On March 16, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported data from the Phase 1/2 ReDiscover trial of zovegalisib (RLY-2608) + fulvestrant at the recommended Phase 3 dose of 400mg twice daily (BID) taken with food (fed) in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. The data are being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.

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"As supported by the data presented, the 400mg BID fed regimen maintains robust efficacy with a safety profile consistent with mutant-selective PI3Kα inhibition," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "These results further support our decision to advance this regimen into the ongoing Phase 3 ReDiscover-2 trial and reinforce our confidence in selectively targeting PI3Kα mutations as a potentially differentiated approach for CDK4/6-experienced patients."

Phase 1/2 ReDiscover Trial – Zovegalisib 400mg Fed Cohort Data Consistent with 600mg Fasted Data

Zovegalisib is currently being evaluated in ReDiscover, an ongoing first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant and in combination with fulvestrant and CDK inhibitors in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.

As of the January 13, 2026 data cut-off date, 60 patients had received the 400mg BID fed regimen. The efficacy population consisted of 57 patients who did not have a PTEN or AKT co-mutation, consistent with the planned pivotal population. All patients had previously received a CDK4/6 inhibitor and at least one prior endocrine therapy in the advanced setting.

Pharmacokinetics of Both Doses are Similar

Pharmacokinetic analyses demonstrate that the 400mg BID fed regimen achieves exposures comparable to the previously evaluated 600mg BID fasted dose, with mean concentrations approaching IC90 in majority of patients and nearly all patients maintaining exposure above the IC80 throughout the dosing interval.

Efficacy Consistent with 600mg BID Fasted

As of the January 13, 2026 data cut-off date, among the 57 efficacy-evaluable patients at the 400mg BID fed dose, which is the recommended Phase 3 dose (RP3D):

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Median follow-up was 12.0 months
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Median progression-free survival (PFS) was 11.1 months (95% CI: 7.3–13.0)
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Median PFS was 11.2 months in patients with kinase mutations (n=33) and 11.0 months in patients with non-kinase mutations (n=24)
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Among 35 patients with measurable disease, confirmed objective response rate (ORR) was 43% (15/35) and in second line only patients the ORR was 52% (11/21)

Maintained Favorable and Differentiated Tolerability Profile

Zovegalisib + fulvestrant at the 400mg BID fed dose was generally well tolerated in the 60 treated patients as of the January 13, 2026 data cut-off. The overall tolerability profile consisted primarily of low-grade, manageable and reversible treatment-related adverse events (TRAEs).

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Safety profile consistent with previously disclosed 600mg BID fasted data
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Majority of hyperglycemia events were Grade 1; no Grade 4-5 hyperglycemia observed
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In the limited cases of Grade 2/3 hyperglycemia, the vast majority occurred in patients that were pre-diabetic at baseline
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Only four patients discontinued due to TRAEs

The data presentation from the ESMO (Free ESMO Whitepaper) TAT Congress 2026 is available on the Relay Therapeutics website in the "Publications/Presentations" section through the following link: View Source

ReDiscover-2 – Ongoing Phase 3 Trial

The Phase 3 ReDiscover-2 trial (NCT06982521) is evaluating zovegalisib 400mg BID administered in combination with fulvestrant versus capivasertib + fulvestrant in patients with PI3Kα-mutated, HR+/HER2- advanced breast cancer who have progressed on prior CDK4/6 inhibitor therapy. The study initiated in mid-2025 and is enrolling globally.

Zovegalisib + fulvestrant has received FDA Breakthrough Therapy designation for the Phase 3 ReDiscover-2 trial population.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.

(Press release, Relay Therapeutics, MAR 16, 2026, View Source [SID1234663574])

On March 16, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported an amendment to its existing convertible note with Avondale Capital, LLC (the "Existing Note") and the issuance of a new non-convertible, unsecured note with Atlas Sciences, LLC (the "New Note").

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Under the amendment to the Existing Note, the maturity date of the Existing Note has been extended to December 31, 2026, with no other changes to the terms. The lender has confirmed that the Existing Note is not in default.

In addition, Outlook Therapeutics entered into the $18.4 million New Note. The Company expects to receive $17 million in net proceeds, after original issue discount. Proceeds from the New Note will be used to pay down a portion of the Existing Note, reducing the balance and leaving approximately $10.8 million of principal and interest remaining on the Existing Note.

The New Note bears interest at a rate equal to the Prime Rate plus 3%, subject to a minimum interest rate of 9.5% per annum, and matures on June 16, 2027.

(Press release, Outlook Therapeutics, MAR 16, 2026, View Source [SID1234663573])

On March 16, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the fourth quarter and full year ended December 31, 2025.

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"2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant’s potential as the combination endocrine therapy of choice in the metastatic setting."

Bohen continued, "In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. With initial clinical results from OP-3136 anticipated in Q2 2026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema’s history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond."

