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 on June 12)
BIOFRONTERA AG/ADR (NASDAQ: BFRA)
BIO-TECHNE Corp (NASDAQ: TECH)
EXACT Sciences Corporation (NASDAQ: EXAS)
Insulet Corporation (NASDAQ: PODD)
Kodiak Sciences Inc (NASDAQ: KOD)
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
Down In The Dumps
(Biotech stocks hitting 52-week lows on June 12)
Acorda Therapeutics Inc (NASDAQ: ACOR)
Amneal Pharmaceuticals Inc (NYSE: AMRX)
ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
Arbutus Biopharma Corp (NASDAQ: ABUS)
Aridis Pharmaceuticals Inc (NASDAQ: ARDS)
BRAINSWAY LTD/S ADR (NASDAQ: BWAY)
Fennec Pharmaceuticals Inc (NASDAQ: FENC)
Innovate Biopharmaceuticals Inc (NASDAQ: INNT)
Melinta Therapeutics Inc (NASDAQ: MLNT)
Minerva Neurosciences Inc (NASDAQ: NERV)
Navidea Biopharmaceuticals Inc (NYSE: NAVB)
NextCure Inc (NASDAQ: NXTC)
Novavax, Inc. (NASDAQ: NVAX)
Novus Therapeutics Inc (NASDAQ: NVUS)
Obseva SA (NASDAQ: OBSV)
RA Medical Systems Inc (NYSE: RMED)
Sellas Life Sciences Group Inc (NASDAQ: SLS)
Sensus Healthcare Inc (NASDAQ: SRTS)
Sierra Oncology Inc (NASDAQ: SRRA)
Unum Therapeutics Inc (NASDAQ: UMRX)
Zomedica Pharmaceuticals Corp (NYSE: ZOM)
Stock In Focus Savara's Pulmonary Disease Drug Does Not Meet Primary Endpoint In Late-stage Study
Savara Inc (NASDAQ: SVRA) said a Phase 3 study dubbed IMPALA that evaluated its Molgradex for the treatment of autoimmune alveolar pulmonary proteinosis, or aPAP, did not meet its primary endpoint. An average A-aDO2 improvement of 12.1 mmHg was observed in the continuous dosing compared to an 8.8 mmHg improvement in the placebo arm, with an estimated 4.6 mmHg treatment difference suggesting the primary endpoint was not met.
However, the study showed statistically significant improvement in the St. George's Respiratory Questionnaire (SGRQ), a key secondary endpoint. Savara said it plans to meet with regulatory authorities in the coming months to discuss the results from the study and a path forward.
The stock plummeted 71.62 percent to $3 in after-hours trading.
Seres To Offer $60M Worth of Shares
Seres Therapeutics Inc (NASDAQ: MCRB) commenced an underwritten registered public offering of $60 million of shares of its common stock. All shares are to be offered by the company.
The stock fell 16.16 percent to $2.75 in after-hours trading.
NuCana's Biliary Tract Cancer Drug Granted Orphan Drug Designation
NuCana PLC (NASDAQ: NCNA) said the FDA has granted orphan drug designation for its investigational drug Acelarin, codenamed NUC-1031 for the treatment of biliary tract cancer. Acelarin is a new chemical entity and is NuCana's ProTide transformation of gemcitabine.
The stock gained 0.84 percent to $11.98 in after-hours trading.
Tetraphase Reorganizes To Focus On Commercializing its Antibiotic
Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) announced a corporate reorganization in a bid to maximize the commercial opportunity for Xerava, its novel tetracycline antibacterial indicated to treatment of complicated intra-abdominal infections in patients 18 years of age and older.
The reorganization will include the elimination of its internal research function, which will result in a reduction of about 24 employees or 20 percent of its employees, and an exploration of out-licensing opportunities for its pipeline of innovative early-stage antibiotics and oncology product candidates.
CEO Guy Macdonald will leave following a transition period that will last through Aug.1, and will be replaced by COO Larry Edwards.
The stock fell 1.54 percent to 73 cents in after-hours trading.
Roche's Rituxan Shows Superiority To Current Standard-Of-Care In Treating Pemphigus Vulgaris
Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit announced positive top-line results from the Phase 3 PEMPHX study evaluating the efficacy and safety of Rituxan compared to mycophenolate mofetil in adults with moderate to severe pemphigus vulgaris. The company noted that the study met the primary endpoint,and showed that Rituxan is superior to MMF – an unapproved treatment and the current standard-of-care - in achieving sustained complete remission.
On The Radar Clinical Trial Readouts
Kezar Life Sciences Inc (NASDAQ: KZR) will present already-released initial Phase 1b topline data for KZR-616 in lupus at the EULAR Annual European Congress of Rheumatology.
Nektar Therapeutics (NASDAQ: NKTR) is due to present Phase 1b data for NKTR-358 in systemic lupus erythematosus, also at the EULAR Annual European Congress of Rheumatology.
Kura Oncology Inc (NASDAQ: KURA) is scheduled to present additional Phase 2 data for Tipifarnib in relapsed or refractory peripheral T-cell lymphoma) at the 24th European Hematology Association Congress.
Urovant Sciences Ltd (NASDAQ: UROV) – after the close
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