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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

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

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 June 1)

  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Aileron Therapeutics Inc (NASDAQ: ALRN) (announced positive interim results for its Phase 1b/2 study of ALRN-6924 as an agent to protect patients against chemotherapy-induced toxicity)
  • argenx SE – ADR (NASDAQ: ARGX)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
  • Cerus Corporation (NASDAQ: CERS)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (reacted to reports of partner Sinovac expressing confidence in its coronavirus vaccine)
  • Emergent Biosolutions Inc (NYSE: EBS) (announced $628-million dollar BARDA funding for rapid development of COVID-19 vaccine candidates)
  • Imara Inc (NASDAQ: IMRA)
  • Immunovant Inc (NASDAQ: IMVT)
  • Inari Medical Inc (NASDAQ: NARI)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • MEI Pharma Inc (NASDAQ: MEIP)
  • Novo Nordisk A/S (NYSE: NVO)
  • Protara Therapeutics Inc (NASDAQ: TARA)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX)
  • Vermillion, Inc. (NASDAQ: VRML)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 1)

  • Ocugen Inc (NASDAQ: OCGN) (announced discontinuation of Phase 3 trial of OCU300 for ocular Graft vs. Host Disease)

Stocks In Focus

Roche's Cancer Therapy Combo Approved For Treatment-Naïve Liver Cancer

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's Momentum Carries Through Ahead of Conference Presentation

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 Shares Slip As Shareholder Lawsuit Accorded Class Action Status

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 the stock 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 To Invest Up To $500M Across Portfolio Of Clinical-Stage Biotechs

Pfizer Inc. (NYSE: PFE) announced the establishment of the Pfizer Breakthrough Growth Initiative, through which the company said it will 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.

Myovant Gains On NDA Submission For Drug Combo to Treat Menstrual Bleeding 

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 1 mg 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 Announces European Nod For Multiple Myeloma Drug

Sanofi SA (NASDAQ: SNY) said the European Commission has approved its Sarclisa in 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 Retires $15M In Debt

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.

Bidding War For Tetraphase Heats Up

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) said a revised offer from Melinta received in response to another revised offer from another suitor, 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 of Tetraphase stock for $0.5872 in cash and 0.7409 AcelRx 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 each for 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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