Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week highs on April 2)
- Denali Therapeutics Inc (NASDAQ: DNLI)
- Dr.Reddy's Laboratories Ltd (NYSE: RDY)(announced a settlement agreement with Celgene Corporation (NASDAQ: CELG) regarding its ANDA related to generic Revlimid pending before Health Canada)
Down In The Dumps
(Biotech stocks hitting 52-week lows on April 2)
- Evoke Pharma Inc (NASDAQ: EVOK)(FDA issued a complete response letter for Gimoti, which is being evaluated for treating symptoms in adult women with acute and recurrent diabetic gastroparesis.
Stock In Focus Advaxis To Offer Common Stock
The company said it intends to use the net proceeds to fund its R&D initiatives and for general corporate purposes.
The stock slid 15.59 percent to $4.98 in after-hours trading.
Novartis' Sandoz Unit Resubmits BLA For Generic White Blood Cell Stimulating Drug
Novartis AG (NYSE: NVS)'s Sandoz unit said it resubmitted its BLA for a proposed biosimilar for pegfilgrastim following the issue of a complete response letter in June 2016 to the originally filed application.
"Pegfilgrastim is a long-acting version of filgrastim and may be prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells," Sandoz said.
Roche Announced Extension of Tender Offer To Acquire Spark
Roche Holdings AG Basel ADR (OTC: RHHBY) and Spark Therapeutics Inc (NASDAQ: ONCE) said the waiting period for the pending acquisition of the latter by the former has been extended to April 25 following the March 18 withdrawal of the premerger notification filed March 1. Roche said it intends to refile a premerger notification on or about April 10.
Consequently, the tender offer to purchase all outstanding Spark shares for $114.50 per share has been extended from April 3 to May 2.
The companies indicated that all terms and conditions of the offer remain unchanged.
ADMA Receives Dept of Health U.S. License For Recently Approved Asceniv
Following FDA approval for ADMA Biologics Inc (NASDAQ: ADMA)'s Asceniv, the company said it has received the Department of Health and Human Services U.S. license, which covers the Boca Raton, Florida manufacturing facility and also authorizes the company to manufacture and enter into interstate commerce with Asceniv.
The shares climbed 4.74 percent to $5.30 in after-hours trading.
FDA Clears Cellectis' IND For Multiple Myeloma Gene-Edited CAR T-cell Therapy
Cellectis SA (NASDAQ: CLLS) said the FDA has approved its IND application to initiate a Phase 1 trial for UCARTCS1 in patients with multiple myeloma. The company said it has ensured the manufacturing and release of UCARTCS1 GMP batches as well as an IRB approval.
"UCARTCS1 is the first allogeneic CAR-T therapy for MM to enter clinical development," the company said.
On The Radar Clinical Trial Readouts Presentations at the American Association For Cancer Research annual meeting 2019
Tocagen Inc (NASDAQ: TOCA) – updated Phase 1 data of Toca 511 & Toca FC (glioma)
TRACON Pharmaceuticals Inc (NASDAQ: TCON) – Poster presentation of Phase 2 data for TRC102 and Temodar (colorectal cancer)
Ascendis Pharma A/S (NASDAQ: ASND) (after the market close)
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