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KMPH Gets FDA Nod, ADMP On Track, OBSV To Report Data Today

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Today's Daily Dose brings you news about the progress related to commercial launch of Adamis Pharma's Symjepi; KemPharm's FDA approval of its pain drug; the regulatory catalyst for Mallinckrodt in August, and ObsEva's big event of today.

Read on...

Adamis Pharmaceuticals Corp. (ADMP) is in discussions with two potential partners relating to the commercial launch of its drug Symjepi.

Symjepi is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis. It received FDA approval last June.

Dennis Carlo, President and CEO of Adamis, said, "Although of course no assurances are possible, my belief is that we are finally nearing the conclusion of this process, and I am hopeful that our next communication will be to announce a definitive agreement and provide information concerning when Symjepi may be available in the market."

ADMP closed Friday's trading at $3.35, up 31.37%.

Kazia Therapeutics Ltd.'s (KZIA) lead drug candidate GDC-0084 has been granted Orphan Drug Designation by the FDA for the treatment of glioblastoma multiforme, the most common and most aggressive form of primary brain cancer.

Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial December 2017. Initial data is expected in late calendar 2018 and the study is expected to complete in 2021.

KZIA closed Friday's trading at $5.38, up 7.90%.

The FDA has approved KemPharm Inc.'s (KMPH) Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Apadaz is an immediate-release fixed-dose combination product consisting of benzhydrocodone hydrochloride, a prodrug of hydrocodone and benzoic acid, and acetaminophen.

Apadaz is scheduled as a C-II product. A C2 drug (also known as a Schedule II substance or C-II drug) is considered to have a high potential for abuse. It is a drug that has been accepted for medical use in the U.S. or has been accepted for medical use with severe restrictions. (Source: Walgreens).

KMPH closed Friday's trading at $6.00, up 13.21%. The stock touched a 52-week high of $7.15 in intraday trading.

Mallinckrodt plc's (MNK) New Drug Application for Stannsoporfin for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice, has been accepted for review by the FDA.

The regulatory agency's decision on Stannsoporfin is expected on August 22, 2018.

Neonatal jaundice is a common condition in neonates that is associated with the yellowing of the skin and the whites of the eyes, typically in the first few days after birth. In most cases, it does not require treatment; however, elevated bilirubin levels in the blood (hyperbilirubinemia) can be toxic and may potentially lead to neurologic complications, including encephalopathy or irreversible brain damage.

Currently, phototherapy is used to help the body clear bilirubin and bring levels down. If approved, Stannsoporfin is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

MNK closed Friday's trading at $16.16, up 1.44%.

ObsEva SA (OBSV) is slated to release top line results from its phase III trial of Nolasiban, dubbed IMPLANT2, on the morning of Monday February 26, 2018.

In the IMPLANT2 study, Nolasiban is being evaluated to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) procedures.

More than 1,000 patients from fertility clinics across 9 European countries were recruited for the study. The primary endpoint is ongoing pregnancy at 10 weeks after embryo transfer.

Also in the pipeline are OBE2109 are OBE022.

OBE2109 is under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM), dubbed EDELWEISS, is also underway.

OBE022 for the potential treatment of preterm labor to delay or prevent preterm birth is under a phase 2a Proof-of-Concept clinical trial, called PROLONG.

Data from the EDELWEISS trial is expected in mid-2018, and top line data from the PROLONG trial are expected around year end 2018.

OBSV closed Friday's trading at $15.22, up 6.43%.

Ultragenyx Pharmaceutical Inc.'s (RARE) Crysvita has received conditional marketing authorisation in Europe for the treatment of X-Linked Hypophosphatemia in children.

XLH is a rare, chronic progressive musculoskeletal disorder that affects children and adults.

Kyowa Hakko Kirin, Kyowa Kirin International, a wholly owned subsidiary of Kyowa Hakko Kirin, and Ultragenyx have been collaborating in the development and commercialisation of Crysvita globally.

In the U.S., Crysvita is under FDA review, with a decision expected on April 17, 2018.

RARE closed Friday's trading at $47.86, up 0.44%.

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