Activist Investing Discloses 9.9% Ownership Interest in Titan Pharma

 David E. Lazar, Chief Executive Officer of Activist Investing LLC (together with its affiliates, “Activist Investing” or “we”), one of the largest stockholders of Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (“TTNP” or the “Company”) with 9.9% of the Company’s outstanding shares, today issued the following statement:

“As disclosed in our initial Schedule 13D filing in April 2022, we continue to engage in discussions with the Board of Directors and management concerning the Company’s strategic alternatives. As a result of our belief in the prospects of the Company and its ability to unlock significant stockholder value through a strategic transaction, we filed an amendment to our Schedule 13D yesterday disclosing an increase in our already sizeable position in the Company to 9.9% of TTNP’s outstanding shares. We remain hopeful that the Company’s strategic review will result in a positive outcome that is in the best interest of all TTNP stockholders.”

https://finance.yahoo.com/news/activist-investing-discloses-9-9-120000616.html

CTI Pivotal Data from Pacritinib Program

 "Our presentions today demonstrate that full dose pacritinib achieved higher response rates and a similar, manageable safety profile compared to lower-dose ruxolitinib in patients with myelofibrosis who have moderate or severe thrombocytopenia," said Adam Craig, President and Chief Executive Officer of CTI BioPharma. "As the commercial launch of VONJOTM (pacritinib) in the U.S. continues to exceed our expectations, we are pleased to highlight VONJO's clinical value as a potential best in class treatment for patients with cytopenic myelofibrosis with platelet counts below 50 × 109/L."

Presentation materials will be available at ctibiopharma.com.

https://finance.yahoo.com/news/cti-biopharma-presents-pivotal-data-110000319.html

Zai Lab: Breakthrough Therapy Designations Granted for Repotrectinib in China

 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.

https://finance.yahoo.com/news/zai-lab-announces-breakthrough-therapy-113000333.html

Blueprint Stock Dives On FDA's Tricky New Requirement For Lead Drug

 The Food and Drug Administration recommended Blueprint Medicines (BPMC) change the ultimate goal of a midstage study on a drug for a rare disorder, leading BPMC stock to crumble Thursday.

Blueprint is testing its drug in patients with indolent systemic mastocytosis. With this disease, a type of cell that lives in connective tissues builds up. This causes a wide array of problems including itching, abdominal pain, bleeding disorders, bone or muscle pain or an enlarged liver. Patients with the indolent form of the disease have a low buildup, so their prognosis is positive.

However, the FDA suggested Blueprint analyze the total change in patients' symptoms. Previously, Blueprint planned to measure the number of patients who responded to treatment with at least a 30% reduction in symptoms, SVB Securities analyst Andrew Berens said in a note to clients. Blueprint will still measure the number of responders, but as a secondary goal of the study.

"Analysis of the delta in magnitude of responses rather than the number of respondents allows all enrolled patients, regardless of baseline disease burden, to contribute to the endpoint, providing results that would be more relevant to the entire patient population," he said.

On today's stock market, BPMC stock toppled 8.9% to 58.77.

BPMC Stock: Expanding Drug's Uses

Blueprint's drug, Ayvakit, is already approved in the advanced form of the same disease.

Further, early-stage testing looked promising, Berens said. In 2020, Blueprint said Ayvakit-treated patients showed a statistically significant decrease in symptoms compared to placebo recipients. But the new FDA requirement does create uncertainty in the test, he said.

"In our view, while we continue to believe in a positive outcome for the study, we note that this increase in granularity likely interjects more statistical uncertainty by considering the depth and variability of responses that are likely to be observed in each group," he said.

Berens kept his market perform rating on BPMC stock.

https://www.investors.com/news/technology/bpmc-stock-dives-on-a-tricky-new-fda-requirement-for-its-leading-drug/

Top Glove's Third-Quarter Earnings Slump as Glove Demand Weakens

 Top Glove Corp.'s earnings plunged in the third quarter as demand for personal protective equipment ebbed as Malaysia moved to the endemic phase.

Third-quarter net profit fell 99% to 15.3 million ringgit ($3.5 million), the company said in an earnings release on Thursday.

Revenue fell 65% to MYR1.46 billion, said Top Glove, the world's largest glove maker.

Compared with the pandemic peak, demand for gloves and average selling prices has softened, Top Glove said.

The Malaysia-listed company is also facing higher production costs due to inflation and the rise in crude-oil prices amid the Russia-Ukraine conflict.

"This is an extremely challenging time for the glove industry and this quarter's results are not reflective of our usual business performance, owing to the ongoing normalization trend coupled with demand supply imbalance," Managing Director Lee Kim Meow said in a statement.

https://www.marketscreener.com/quote/stock/TOP-GLOVE-CORPORATION-BHD-6496122/news/Top-Glove-s-Third-Quarter-Earnings-Slump-as-Glove-Demand-Weakens-40677843/

Thermo Fisher tests cleared by FDA

 Thermo Fisher Scientific Inc. said the Food and Drug Administration has cleared its Thermo Scientific EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of Systemic Sclerosis and Systemic Lupus Erythematosus.

