personnel and share-based compensation).
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2025 and 2026 across numerous programs:

Kv7 Activator (Opakalim):

Deliver top-line results from Phase 2 study in major depressive disorder study in 4Q 2025.
Continue two Phase 2/3 studies in focal epilepsy with initial top-line results expected in 1H 2026.
Lead TRAP and MoDE Extracellular Degraders (BHV-1400 and BHV-1300)

Continue enrollment of patients with IgAN and Graves’s disease in expanded Phase 1b and advance to pivotal studies in IgAN and Graves’ disease.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Initiate Phase 2 clinical trial in obesity in 4Q 2025.Continue ongoing Health Authority interactions to discuss SMA registrational path in the US and Europe.
Glutamate Modulator (VYGLXIA):

We requested a Type A meeting with FDA as part of initiating an appeal process for the SCA CRL and plan to meet with the FDA to discuss potential next steps.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of September 30, 2025, totaled approximately $263.8 million.

Third Quarter 2024 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $141.2 million for the three months ended September 30, 2025, compared to $157.6 million for the three months ended September 30, 2024. The decrease of $16.4 million was primarily due to decreases in direct program spend, largely related to BHV-2000 and opakalim, which were partially offset by increased personnel costs including non-cash share-based compensation, as compared to the same period in the prior year. Non-cash share-based compensation expense was $13.9 million for the three months ended September 30, 2025, an increase of $6.8 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $28.2 million for the three months ended September 30, 2025, compared to $20.6 million for the three months ended September 30, 2024. The increase of $7.7 million was primarily due to increased non-cash share-based compensation expense and increased legal costs. Non-cash share-based compensation expense was $7.6 million for the three months ended September 30, 2025, an increase of $2.6 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $3.8 million for the three months ended September 30, 2025, compared to other income, net of $17.8 million for the three months ended September 30, 2024. The decrease of $21.6 million was primarily due to an increase in non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the Note Purchase Agreement), a decrease in gains recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), and decreased investment income.

Net Loss: Biohaven reported a net loss for the three months ended September 30, 2025 of $173.4 million, or $1.64 per share, compared to $160.3 million, or $1.70 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended September 30, 2025 was $155.9 million, or $1.47 per share, compared to $164.1 million, or $1.74 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, NOV 10, 2025, View Source [SID1234659737])