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The Daily Biotech Pulse: Cumberland's Positive Anti-Bacterial Readout, FDA Nods For Bristol-Myers, Astellas

Shanthi Rexaline

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 May 26)

  • ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15)
  • Aeglea Bio Therapeutics Inc (NASDAQ: AGLE)(announced positive one-year Phase 1/2 study and Phase 2 open-label extension study of pegzilarginase in Arginase 1 Deficiency patients)
  • Allogene Therapeutics Inc (NASDAQ: ALLO)
  • Altimmune Inc (NASDAQ: ALT)
  • argenx SE – ADR (NASDAQ: ARGX)( announced positive top-line data from a late-stage study of efgartigimod in patients with generalized Myasthenia Gravis)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)(gained on sell-side comment on the company being a potential target for Sanofi SA (NASDAQ: SNY)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • Catalent Inc (NYSE: CTLT)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • Evoke Pharma Inc (NASDAQ: EVOK)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • GENMAB A/S/S ADR (NASDAQ: GMAB)
  • Harpoon Therapeutics Inc (NASDAQ: HARP)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Immunomedics, Inc. (NASDAQ: IMMU)
  • Immunovant Inc (NASDAQ: IMVT)
  • Intellia Therapeutics Inc (NASDAQ: NTLA)
  • Iovance Biotherapeutics Inc (NASDAQ: IOVA)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)(announced FDA acceptance of its regulatory filing for Eysuvis, 0.25%, to treat the signs and symptoms of dry eye disease)
  • Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)
  • MEI Pharma Inc (NASDAQ: MEIP)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Minerva Neurosciences Inc (NASDAQ: NERV)
  • Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
  • Ovid Therapeutics Inc (NASDAQ: OVID)
  • Passage Bio Inc (NASDAQ: PASG)
  • PDL BioPharma Inc (NASDAQ: PDLI)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)
  • Protara Therapeutics Inc (NASDAQ: TARA)(received Fast Track designation for intravenous choline chloride for the treatment of intestinal failure associated liver disease)
  • Qiagen NV (NYSE: QGEN)
  • Seres Therapeutics Inc (NASDAQ: MCRB)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • TG Therapeutics Inc (NASDAQ: TGTX)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 26)

Stocks In Focus Cumberland Announces Publication of Positive Data For FDA-approved Antibiotic In Treating Bacteremia and Endocarditis

Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) announced a new publication in Drugs - Real World Outcomes, detailing the positive clinical outcomes with Vibativ in treating patients with bacteremia or endocarditis.

Vibativ has been approved by the FDA for the treatment of serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia. It is also approved for complicated skin and skin structure infections.

The stock jumped 31.92% to $4.67 in after-hours trading.

Bristol-Myers Squibb Opdivo/Yervoy Combo Approved First-Line Lung Cancer Treatment

Bristol-Myers Squibb Co (NYSE: BMY) announced FDA approval for Opdivo 360 mg plus Yervoy 1 mg/kg, given with two cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression, the company said.

Astellas Gets Label Expansion For Bladder Dysfunction Drug

ASTELLAS PHARMA/ADR (OTC: ALPMY) said the approved its VESIcare LS oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity, a form of bladder dysfunction related to neurological impairment, in children ages two years and older. VESIcare tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.

Coherus To Join S&P SmallCap 600 Index

Coherus Biosciences Inc (NASDAQ: CHRS) is set to join the S&P 500 SmallCap 600 Index, replacing Opus Bank (NASDAQ: OPB), effective June 1.

In after-hours trading, the stock rallied 8.20% to $18.35.

Mersana ADC Conjugate Found Safe, Effective

Mersana announced interim data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536 in patients with ovarian cancer and non-small cell lung adenocarcinoma. Of the 20 ovarian cancer patients, 10% achieved confirmed complete response and 25% confirmed partial responses, rendering the overall response rate at 35%. It was also found to be generally well tolerated.

These data are to be presented at the ASCO 2020 Virtual Scientific Program.

Teligent To Effect 1-for-10 Reverse Stock Split

Teligent Inc (NEW JERSEY) (NASDAQ: TLGT) said a 1-for-10 reverse stock split of its common stock will take effect as of May 28.

