The Daily Biotech Pulse: Intersect ENT Jumps On M&A Speculation, VIVUS Files For Bankruptcy

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 July 7)

• AbbVie Inc ABBV
• ACADIA Pharmaceuticals Inc. ACAD
• Akebia Therapeutics Inc AKBA
• Akero Therapeutics Inc AKRO
• Alnylam Pharmaceuticals, Inc. ALNY
• argenx SE – ADR ARGX
• BioMarin Pharmaceutical Inc. BMRN
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• BioSpecifics Technologies Corp. BSTC (FDA approved the cellulitis drug it had licensed to Endo International PLC ENDP)
• Cerus Corporation CERS (announced study results demonstrating that its INTERCEPT Blood System inactivates SARS-CoV-2 in plasma components intended for transfusion)
• Corvus Pharmaceuticals Inc CRVS ( announced initiation of a Phase 1 study of a potential coronavirus treatment)
• Crispr Therapeutics AG CRSP
• Cytokinetics, Inc. CYTK
• DexCom, Inc. DXCM
• Fate Therapeutics Inc FATE
• GENMAB A/S/S ADR GMAB
• Immunomedics, Inc. IMMU
• Incyte Corporation INCY
• Intellia Therapeutics Inc NTLA
• MacroGenics Inc MGNX
• NeoGenomics, Inc. NEO
• Novavax, Inc. NVAX ( announced $1.6 billion funding for its coronavirus program)
• Pacira Biosciences Inc PCRX (pre-announced second-quarter revenues above consensus)
• Regeneron Pharmaceuticals Inc REGN (announced $450 million U.S. government funding for its antibody cocktail, which is being evaluated for COVID-19)
• Seattle Genetics, Inc. SGEN
• TG Therapeutics Inc common stock TGTX
• Twist Bioscience Corp TWST
• Unum Therapeutics Inc UMRX (announced the acquisition of privately-held biopharma Kiq)
• VBI Vaccines Inc VBIV
• Vertex Pharmaceuticals Incorporated VRTX
• Zai Lab Ltd ZLAB (announced in-licensing of Turning Point Therapeutics Inc's TPTX lead cancer drug in Greater China)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 7)

• Ayala Pharmaceuticals Inc AYLA
• immatics biotechnologies GmbH IMTX (announced July 2 a business combination with blank cheque company Arya Sciences Acquisition and began trading on Nasdaq)
• Repare Therapeutics Inc RPTX
• Sonnet Biotherapeutics Holdings Inc SONN

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

Stocks In Focus

Intersect ENT Rallies On Reports of M&A Approach From Medtronic

Medical device company Intersect ENT Inc's XENT shares saw strong buying interest in after-hours trading after a Bloomberg report said rival Medtronic PLC MDT has tabled a bid for the former. The board of Intersect ENT is reportedly reviewing the offer.

Intersect ENT shares soared 29.59% to $18 in after-hours trading.

GenMark Pre-announces Above-Consensus Q2 Revenues

GenMark Diagnostics, Inc GNMK pre-announced second-quarter results, expecting revenues of $40.1 million, up 118% year-over-year. Analysts, on average, estimate revenues of $31.39 million.

The company noted that about 90% gross placements included interest in COVID-19 testing, and SARS-CoV-2 consumable revenues accounted for about 48% of ePlex revenues.

The stock rallied 10.33% to $17.20 in after-hours trading.

Merck's Keytruda-Combo Treatment For Liver Cancer Rejected By FDA

Merck & Co., Inc. MRK and Eisai Co., Ltd ESALY said the FDA has issued a Complete Response Letter, or CRL, regarding their applications seeking accelerated approval of Keytruda, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of patients with unresectable hepatocellular carcinoma.

The CRL was issued on the grounds that there isn't enough evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease.

VIVUS Files For Chapter 11, To Be Taken Over By Debtor Icahn's IEH Biopharma

VIVUS, Inc. VVUS said it has completed the solicitation of an in-court prepackaged plan of reorganization, under which its creditor IEH Biopharma will take 100% ownership of VIVUS ahead of its July 7 chapter 11 filing.

The company believes the prepackaged plan satisfies all requirements necessary for confirmation by the Court. Upon confirmation of the prepackaged plan, VIVUS intends to consummate the restructuring transactions shortly thereafter.

Under the plan, VIVUS stockholders of record as of July 2 will receive, subject to the satisfaction of certain conditions, a pro rata share of $5 million and a non-transferable contractual contingent value right to earn another $2 per share if the company meets certain financial milestones in both 2021 and 2022.

The company also said its shares will be delisted from the Nasdaq.

The stock slumped 25.70% to 60 cents in after-hours trading.

NextCure Begins Phase 1/2 Clinical Trial of Immunomedicine In Solid Tumors

NextCure Inc NXTC announced the initiation of a Phase 1/2 clinical trial for NC410, a novel immunomedicine developed to block immune suppression mediated by an immune modulator called LAIR-1. The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC410 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose.

Initial data from the Phase 1 portion of the trial is due to be released in the second half of 2021.

After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of NC410 will be evaluated in select tumor types.

In after-hours trading, the stock moved up 2.69% to $19.10.

Offerings

Akero priced an underwritten public offering of 5.228 million shares of its common stock at $36 per share. All the shares are being offered by the company.

The stock was seen slipping 0.84% to $36.75 in pre-market trading Wednesday.

Vir Biotechnology Inc VIR priced its previously announced underwritten public offering of 7.143 million shares at $42 per share, for generating gross proceeds of about $300 million. The offering is expected to close on July 10.

The stock edged down 0.23% to $44.25 in after-hours trading.

Ascendis Pharma A/S ASND priced its underwritten public offering of 4.225 million ADSs, each of which represents one ordinary share of Ascendis, at $142 per ADS. All of the ADSs are being offered by the company. The offering is expected to close on or about July 10.

The ADSs were slipping 0.75% to $146.50 in after-hours trading.

Pacira Biosciences said it priced its $350 million aggregate principal amount of convertible senior notes due 2025 in a private placement to qualified institutional buyers. The offering size was increased from the previously announced offering size of $300 million. The sale of the notes to the initial purchasers is expected to settle July 10. The company expects the net proceeds from the offering to be about $339 million.

The stock added 0.61% to $54.50 in after-hours trading.