Dafinchi AI

VERU

Healthcare

6d

Innovative Tissue-Selective Weight Loss Drug Demonstrates Promising Phase 2b Results

Veru's drug candidate Inovasaram has shown in Phase 2b that it can selectively target fat tissue while preserving lean mass in older patients, a significant advancement over existing GLP-1 therapies.
The Phase 2b trial demonstrated a 42% greater fat loss with the 6 mg dose of Inovasaram combined with semaglutide, with statistical significance (p=0.017).
Inovasaram preserved 100% of lean mass during the trial, reducing the risk of muscle loss associated with weight management in older adults.
Physical function, measured by stair climb test, was preserved in patients treated with Inovasaram, with a 59.8% reduction in physical decline compared to placebo.
Positive safety profile was confirmed in the maintenance extension study, with no significant adverse events related to muscle or bone health.
The company plans to develop a novel modified release oral formulation of Inovasaram, protected by patents through 2037, to improve chronic weight management.

VERU

Healthcare

6d

Financial Performance Summary

Cash, cash equivalents, and restricted cash totaled $15 million as of June 30, 2025, down from $24.9 million as of September 30, 2024.
Current cash is sufficient to fund operations into the next calendar year, beyond the expected FDA end of Phase 2 meeting for Inovasaram.
For Q3 2025, research and development costs decreased to $3 million from $4.8 million in the prior quarter due to the wind down of the Phase 2b quality clinical study for Inovasaram.
For the nine months ended June 30, 2025, R&D costs increased to $12.7 million from $9.5 million due to Phase 2b clinical study expenses, partially offset by decreased spending on terminated programs.
Net loss from continuing operations for the nine months was $17 million or $1.16 per diluted share, improved from $26.7 million or $2.04 per diluted share in the prior period.
Net loss from continuing operations was $7.3 million or $0.50 per diluted share, improved from a net loss of $10.3 million or $0.71 per diluted share in the prior year quarter.
Net loss from discontinued operations related to the FC2 business was $7.2 million or $0.49 per diluted share, including a $4.3 million loss on sale.
Net working capital was $9.5 million as of June 30, 2025, compared to $23.4 million as of September 30, 2024.
Selling, general and administrative expenses decreased to $5 million from $5.8 million primarily due to lower share-based compensation.
Selling, general and administrative expenses for the nine months decreased to $15.4 million from $18.4 million due to lower share-based compensation.
The company is not profitable and has negative cash flow from operations, requiring additional capital to support drug development.
The company recognized a gain on sale of fee assets of $485,000 compared to $110,000 in the prior quarter.
The company recorded gains on sale of NTAPI assets of $2.2 million and a gain on extinguishment of debt of $8.6 million related to the sale of the FC2 Female Condom business.

Sangamo Therapeutics, Inc.

SGMO

Healthcare

1w

Positive Top-Line Results from Fabry Disease Registrational Study

Sangamo announced positive top-line results from the Phase 1/2 STAAR study evaluating ST-920 for Fabry disease, with a mean eGFR slope of almost 2 at 52 weeks.
The FDA has agreed that the mean eGFR slope will serve as the primary approval endpoint under the accelerated approval pathway.
Patients who received ST-920 showed a significant improvement in renal function, with many able to withdraw from enzyme replacement therapy (ERT) and avoid over 1,000 infusions.
The study demonstrated durable expression of alpha-Gal A enzyme activity and stabilization of cardiac function, which is notable given the progressive nature of Fabry disease.
Management emphasized the potential of a single dose of ST-920 to transform patient lives, with some patients experiencing reduced pain medication use and improved quality of life.
The company plans to submit a BLA as early as Q1 2026 and will present additional data at the ICIEM2025 conference.

Anika Therapeutics, Inc.

ANIK

Healthcare

2w

Disappointing Phase III Hyalofast Trial Results and Impact on FDA Submission Timeline

The U.S. pivotal Phase III trial for Hyalofast missed its primary endpoints, with statistical significance not achieved on co-primary measures of KOOS Pain and IKDC Function.
The trial faced challenges due to declining use of microfracture, higher dropout rates, missed visits during COVID, and reduced evaluable sample size.
Despite the miss on primary endpoints, secondary endpoints showed statistical significance, and international data with positive 15-year outcomes support the product's value.
The company plans to submit the third and final PMA module in the second half of 2025, extending the review timeline to 2027 to ensure thorough review and dialogue with the FDA.

Karyopharm Therapeutics Inc.

KPTI

Healthcare

1w

Strategic Focus on Phase III Readouts and Clinical Progress

The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.

