The Daily Biotech Pulse: Nabriva Jumps On Data, Larimar Wilts After Study Put On Hold, Travere To Delay Regulatory Filing

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 25)

• ESSA Pharma Inc. EPIX
• Pieris Pharmaceuticals, Inc. PIRS (moved on a R&D pact with Roche Holdings AG RHHBY in the field of respiratory and ophthalmology)
• PLx Pharma Inc. PLXP
• PRA Health Sciences, Inc. PRAH
• ShockWave Medical, Inc. SWAV
• Syneos Health, Inc. SYNH
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 25)

• 89bio, Inc. ETNB
• Allogene Therapeutics, Inc. ALLO
• Amicus Therapeutics, Inc. FOLD
• Atreca, Inc. BCEL
• Axcella Health Inc. AXLA
• Aytu Biopharma, Inc. AYTU
• Bolt Biotherapeutics, Inc. BOLT
• Chembio Diagnostics, Inc. CEMI
• ChemoCentryx, Inc. CCXI
• Coherus BioSciences, Inc. CHRS
• Impel NeuroPharma, Inc. IMPL
• Intercept Pharmaceuticals, Inc. ICPT
• Ionis Pharmaceuticals, Inc. IONS
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Lyra Therapeutics, Inc. LYRA
• Nymox Pharmaceutical Corporation NYMX
• Spruce Biosciences, Inc. SPRB
• Vivos Therapeutics, Inc. VVOS
• Viking Therapeutics, Inc. VKTX

Stocks In Focus

Nabriva's Antibiotic Aces a Late-stage Trial In China.

Nabriva Therapeutics NBRV and partner Sinovant Sciences announced positive topline results from Sinovant's Phase 3 bridging study of lefamulin in Chinese adults with community-acquired bacterial pneumonia.

Lefamulin was shown to be non-inferior to moxifloxacin, with 76.8% of lefamulin-treated patients meeting the efficacy endpoint of Investigator Assessment of Clinical Response at Test of Cure, compared to 71.4% of patients treated with moxifloxacin.

Consistent with previously reported clinical trial results, lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events comparable to that of moxifloxacin.

Sinovant also announced an agreement with Sumitomo Pharmaceuticals to acquire development and commercialization rights for lefamulin in Greater China.

Nabriva's Lefamulin was approved to treat CABP in the U.S. in August 2019 and is marketed under the trade name Xenleta.

Nabriva shares jumped 40.54% to $2.08 in after-hours trading.

Travere Will Not Pursue Accelerated Approval of Drug to Treat Kidney Scarring In Second Half of 2021

Travere Therapeutics, Inc. TVTX said it received final pre-NDA meeting minutes, wherein the FDA acknowledged the high unmet need for approved therapies for the treatment of focal segmental glomerulosclerosis but indicated the available data from the interim assessment of the DUPLEX study evaluating its sparsentan for the indication would not be adequate to support an accelerated approval at this time.

The company said it now no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.

Subject to further discussion with the FDA, the company believes that it may be possible to provide sufficient additional estimated glomerular filtration data from in the first half of 2022. The FDA has encouraged the company to request a follow-up meeting to further explore this option in greater detail, and a Type A meeting is expected to occur in the third quarter of 2021.

The stock slipped 8.45% to $16.25 in after-hours trading.

Larimar's Phase 1 Study of Friedreich's Ataxia Placed On Clinical Hold

Larimar Therapeutics, Inc. LRMR said the FDA has placed its CTI-1601 clinical program on hold and that it will not be closing a previously announced private placement financing. CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia, who are unable to produce enough of this essential protein.

The clinical hold follows the previous notification by Larimar to the FDA of mortalities that occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study. CTI-1601 is currently in Phase 1 clinical trials in the U.S.,

The stock plunged 45.23% to $7.40 in after-hours trading.

Qiagen, Mirati to Develop Companion Diagnostic For KRAS Mutant Cancers

QIAGEN N.V. QGEN and Mirati Therapeutics Inc. MRTX announced a global collaboration to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRAS-G12C mutation who may benefit from treatment with adagrasib, Mirati's investigational oral small molecule inhibitor of KRAS-G12C.

The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer, and allows for further development of tests for other Mirati oncology programs.

NeoVasc Notified of Non-compliance With Nasdaq Listing Standards

NeoVasc Inc NVCN said it has received written notification from the Nasdaq that it is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq.

The company said it has been provided 180 calendar days, or until November 22, to regain compliance.

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

Altimmune's Intranasal COVID-19 Vaccine Found Effective Against South African Variants In Animal Study

Altimmune, Inc. ALT announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa.

B.1.351 carries multiple mutations in the receptor-binding domain including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.

The stock was up 6.61% at $12.68 in premarket trading Wednesday.

Selecta Gains On Insider Buying

Selecta Biosciences, Inc. SELB revealed in a filing that Timothy Springer, a director of the board, bought 2,773,479 shares of the company at $3.19 apiece. The stock gained 9.52% to $3.91 in after-hours trading.

Neuroone Announces Uplisting to Nasdaq

NeuroOne Medical Technologies Corporation Common Stock NMTC, a MedTech company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, said its shares have been approved to uplist to the Nasdaq. Trading of the shares on the Nasdaq is expected to begin effective Wednesday, under the Company's existing ticker symbol "NMTC".

On The Radar

Clinical Readouts/Presentations

Chiasma, Inc. CHMA is scheduled to virtually present at the American Association of Clinical Endocrinology 2021 Annual meeting encore new data from the MPOWERED Phase 3 study of Mycapssa in adults with acromegaly.

Earnings

BioLineRx Ltd. BLRX (before the market open)