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Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs Dec. 14)
(Biotech Stocks Hitting 52-week Lows Dec. 14)
Mediwound Ltd (NASDAQ:MDWD) announced the signing of a distribution agreement with UAE's Ghassan Aboud Group, giving the latter an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns.
Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year, the company said.
The stock was up 7.69% at $3.92 premarket Tuesday.
Kezar Life Sciences Inc (NASDAQ:KZR), Legend Biotech Corp (NASDAQ:LEGN) and MediciNova, Inc. (NASDAQ:MNOV) announced separately that their shares will be added to the Nasdaq Biotech Index prior to the open of the market on Dec. 21.
Kezar shares were up 13.92% premarket at $6.30, while Legend Biotech rose 2.47% to $30.74.
ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) announced that CFO Satyavrat Shukla will step down from the role effective Dec. 31 to pursue another opportunity. The company said it has initiated a search for a new CFO
In after-hours trading, the stock declined 0.97% to $3.06.
Related Link: The Week Ahead In Biotech: 2 IPOs Plus FDA Decisions On Moderna's COVID Vaccine And Drugs From Amgen, MacroGenics
Opiant Pharmaceuticals Inc (NASDAQ:OPNT) said the BARDA has announced an additional commitment of up to $3.5 million to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million, Opiant said.
The company said it remains on track to file an NDA for the investigational asset by the end of 2021.
The stock jumped 22.26% to $10.16 premarket.
Mesoblast limited (NASDAQ:MESO) announced mixed top-line results from the DREAM-HF Phase 3 study of its allogeneic cell therapy rexlemestrocel-L in 537 patients with advanced chronic heart failure.
Over a mean 30 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial treatment with rexlemestrocel-L on top of maximal therapies had 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process, the company said.
Yet there was no reduction in recurrent non-fatal decompensated heart failure events, which was the trial's primary endpoint, the company said.
The stock was down 14.15% premarket at $14.50.
Neovasc Inc (NASDAQ:NVCN) said it has received written notification from the Nasdaq that the company is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. The company has been given until June 14, 2021 to regain compliance.
Burning Rock Biotech Ltd (NASDAQ:BNR) announced a licensing agreement with OncoCyte Corp (NYSE:OCX) to bring the latter's DetermaRx, a risk stratification test for early stage lung cancer patients, to China.
In premarket trading Tuesday, Burning Rock shares were slipping 0.41% to $24.55, while OncoCyte was advancing 19.34% to $2.53.
Ocular Therapeutix Inc (NASDAQ:OCUL) said it has commenced an underwritten public offering of $75 million of its common stock. All of the shares in the offering are to be sold by the company.
The stock was down 3.67% at $21.50 premarket Tuesday.
Mirum Pharmaceuticals Inc (NASDAQ:MIRM) priced its previously announced underwritten public offering of 3.75 million shares of its common stock at $20 per share for raising gross proceeds of $75 million.
The stock fell 15.75% to $20.22 in premarket trading.
Castle Biosciences Inc (NASDAQ:CSTL) said it has commenced a proposed underwritten public offering of $125 million of its common stock.
In after-hours trading, the stock moved down 1.08% to $61.25.
Cellectis announced the launch, subject to market conditions, of an underwritten public offering of $100 million of its ADSs, each representing one ordinary share of Cellectis.
The stock was down 8.81% premarket at $28.46.
BioCardia said it has entered into definitive agreements with investors for the sale of 1.89 million shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market. The offering is expected to close Dec. 16.
In premarket trading Tuesday, BioCardia shares were retreating 4.46% to $4.28.
FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Novartis AG's (NYSE:NVS) supplemental new drug application for Entresto (sacubitril and valsartan) tablets, for the proposed indication of heart failure with preserved ejection fraction.
Gossamer Bio Inc (NASDAQ:GOSS) will release initial results from the ongoing two-week Phase 1b clinical trial of GB002, its inhaled PDGFR inhibitor, for the treatment of pulmonary arterial hypertension. The release is scheduled for 11 a.m.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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