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FDA Panel Split On DURECT's Drug, Intellipharma Plunges, BNTX To Acquire NTGN

pharma 072817 16jan20 lt

Today's Daily Dose brings you news about the FDA panel's split verdict on DURECT's postoperative nonopioid pain relief depot, BioNTech's acquisition of Neon Therapeutics and the FDA designating Envafolimab as an orphan drug for the treatment of biliary tract cancer.

Read on…

The FDA's Anesthetic and Analgesic Drug Products Advisory Committee has delivered a split verdict over whether the regulatory agency should approve DURECT Corp.'s (DRRX) resubmitted New Drug Application for POSIMIR, a postoperative pain relief depot.

POSIMIR, a nonopioid, locally-acting analgesic, is designed to be administered directly into the surgical site to deliver the anesthetic bupivacaine for up to three days after surgery.

The committee voted 6-6 on the safety and efficacy of POSIMIR. The FDA's final decision date is yet to be announced.

The FDA had issued a Complete Response Letter for POSIMIR in February 2014.

The trading of DURECT's common stock was halted on Thursday. In extended trading, the stock was up 0.39% to $2.55.

Shares of Intellipharmaceutics International Inc. (IPCIF.OB) plunged more than 70% on Thursday, following the FDA Advisory Committees' negative votes on the Company's drug candidate Aximris XR abuse-deterrent oxycodone hydrochloride extended-release tablets.

The Company is seeking approval of Aximris XR for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, which reviewed the resubmitted New Drug Application for Aximris XR voted 24 to 2 against recommending approval of the drug.

IPCIF.OB closed Thursday's trading at $0.20, down 70.15%.

Neon Therapeutics Inc. (NTGN) is all set to be acquired by BioNTech (BNTX) in an all-stock transaction valued at approximately $67.0 million or $2.18 per share.

Neon is a biotechnology company developing novel neoantigen-based T cell therapies. The acquisition is expected to further expand BioNTech's growing CAR-T and TCR therapy pipeline through the addition of neoantigen-specific cell therapies, including a T cell therapy targeting shared RAS oncogenes.

Upon closing, Neon will operate as a subsidiary of BioNTech. The transaction is expected to close in the second quarter of 2020.

NTGN closed Thursday's trading at $1.70, up 38.21%.

The FDA has granted China-based 3D Medicines' Envafolimab orphan drug designation for the treatment of biliary tract cancer.

Envafolimab is currently in phase I trials in the US and Japan and is being studied in China in a phase II registration trial as a single agent in high microsatellite instability (MSI-H) tumor patients, and in combination with gemcitabine and oxaliplatin in a phase III registration trial in biliary tract cancer.

Last month, TRACON Pharmaceuticals (TCON) signed a collaborative partnership agreement with 3D Medicines and Jiangsu Alphamab Biopharmaceuticals Co., Ltd., for the development of Envafolimab.

As part of the agreement, TRACON will be responsible for the clinical development and commercialization of Envafolimab in soft tissue sarcoma in North America, with the majority of the development activities expected to occur in the U.S. TRACON will bear the costs of clinical trials and 3D Medicines and Jiangsu Alphamab will supply Envafolimab at pre-negotiated prices.

TCON closed Thursday's trading at $4.30, up 46.76%.

Titan Pharmaceuticals Inc. (TTNP) announced that it has not received the vote needed for approval to effect a reverse split of the common stock under the Delaware General Corporation.

According to the Company, as of the close of business on January 16, 2020, only 60% of the shares entitled to vote at the meeting have been voted and while the majority of those that did vote were in favor of the Reverse Split Proposal, the affirmative vote necessary for approval under the Delaware General Corporation has not been received.

Accordingly, the Company has determined to cancel the meeting and seek stockholder approval for the Reverse Split Proposal at a later date.

TTNP closed Thursday's trading at $0.25, down 4.94%. In after-hours, the stock was up 14.60% to $0.28.

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