Novartis Announces Positive Data For Multiple Sclerosis, Breast Cancer Drugs

Novartis AG (NYSE: NVS) announced new data from the Phase 3 ASCLEPIOS study and the Phase 2 APLIOS study that is evaluating its B-cell therapy ofatumumab in patients with relapsing multiple sclerosis, or RMS. These data were virtually presented at the 6th Congress of the European Academy of Neurology.

The Phase 3 study, which evaluated ofatumumab versus teriflunomide within the first and second year of treatment, showed a greater proportion of patients treated with ofatumumab achieved NEDA-3 – a comprehensive composite measure used to measure outcomes in patients with RMS – both in year 1 and year 2.

A separate analysis from the APLIOS Phase 2 trial, evaluating 284 RMS patients, showed ofatumumab treatment led to rapid and sustained depletion of both CD20+ B- and T-cells in patients with RM3.

The FDA is set to rule on ofatumumab in June.

Separately, Novartis announced a new exploratory subgroup analysis of the Phase 3 MONALEESA-3 and MONALEESA-7 trials, to be presented during the ASCO 2020 Virtual Scientific Program, which reinforced the overall survival benefit of Kisqali in HR+/HER2- advanced breast cancer.

Sonoma's Eye Care Product Gets CE Marking; Company Announces Expanded Agreement With European Distribution Partner

Sonoma Pharmaceuticals Inc (NASDAQ: SNOA) announced it received a new CE Marking for its Microdacyn60 Eye Care based on its patented Microcyn Technology. The formulation, according to the company, is a safe and efficacious method to keep areas around the eye and eyelids/eyelashes clean and remove foreign materials.

View more earnings on IBB

The company also announced a new 10-year license, distribution and supply agreement with its distribution partner Brill International to market the eye care product under the private label Ocudox in the European markets of Italy, Germany, Spain, Portugal and the U.K.,subject to Brill meeting certain annual minimum purchase requirements.

The stock gained 7.81% to $5.80 in after-hours trading.

Roche Announces Positive Late-Stage Results Of Port Delivery System With Ranibizumab In Wet Age-Related Macular Degeneration

Roche Holdings (OTC: RHHBY) announced positive top-line results from the phase 3 Archway study evaluating Port Delivery System, or PDS, with ranibizumab in people living with neovascular or wet age-related macular degeneration.

PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months.

Offerings

Atara Biotherapeutics Inc (NASDAQ: ATRA) priced its underwritten public offering of 12.63 million of its common stock at $11.32 per share, and pre-funded warrants to purchase 2.87 million of its common stock at $11.3199 per pre-funded warrant share.

The company expects to generate gross proceeds of $175.5 million from the offering. The offering is expected to close on or about May 29.

Medical device maker Neovasc Inc (NASDAQ: NVCN) announced an offering of convertible notes and warrants to Stur Medical Group for gross proceeds of up to $5 million. The company also said all of its remaining 2017 notes have been fully paid or converted. The combined transactions, according to the company, will improve the fully diluted share capital, likely allowing to pursue refinancing options with long-term investors.

argenx SE – ADR (NASDAQ: ARGX), which announced Tuesday a positive clinical readout, said it has commenced a global offering of $500 million of ordinary shares, which may be represented by ADSs.

NuVasive, Inc. (NASDAQ: NUVA) said it intends to offer $400 million aggregate principal amount of convertible senior Notes due 2023 in a private placement to qualified institutional buyers.

Zomedica Pharmaceuticals Corp (NYSE: ZOM) priced its public offering of 133.33 million shares of its common stock, along with warrants to purchase up to 133.33 million common stock, at a combined 15 cents per share and accompanying warrant.

Fortress Biotech (NASDAQ: FBIO) said it has priced an underwritten public offering of 555,556 shares of its 9.375% Series A cumulative redeemable perpetual preferred stock at a price of $18 per share, with expected gross proceeds to Fortress of about $10 million.

Sanofi priced its registered offering of 11.8 million shares of Regeneron Pharmaceuticals Inc (NASDAQ: REGN) at $515 per share. As previously announced, Regeneron will repurchase about 9.8 million shares or $5 billion in common stock from Sanofi. Sanofi said it expects to use the net proceeds of the offering and the repurchase to further execute on its strategy to drive innovation and growth.

On The Radar Earnings

REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) (before the market open)
Trinity Biotech plc (NASDAQ: TRIB) (before the market open)

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