FDA Delays Decision On HRTX Drug, KPTI On Watch, ADMP To Resubmit NDA In Q2

Today’s Daily Dose brings you news about Adamis Pharma’s upcoming regulatory catalyst, the delay in FDA decision related to Eton Pharma’s drug candidate, the global license agreement between Five Prime and Seattle Genetics, and Karyopharm’s date with FDA.

Read on…

Adamis Pharmaceuticals Corp. (ADMP) expects to resubmit ZIMHI New Drug Application early in the second quarter of 2020.

ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose.

The Company was issued a Complete Response Letter by the FDA for ZIMHI last November.

ADMP closed Wednesday’s trading at $0.69, down 9.47%.

The FDA decision on Eton Pharmaceuticals Inc.’s (ETON) New Drug Application for ET-105 is likely to be delayed as the Company has been asked to conduct a human factors validation study with the revised labeling to demonstrate that the intended users can prepare and administer the oral suspension safely and effectively.

ET-105 is proposed as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.

The decision date on ET-105 is due on March 17, 2020. Eton remains confident that it can successfully complete the requested human factors validation study, however, the study is unlikely to be completed by the due date.

ETON closed Wednesday’s trading at $6.80, down 6.98%.

Five Prime Therapeutics Inc. (FPRX) has entered into a global license agreement with Seattle Genetics, Inc. (SGEN) to develop and commercialize novel antibody-drug conjugate therapies using monoclonal antibodies developed by Five Prime.

As part of the deal, Five Prime has granted Seattle Genetics an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target and Seattle Genetics will be responsible for research, development, manufacturing, and commercialization of antibody-drug conjugate, or ADC, products based on these antibodies.

The agreement entitles Five Prime to receive $5 million upfront payment and also receive up to a combined total of $525 million in future milestone payments for the first two ADC product candidates.

FPRX closed Wednesday’s trading at $5.23, up 18.33%.

Shares of Heron Therapeutics Inc. (HRTX) fell more than 8 percent in extended trading on Wednesday, following news that the FDA has postponed the decision date on the Company’s New Drug Application for HTX-011 by up to three months.

HTX-011 is proposed for the management of postoperative pain.

The FDA had turned down HTX-011 on April 30, 2019, due to issues related to chemistry, manufacturing and controls and non-clinical information. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019 and was initially assigned a decision date of March 26, 2020. But now that the decision date has been delayed by three months, the U.S. regulatory agency is expected to announce its decision on June 26, 2020.

HRTX closed Wednesday’s trading at $21.66, up 2.48%. In after-hours, the stock was down 8.13% at $19.90.

Karyopharm Therapeutics Inc.’s (KPTI) supplemental New Drug Application seeking accelerated approval for oral XPOVIO tablets has been accepted for priority review by the FDA, with a decision date set for June 23, 2020.

The second indication sought for the drug is for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who have received at least two prior therapies.

XPOVIO received accelerated FDA approval in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma. Launched in July 2019, the drug brought home net product sales of $30.5 million for full-year 2019.

KPTI closed Wednesday’s trading at $16.32, down 0.12%.

Roche’s (RHHBY.OB) supplemental Biologics License Application for Tecentriq as a first-line treatment for certain people with advanced non-small cell lung cancer has been granted priority review by the FDA, with a decision date set for June 19, 2020.

This time, the Company has sought approval of Tecentriq as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.

Tecentriq is already indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, and small cell lung cancer.

RHHBY.OB closed Wednesday’s trading at $44.73, up 1.44%.

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