FDA Nod For ABMD, AERI Faces FDA Panel In Oct, IPCI Put On Notice, PFE Sues JNJ

Today’s Daily Dose brings you news about Acceleron Pharma’s public offering; pre-market approval of Abiomed’s Impella RP heart pump; FDA panel review of Aerie’s Rhopressa; NASDAQ notification for Intellipharmaceutics; positive data from Karyopharm’s phase II/III SEAL study and Pfizer’s suit against Johnson & Johnson.

Read on…

Acceleron Pharma Inc. (XLRN) has priced an underwritten public offering of 5.40 million shares of common stock at a price of $37.00 each. The gross proceeds from the offering are estimated to be about $200 million.

In connection with this offering, Acceleron has granted the underwriters a 30-day option to purchase up to an additional 810,810 shares of common stock.

The Company’s lead product candidate is Luspatercept, which is being developed for Myelodysplastic Syndromes (MDS) Beta-Thalassemia, and Myelofibrosis.

A phase III study of Luspatercept in patients with anemia due to lower-risk MDS with ring sideroblasts who require regular RBC transfusions, dubbed MEDALIST, and a phase III study of Luspatercept in patients with anemia due to beta-thalassemia who require regular RBC transfusions, dubbed BELIEVE, are underway.

The top-line results from the MEDALIST and BELIEVE phase III trials are expected in mid-2018.

XLRN closed Wednesday’s trading at $37.73, down 3.18%.

Abiomed Inc. (ABMD) has received FDA’s pre-market approval for Impella RP heart pump, which is indicated for providing temporary right ventricular support for up to 14 days in patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure.

ABMD closed Wednesday’s trading at $157.42, up 0.20%. In after-hours, the stock gained 2.91% to $162.

Aerie Pharmaceuticals Inc.’s (AERI) New Drug Application for Rhopressa 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension is scheduled to be reviewed by an FDA panel on October 13, 2017.

The FDA’s final decision is expected around February 28, 2018.

AERI closed Wednesday’s trading at $53.40, down 8.87%. In after-hours, the stock was up 2.62% to $54.80.

Intellipharmaceutics International Inc. (IPCI) (IPCI.TO) has been notified that it is not in compliance with the minimum market value of listed securities requirement set…

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