SIGA Technologies, Inc.

SIGA

Healthcare

1w

Expansion of U.S. Government Funding for Pediatric Smallpox Treatment

SIGA received an additional $13 million in development funding from the U.S. government specifically for pediatric smallpox treatment development.
The funds will support activities up to regulatory filings, including a new pediatric formulation of TPOXX.
A follow-up clinical trial will evaluate a refined pediatric formulation, including meal effects on absorption.
The pediatric program aims to address an unmet need for children too small for current oral formulations.
This funding reaffirms the U.S. government's strategic emphasis on biodefense and pediatric preparedness.
The company is on track to submit an IND for the pediatric program in the second half of 2025.

ANI Pharmaceuticals, Inc.

ANIP

Healthcare

1w

Financial Performance Summary

Adjusted non-GAAP EBITDA was $54.1 million, a 63% increase from the prior year period, and adjusted non-GAAP EPS was $1.80, up from $1.02.
ANI Pharmaceuticals reported record Q2 2025 results with net revenues of $211.4 million, up 53% year-over-year on an as-reported basis and 37% organically.
Cash flow from operations was $110.8 million in the first half of 2025, with unrestricted cash increasing to $217.8 million at quarter-end.
Generics revenues increased 22% to $90.3 million, supported by new product launches including prucalopride tablets with 180-day exclusivity.
Non-GAAP gross margin improved to 64.9%, up over 6 points from the prior year, due to favorable product mix and strong generics performance.
Operating expenses increased, with R&D up 130% to $16 million and SG&A up 66% to $67.1 million, reflecting investments in sales teams and clinical studies.
Rare Disease revenues doubled year-over-year to $104 million, driven by Cortrophin Gel revenues of $81.6 million, up 66% year-over-year.

BioCryst Pharmaceuticals, Inc.

BCRX

Healthcare

2w

Record-Breaking U.S. Launch Performance of ORLADEYO in Year 5

Q2 was the best quarter since approval for ORLADEYO in terms of revenue and new patient demand.
U.S. prescriptions increased over 10% compared to Q1 2021 and over 15% compared to Q1 2025.
Revenue exceeded expectations by over $22 million in Q2, with 45% YoY growth.
Demand driven by increased prescriber confidence, real-world evidence, and expanding patient segments, including normal C1 inhibitor patients.

Madrigal Pharmaceuticals, Inc.

MDGL

Healthcare

1w

Extended Patent Protection for Rezdiffra to 2045

The new U.S. patent issued on June 2025 extends protection till February 2045, a full year longer than previous.
Patent covers claims related to Rezdiffra’s weight-threshold dosing regimen as prescribed in its FDA label.
Patent is based on clinical findings from the Phase III MAESTRO-NASH trial showing dose optimization based on body weight.
The patent provides a strategic privilege of time, allowing long-term planning and pipeline development.
Potential generic competitors would need to infringe on the patent by adopting the Rezdiffra label, strengthening Madrigal’s market position.

Revolution Medicines, Inc.

RVMD

Healthcare

1w

Advancement of RAS(ON) Inhibitors and Pipeline Progress

Revolution Medicines has a pipeline of three clinical-stage RAS(ON) inhibitors: daraxonrasib, elironrasib, and zoldonrasib, with recent publications highlighting their innovative chemistry and mechanism of action.
Daraxonrasib received Breakthrough Therapy designation from the FDA for metastatic pancreatic cancer with KRAS G12 mutations, emphasizing its potential to address a large unmet medical need.
The company is progressing towards multiple registrational trials, including a Phase III in second-line pancreatic cancer (RASolute 302), and plans to initiate first-line and adjuvant trials later in 2025.
Elironrasib and zoldonrasib are showing promising clinical data, with elironrasib granted Breakthrough Therapy designation for KRAS G12C NSCLC, and ongoing studies for G12D mutations and combination therapies.

Eli Lilly and Company

LLY

Healthcare

1w

Positive Phase III Data for Obesity Drug Orforglipron

Lilly announced positive topline results from the ATTAIN-1 Phase III trial of orforglipron, an oral GLP-1 receptor agonist, in people with obesity without diabetes.
Patients on the highest dose of orforglipron lost over 27 pounds (12.4% of body weight), with notable improvements in metabolic markers such as blood pressure, cholesterol, and inflammation.
The safety profile was consistent with the injectable GLP-1 class, with gastrointestinal side effects being most common and low discontinuation rates (5-10%).
Lilly plans to submit orforglipron for regulatory approval globally within the year, with additional Phase III trials ongoing in diabetes, weight maintenance, and other indications.