With these new tests, the company said, the EliA portfolio provides a more robust clinical offering through a comprehensive menu of automated connective tissue disease tests.

RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value. Also, in patients who are positive for RNA Polymerase III, up to 70% may have no other SSc associated antibodies present. The EliA RNA Pol III test completes a criteria based EliA SSc panel and is the first fully automated RNA Polymerase test available in the U.S.

The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA negative patients.

https://www.marketscreener.com/quote/stock/THERMO-FISHER-SCIENTIFIC-14623/news/Thermo-Fisher-Scientific-Tests-Get-FDA-Clearance-40681947/

Something Fishy About Tuna and Melanoma Risk

 Heavier consumption of fish, including tuna and other non-fried fish, was associated with an increased risk of melanoma, findings from a large prospective cohort study indicated.

Examining data on nearly half a million participants from the NIH-AARP Diet and Health Study revealed that individuals in the highest quintile of total fish intake had a 22% higher risk for malignant melanoma compared to those in the bottom quintile, after multivariable adjustment that included melanoma-specific risk factors (HR 1.22, 95% CI 1.11-1.34, P=0.001 for trend).

A similarly higher risk was also seen for melanoma in situ (HR 1.28, 95% CI 1.13-1.44, P=0.002 for trend), according to the study from Eunyoung Cho, ScD, of Brown University School of Public Health in Providence, Rhode Island, and colleagues.

"Our findings may be explained by contaminants in fish, such as polychlorinated biphenyls, dioxins, arsenic and mercury," the group wrote in Cancer Causes & Control. "Higher fish intake is associated with higher level of body burden of each of these contaminants, which are associated with higher risk of skin cancer."

The associations were consistent across several demographic and lifestyle factors and for both tuna and non-fried fish:

• Tuna, malignant melanoma: HR 1.20 (95% CI 1.09-1.31)
• Tuna, melanoma in situ: HR 1.17 (95 CI 1.05-1.31)
• Non-fried fish, malignant melanoma: HR 1.18 (95% CI 1.07-1.30)
• Non-fried fish, melanoma in situ: HR 1.25 (95% CI 1.11-1.42)

Fried fish, meanwhile -- which has never been accused of being healthy -- was associated with a small though non-significant lower risk for malignant melanoma (HR 0.90, P=0.06 for trend).

"The authors did their best to control for confounding factors, but technically, it is just rather difficult to adequately control for the most important one -- lifetime sun exposure," Teresa Fung, ScD, RD, of Harvard T. H. Chan School of Public Health in Boston, told MedPage Today.

Fung noted that the researchers used geographical ultraviolet radiation (UVR) quantity to approximate sun exposure, and also controlled for physical activity, as people tend to exercise outdoors. "Those were helpful and important, but sun exposure remained inadequately controlled for," she said.

"I am not alarmed by the results of this study, and there is no need to reduce fish intake," said Fung. "However, for general good nutrition practice, fried fish in the form of fish sandwich (white bread) is generally not a healthy food."

For their study, Cho's group examined data from 491,367 participants (ages 50-71) from the NIH-AARP Diet and Health Study, which in 1995-1996 mailed questionnaires to AARP members in six states (California, Florida, Louisiana, New Jersey, North Carolina, Pennsylvania) and two metropolitan areas (Detroit, Atlanta).

People with a history of cancer, who had died, moved out of the study area, or who had an extreme caloric intake (less than 426 kcal or above 6,760 kcal) were excluded from the study. About 90% of the study population were non-Hispanic white.

At baseline, people who consumed higher quantities of fish were more likely to be men, be younger in age, as well as higher education levels, physical activity levels, body mass index, daily caloric intake, and alcohol intake.

Individuals were followed for a median 15.5 years, for a total of more than 6.6 million person-years of follow-up. By the end of the study period, there were 5,034 total cases of malignant melanoma and 3,234 cases of melanoma in situ. Median age at diagnosis was 70.8 years.

Other covariates for the multivariable analysis included age, sex, education, family history of cancer, alcohol intake, smoking history, and daily caloric intake. Fish types included canned tuna, fried fish or fish sticks, or non-fried fish (cod, clams, shrimp, flounder, crabs, etc.).

A limitation of the study included the assumption that dietary and lifestyle habits did not change from participants' baseline questionnaire, the authors noted. Furthermore, UVR exposure was not estimated based on individuals' behavior. Researchers also lacked data on melanoma risk factors such as mole count, hair color, and history of sunburn.

Disclosures

The authors disclosed no completing interests.

Primary Source

Cancer Causes & Control

Source Reference: Li Y, et al "Fish intake and risk of melanoma in the NIH‑AARP diet and health study" Cancer Causes Control 2022: DOI: 10.1007/s10552-022-01588-5.

https://www.medpagetoday.com/hematologyoncology/skincancer/99146