StemCell Therapy

Here's a roundup of top developments in the biotech space over the last 24 hours:

(Biotech Stocks Hitting 52-week Highs June 1)

(Biotech Stocks Hitting 52-week Lows June 1)

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the FDA approved its Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Allena Pharmaceuticals Inc (NASDAQ: ALNA) shares were surging ahead of the company's presentation at the Jefferies Virtual Healthcare Conference. The shares were higher in Monday's regular session, reacting to an initiation by H.C. Wainwright with a Buy rating and $10 price target.

Analyst Edward White said the biopharma is an "undervalued enzyme therapeutic company."

Following a 31.55% jump to $2.21 in Monday's regular session, Allena shares were rallying by 35.29% to $2.99 in Tuesday's premarket session.

Esperion Therapeutics Inc (NASDAQ: ESPR) shares came under pressure after a federal district court accorded class action status to a lawsuit filed on behalf of investors, alleging the company issued misleading statements about its non-statin cholesterol-lowering drug Nexletol in a bid to artificially inflate thestock price.

The stock fell after it was evident the drug did not have a clear path to regulatory approval, the lawsuit alleged.

The stock slid 3.07% to $40.77 in after-hours trading.

Related Link:The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight

Pfizer Inc. (NYSE: PFE) announced the establishment of the Pfizer Breakthrough Growth Initiative, through which the company said itwill invest up to $500 million in biotechnology companies to help provide funding and access to its scientific expertise to ensure continuity of the biotechnology companies' most promising clinical development programs.

Sumitovant Biopharma said its affiliate Myovant Sciences Ltd (NYSE: MYOV) has submitted an NDA for the once-daily relugolix combo tablet, comprising relugolix 40 mg, estradiol 1mg and norethindrone acetate 0.5 mg, for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

The stock was trading 0.95% higher at $17.09 in the premarket session.

Sanofi SA (NASDAQ: SNY) said the European Commission has approved its Sarclisain combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

Aytu Bioscience Inc (NASDAQ: AYTU) said it has retired $15 million debt assumed in connection with its previously announced acquisition of Cerecor Inc's(NASDAQ: CERC) Commercial Portfolio.

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) said a revised offer from Melinta received in response to another revised offer from anothersuitor,AcelRx Pharmaceuticals Inc (NASDAQ: ACRX), has been deemed a superior offer by its board.

Melinta and AcelRx have been engaged in a bidding war to lap up Tetraphase, with both companies sweetening their respective bids a few times.

The revised AcelRx offer received May 27 called for exchanging each unit ofTetraphase stock for $0.5872 in cash and 0.7409AcelRx shares, representing $1.70 in upfront per share value, and one CVR, entitling the holders to receive potential payments of up to $16 million in cash upon the achievement of certain future Xerava net sales milestones starting in 2021.

Melinta's most recent bid offered $39 million in cash,plus an additional $16 million in cash potentially payable under CVR to be issued in the proposed acquisition.

In premarket trading Tuesday, Tetraphase gained 6.9% to $2.48, while AcelRx shares were surging higher by 6.3% to $1.35.

OraSure Technologies, Inc. (NASDAQ: OSUR) said it has commenced an underwritten public offering of 8 million shares of its common stock.

The stock slipped 4.32% to $13.51 in after-hours trading.

Adaptimmune priced its underwritten public offering of 20.5 million shares of its ADSs at $11 eachfor gross proceeds of $225.5 million. The company expects the offering to close on or about June 4.

Kaleido Biosciences Inc (NASDAQ: KLDO) priced its underwritten public offering of 4.75 million shares of its common stock at $7.50 per share. The company expects to raise gross proceeds of $35.6 million from the offering. All the shares are being offered by the company. The offering is expected to close June 4.

The stock was trading 2.87% higher at $8.24 in the premarket session.

Allogene Therapeutics Inc (NASDAQ: ALLO) priced its underwritten public offering of 11.702 million shares at $47 per share for gross proceeds of $550 million.The offering is expected to close on or about June 4.

The stock fell 0.57% to $48.66 in after-hours trading.

Guardant Health Inc (NASDAQ: GH) announced the commencement of a proposed underwritten public offering of 10 million shares of its common stock, of which 3 million shares are being offered by Guardant Health and 7 million by SoftBank Investment.

The stock was up 0.1% at $48.99 premarket.

G1 Therapeutics Inc (NASDAQ: GTHX) said it has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $100 million. The company plans to use the proceeds to fund commercialization and further development of trilaciclib, its first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

Intellia Therapeutics Inc (NASDAQ: NTLA) said it has commenced an underwritten public offering of $75 million of shares of its common stock. All of the shares in the proposed offering are to be sold by Intellia.

Intellia shares were trading 0.91% higher at $20.73 premarket Tuesday.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

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The Daily Biotech Pulse: FDA Nod For Roche's Combo Therapy In Liver Cancer, Allena Rips Higher, Pfizer To Invest Up To $500M In Biotechs - Benzinga

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