Recent Progress

Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.
Presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.
Continued enrollment in the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.
Completed an underwritten public offering of an aggregate of 11,500,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of approximately $218.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Anticipated Upcoming Events

Report initial clinical results for OP-3136 in Q2 2026 at a major medical conference.
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer in the fall of 2026.
Fourth Quarter and Full Year 2025 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2025, were $505.4 million.

Net loss for the quarter and year ended December 31, 2025 was $46.1 million and $162.5 million, respectively, as compared to $33.6 million and $129.5 million for the quarter and year ended December 31, 2024, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $43.2 million and $157.7 million for the quarter and year ended December 31, 2025, respectively, as compared to $32.3 million and $124.5 million for the quarter and year ended December 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and personnel-related costs, partially offset by a decrease in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $40.6 million and $145.5 million for the quarter and year ended December 31, 2025, respectively, excluding $2.6 million and $12.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $6.9 million and $21.0 million for the quarter and year ended December 31, 2025, respectively, as compared to $4.5 million and $17.7 million for the quarter and year ended December 31, 2024. The increase in G&A expenses was primarily due to increased spending on corporate-related costs.

Non-GAAP G&A expenses were $5.2 million and $15.6 million for the quarter and year ended December 31, 2025, respectively, excluding $1.7 million and $5.4 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, MAR 16, 2026, View Source [SID1234663572])

On March 16, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology platform company committed to accelerating access to innovative medicines, reported that based on a productive Type B meeting with the U.S. Food and Drug Administration (the "FDA") and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig’s potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial. The Company intends to initiate a registrational Phase 3 trial, in combination with immunochemotherapy, as early as Q4 2026. Final study design details will be discussed with FDA.

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"We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "This important regulatory milestone builds on compelling Phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and to bringing givastomig to patients as quickly as possible."

About the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer

The Phase 1b dose expansion data (per the Company’s January 6, 2026 press release) showed that givastomig, dosed at 8 mg/kg every two weeks (Q2W) and 12 mg/kg Q2W, produced:

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Robust efficacy, with a 75% objective response rate (ORR) (77% ORR observed at 8 mg/kg, 73% ORR observed at 12 mg/kg, n=52 evaluable)
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Responses across a wide range of PD-L1 and CLDN18.2 expression levels
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Durable responses with 16.9-month mPFS (median progression free survival) and an 82% 6-month landmark PFS rate (n=53 evaluable)
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Good overall tolerability in combination with immunochemotherapy, without dose dependent toxicity
Detailed Phase 1b expansion data are expected to be presented at a major medical conference in H2 2026.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, NovaBridge Biosciences, MAR 16, 2026, View Source [SID1234663571])

On March 16, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, reported the presentation of two Trial-in-Progress posters featuring Itareparib (NMS-03305293) at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026, taking place March 16–18, 2026 in Paris, France.

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The presentations highlight ongoing clinical studies of Itareparib, NMS’s non-trapping, PARP1-specificinhibitor, the only third-generation inhibitor in clinical development. Itareparib is highly brain- and tumor-penetrant, providing an advantage for widely metastatic disease. Itareparib is being studied in combination with established DNA-damaging therapies in two areas of high unmet medical need: recurrent non-BRCA-mutated ovarian cancer and relapsed extensivestage small cell lung cancer (ES-SCLC), including patients with brain metastases.

The posters are:

Poster 57TiP – Phase 1a/1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1- Selective Inhibitor, in Combination with Topotecan in Recurrent HR-Proficient / Refractory Ovarian Cancer.
Poster 58TiP – Poster 58TiP – PARPA-293-004: Phase 1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1-Selective Inhibitor, in Combination with Temozolomide in Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Both studies are open and actively recruiting:

Non-BRCA-mutated ovarian cancer study: NCT06930755
ES-SCLC study: NCT06931626
"These studies reflect our strategy of advancing Itareparib in combination settings where conventional PARP1 approaches have historically been constrained," said Lisa Mahnke, MD PhD, Group CMO. "We believe the differentiated profile of Itareparib has the potential to broaden the use of PARP1 biology beyond traditional BRCA-mutated settings and into larger patient populations through rational combinations with DNA-damaging therapies."

Ovarian cancer and ES-SCLC remain aggressive malignancies with significant unmet need, particularly in relapsed or refractory settings where patients often face limited treatment options and poor outcomes. Through these studies, NMS is evaluating Itareparib for its potential to enhance the activity of widely used chemotherapeutic backbones while maintaining a combination-enabling tolerability profile.

Itareparib is currently being developed across multiple tumor settings, with near-term clinical readouts expected from its ongoing combination programs.

About Itareparib
Itareparib is a novel PARP1 inhibitor, designed to be used in combination, and distinguished by a non-trapping mechanism of action as shown preclinically with high potency, PARP1 selectivity and brain penetrance. Clinically (Geurts et al ENA 2023), the profile improves on poor bone marrow features of trapping PARP1 inhibitors (Yap et al AACR (Free AACR Whitepaper) 2024) and thus removes traditional barriers to combining a DNA damage repair inhibitor with a DNA damaging agent in non-BRCA-mutated tumors.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663570])