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IMMU Gets Early FDA Nod, KNSA's PN Trial Meets Goals, MYOV In Good Spirits

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Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

Read on…

Shares of Immunomedics Inc. (IMMU) were up over 28 percent in extended trading on Wednesday, following the receipt of accelerated approval for the Company's Trodelvy in previously-treated metastatic triple-negative breast cancer.

The FDA's approval comes more than a month ahead of the original decision date of June 2, 2020.

Trodelvy, also known as Sacituzumab govitecan, becomes the first antibody-drug conjugate approved by the FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer.

The FDA's Accelerated Approval of Trodelvy is based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase 2 study. Continued approval depends upon the verification of clinical benefit in the confirmatory Phase 3 ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee (DSMC) for compelling evidence of efficacy across multiple endpoints. The topline results are expected by mid-2020.

Trodelvy will sport a black box warning for severe neutropenia and severe diarrhea.
Analysts expect the drug to achieve blockbuster sales.

IMMU closed Wednesday's trading at $21.99, up 1.24%. In after-hours, the stock was up 28.72% at $28.28.

Kiniksa Pharmaceuticals Ltd.'s (KNSA) phase IIa clinical trial evaluating Vixarelimab (KPL-716) in prurigo nodularis has met the trial goals.

The study met the primary efficacy endpoint of a statistically significant reduction in the weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) at Week 8. The secondary efficacy endpoint of a statistically significant improvement in prurigo nodularis-investigator's global assessment (PN-IGA) 0/1 at Week 8 was also achieved, according to the Company.

Prurigo nodularis, or PN, is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, causing people to scratch themselves to the point of bleeding or pain. (Source: NIH). Currently, there are no approved drugs for prurigo nodularis.

KNSA touched a new high of $21.74 in intraday trading on Wednesday, before closing the day at $19.98, down 2.30%.

Mallinckrodt plc's (MNK) New Drug Application for Terlipressin, proposed for the treatment of hepatorenal syndrome type 1 (HRS-1), has been accepted for review by the FDA, with a decision date set for September 12, 2020.

HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis, affecting between 30,000 and 40,000 patients in the U.S. annually.

The condition has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated. Currently, there are no approved drug therapies for HRS-1 in the U.S.

MNK closed Wednesday's trading at $3.48, up 14.10%.

Myovant Sciences' (MYOV) phase III study of once-daily Relugolix combination therapy in women with pain associated with endometriosis has yielded positive results.

In the study, dubbed SPIRIT 2, which evaluated a combination of Relugolix 40 mg plus Estradiol 1.0 mg, and Norethindrone acetate 0.5 mg, the co-primary endpoints met with 75.2% response rate for dysmenorrhea (menstrual pain) and 66.0% response rate for non-menstrual pelvic pain.

Women receiving Relugolix combination therapy, on average, had a 75.1% reduction on the Numerical Rating Scale for dysmenorrhea from 7.2.

The trial also achieved six key secondary endpoints, including improvement in the impact of pain on daily activities and a greater proportion of women not using opioids, with a generally well-tolerated safety profile including minimal bone mineral density loss.

SPIRIT 2 is the first of two phase III studies of once-daily Relugolix combination therapy in women with pain associated with endometriosis, and the second study is known as SPIRIT 1.

In a separate clinical study, Relugolix combination therapy achieved a 100% ovulation inhibition in 67 healthy women with no women ovulating during the 84-day treatment period. There was a 100% return of ovulation or menses upon discontinuation of treatment in this study.

The top-line results from the SPIRIT 1 study are due this quarter.

MYOV closed Wednesday's trading at $12.02, up 3.80%.

Prothena Corp. plc (PRTA) announced that Part 1 of the PASADENA study of experimental drug Prasinezumab in patients with early Parkinson's disease has not met the primary objective, but showed signals of efficacy.

PASADENA is a two-part phase II clinical study in early Parkinson's disease patients that is being conducted by Roche. Prothena licensed Prasinezumab to Roche in 2013.

Roche is evaluating the data from Part 1 of the PASADENA study to determine the next steps. A further update on Prasinezumab is expected later this year.

PRTA closed Wednesday's trading at $11.76, down 2.00%.

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